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Medical Equipment Maintenance Program

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1. Service provider Engineer or technician Provide maintenance that cannot be performed in house They are product oriented and specialized in a certain field engineers and technicians from other disciplines as outlined above and to provide them with training related to medical technology The size of a health care organization the number and type of medical equipment in the maintenance programme the skills found in the local marketplace and the financial capacity of the organization will be the basis for identifying the correct blend of engineers and technicians Almost all maintenance programmes will find it necessary to complement the internal staff with external service providers either the vendor manufacturer s service representatives or third party service representatives Such providers may perform the IPM and CM for equipment that internal staff are not able to complete Furthermore repair work on the most sophisticated medical equipment is only accomplished 3 In addition to numerous workshops conducted by the World Health Organization WHO in Nepal and the Russian Federation as well as in various African and Baltic nations etc the Pan American Health Organization has conducted numerous workshops on clinical engineering and HTM in countries throughout Latin America and the Caribbean in cooperation with ACCE www accenet org Engineering World Health www ewh org also conducts technical tr
2. All meeting participants and people involved in the development of these documents were asked to complete a declaration of interest form and no conflicts were identified 1 Available at http www healthpartners int co uk our_expertise how to manage series html 2 First WHO Global Forum on Medical Devices context outcomes and future actionsis available at http www who int medical devices gfmd report final pdf accessed March 2011 WHO Medical device technical series Definitions Recognizing that there are multiple interpretations for the terms listed below they are defined as follows for the purposes of this technical series Health technology The application of organized knowledge and skills in the form of devices medicines vaccines procedures and systems developed to solve a health problem and improve quality of life It is used interchangeably with health care technology Medical device An article instrument apparatus or machine that is used in the prevention diagnosis or treatment of illness or disease or for detecting measuring restoring correcting or modifying the structure or function of the body for some health purpose Typically the purpose of a medical device is not achieved by pharmacological immunological or metabolic means Medical equipment Medical devices requiring calibration maintenance repair user training and decommissioning activities usually managed by clinical engineers Medical equipme
3. Experience No experience required above minimum education One year experience as a biomedical equipment technician in a health care setting preferred WHO Medical device technical series 79 80 Appendix G 2 Biomedical equipment technician mid level Job description Performs tasks involving the installation and maintenance of therapeutic diagnostic and monitoring medical equipment These activities include 1 Performance of both routine and complex tasks associated with the installation maintenance and repair of a diverse range of clinical equipment including life Support equipment 2 Working independently in both routine and complex tasks Being able to prioritize work and initiate new work and tasks 3 Being able to effectively work with clinicians to troubleshoot clinical problems with medical equipment Being able to solve technology problems for the clinicians Providing training mentoring and guidance for entry level technicians Participation in committees as requested Coordination of initial inspection and installation of new equipment as requested Coordination and management of projects from start to completion performing any necessary communication and follow up with owner department 8 Assisting with pre purchase evaluations of equipment as required Participation in incident investigations as requested and provides follow up to management Education Two year degree equivalen
4. Failure The condition of not meeting intended performance or safety requirements and or a breach of physical integrity A failure is corrected by repair and or calibration Inspection Inspection refers to scheduled activities necessary to ensure a piece of medical equipment is functioning correctly It includes both performance inspections and safety inspections These occur in conjunction with preventive maintenance corrective maintenance or calibration but can also be completed as a stand alone activity scheduled at specific intervals Inspection and IPM refers to all the scheduled activity necessary to ensure a piece of medical equipment is functioning preventive correctly and is well maintained IPM therefore includes inspection and preventive maintenance maintenance IPM Two common nomenclatures are the Global Medical Device Nomenclature http www gmdnagency com and the Universal Medical Device Nomenclature System https www ecri org Products Pages UMDNS aspx Medical equipment maintenance programme overview Performance These activities are designed to test the operating status of a medical device Tests compare the inspections performance of the device to technical specifications established by the manufacturer in their maintenance or service manual These inspections are not meant to extend the life of equipment but merely to assess its current condition Performance inspections are sometimes ref
5. jkEratioalrm jlowairpressurealarm _ _ _____ _ _ ebrteregatos switches jdsibraetansdues jealibrate compressor cutout replace 0702 ______ replace compressor fes Jecrdpatsued C WHO Medical device technical series 711 0 3 Work order form Request for service Department Date Clinician technician reporting problem Location of device Problem description Date time Service record Service engineer name Date time responded Action taken Has the problem been corrected Is follow up work necessary When will follow up work be performed Follow up action Service engineer name Date time responded Action taken Has the problem been corrected Is futher follow up work necessary If so describe on reverse side of this form Note Keep this form in the active file for at least 15 days after the completion of final repairs Adapted from Medical Consultants Network Inc Reference 1004 Biomedical Engineering Medical equipment maintenance programme overview Appendix Samples of inspection labels E 1 Record of inspection E 2 Record of inspection test results E 3 Notification of defect WHO Medical device technical series 73 Appendix E 1 Record of inspection This type of label indicates the dat
6. Calculating IPM workload The following procedure and charts are used to calculate IPM workload This mathe matical methodology is used by service companies to calculate the IPM workload of the accounts they bid on If the clinical engineering department calculates the actual work needed to accomplish this task and acquires the staff to do this work the more likely the work will be accomplished and the goals achieved The steps are as follows 1 Identify the areas to be covered for IPM a group of equipment a department a new wing a whole facility 2 Create a complete inventory of each item to be covered for IPM 3 Record time it takes a technician to perform the inspection procedure Each piece of equipment should be analysed the inspection frequency and times entered into a spreadsheet and the total annual time for inspection and preventive maintenance calculated for the list of equipment to be covered An example of this is provided in Chart A Chart A Calculating IPM workload detailed method Laboratory chemistry department Laboratory blood refrigerator 11 0 2 1 05 07 Laboratory specimen refrigerator 1 05 1 05 1 Heating block 2 0 25 0 0 05 Spectrophotometer 3 0 5 1 0 75 2 25 Bilirubin analyser 2 0 75 1 1 0 25 Chemistry analyser 3 3 0 1 40 13 0 Printer module 2 0 3 0 0 0 6 Computer printer 2 0 3 0 0 0 6 Computer monitor 0 25 0 0 0 25 Chemistry analyser 3 45 1 6 0 19 5 Microscope 1 0
7. Proper operation of the equipment Performance specifications in the manufacturer s service literature should be used if available Clinical alarm functionality and audibility if applicable Passage of electrical safety requirements if applicable Inclusion into or exclusion from the equipment management programme Compliance on labelling of equipment to ensure that the equipment has been evaluated for safety and suitability for intended use by a nationally or internationally recognized testing laboratory ga 3 If equipment passes all required inspections the technician will affix a clinical equipment maintenance inspection sticker or other means of identification in a visible location on the device Medical equipment maintenance programme overview 4 The clinical engineering technician who performs the inspection is responsible for ensuring the completion of the initial inspection documentation If the technician determines that an in service orientation training would be beneficial the technician will make a recommendation to the hospital education department or the department manager Should a manufacturer in service demonstration be required the technician will assist in coordinating this effort with the hospital education department B Testing of devices brought in for demonstration or trial evaluation The hospital is responsible for the safety of all patients staff and visitors equipment for loan evaluation
8. WO MEDICAL DEVICE TECHNICAL World Health Organization Medical equipment maintenance programme overview WHO Medical device technical series 23 WHO Library Cataloguing in Publication Data Medical equipment maintenance programme overview WHO Medical device technical series 1 Appropriate technology 2 Equipment and supplies 3 Maintenance World Health Organization ISBN 978 92 4 150153 8 NLM classification WX 147 World Health Organization 2011 All rights reserved Publications of the World Health Organization are available on the WHO web site www who int or can be purchased from WHO Press World Health Organization 20 Avenue Appia 1211 Geneva 27 Switzerland tel 41 22 791 3264 fax 41 22 791 4857 e mail bookorders who int Requests for permission to reproduce or translate WHO publications whether for sale or for noncommercial distribution should be addressed to WHO Press through the WHO web site http www who int about licensing copyright form en index html The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country territory city or area or of its authorities or concerning the delimitation of its frontiers or boundaries Dotted lines on maps represent approximate border lines for which there may not yet
9. and 10 1 This ratio is achievable only when substantial supporting resources are available and only after an extended period of performance improvement For planning purposes in developing countries this measure may be much higher especially for new programmes in resource constrained environments However the cost of service ratio should be monitored over time and be used as a guide for performance improvement efforts Over time there will be opportunities to make additional investments in the maintenance programme For example the programme may consider providing service for a particular type of equipment by using internal resources and staffing rather than outsourcing the work At each such opportunity a simple business plan should be drawn up that includes the initial and operating costs of the proposal Then the costs and benefits of the current situation and the new proposal can be compared This decision making process for new investments 15 particularly effective when it is informed by actual data from the programme 4 3 2 Physical resources A maintenance programme relies on a number of physical resources These include the workspace tools and test equipment supplies replacement parts and operation and service manuals needed to perform maintenance When planning a maintenance programme each of these should be considered individually as follows Workspace The location in which maintenance will take plac
10. e The clinical engineering department being kept well informed of a device s elapsed usage time for the determi nation of PM frequency e The clinical users being alert to changes or issues with the equip ment and immediately contacting the clinical engineering department when such problems are detected e The clinical staff being able to locate all essential equipment and inform technical personnel of location e Devices in storage being brought out for inspection e Minimal time being spent in the department e An improved working relationship with the clinical department Providing clinical users with a list of the scheduled IPM work a few weeks in advance a copy of IPM results or a list of problems identified solved or remain to be addressed are just a few examples of good communication practice 5 3 9 Managing use and user error The work of clinicians including the use of health technology can be viewed as a series of activities intended to achieve a particular clinical objective diagnosis treatment monitoring or life support However a user may be unable to meet this objective due to use error a problem related to the use of a medical device This is distinct from the term user error which implies that the user of the device caused the problem Investigation of use error includes consideration of the user the patient the device the environment and other systemic factors that may block the
11. for equipment with therapeutic energy output including the energy readings from the last few inspections on the next inspection form helps identify potential problems as equipment energy levels may slowly drift over time Additionally knowing when routine maintenance parts were last replaced helps identify if or when the parts should be replaced again and helps explain the condition of the parts during the current inspection For CM the technician records what actions were taken including the time and the cost of those actions 6 4 Safety There are various safety aspects to consider when implementing a successful and effective maintenance programme such as the safety of technical personnel while performing maintenance safety of the user following maintenance and general infection control The safety of equipment maintenance personnel is fundamental Therefore it is important to have a lock out tag out policy to protect personnel from unexpected activation of equipment and release of stored energy This policy ensures that when working on electrical equipment WHO Medical device technical series 37 38 it is essential to disconnect it from the electrical power source One or more physical locks may be applied to keep the power source disconnected lock out so that it is not inadvertently reconnected before the repair is completed When it is not possible to physically lock out the power source prominent
12. for several measurement periods months or quarters b making a change in the way things are done and c continuing to measure the performance and quality If the new procedures demonstrate positive improvements then the change WHO Medical device technical series 33 34 was effective one If indicators do not improve revisit the original performance analysis adjust accordingly and repeat the process This systematic approach of managing programme performance improvement can have a very positive impact over a period of several years Additionally by measuring the improve ment in performance and quality after Medical equipment maintenance programme overview making changes to the system in which the technicians operate e g install a remote workshop purchase automated test equipment upgrade to a CMMS system etc the cost of these changes can be justified the changes will be well accepted by the staff and further systemic changes can continue to be made 6 Implementation 6 1 Inspection and preventive maintenance 6 1 1 IPM procedures Using the correct and appropriate procedures for equipment maintenance can make the difference between having reliable and properly functioning equipment and not As discussed in section 5 3 1 the procedures used in performing IPM activities should be defined prior to execution of the inspection or maintenance work through a careful review of each type of equipment or
13. regional health system 86 Appendix H 4 Managing a maintenance programme within a regional health system 87 Figures and tables Figure 1 Components of a maintenance programme 10 Figure 2 Critical factors in planning a maintenance programme 14 Table 1 Financial resources required for a maintenance programme 16 Table 2 Classification and roles of technical personnel 21 Figure 3 Management aspects of a maintenance programme 23 Table 3 Service agreement types 25 WHO Medical device technical series Preface Health technologies are essential for a functioning health system Medical devices in particular are crucial in the prevention diagnosis and treatment of illness and disease as well as patient rehabilitation Recognizing this important role of health technologies the World Health Assembly adopted resolution WHA60 29 in May 2007 The resolution covers issues arising from the inappropriate deployment and use of health technologies and the need to establish priorities in the selection and management of health technologies specifically medical devices By adopting this resolution delegations from Member States acknowledged the importance of health technologies for achieving health related development goals urged expansion of expertise in the field of health technologies in particular medical devices and requested that the World Health Organization WHO take specific actions to support Member States One of WHO s strategic objec
14. A World Health y ENSE Organization Medical equipment maintenance programme overview WHO Medical device technical series WHO MEDICAL DEVICE TECHNICAL SERIES TO ENSURE IMPROVED ACCESS QUALITY AND USE OF MEDICAL DEVIC HUMAN RESOURCES FOR MEDICAL DEVICES WHO MEDICAL DEVICE TECSNICAL SERIES MEDICAL DEVICE gt INNOVATION 3 5 o Q 2 o g amp 5 a a gt S 5 lt mm 5 o mmm o 7 p 5 gt m x 4 o 0 MEDICAL DEVICE lt wid TOC Medical devices Assessment MEDICAL DEVICE NEEDS ASSESSMENT NOMENCLATURE PROCESS eE MEDICAL DEVICES 3 x BY HEALTH CARE CLINICAL FACILITY PROCEDURE PROCUREMENT MEDICAL DEVICE POST MARKET PROCESS DONATIONS S RVEILLANCE AND CONSIDERATIONS FOR ADVER SOLICITATION AND PROVISION Peer INTRODUCTION TO MEASURING DECOMMISSIONING MEDICAL EQUIPMENT INVENTORY MANAGEMENT GCVICE TECHNICAL SERIE d MEDICAL EQUIPMENT MAINTENANCE PROGRAMME OVERVIEW AL OEVICE SERIES COMPUTERIZED MAINTENANCE MANAGEMENT SYSTEM MEDICAL DEVICE TECHNICAL SURIS SAFE USE OF MEDICAL DEVICES CLINICAL EFFECTIVENESS VICE TECHNICAL SERIE MEDICAL DEVICES
15. List the steps to be taken to perform inspection and preventive maintenance WHO Medical device technical series 59 60 Appendix 2 Anaesthesia analgesia unit gas machine FDA risk 2 Safety insp yr 2 Programme risk score Perf 12 Risk group Life support PM checks yr 12 Procedure 1 Inspect exterior of equipment for damage or missing hardware 2 Inspect the power cord strain relief and plug s for any signs of damage unit off open user accessible covers and inspect unit for damage 4 Clean unit interior components and exterior with vacuum or compressed air 5 Inspect interior for signs of corrosion or missing hardware Repair as required 6 Inspect electrical components for signs of excessive heat or deterioration 7 Inspect all external quick disconnect O rings 8 Inspect condition of all tubing replace if necessary 9 Inspect all cables for excessive wear 10 Inspect inspiratory and expiratory flow valves 11 Inspect internal circuits by leak testing 12 Verify correct operation of gas scavenger systems 13 Verify correct vaporizer calibration 14 Verify correct flow meter calibration 15 Verify correct operation of ventilator rate volume flow 16 Verify correct operation of all buttons controls displays and or indicators 17 Verify correct operation of unit in all functional modalities 18 Clean exterior of unit including all accessories cables contr
16. The average time elapsed between failures Repeated failures The number of failures within a specified period of time e Response time The time between a request for service and the start of repair e Repair time The time between the start and finish of repair Downtime The percentage of time that a device is out of service e Delinquent work orders Work orders not completed within 30 days 5 5 Performance improvement For a maintenance programme performance improvement applies to every aspect of the programme with the ultimate objective of improving patient care The performance improvement process has the following steps 1 dentify opportunities for improve ment This is one of the outcomes of careful and thorough performance monitoring as described above 2 Identify best practices These are actions that have been recognized within the profession as leading to improved performance They are found in clinical engineering literature and through collaboration with professional colleagues 3 Improve performance Performance improvement projects should be based on best practices The aspect of performance selected for improvement should be closely monitored until the desired level of performance is achieved Specific changes should be measured systematically to determine if the changes improve performance and quality This can be done by a carefully measuring the performance and quality indicators
17. The complexity of the programme depends on the size and type of facility its location and the resources required However the principles of a good maintenance programme will be the same if it is in an urban area in a high income country or a rural setting in a low to middle income country Maintenance m m Inspection Preventive maintenance Medical equipment maintenance programme overview Corrective maintenance 2 Purpose The objective of this document is to pro vide information regarding the compo nents of an effective medical equipment maintenance programme It can assist health care organizations especially those in developing countries with plan ning managing and implementing the maintenance of medical equipment It is intended to be concise and flexible and may be adapted to various settings and levels of technical resources as required It focuses on general principles rather than being a rigid model so that each country or institution can design an ap propriate programme to meet their own specific requirements The document is intended for those responsible for planning managing and implementing health technology management services at the facility local regional and national levels particularly in resource constrained countries where such services may not yet be fully established It may also be of value to engineers and technicians responsible for carrying out the many tasks described
18. The number of management personnel required in a clinical engineering group depends on the size and structure of the group and is based primarily on maintaining an appropriate span of control for each supervisor and manager Sample job descriptions for the positions outlined above are provided in Appendix G 5 Management Once established it is essential to manage the programme in an effective and economical manner Programme management has several aspects that are typically addressed concurrently as seen in Figure 3 Figure 3 Management aspects of a maintenance programme Financial management Personnel Operational management management Performance Performance improvement monitoring 5 1 Financial management Financial management for a maintenance programme focuses primarily on two tasks monitoring costs and managing the budget Costs are monitored by accurately documenting all of the time and expenses associated with maintenance activities For work performed by technical personnel this is typically accomplished by recording this information on a work order document followed by entry into the CMMS if available Specifically for work performed by external service providers the contract costs or the itemized costs for service are recorded on the work order or into the CMMS The result is that for each medical device in the inventory there is a history of all time and expenses associated with mainta
19. achievement of a clinical objective The root cause of user error is typically easier to identify However in both cases clinical engineers and biomedical equipment technician can be instrumental in working with clinicians to resolve these issues They are responsible for providing them with adequate training or retraining if appropriate on the operation of a device and working with the users to identify factors leading to use error A well trained user is aware that when preventive maintenance performance or safety inspections are done the equipment is adjusted to test its various modes of operation Therefore the settings that the user may be used to having left untouched on their equipment will have been changed and they should check the settings and adjustments before using it with patients once again Additionally if users are expected to provide basic routine maintenance on a device the clinical engineering department is responsible for training them on the correct procedures The overall result will be a user who feels ownership for the equipment takes good care of the equipment operates and maintains it well leading to a reduced workload for the clinical engineering department and improved lifespan for the equipment 5 3 10 Travel Travel is an important component of an effective maintenance programme If extensive travel between facilities is required or the accessibility of facilities is difficult there will
20. be marked in this way If the equipment has not been located for two consecutive maintenance cycles it will be removed from service and deleted from the records and or deactivated in the CMMS To assure IPM quality technician competency and the correct execution of IPM procedures and practices need to be evaluated by clinical engineering management Maintenance completion rates lists of equipment unable to be located PM yield rates and other quality or performance related statistics will be reported to the relevant safety committee and the clinical engineering department staff at least quarterly Longer or shorter preventive maintenance intervals are adopted after documented justification based on previous PM yield data relevant safety information and other service history records WHO Medical device technical series 51 52 Appendix A 4 Work order system for corrective maintenance The clinical engineering department has adopted a standard work order system for all departments requesting maintenance on clinical equipment When a malfunction occurs with a piece of clinical equipment that is encompassed within the programme of the clinical engineering department the user department shall notify clinical engineering by telephone on line web request interdepartmental mail or bringing the device to the clinical engineering office Purpose To provide guidelines for the receipt and processing of clinical engineering service r
21. be significant effects on work assignments productivity standards vehicle and other travel expenses etc For example in remote areas it may take a day or more to travel to a local clinic Thus travel time should be considered when planning maintenance activities However it may be also reasonable to develop and support user maintenance where it may be WHO Medical device technical series 3l 32 difficult to transport the tools equipment and technician to the site 5 4 Performance monitoring For effective management of the maintenance programme it is important to measure performance Most performance measures do not have a standard or benchmark to compare with In such cases the manager should monitor performance over time investigate any significant trends and identify opportunities for improvement It is also important to communicate regularly with colleagues who are managing similar programmes By comparing performance data managers can identify and take advantage of improvement opportunities Those with the financial resources may consider subscribing to a benchmarking service that will support detailed performance monitoring Several important performance measures are described below but note that without a CMMS it is very difficult to calculate some of these measures However it is important to conduct some sort of performance monitoring on a regular basis in order to to identify opportunities for improv
22. contractors In practice the typical approach is to establish some level of management and technical capability within the health care organization Some of the maintenance activities may also be conducted by employees of the health care organization Other maintenance activities may be conducted by service contractors or other external service providers One of the most important management activities is to decide which services should be provided by which combination of internal and external service providers based on the capacity of the facility and its staff Further details on management and implementation are found in sections 5 and 6 which help in designing an appropriate methodology for a given context 4 3 Resources Resources needed for maintenance are difficult to project This requires a maintenance history calculations of the staff requirement and knowledge of when a piece of equipment might fail Maintenance also requires appropriate staff skills education and experience Outside vendors are necessary for the maintenance of complex equipment Maintenance requires access to equipment parts which may be difficult to obtain due to budget limitations and procurement difficulties particularly when purchasing from abroad To prepare for such challenges it is important to consider in advance the financial physical and human resources necessary to properly execute the intended activities WHO Medical device technica
23. document the date the CM work was done e Return the device to service WHO Medical device technical series 55 56 Appendix A 6 Infection control All clinical engineering employees will be aware of current hospital policies regarding infection control Employees will not knowingly expose themselves or others to any types of infectious waste Purpose To provide all employees with a safe clean working environment to protect clinical engineering technicians from contaminated equipment Procedure General precautions 1 Visibly contaminated equipment will not be accepted for repair until adequately cleaned by the appropriate department Appropriate personal protective equipment is worn to handle equipment 2 All clinical engineering technicians will observe isolation guidelines as well as the dress and scrub procedures for the area in which they are working Clinical engineering technicians should not enter isolation rooms or restricted areas without obtaining permission from the charge nurse 3 All clinical engineering employees will attend annual infection control education This training will be documented in the employees personal training record in the clinical engineering department 4 Hand washing is required whenever a Hands become contaminated with blood or body fluids b Protective gloves are removed c Between patient contacts d Eating drinking applying cosmetics and handling contact le
24. examples of inspection forms and labels Some hospitals use coloured inspection stickers to indicate when the device was last inspected in e g yellow this year blue last year pink two years ago etc This helps readily identify which equipment is next due for inspection 5 3 8 Communication Keeping in mind that the ultimate objective of a maintenance programme is to improve patient care it is essential to develop strong working relationships with clinicians and to understand their needs The user will know what to expect from the clinical engineering department and vice versa Respect is shown to the user for their role in helping to complete the maintenance resulting in appreciation for the work and responsibilities of the clinical engineering unit Furthermore having an effective dispatch communication system in place will ensure that repair requests from users are promptly relayed to technical personnel for timely response Many maintenance programmes have also found it helpful for technical personnel to regularly contact clinical personnel preferably in person to inquire about any equipment related problems they are experiencing In this way the technical personnel become accepted as part of the clinical team Ultimately effective communication with the clinical users leads to Clinical staff understanding the reason behind inspecting and maintaining equipment and the benefits of such a programme
25. for prioritizing corrective maintenance activities Monitor services provided under service contracts e Work closely with clinicians Clinical engineering department manager technician Performance Monitor performance measures Clinical engineering department monitoring manager Performance e Compare performance objectives annually identify Clinical engineering department improvement opportunities for improvement manager WHO Medical device technical series 85 86 Appendix H 3 Planning a maintenance programme within a regional health system Inventory Create inventory of all medical equipment in the system using Clinical engineering department full featured CMMS software Methodology Define maintenance methodologies Clinical engineering department simple and moderate maintenance tasks hospital staff critical equipment of greater complexity service contracts with first look by hospital staff manager Financial resources Identify financial resources moderate Plan for service contracts Develop budget for implementing the programme Develop budget for operating the programme Identify budget sources Clinical engineering department manager Physical resources Identify physical resources some space tools and equipment Clinical engineering department manager Plan for build out of space and acquisition of tools and equipment Architect Plan fo
26. manufacturer or vendor for a fee If the hospital has developed a competent staff of biomedical equipment technicians service training by the vendor is a good investment as it enables the hospital to eliminate vendor related costs and may also lead to the hospital being able to assume repair responsibilities 5 3 Operational management 5 3 1 Developing or changing IPM procedures For IPM to be conducted properly procedures are either selected or written so they provide sufficient testing and maintenance for specific devices and their features The process of selecting or writing must begin with a good understanding of the technology in general and the relevant model of equipment When developing new procedures for either old or new equipment it is best to take the most conservative approach and use the manufacturer s IPM procedure manual as a baseline The equipment owner should expect IPM procedures from the manufacturer to e Be well designed and easy to understand e Clearly explain every step in the procedure Explain what test equipment is required e Explain what the upper and lower limits for measurements the biomedical equipment technician will take e Show how to replace parts Medical equipment maintenance programme overview e Explain the required frequency of specific steps e Provide recommended forms to be used for the IPM procedure e Be provided in the predominant major language of the regio
27. minimum of four years experience as a biomedical equipment technician WHO Medical device technical series 81 82 Appendix G 4 Clinical engineering supervisor manager Job description Responsible for directing and managing clinical engineering activities directly related to safe and effective medical equipment These activities include CONDARWNE rrr Nr O 13 14 15 15 17 Acquisition maintenance and repair of the medical equipment Assisting and overseeing writing specifications for new equipment Evaluation and assistance in acquiring new technology for patient care Coordination of preventive maintenance and repairs by outside service personnel Evaluation of possible service contracts and outside vendor relationships Maintaining familiarity with regulatory codes and standards Collaboration with clinical staff to provide the highest level of patient safety Ensuring that applicable accreditation standards are met Ensuring departmental policies and procedures are followed Managing other projects as assigned Managing department productivity and performance improvement initiatives Assistance in the management of the computerized maintenance management system Ensuring the timely completion and documentation of all maintenance activities Maintaining the stock of repair parts to ensure appropriate maintenance of equipment Ensuring timely completion of preventive maintenance Repres
28. model Most IPM procedures are completed by technical personnel from the clinical engineering department In some cases however routine and easy to perform tasks are completed by the user This saves time for technical personnel to perform more technically complex and critical tasks and also provides the user with a sense of ownership The type of inspection the user might perform would be pre use or daily checks where required Examples of this might be daily calibration of portable blood glucose monitors daily testing of defibrillators or checking the standard calibration of laboratory equipment It is the responsibility of the clinical engineering department to train the user to perform these tasks See section 5 3 9 for further information on user interaction Appendix A 3 provides a sample policy on inspection and preventive maintenance procedure 6 1 2 Problem identification When IPM identifies a problem the device can either be set aside for later repair 50 the IPM work can continue on schedule or the repair can be completed as part of the IPM process If the IPM activities or related repairs are not accomplished in a certain pre defined period the work order should be left open and the staff should inspect or repair the device as soon as reasonably possible Higher priority devices not inspected in previous IPM periods should be located and inspected first Appendix A 5 presents a sample policy regarding correct
29. performance verification and safety testing 3 2 Minimal visual inspection Equipment incident history Any information available regarding service history that can be considered when evaluating the device type to determine an EM number Significant more than one every 6 months 2 Moderate one every 6 9 months Average one every 9 18 months 0 Minimal one every 18 30 months 1 Insignificant less than one in the past 30 months 2 Included devices All devices with a total EM number of 12 or more will be included in the programme and scheduled for inspections and preventive maintenance During the acceptance testing any new device will be included in the programme if the device has been previously evaluated and classified for inclusion If the device has not been previously evaluated a new device classification will be created It will be evaluated according to the outlined procedure to produce an EM number and will be included in the programme if appropriate If included a performance assurance inspection and preventive maintenance procedure will be written for the new device WHO Medical device technical series 45 46 Maintenance interval The maintenance requirement values are also used to determine the interval between each inspection and maintenance procedure for each device type e All devices classified as extensive characteristic value of 4 or 5 are given a preventive main
30. to using the device with patients When direct communication is not possible a prominent note should be placed on the device so that it is not used without being checked by the clinician Lastly when working in the clinical environment technical personnel should be aware of infection control risks that they might encounter patients with airborne infections such a tuberculosis for example and if there is any doubt they should ask clinicians in the area In particular if asked to work on a medical device that appears to be contaminated they should request assistance in cleaning the device from the clinical user who will have knowledge regarding the potential contaminants and their associated hazards Additionally technical personnel should be aware of infection hazards that their work might create for patients For example patients with compromised immune systems certain organ transplant patients patients with AIDS and others or otherwise susceptible to infection such as premature infants can be severely affected by moulds and spores disturbed and dispersed by maintenance activities in the clinical environment Again when in doubt equipment maintainers should communicate with clinicians about potential risks and ways to manage those risks See Appendix A 6 for a sample infection control policy 7 Concluding remarks Timely and economical maintenance activities maximize the value of health technology resources whic
31. 3 15 5 Hypo hyperthermia machine 4 5 18 5 Light surgical portable 4 3 8 N Light source fibre optic 3 3 1 N Microscope ophthalmic slit lamp 3 3 10 N Class Included N Not included Inspection frequency A Annual S Semi annual T Three yearly WHO Medical device technical series 47 48 Appendix A 2 Initial testing and evaluation Purpose To assure that all clinical equipment is inspected prior to its initial use Policy All clinical equipment coming into the hospital is tested before initial use and appropriately added to an inventory These tests evaluations and inventories are documented All clinical equipment falling under the responsibility of the clinical engineering department is covered by this policy regardless of ownership and must pass the incoming inspection before it will be allowed into the hospital Examples of ownership categories are Rental leased equipment e Physician owned equipment Donated loaned equipment e Hospital owned equipment Procedures A Hospital owned equipment 1 When notified that new clinical equipment is received in the hospital the clinical engineering department will initiate a work order 2 clinical engineering department will ensure that the new equipment is inspected for a Presence of all accessories required for proper operation b Presence of operators manuals and technical service manuals and schematics if applicable c
32. 5 1 15 2 0 Laboratory freezer 1 0 3 1 05 0 8 Laboratory mixer 2 0 25 0 0 0 5 Centrifuge 2 0 5 1 1 0 2 0 WHO Medical device technical series 65 66 Chemistry analyser 3 3 0 1 5 0 14 0 Refrigerator 1 0 3 1 04 07 Chemistry analyser 3 3 0 1 4 0 13 0 Water purification system 1 1 0 1 2 0 3 0 Total 76 9 hrs Labour and delivery department Fetal monitor 4 0 75 0 0 3 0 Ultrasound scanner 1 3 0 1 5 0 8 0 Video monitor 1 05 0 0 05 Infant radiant warmer 2 0 75 1 1 0 25 Infant radiant warmer 2 0 75 1 1 0 2 5 Pulse oximeter 1 0 3 1 04 07 Warming blanket 1 0 5 1 1 0 1 5 Fetal monitor 4 0 75 0 0 3 0 Physiological monitor 0 75 1 1 0 1 75 Doppler blood flow probe 2 0 3 0 0 0 6 Syringe pump 0 5 0 75 1 25 Electrosurgical unit 1 1 0 1 1 0 2 0 Fetal monitor 4 0 75 0 0 3 0 Fetal blood gas monitor 2 15 1 2 0 5 0 Fetal monitor 4 0 75 0 0 3 0 Fetal blood gas monitor 2 15 1 2 0 5 0 Total 43 3 hrs An alternate simplified method to do this is to generally categorize each device into one of three classifications 1 Simple device inspected once per year with no PM required 2 Intermediate devices inspected once or twice per year some PM may be required 3 Advanced systems inspected 2 4 times per year extensive PM required This method requires some familiarity with the equipment and maintenance procedures The
33. Develop policies for prioritizing corrective maintenance activities Monitor services provided under service contracts Participate in medical equipment planning incident investigation and committee activities Clinical engineering department manager e Work closely with clinicians and conduct customer satisfaction surveys Clinical engineering department manager technician Performance monitoring Monitor performance measures plus additional measures supported by the CMMS Manage compliance with applicable standards performance benchmarking and implementation of best practices Clinical engineering department manager Performance improvement Prepare written report comparing performance to objectives and identifying opportunities for improvement Implement performance improvement initiatives and monitor for success Clinical engineering department manager WHO Medical device technical series 87 Department of Essential Health Technologies World Health Organization 20 Avenue Appia CH 1211 Geneva 27 Switzerland Tel 41 22 791 21 11 E mail medicaldevices who int http www who int medical devices en 9 ISBN 978 92 4 150153 8 789241 501538
34. IPM workload can be calculated and related to staff time so they can be matched as closely as possible Work can be assigned manually by management personnel or automatically by the CMMS using rules established by management Greater efficiency can be gained by creating a system where IPM technicians can focus on the work at hand without interruption This will require sufficient staff to be able to handle repairs or service calls that may be unrelated to IPM work 5 3 4 Prioritization of work Exact matches between workload for the equipment in the hospital and the staff available to do the work are rare So rather than plan a programme with the goal to inspect and maintain all the equipment and then not completing the scheduled work thus leaving some WHO Medical device technical series 27 28 of the critical high risk or life support equipment not serviced it is better to carefully identify the equipment in the health care facility that is the most important to inspect and maintain and schedule this work as a priority Creating such a tiered process where the most important equipment is dealt with first is a better use of limited resources When additional staff is added and their training completed the next lower tier of equipment can be added to the schedule Managing the process in this manner gives the manager more control over both the work and the outcome The following are examples of how maintenanc
35. WHO Medical device technical series 12 3 Maintenance related definitions Key terms used in the discussion of medical equipment maintenance are defined below Acceptance testing The initial inspection performed on a piece of medical equipment prior to it being put into service When the device first arrives in the health care facility it is checked ensure it matches the purchase order it is functioning as specified the training for users has been arranged and it is installed correctly If a computerized maintenance management system CMMS is available it is registered into the CMMS Calibration Some medical equipment particularly those with therapeutic energy output e g defibrillators electrosurgical units physical therapy stimulators needs be calibrated periodically This means that energy levels are to be measured and if there is a discrepancy from the indicated levels adjustments must be made until the device functions within specifications Devices that take measurements e g electrocardiographs laboratory equipment patient scales pulmonary function analysers etc also require periodic ca ibrafionto ensure accuracy compared to known standards Clinical engineer A professional who supports and advances patient care by applying engineering and managerial skills to health care technology American College of Clinical Engineering While a clinical engineer is a specialized biomedical engineer the term
36. aha org Biomedical Instrumentation and Technology www aami org publications BIT Hospital www elhospital com Engineering World Health www ewh org International Electrotechnical Commission www iec ch Journal of Clinical Engineering journals Iww com jcejournal Online discussion groups e nfratech infratechonline net e Biomedtalk www ecri org biomedtalk Books and articles e Dyro J Clinical engineering handbook Burlington Elsevier Academic Press 2004 e Atles LR Practicum for biomedical engineering and technology management issues Dubuque Kendall Hunt Publishing 2008 Temple Bird C et al How to organize the maintenance of your healthcare technology How to Manage series of health care technology guides no 5 St Alban s Ziken International Health Partners International 2005 WHO Medical device technical series 41 42 e Geisler E Heller Managing technology healthcare Management of Medical Technology Series Boston Kluwer Academic Publishers 1996 e Health technologies the backbone of health services Geneva World Health Organization 2003 e Bryce CL Cline KE The supply and use of selected medical technologies Health Affairs 1998 17 1 213 224 Jonsson E et al Executive summary of ECHTA ECAHI project The European Collaboration for Health Technology Assessment and Health Interventions 2001 e Pammolli F et al Medical devices competitiveness and impact on public health expendi
37. aining programmes in Costa Rica and Kenya ORBIS International conducts similar programmes in Bangladesh China Ethiopia India Peru and Viet Nam by highly trained specialists who focus on a single technology or small group of technologies These outside vendors should operate under the supervision of in house biomedical equipment technicians for the purpose of service management cost control and the opportunity to become increasingly familiar with other equipment Having some lower level general staff to undertake less technical work is acceptable but most of the maintenance staff will need to have electronics training and an understanding of the functioning of test equipment concepts of electronic calibrations and the operating principles of the medical equipment in order to do the job effectively In addition investing in higher level technicians may allow the clinical engineering department to eventually provide in house service on even the highest level laboratory surgical and imaging equipment In general the more the work that can be undertaken by in house technical staff helps to limit the overall cost of maintaining the hospital s medical equipment Hiring well trained and qualified biomedical equipment technicians who can assume more WHO Medical device technical series 21 22 responsibility will reduce the cost of maintaining a hospital s equipment Where substantial resources are available to support t
38. amme A detailed list of test equipment and the devices they are required for is provided in Appendix F Supplies These primarily consist of cleaning and lubricating supplies and need to be acquired in sufficient quantities The manufacturers service manuals give cautions about using the wrong cleaning agents which can damage labelling and the plastic surfaces of some equipment Replacement parts When planning an IPM programme it is possible to forecast in advance what parts need to be replaced and how of ten by referring to the manufacturer s guidelines Thus based on the number of devices at the facility the replacement parts or parts kits to be used during preventive maintenance e g batteries filters valves tubing seals etc can be ordered many months in advance optimizing any volume discounts and minimizing shipping costs Most impor tantly the replacement parts will be on hand when needed This practice will improve reliability and availability of the equipment and increase the productivity of the staff performing the maintenance In many countries the problem of obtaining replacement parts at a reasonable cost and in a timely manner can be substantial However knowing what will be needed and the associated costs will help in planning maintenance and informing management in advance This may lead to funds being redirected to critical areas The use of generic parts instead of the manufacturer
39. ant Section 5 3 4 discusses methods for prioritizing work which are also helpful in the selection of equipment for inclusion in an inventory Appendix A 1 outlines one specific method in greater detail The clinical engineering department is responsible for developing and maintaining the inventory They are responsible for routinely checking that all the equipment being tracked within a health care facility is in the inventory and that all the equipment listed in the inventory can be located The team may find it convenient to perform an inventory while carrying out routine inspections or PM activities Furthermore when new equipment arrives it should be inspected and then added to the inventory Appendix A 2 outlines a policy for initial testing and evaluation while Appendix D 1 provides a sample form for new equipment received Please also refer to Introduction to medical equipment inventory management in this technical series for further information 4 2 Methodology A maintenance programme can be implemented in any number of ways so it is important to consider the variety of methodologies that are available For example it is possible for a health care organization to establish service contracts with device manufacturers independent service organizations ISOs or a combination of both In such cases it is essential for the health care organization to have personnel to monitor and manage the activities of these service
40. approximate inspection times and frequencies for each class of equipment is entered into the chart and the calculations are done to yield the total IPM work time An example of this method is found in Chart B Medical equipment maintenance programme overview Chart Determining workload This example uses the chemistry and delivery room inventory above Number of devices 5 Chemistry 8 Chemistry 4 Chemistry 1 Delivery 14 Delivery 3 Delivery Total number of devices 6 0 22 0 7 0 Hours inspection 0 3 0 5 1 0 Inspections year 1 0 1 5 4 0 Total hours inspecting equipment 18 16 5 28 0 Total Workload 46 3 This method yields the total time needed to provide complete inspection and preventive maintenance on this inventory This example did not take into account the time needed to travel to the clinical site to perform the work the time to get ready for work in a particular area gather correct paperwork test equipment tools and PM parts or the time it takes to complete the paperwork after the work is done These tasks are variable depending where the department is located with respect to the clinical areas where the work takes place and what type of equipment will be maintained Additionally time should be taken out of the normal work day for lunch short breaks and short conversations with the clinical staff to build rapport and to learn about how the equipment has been functioning All things considered this
41. ask performed on the device As a result the inventory database will contain the entire technical and financial history for each device in the inventory Appendix 4 provides sample policy outlining how to manage a work order system for corrective maintenance and Appendix D 3 provides an example of an actual work order form From a regulatory point of view work that was not documented is work that was never performed Additionally when a problem with a piece of equipment occurs itis helpful to see what previous work was done and what the measurement values were Therefore it is invaluable to have thorough documentation of all service events which have taken place over the life of the equipment Being able to keep this in a CMMS for electronic retrieval is ideal but simply having the information available in a paper format is still useful The maintenance programme must strive for accurate records of both the total list of equipment requiring maintenance as well as an accurate accounting of the specific work completed Using an organized CMMS system to print appropriate procedures for each scheduled activity and a good system of annotations and coding to record the results of the IPM for quality control and productivity analysis purposes are good methods to keep records Another important aspect of equipment control and tracking is keeping accurate records of locations of equipment to facilitate quick location of equipm
42. ations medical equipment inventory management medical equipment maintenance computerized maintenance management systems medical device data medical device nomenclature medical devices by health care setting medical devices by clinical procedures medical device innovation research and development Medical equipment maintenance programme overview These documents are intended for use by biomedical engineers health managers donors nongovernmental organizations and academic institutions involved in health technology at the district national regional or global levels Maintenance series and external guidance Three documents in this technical series have been developed specifically to aid a health facility or a national ministry of health to establish or improve a medical equipment maintenance programme The documents address medical equipment inventory management maintenance and computerized maintenance management systems Each of these documents can be used as a stand alone document but together they present all of the factors to consider when developing a medical equipment maintenance programme Furthermore a six volume comprehensive series of manuals for the management of healthcare technology known as the How To Manage series exists for people who work for or assist health service provider organizations in developing countries and are publicly available Methodology The documents in this ser
43. ay set point j Thermometer verification test k Patient temperature display test Probe resistance Patient temp display 1355 37 C20 3 C L Low temperature backup thermostat m Ground resistance less than 0 5 ohm Leakage current Chassis grounded Chassis ungrounded Patient probe Adapted from Medi Therm II hyper hypothermia service manual 2008 70 Medical equipment maintenance programme overview QA inspection form Volume ventilator inspection Date Inspected by Device type Control no Equipment owner Manufacturer Serial no Hour meter NTA ITEM QUALITATIVE TASK ITEM 3 Location ITEM PASS miae enessbrm line cord 1 4 2 zi 23 _ max leakage current 24 2s 2s 37 mode 28 pesuesuppot 2s __ nebulfizer function E rates Sig ais sGHfundon Adapted from MEDIQ PRN quality assurance programme form ventilator service report 1998 low oxygen pressure alarm low exhale alarm minute volume alarm low PEEP alarm low CPAP alarm Tigh rate alarm temperature alarm high oxygen 96 alarm lowoxygen alarm eitoeydeslamm vent INOP alarm
44. be full agreement The mention of specific companies or of certain manufacturers products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned Errors and omissions excepted the names of proprietary products are distinguished by initial capital letters All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication However the published material is being distributed without warranty of any kind either expressed or implied The responsibility for the interpretation and use of the material lies with the reader In no event shall the World Health Organization be liable for damages arising from its use Design amp layout LIV Com Sarl Le Mont sur Lausanne Switzerland Medical equipment maintenance programme overview Contents Preface Maintenance series and external guidance Methodology Definitions Acknowledgements Declarations of interests Acronyms and abbreviations Executive summary 1 2 3 4 Introduction Purpose Maintenance related definitions Maintenance programme planning 4 1 4 2 4 3 Inventory Methodology Resources 4 3 1 Financial resources 4 3 2 Physical resources 4 3 3 Human resources Management 5 1 9 2 5 4 59 Financial management Personnel management 5 2 1 Service vendors 5 2 2 Training Operati
45. being placed into service Hospital technical staff is not responsible for the maintenance of this equipment WHO Medical device technical series 49 50 Inspection and preventive maintenance procedure Equipment to be covered by the programme will typically include life support equipment laboratory equipment surgical and critical care equipment imaging equipment equipment which could cause patient injury or death if it fails equipment required to be maintained by regulations equipment on an outside vendor maintenance programme equipment under lease where maintenance is part of the lease and equipment under warranty Procedure l Allequipment due for maintenance needs to be identified one month prior to the maintenance date The list of maintenance tasks can be generated automatically by a computerized maintenance management system CMMS if in place 2 Parts required for preventive maintenance are ordered and made available for the equipment in this period 3 Theinspection and preventive maintenance IPM tasks will be assigned to specific biomedical technicians 4 Work orders will be generated and distributed to the assigned technicians 5 Maintenance will be performed in accordance with the established IPM procedure These IPM procedures will be based on manufacturer s recommendations industry recommendations and facility experience 6 The assigned technician will document on the work orde
46. cation and degree Table 2 provides a classification of the types of technical personnel and their typical duties In many countries there is a shortage of qualified clinical engineers and biomedical equipment technicians A long term solution is to develop the educational infrastructure so that qualified technical personnel can be created within the country or region It may be a good idea to include universities within the country or region in human resource planning as they can develop formal degree programmes and provide continuing education for technical personnel In the short term it is necessary to recruit Table 2 Classification and roles of technical personnel Engineer Biomedical engineer or clinical engineer Management specialized maintenance supervision of external service provider needs assessment planning and user training Other related fields Require a training course and certificates to work e g electrical engineer mechanical engineer in the medical device field Primary focus is on the maintenance of medical equipment and sometimes managerial positions Technician Biomedical equipment technicians Primary focus on specialized medical equipment repair and maintenance technologist polyvalent technician Other related fields e g electrical or medical Preventive maintenance and repair of less complex equipment It is important that they receive specialized training for high risk medical devices
47. cation rate The proportion of equipment scheduled to be inspected in the assignment period but not located before the end of the inspection period is known as the equipment location rate This indicator primarily measures the accuracy of the inventory database in the CMMS system It also provides an indication of the effectiveness of the policies to keep the inventory accurate as well as measuring the quality of communications between clinicians and the medical equipment maintenance department particularly when equipment is moved loaned or put into storage 5 4 3 IPM yield IPM yield is the percent of scheduled IPM procedures performed where problems were found that affected equipment Operation or safety note cosmetic problems which do not affect function or safety are not included This indicator measures the general reliability of the medical equipment at the facility When individual models of equipment are analysed it can be useful to compare the reliability of one model against another Furthermore it is a measure of the effectiveness of the maintenance programme if equipment is being well maintained the percentage will be low Alternatively if problems are discovered upon inspection that should have been detected by the user the percentage will be higher than anticipated As such IPM yield may also indicate how well clinicians report problems they find with equipment 5 4 4 IPM productivity The productivity and
48. ction regulators Pressure meter Incubators infant warmers laboratory ovens Temperature probe thermometers Infusion pumps traction units Stop watch timers Centrifuges Photo or contact tachometer Electrical outlets Receptacle testers Isolated power systems Isolated power tester Non invasive blood pressure monitors Non invasive blood pressure simulator Dialysis machine pH conductivity meter Various Variable resistance box variable capacitance box WHO Medical device technical series 77 78 Appendix G Examples of job descriptions G 1 Biomedical equipment technician entry level G 2 Biomedical equipment technician mid level G 3 Biomedical equipment technician senior level G 4 Clinical engineering supervisor manager Medical equipment maintenance programme overview Appendix G 1 Biomedical equipment technician entry level Job description Performs tasks involving the installation and maintenance of therapeutic diagnostic and monitoring medical equipment These activities include 10 11 L3 14 15 Installation maintenance and repair of a diverse range of medical equipment Performing electrical safety inspections on medical equipment using specialized test equipment Assisting in the systematic preventive maintenance programme of medical equipment Documenting all work performed including new equipment insp
49. ctly affect human lives They are considerable investments and in many cases have high maintenance costs It is important therefore to have a well planned and managed maintenance programme that is able to keep the medical equipment in a health care institution reliable safe and available for use when it is needed for diagnostic procedures therapy treatments and monitoring of patients In addition such a programme prolongs the useful life of the equipment and minimizes the cost of equipment ownership A maintenance strategy includes procedures for inspection as well as preventive and corrective maintenance Performance inspections ensure that equipment is operating correctly safety inspections ensure the equipment is safe for both patients and operators and preventive maintenance PM aims to extend the life of the equipment and reduce failure rates Additionally some hidden problems may be discovered during a scheduled inspection However performing inspections of equipment only ensures that the device is in good operating condition at the time of inspection and cannot eliminate the possibility of failure during future use the nature of most electrical and mechanical components is that they can potentially fail at any time Corrective maintenance CM restores the function of a failed device and allows it to be put back into service An effective medical equipment maintenance programme consists of adequate planning management and implementat
50. devices of varying complexity Early in the process of planning a maintenance programme it is essential to determine the types of devices that need to be included in the programme This will depend on the types of facilities to be covered by the programme ranging from primary care clinics to tertiary hospitals and the range of devices in those facilities The clinical engineering department should identify and select the devices to be included in the inventory and which of those to include in the maintenance programme While some may prefer to record all equipment in the facility and some government agencies may require this studies have shown that not all equipment needs to be tracked in an inventory inspected or maintained and very few hospitals or health care organizations have the manpower to accomplish this level of effort Approaches Figure 2 Critical factors in planning a maintenance programme Inventory The types and numbers of medical devices to be tracked by the hospital and those that are specifically included in the maintenance programme Medical equipment maintenance programme overview Critical factors Methodology Identification of the method by which maintenance will be provided to the items included in the programme Resources The financial physical and human resources available to the programme to selecting equipment to record an inventory and a maintenance programme are import
51. e all maintenance services in house In such circumstances it may be necessary to make use of external service providers for a significant portion of the maintenance activities There are generally two categories of external service providers equipment manufacturers and independent service organizations Many equipment manufacturers offer scheduled and unscheduled maintenance services for the equipment they manufacture Some also offer maintenance services for Medical equipment maintenance programme overview equipment from other manufacturers in some cases extending to all the medical equipment in a health care organization Independent service organizations range in size some specialize in a particular type of medical equipment and others offer maintenance services for a wide variety of equipment types In some parts of the world there are many external service providers which offer the clinical engineering department manager a wide variety of options However in other parts of the world the number of external service providers is much more limited In some cases these companies find it uneconomical to offer services in remote areas with small inventories of equipment They are more likely to expand their service areas if it possible to negotiate a contract that covers a large inventory of equipment especially if that inventory has a reasonable level of standardization in terms of manufacturer and model In some cases it
52. e may be prioritized Risk based prioritization One method used to prioritize medical equipment IPM is based on assigning the highest priority to equipment with the highest likelinood of causing patient injury if it fails Categorizing devices by maintenance priority and identifying those that are of such a low risk that maintenance is not necessary requires a systematic approach For over 20 years the Joint Commission for the Accreditation of Healthcare Organizations has required a risk based approach to prioritizing IPM of medical equipment 3 An example of how this risk based technique is implemented is shown in Appendix A 1 Mission based prioritization 4 This methodology is based on the question Which devices are most important to us in providing the majority of our patient care For example if the hospital s priorities were caring for people living with HIV and caring for pregnant women and their children the equipment used in this type of care would become the priority The second priority after this work is completed would then be those devices with the highest risk as described by the method listed in the previous section Medical equipment maintenance programme overview Maintenance based prioritization 5 This methodology analyses which devices have a significant potential to harm a patient if they do not function properly and have a significant potential to function improperly if they are not provided
53. e should be considered when planning the programme One option is in the location where the equipment usually resides For some types of equipment such as X ray systems laboratory analysers sterilizers and surgical lights going to the equipment is the only option In this case planning to take essential tools and test equipment to the work site or equipping a space closer to the equipment is necessary The second option is to transport the equipment to the clinical engineering department s repair shop to have the IPM or CM performed This may be a time consuming process but the clinical engineering department may be the only location where some maintenance can be performed A good workspace is clean and well organized It provides good lighting and access to utility systems required by the equipment electricity and medical gases for example It includes work benches and storage space for tools and test equipment repair parts and supplies and equipment awaiting repair It also includes space for records and documentation service and operator manuals and access to whatever computer resources are required Inclusion of computer resources in the workspace is also important to consider Basic documentation may be maintained with paper records but the use of a computer spreadsheet database programme or computerized maintenance management system CMMS supports good record keeping performance monitoring and performance i
54. e the device was serviced or inspected and may indicate when the next service is due These tags are sometimes printed in different colours one for each year or inspection cycle so that it is easier to identify devices that are due for inspection This tag may be covered with plastic adhesive cover to protect it from being defaced during the cleaning process DATE DUE 74 Medical equipment maintenance programme overview Appendix E 2 Record of inspection test results This label provides space to record the output readings taken during the performance assurance inspection These can be used to record outputs on many energy producing devices including ultrasound therapy equipment lasers defibrillators electrocurrent therapy devices nerve stimulators etc CLINICAL ENGINEERING PERFORMANCE TEST RESULTS ULTRASOUND OUTPUT ID _ ULTRASOUND ACTUAL SETTING WATTS OUTPUT WATTS WHO Medical device technical series 75 76 Appendix E 3 Notification of defect This label is placed on medical equipment that has been inspected by the clinical engineering staff and found to be defective It is printed on very brightly coloured paper to attract the clinician s visual attention and prevent inadvertent use of the device DANGER Do Not Use With AC Power Source Medical equipment maintenance programme overview Appendix Test equipment per medical device cat
55. echnical personnel it is typical that one technical person may be responsible for the maintenance of several hundred medical devices However countries without such support resources the number of devices per technical person must be greatly reduced This is especially true in the early stages of implementing a health technology management programme Over time performance improvement efforts will increase the productivity of individual personnel Care should be taken however to avoid overburdening technical personnel at the outset of new programmes Management Personnel Engineering management staff provide leadership for the maintenance pro gramme In concert with hospital admin istration they set department policies provide budget recommendations Medical equipment maintenance programme overview supervise technical staff arrange for training set priorities for the department activities and administer the overall programme The background of those in this position may include a technical degree two years with many years of experience in medical equipment service but a preferable combination would be someone with a four year engineering degree and familiarity with the health care environment and health care technology Management personnel can also have a combination of business and technical training They may be engineers or technicians who have additional training and experience in management and supervision
56. ections corrective and preventive maintenance and special requests as required Maintaining documentation in an accurate and timely manner Assisting hospital clinical and technical staff in the proper operation and maintenance of clinical equipment Communication with users regarding status of repairs Meeting the needs of clinical departments and obtaining loaner or replacement equipment as required Acceptance testing on new clinical equipment per department policy Being aware of patient and work safety issues reports problems found and assists with correction of issues as required Identifying and recommending medical equipment that is obsolete has an extensive repair history no longer has service support from the manufacturer or has identified safety problems Providing good customer service answering phones in a pleasant manner screening and referring calls as appropriate and providing information to staff visitors and patients upon request Maintaining a professional appearance and approach to work Maintaining good relationships with fellow workers clinical staff and other hospital workers Maintaining a high level of productivity Making suggestions to improve department productivity when appropriate Maintaining a clean and safe work place Following all departmental policies and procedures Education Two year degree or equivalent training in electronics biomedical equipment technology or a related field is required
57. effectiveness of the IPM staff is an important management measure By modifying department poli cies levels of training test equipment and or forms or procedures great im provements in individual or group pro ductivity can be achieved However this can be managed only if targeted activities are measured The most important IPM productivity measurement in use today is IPM productivity IPM productivity is an expression of the actual time it takes an individual to com plete a single scheduled IPM procedure divided by the time the IPM procedure is expected to take The actual time taken does not include preparation or set up time merely the actual time it takes the technician to perform the individual pro cedure on each device The results from individual inspections can then be added up to measure the daily weekly or month ly productivity levels The number for all technicians can be added to calculate the results for an entire maintenance programme The expected IPM comple tion time is initially obtained from out side sources such as the manufacturer s maintenance manual Eventually after several years of experience and collecting accurate data you can use past experi ence to guide expected completion times 5 4 5 CM performance measures In addition to the measures already mentioned there are certain measures that may be recorded to specifically monitor CM performance For example Mean time between failures
58. egory Electrosurgical units Radio frequency electrosurgical analyser Defibrillators Defibrillator analyser All electrical equipment Electrical safety analyser Anaesthesia machines ventilators Test lung Anaesthesia machines ventilators Ventilation analyser Heart lung machines hyper hypothermia machines warming pad pumps dialysis machines Fluid flow meter Anaesthesia machines ventilators CO insufflators vacuum 2 regulators air O blenders lasers Gas flow meters Physiological monitors intra aortic balloon pumps defibrillators EEG machines machines Physiological simulators ICU monitors EKG machines Arrhythmia simulators IV pump surgical irrigation pump Graduated cylinder Radiographic and fluoroscopic equipment lonization chamber radiation analyser kVp meter Surgical and ophthalmic lasers Laser power meter laser thermal imaging plates Most electronic equipment Multimeter oscilloscope function generator Radiographic mammography ultrasound CT MR Phantoms Air O blenders anaesthesia machines medical gas systems Oxygen analyser Pacemakers Pacemaker analyser Scales traction units Ventilators heart lung machine anaesthesia machine Scales spring scale floor scale balance weights Pneumatic tester pneumatic flow meter Medical gas systems insufflators lasers haemodialysis machines su
59. ement 5 4 1 Completion rate of assigned IPM The completion rate is percentage of procedures completed It can be measured at the end of an assignment period e g monthly bi monthly or quarterly A good completion rate goal is to be above 90 This measure could also be calculated to evaluate the completion rate of each priority group starting with the highest priority group The highest 1 The Association for the Advancement of Medical Instrumentation offers AAMI s Benchmarking Solution which is a online self assessment tool for clinical engineering www cami org abs It supports performance monitoring assessment of best practices and performance improvement ECRI Institute www ecri org offers Biomedical Benchmark which provides several valuable tools for medical technology management including detailed benchmarking capabilities for medical equipment maintenance activities Medical equipment maintenance programme overview priority devices should have the highest completion rate goal e g over 95 with lower priority groups having lower goals This indicator is used to measure the productivity and effectiveness of the IPM staff the ability of the technical personnel and the adequacy of the staffing levels IPM completion rates for each technician must take into consideration the expected time it takes to complete an IPM procedure so the technician is not overloaded or underloaded with work 5 4 2 Equipment lo
60. ent for procedures If attention is given to keeping accurate records and information many hours can be saved in trying to locate equipment that was recently removed from service disposed of put in storage or was moved to a different department Keeping database information updated is an ongoing task which is well worth the effort when striving for good programme management 5 3 6 Computerized maintenance management systems In most modern health care facilities the number of pieces of medical equipment and the number of service events are so large that keeping and organizing this information can only be done by a computer system Thus a computerized maintenance management system CMMS a software tool that is able to run on a stand alone computer can be very useful in managing the medical equipment maintenance programme In an effort to effectively manage a good programme a CMMS system may provide the following capabilities e Keep an inventory of each device in the facility including the ability to easily add or change the equipment information e Keep track of past service events e g IPM CM recalls software updates etc and retrieve or print them if needed e Store IPM procedures and related information e Schedule IPM procedures change the schedule of IPM procedures and print a summary list of what has been scheduled e Print individual IPM forms with the appropriate procedure the past few service eve
61. entified during preventive maintenance 54 Appendix A 6 Infection control 56 Appendix B Examples of inspection and preventive maintenance procedures 58 Appendix B 1 Procedure template 59 Appendix B 2 Anaesthesia analgesia unit gas machine 60 Appendix B 3 Centrifuge table top 61 Appendix B 4 Monitor ECG 62 Appendix B 5 Pump infusion 63 Appendix B 6 X ray system mobile 64 Appendix C Calculating IPM workload 65 Appendix D Examples of inventory and inspection forms 68 Appendix 0 1 New equipment received form 69 Appendix D 2 Equipment inspection forms 70 Appendix D 3 Work order form 72 Appendix Samples of inspection labels 78 Appendix E 1 Record of inspection 74 Appendix E 2 Record of inspection test results 75 Appendix E 3 Notification of defect 76 Appendix F Test equipment per medical device category 77 Medical equipment maintenance programme overview Appendix G Examples of job descriptions 78 Appendix G 1 Biomedical equipment technician entry level 79 Appendix 6 2 Biomedical equipment technician mid level 80 Appendix G 3 Biomedical equipment technician senior level 81 Appendix G 4 Clinical engineering supervisor manager 82 Appendix H Examples of actions performed when developing maintenance programmes at the facility level 83 Appendix H 1 Planning a maintenance programme at district hospital 84 Appendix H 2 Managing a maintenance programme at a district hospital 85 Appendix H 3 Planning a maintenance programme within a
62. enting clinical engineering at meetings as assigned Instructing hospital personnel on safe and proper operation and maintenance of medical equipment Education Requires a two year degree in clinical biomedical engineering or equivalent A four year degree in clinical biomedical engineering is preferred Experience Work requires minimum of three years of clinical biomedical technology experience including management and leadership experience Medical equipment maintenance programme overview Examples of actions performed when developing maintenance programmes at the facility level H 1 Planning a maintenance programme at a district hospital H 2 Managing a maintenance programme at a district hospital H 3 Planning a maintenance programme within a regional health system H 4 Managing a maintenance programme within a regional health system WHO Medical device technical series 83 84 Appendix 1 Planning maintenance programme at district hospital Inventory e Create an inventory of all medical equipment in the hospital Clinical engineering department using computer spreadsheet or simple CMMS software Methodology e Identify current resources Clinical engineering department Define maintenance methodologies Simple maintenance tasks hospital staff critical equipment of greater complexity service contracts manager Financial resources Plan for service contracts Clin
63. equests Procedure 1 Upon receipt of the request a work order will be initiated This includes priority designation and delegation of the work order to a technician for completion Both will normally be determined by the appropriate clinical engineering manager Input from users is encouraged with regard to priority assignment The priority categories are as follows Emergency urgent e This describes situations of dire need and severe safety concerns for patients visitors or staff The lack of immediate action could lead to severe consequences for the hospital and or potential loss of life or disability e Emergency requests are accepted by phone or verbally and will be addressed by the chief biomedical engineer e Under such circumstances documentation will be completed at the earliest possible opportunity e Should an outside vendor be required to rectify the problem the chief biomedical engineer will test and evaluate the equipment upon return prior to being taken into service Urgent e This category is used for failures that require immediate attention because the operation of the hospital facility is compromised e A work order can be hand carried to the clinical engineering department The response to the request will be as soon as possible only an emergency request will pre empt this work order Ill Routine e This describes an action that needs to be taken but the situation does not compromise the primary function
64. ere a numerical value has been assigned to each device type by classifying its equipment function clinical application and required maintenance Adding the number from each subgroup and adding or subtracting a factor based on equipment failure history yields an equipment management EM number EM number equation EM Function Application Maintenance History Equipment function Includes various areas in which therapeutic diagnostic analytical and miscellaneous equipment is used Therapeutic Life support 10 Surgical and intensive care 9 Physical therapy and treatment 8 Diagnostic Surgical and intensive care monitoring 7 Additional physiological monitoring and diagnostic 6 Analytical Analytical laboratory 5 Laboratory accessories 4 Computers and related 3 Miscellaneous Patient related and other 2 Physical risk associated with clinical application Lists the potential patient or equipment risk during use Potential patient death 5 Potential patient or operator injury 4 Inappropriate therapy or misdiagnosis 3 Equipment damage 2 No significant identified risk 1 Medical equipment maintenance programme overview Maintenance requirements Describes the level and frequency of maintenance required as noted by the manufacturer or through experience Below average Extensive routine calibration and part replacement required 5 Above average 4 Average
65. erred to as performance assurance inspections Predictive This activity involves a forecasting technique to determine the rate of failure of certain types of maintenance replaceable components e g batteries valves pumps seals The maintenance interval is then set so components are replaced before they fail ensuring the equipment continues to operate reliably In health care this is primarily done in a facility that has a large number of medical devices from a single manufacturer or model Preventive maintenance PM PM involves maintenance performed to extend the life of the device and prevent fai ure PM is usually scheduled at specific intervals and includes specific maintenance activities such as lubrication cleaning e g filters or replacing parts that are expected to wear e g bearings or which have a finite life e g tubing The procedures and intervals are usually established by the manufacturer In special cases the user may change the frequency to accommodate local environmental conditions Preventive maintenance is sometimes referred to as planned maintenance or scheduled maintenance This document uses these terms interchangeably Repair A process used restore the physical integrity safety and or performance of a device after a failure Used interchangeably with corrective maintenance Safety inspections These are performed to ensure the device is electrically and mechanica
66. example yields about two weeks of work for a single technician to accomplish this work in a careful and thorough manner WHO Medical device technical series 67 68 Appendix D Examples of inventory and inspection forms D 1 New equipment received form D 2 Equipment inspection forms D 3 Work order form Medical equipment maintenance programme overview Appendix 0 1 New equipment received form Date Tech name Equipment Floor Dept Functional units Function score Risk score Maintenance score Note Arrival date Asset Installation date Model Warranty date Serial Purchase price Vendor Replacement cost Manufacturer Life expectancy PM schedule monthly annual etc Work order Purchase order Incoming yrs Comments MM WHO Medical device technical series 69 0 2 Equipment inspection forms Hyper Hypothermia Machine Functional check and inspection form Location Control number Manufacturer Model Action taken SM date initals e Flow P f Level switch activation g Cold water reservoir controls Flow switch activation h Blanket water temperature controller Display within 1 deg 1 8 of set point Thermometer within 1 deg C 1 8 F of set point High temperature back up thermostat Shut down rel
67. gs the accuracy of the calibrations and the margin of safety for the patients and staff as well as the efficiency of the staff doing the maintenance Various tools and test equipment are required to perform IPM and or CM procedures depending on the type of equipment in service It is possible to perform a large proportion of IPM and CM procedures satisfactorily with a basic set of electronic service tools and test equipment e g temperature meter volt meter force gauge oscilloscope resistance and capacitance substitution boxes an electrical safety meter Small hospitals or clinics with a limited amount of medical equipment can run their programme with just several pieces of basic test equipment e g a physiological simulator safety analyser and some basic tools In larger facilities with more complex equipment more advanced tools and test equipment may be necessary For example in a large hospital with more than a few operating rooms and modern electrosurgery equipment an electrosurgical analyser may be a prudent purchase Purchasing more advanced tools and test equipment will enable clinical engineering technical staff to calibrate maintain and repair a wider variety of medical equipment If it is not possible to procure and maintain certain test equipment it may not be appropriate to take responsibility for the maintenance of the associated device The life of tools and test equipment may exceed ten years if they a
68. gy 2001 35 3 167 176 6 Fennigkoh L Smith B Clinical equipment management Joint Commission on Accreditation of Healthcare Organizations Plant Technology and Safety Management Series 1989 2 3 12 Medical equipment maintenance programme overview Useful resources All URLs accessed 29th April 2011 Association for the Advancement of Medical Instrumentation www aami org e AAMI benchmarking solution www aami org abs e Electrical safety manual www aami org publications books esm html e Computerized maintenance management systems www aami org publications books cmms html Medical equipment management manual www aami org publications books mem html Medical electrical equipment standard 60601 1 www aami org publications standards 60601 html ECRI Institute www ecri org e Health devices system www ecri org Products Pages Health Devices System aspx Biomedical benchmark www ecri org Products Pages BiomedicalBenchmark aspx Joint Commission Joint Commission International e Accreditation standards United States www jointcommission org e Accreditation standards international www jointcommissioninternational org National Fire Protection Association www nfpa org e Standard for health care facilities NFPA 99 e National electrical code 70 Other online resources e 24x7 www 24x mag com American College of Clinical Engineering www accenet org American Hospital Association www
69. h is especially important when resources are limited When the various financial physical and human resource aspects are carefully examined even with certain resource constraints a successful programme that suits the needs of a particular context can be designed and executed However the programme must be considered an integral part of health care delivery with a minimum set of resources designated to fulfil the tasks outlined by the programme Only in this way will patients have access to the medical equipment that can provide them with an accurate diagnosis effective treatment or appropriate rehabilitation WHO Medical device technical series 39 References 1 Cohen T AAMI s Benchmarking solution analysis of cost of service ratio and other metrics Biomedical Instrumentation amp Technology 2010 4 4 346 349 2 Malkin R Medical instrumentation the developing world Memphis Engineering World Health 2006 3 Accreditation manual for hospitals volume Standards Oakbrook Terrace Joint Commission on Accreditation of Healthcare Organizations 2002 4 Wang Levenson Equipment inclusion criteria new interpretation of JCAHO s medical equipment management standard Journal of Clinical Engineering 2000 25 26 35 5 Ridgeway Classifying medical devices according to their maintenance sensitivity a practical risk based approach to PM program management Biomedical Instrumentation and Technolo
70. ical engineering department Develop the budget for implementing the programme manager Develop the budget for operating the programme Identify budget sources Physical resources Plan for build out of space and acquisition of tools and Architect equipment Plan for basic computer resources Administrator Human resources Plan additional training for technicians Identify managerial capabilities within the hospital for management of the programme Develop links to external resources Clinical engineering department manager administrator Medical equipment maintenance programme overview Appendix 2 Managing maintenance programme at district hospital Personnel e Assign scheduled and unscheduled work to the repair Clinical engineering department management person manager e Monitor hours worked by the technician and timely completion of scheduled and unscheduled work assignments Document work on work order forms and if available in Technician the CMMS software Financial Monitor costs associated with service contracts and with Clinical engineering department management work carried out by the technician manager Compare costs to budget review variances plan for future budgets Operational Develop procedures and schedules for inspection and Clinical engineering department management preventive maintenance manager Develop policies
71. ician will find that the device performs within its Medical equipment maintenance programme overview design specifications as defined by the manufacturer In such instances it is necessary to communicate with the device user and examine the work environment to determine why the device did not function as expected See section 5 3 8 on managing use error and section 6 2 2 on factors affecting equipment failure for further information 6 2 2 Factors affecting equipment failures When investigating an unexplained failure environmental factors should be taken into due consideration For example medical devices that require electrical power may be adversely affected by power issues Ideally electrical power should have a steady voltage of the appropriate value be free of transient distortions such as voltage spikes surges or dropouts and be reliable with only rare loss of power Unfortunately these ideal characteristics do not always exist in many developing countries Technical personnel should collaborate with those responsible for the electrical power system in the health care organization to help make the system function as effectively as possible This may include purchasing voltage regulators installing uninterruptable power supplies UPS using surge protectors and avoiding connecting extension leads plug boards in series Furthermore technical personnel should work with the facility personnel to ensure that a fu
72. ies were written by international experts in their respective fields and reviewed by members of the Technical Advisory Group on Health Technology TAGHT The TAGHT was established in 2009 to provide a forum for both experienced professionals and country representatives to develop and implement the appropriate tools and documents to meet the objectives of the GIHT The group has met on three occasions The first meeting was held in Geneva in April 2009 to prioritize which tools and topics most required updating or developing A second meeting was held in Rio de Janeiro in November 2009 to share progress on the health technology management tools under development since April 2008 to review the current challenges and strategies facing the pilot countries and to hold an interactive session for the group to present proposals for new tools based on information gathered from the earlier presentations and discussions The last meeting was held in Cairo in June 2010 to finalize the documents and to help countries develop action plans for their implementation In addition to these meetings experts and advisers have collaborated through an online community to provide feedback on the development of the documents The concepts were discussed further during the First WHO Global Forum on Medical Devices in September 2010 Stakeholders from 106 countries made recommendations on how to implement the information covered in this series of documents at the country level
73. ining that device This information may be used to calculate the cost of service ratio described in section 4 3 1 Managing the maintenance budget is not unlike managing any other organizational budget The established budget repre sents the target or benchmark for the programme Actual costs are compared to the budget Any difference between actual and budget data triggers a review of the reasons for the variance Budget ing can be problematic with regard to CM costs because such costs are un predictable An unexpected and expen sive repair required for a critical medical device can cause a substantial budget variance However expenses of this type must be anticipated as much as possible so that over time the average level of CM expenses remains within the target bud get It is a good idea to allocate the cost of repair to a separate account from the IPM work This will allow for accurate cost accounting and future budgeting for IPM and more accurate repair accounting Additionally it is important to consider adjusting the maintenance budget after acquisition of new equipment or removal of existing equipment as this affects costs associated with both IPM and CM 5 2 Personnel management The purpose of personnel management is to provide support to the maintenance programme s human resources so that programme objectives are achieved Work assignments should be made to match the skills of the technical personnel and to p
74. ion Planning considers the financial physical and human resources required to adequately implement the maintenance activities Once the programme has been defined financial personnel and operational aspects are continually examined and managed to ensure the programme continues uninterrupted and improves as necessary Ultimately proper implementation of the programme is key to ensuring optimal equipment functionality WHO Medical device technical series 10 1 Introduction Medical equipment maintenance can be divided into two major categories inspection and preventive maintenance IPM and corrective maintenance CM see Figure 1 IPM includes all scheduled activities that ensure equipment functionality and prevent breakdowns or failures Performance and safety inspections are straightforward procedures that verify proper functionality and safe use of a device Preventive maintenance PM refers to scheduled activities performed to extend the life of a device and prevent failure i e by calibration part replacement lubrication cleaning etc Inspection can be conducted as a stand alone activity and in conjunction Figure 1 Components of a maintenance programme with PM to ensure functionality this is important as PM can be fairly invasive in that components are removed cleaned or replaced It is essential for any health care facility regardless of its size to implement a maintenance programme for medical equipment
75. ive actions identified during preventive maintenance 6 2 Corrective maintenance 6 2 1 Troubleshooting and repair Identification of a device failure occurs when a device user has reported a problem with the device mentioned earlier it may also occur when a technician in the clinical engineering department finds that a device is not performing as expected during IPM In order to return equipment to service as quickly as possible efficient troubleshooting is required to verify the failure and determine its origin In some cases the technician will find that the device itself has failed and must be repaired The technician then determines what steps are necessary to correct the problem and return the device to full functionality The technician initiates the corrective maintenance performing some steps themselves and making use of in house expertise or external service providers when necessary This corrective maintenance may be accomplished at various levels Component level Component level troubleshooting and repair isolates the failure to a single replaceable component In electrical devices mechanical devices and for discreet WHO Medical device technical series 35 36 components of electronic devices such as resistors or capacitors in an electronic circuit or fuses this is often the most effective repair approach In relation to electronic devices however component level repair may be time consumi
76. l series 16 4 3 1 Financial resources The financial resources required for a maintenance programme as one component of a comprehensive HTM programme fall into two categories initial costs and operating costs Initial costs are investments that must be made before the programme begins Operating costs are ongoing expenses required to keep the programme in operation Table 1 summarizes the major items within each category Table 1 Financial resources required for a maintenance programme Operation utilities Physical Space tools resources test equipment maintenance computer resources calibration vehicles Human Recruiting initial _ Salaries benefits resources training turnover continuing education Direct not applicable Service contracts maintenance parts and materials travel shipping The first step in calculating costs is to specify the physical and human resources needed based on the number and types of medical equipment in the inventory and on the level and type of maintenance methodology selected The initial and operating costs are then calculated using the applicable rates in the country or region For the IPM component specifically it is helpful to estimate the workload required by the programme This is a relatively straightforward process if the estimated time for inspections is known By counting the number of devices of each type each common nomenclatu
77. ld work with responsible donor agencies and insist on adherence to appropriate guidelines Please refer to Medical device donations considerations for solicitation and provision this technical series for more information In all cases it is important to discuss with the supplier if manuals are available or can be made available in the local language perhaps at an additional cost 4 3 3 Human resources Developing the human resources nec essary to operate an effective mainte nance programme is a slow and steady process The first step is to identify the number and type staff that a facility or group of facilities requires For example a small health care facility may have a single technician who provides services for a small inventory of relatively simple equipment On the other hand a clini cal engineering department serving a large number of health care facilities especially when those facilities include higher level hospitals will have a large number of technical and management personnel including specialists in par ticular technologies with multiple levels of supervision In general however there are two categories of clinical engineering personnel technical and management Technical Personnel Within the category of technical personnel are engineers and technicians Biomedical or clinical engineers are educated in general engineering principles the physical and biological sciences and their application
78. ll equipment that needs to be opened and vacuumed or blown clean will be done away from patient care or employee work areas whenever possible Equipment that can be carried or rolled easily will be removed to the clinical engineering workshop for cleaning Clinical engineering personnel will wear masks to eliminate the risk of breathing the dust from any machine All equipment that cannot be moved from the employee work area will be vacuumed as opposed to blown clean so as not to contaminate the work environment WHO Medical device technical series 57 58 Examples of inspection and preventive maintenance procedures B 1 Procedure template B 2 Anaesthesia analgesia unit gas machine B 3 Centrifuge table top B 4 Monitor ECG B 5 Pump infusion B 6 X ray system mobile Medical equipment maintenance programme overview Appendix B 1 Procedure template Equipment type Name and or type of equipment Risk score Available from the national Safety inspections year Refer to manufacturer s regulatory agency or consult service manual the United States Food and Drug Administration FDA Programme risk EM number Refer to Appendix A 1 fo Performance inspections year Refer to manufacturer s determine risk EM number service manual Risk group equipment Refer to Appendix A 1 to PM checks year Refer to manufacturer s function category determine category service manual
79. lly safe These inspections may also include checks for radiation safety or dangerous gas or chemical pollutants When these inspections are done the results are compared to country or regional standards as well as to manufacturer s specifications The frequency of safety inspections may be different than planned maintenance and performance inspections and are usually based on regulatory requirements WHO Medical device technical series 13 4 Maintenance programme planning Planning a maintenance programme is part of a broader effort to establish a comprehensive programme for health care technology management HTM This planning process includes a review of critical factors as shown in Figure 2 The challenge for planners is to balance these factors to design a maintenance programme that is appropriate and cost effective for their situation 4 1 Inventory Medical devices range from relatively simple to highly complex For example manual devices to measure blood pressure sphygmomanometers have only few components and are easily repaired assuming that parts calibration instruments and basic hand tools are available At the other extreme are advanced imaging and laboratory devices Repair of a magnetic resonance imaging system requires extensive financial physical and human resources Between these extremes are infusion pumps defibrillators ECG electrocardiograph machines and hundreds of other types of medical
80. may be reasonable to consider liaising with other health care facilities in order to provide better justification for the external service providers to enter the local market There are several types of service agreements as outlined in Table 3 Service agreements can include various levels of scheduled maintenance unscheduled maintenance or a combination of the two Flexibility in the terms of service agreements is valuable to the clinical engineering department manager but care must be taken to fully understand those terms before entering into a formal agreement Additionally it is advisable to check the references of any outside vendor prior to hiring them After a service agreement is in place it is essential to monitor the performance of the service provider This is necessary to make sure that the terms of the agreement are being met and that the health care organization is receiving the services it Table 3 Service agreement types Full service Quick response available at Fixed all times Time and Varying response time Hourly charge material available as needed plus cost of service parts Shared Internal staff provides responsibility initial response and repair External staff follows up as and when required needs All maintenance activities they perform and associated costs should also be recorded i e ina CMMS if available and reviewed on a regular basis 5 2 2 Training For the
81. mme risk score Perf 2 Risk group Diagnostic PM checks yr 2 Procedure Inspect exterior of equipment for damage or missing hardware Inspect the power cord strain relief and plug s for any signs of damage Turn unit off open user accessible covers and inspect unit for damage Clean unit interior components and exterior with vacuum or compressed air Inspect interior for signs of corrosion or missing hardware Repair as required Inspect electrical components for signs of excessive heat or deterioration Verify accuracy of kVp mA time per manufacturer s specifications Verify correct operation of electrical locks tube and table Verify correct operation of other electrical functions Inspect batteries if applicable service as required Verify correct support and travel of stationary and movable rails Verify smooth operation of the drive system Verify correct operation of display devices if applicable Verify correct operation within specifications of collimators auto and manual Verify correct calibration using manufacturer s specifications Verify correct operation of all buttons controls displays and or indicators Verify correct operation of unit in all functional modalities Clean exterior of unit including all accessories cables controls and displays On nab Medical equipment maintenance programme overview Appendix C
82. mprovement see section 5 3 6 for more information Additionally when internet access is available it can be a valuable resource Many technical resources are available online at little or no cost and online educational programmes may be an option to further technical knowledge and facilitate training Furthermore inexpensive voice communication and e mail communication enable effective collaboration across wide distances However where internet communication is unreliable keeping in touch by mobile phone can be an effective alternative The clinical engineering workshop is typically found within the facility itself but if the programme includes multiple facilities it may be more economical to establish a centralized repair depot Tools and test equipment The productivity of biomedical equipment technicians BMETs will be limited without appropriate tools and test equipment As purchases are planned it should be noted that investment in tools and test equipment results in 1 An example of an online educational opportunity is the series of courses developed by the University of Vermont in USA http its uvm edu medtech index html Spanish language versions of the courses are offered through Universidad CES Colombia and Pontifica Universidad Cat lica de Peru WHO Medical device technical series 18 reduced maintenance costs In addition having the right equipment will greatly increase the reliability of the readin
83. n a specialized outside trainer to teach staff about mainte nance of a particular piece or type of equipment e The clinical engineering department bringing in one of the manufactur trainers to present to biomedical equipment technicians about main tenance and operation Or training can take place outside the organization at e Third party training programmes designed to explain several models of a specific technology e Manufacturer s training programmes specifically designed for equipment technicians The methods of training suggested above progress from the least expensive to the most expensive to implement So depending on hospital resources local availability of information sources and the ability to coordinate with other hospitals who might have technicians to train as well the hospital can choose a methodology that best matches their resources It should be noted however that the most effective training methods for sophisticated equipment are the more expensive options The most sophisticated equipment in hospital settings consists of computer based multi component systems WHO Medical device technical series 25 26 Most of the performance inspection and verification of this equipment is performed by software based inspection systems built into the equipment itself Obtaining access to the computer codes and understanding how to maintain this equipment may only come with training provided by the
84. n country If this is not possible the department will then have to consider if this is the best purchase for them or if they can afford to translate the manuals themselves Procedures should not be changed until the owner has some experience with the device Then based on inputs from biomedical equipment technicians and or other organizations who also own the equipment or industry recommendations IPM procedures can be changed If this is done the justification for deviating from the manufacturer s suggested IPM procedure should be thoroughly documented for future reference The decision to make this change should also be reviewed periodically e g annually to make sure the conditions leading to the change persist In most cases the unique characteristics and features of devices require unique inspection steps for each different model However in some cases a generic procedure for all manufacturers and models e g oto ophthalmoscope fibre optic light source microscope can be used While using available generic procedures may be very convenient it must be done with understanding and discernment as some are written with the intention of providing only the most basic steps in an inspection Appendix B contains a procedure template and a few sample generic procedures 5 3 2 Setting IPM frequency The frequency of IPM is specified by the manufacturer of the equipment in the maintenance manual In cases where there is s
85. nctional back up generator is in place and that the switch to auxiliary power is made in under 10 seconds Another alternative may be to select and purchase equipment that is battery operated When considering acquiring new equipment it is also important for the technical personnel to ensure that the electrical power system is capable of supporting it When it cannot it often makes sense to opt for less sophisticated and more robust equipment Similarly technical personnel should be aware of how medical devices interact with other utility systems e g medical gas and vacuum systems temperature control and ventilation systems water supply information technology and communication infrastructure etc And once again they should collaborate with others in the organization to optimize the ability of the utility systems to support medical equipment Unique aspects of the physical environ ment such as high temperature and humidity can adversely affect medical equipment designed for use in temper ate climates or controlled environments Maintenance procedures in a particular country or region may need to be ad justed based on these local factors The age and condition of the health care facility may also play a role in medical equipment failure Over time utilities systems will degrade and may become overloaded and or outdated Older facilities will have been built to older standards Even new facilities may not meet all a
86. ng and difficult Modern electronic circuit boards digital circuit boards especially are frequently not repairable at the component level In those cases board level or even system level repair need to be considered e Board level For electronic devices it is common to isolate failures to a particular circuit board and to replace the entire circuit board rather than a given electronic component e Device or system level In some cases even board level troubleshooting and repair is too difficult or time consuming In such cases it can be more cost effective to replace the entire device or subsystem It is important to choose an appropriate level of maintenance for each situation This is dependent on the availability of financial physical and human resources as well as on the urgency of a particular repair request For high priority cases for example device level repairs may be preferred When more time is available board or component level repair may be feasible If component level repair is proposed part replacement may be necessary For this approach there are a few options from which to choose The replacement can be made with specialized parts from the manufacturer with generic parts of the same or higher specifications e g fuses or with spares reclaimed from non functional or obsolete equipment only after thorough risk assessment and permission of the clinical engineering manager In some cases the techn
87. nses are prohibited in areas where there is a risk of occupational exposure to blood or body fluids Personal protective equipment PPE 1 Disposable gloves are available within the clinical engineering department for all workers at risk of exposure for use at their discretion or as required 2 Eye protection and or a facemask will be worn whenever handling equipment that puts the employee at risk of occupational exposure to blood or body fluids through splashing Medical equipment maintenance programme overview 3 Personal protective equipment i e gowns gloves masks and goggles will be supplied by the user department whenever needed 4 Contaminated supplies i e gowns gloves masks and absorbent towels are to be placed in sturdy plastic bags and tightly closed for appropriate disposal Equipment precautions 1 All equipment containing serviced filters will have the filters cleaned replaced according to manufacturer recommendations Gloves will be worn during non HEPA high efficiency particulate air filter changes These filters will be placed in normal waste Any equipment containing a HEPA filter requires that gloves particulate respirator gown and protective eyewear are worn These filters will be disposed of as infectious waste All replaced filters from the clinical laboratory should be considered contaminated and disposed of as infectious waste Appropriate PPE will be worn A
88. nt is used for the specific purposes of diagnosis and treatment of disease or rehabilitation following disease or injury it can be used either alone or in combination with any accessory consumable or other piece of medical equipment Medical equipment excludes implantable disposable or single use medical devices 3 World Health Assembly resolution WHA60 29 May 2007 http www who int medical devices resolution wha60_29 en1 pdf accessed March 2011 4 Information document concerning the definition of the term medical device Global Harmonization Task Force 2005 http www ghtf org documents sg1 sg1 291162005 pdf accessed March 2011 Medical equipment maintenance programme overview Acknowledgements Medical equipment maintenance programme overview was developed under the primary authorship of Frank R Painter University of Connecticut Hartford Connecticut United States of America and Matthew F Baretich Baretich Engineering Fort Collins Colorado USA and under the overall direction of Adriana Velazquez Berumen WHO Geneva Switzerland as part of the Global Initiative on Health Technologies project funded by the Bill amp Melinda Gates Foundation The draft was reviewed by Jennifer Barragan WHO Jorge Calil Universidade Estadual de Campinas Adham Ismail WHO Jennifer Jackson Sapienza University lyad Mobarek WHO Rob Parsons consultant Lisa Stroux WHO Billy Teninty Engineering World Health and edited b
89. nts for reference and the expected IPM completion date time e Record and store the results of the IPM inspection procedures including tasks that passed or failed the measurements taken and the acceptable range of measured values e Record the CM activity including the problem with the device time spent in the repair process a description of the work done and the list of parts used e Produce summary reports of PM completion rates IPM that failed and required repair work gt IPM actual versus expected com pletion times Inventory lists of equipment by WHO Medical device technical series 29 30 location owner or device type Repairs completed in a certain time period List of parts used to repair equip ment over a certain time period In some countries where there is a shortage of staff and particularly of adequately trained staff the process of implementing a CMMS may begin as a dual system The initial inventory is taken on computer but also on paper so that there is a back up option and staff can be confident that there is a form of record keeping available with which they feel comfortable The active development of an inventory may also function as an extended training period Once the initial inventory is established and staff are more comfortable with computers and with the inventory system the paper records can be phased out Computerized maintenance management Sy
90. of the hospital facility Medical equipment maintenance programme overview e Routine work orders can be sent through the hospital facility interdepartmental mail system e The requesting department will be notified once the order has been received and the work has been scheduled IV Deferred e Routine requests may be deferred based on workload or priority No work order may be deferred for more than 10 normal working days without the approval of the clinical engineering manager 2 Information to identify the equipment the respective department and to describe the problem should be provided on the work request by the person originating the request for service or by the technician This may include the following a Inventory identification number b Cost center usually the user department c Equipment description Telephone number Name of contact Location of equipment Description of the problem ga 7 0 Upon completion of the work the technician will complete the work order within one day including all information relating to the service request All work orders are dated and logged for record keeping In the event that a work order cannot be completed in the requested time or within twelve business days the technician will notify the request originator or department manager and inform them of the reasons that the equipment repair will be delayed and provide them with an estimated time of repair It is the responsibili
91. ols and displays 0 o0o0RCN LLL oN oJ A UNEO WHO Medical device technical series 61 62 4 Monitor ECG FDA risk 2 Safety insp yr 2 Programme risk score Perf 2 Risk group Diagnostic PM checks yr 2 Procedure Inspect exterior of equipment for damage missing hardware Inspect the power cord strain relief and plug s for any signs of damage Turn unit off open user accessible covers and inspect unit for damage Clean unit interior components and exterior with vacuum or compressed air Inspect interior for signs of corrosion or missing hardware Repair as required Inspect electrical components for signs of excessive heat or deterioration Inspect patient cable and connectors for mechanical or electrical damage Verify correct detenting and lead shorting of lead selector switch Verify vertical gain and calibration pulse Inspect monitor diagnostic switch Verify correct sweep size linearity centring speed and vertical spacing Verify correct amplifier frequency response and common mode rejection Verify correct brightness and focus of trace Verify correct operation of freeze and cascade controls if applicable Verify accuracy of heart rate meter at 3 points for 3 accuracy Verify operation of high and low alarms for c
92. ols and displays Medical equipment maintenance programme overview Appendix B 3 Centrifuge table top FDA risk 1 Safety insp yr 1 Programme risk score Perf insp yr 4 Risk group Diagnostic PM checks yr 4 Procedure Inspect exterior of equipment for damage or missing hardware Inspect the power cord strain relief and plug s for any signs of damage Turn unit off open user accessible covers and inspect unit for damage Clean unit interior components and exterior with vacuum or compressed air Clean motor with compressed air Check brushes if applicable Inspect interior for signs of corrosion or missing hardware Repair as required Inspect electrical components for signs of excessive heat or deterioration Verify correct operation of lid and safety mechanism Inspect lid gasket Verify smooth operation of the timer and correct operation of braking Verify correct operation of tachometer if applicable Verify head balance Check for vibrations and excess noise Verify correct operation of refrigeration and thermostat if applicable Verify speed setting using a test photo tachometer Inspect motor brushes and armature for wear Clean out carbon build up Lubricate motor and mechanical parts where applicable Verify correct operation of all buttons controls displays and indicators Verify correct operation of unit in all functional modalities Clean exterior of unit including all accessories cables contr
93. onal management 5 3 1 Developing or changing IPM procedures 5 3 2 Setting IPM frequency 5 3 3 Scheduling maintenance 5 3 4 Prioritization of work 5 3 5 Keeping records 5 3 6 Computerized maintenance management systems 5 3 7 Tags and labels 5 3 8 Communication 5 3 9 Managing use and user error 5 3 10 Travel Performance monitoring 5 4 1 Completion rate of assigned IPM 5 4 2 Equipment location rate 5 4 3 IPM yield 5 4 4 IPM productivity 5 4 5 CM performance measures Performance improvement NN OOS N DOS pi puit CO C0 CO w C02 CO C2 CO CO Q2 CO PO PO PO PO PO PO PO PO PO P9 CO CO CO OO O WHO Medical device technical series 6 Implementation 35 6 1 Inspection and preventive maintenance 35 6 1 1 IPM procedures 35 6 1 2 Problem identification 35 6 2 Corrective maintenance 35 6 2 1 Troubleshooting and repair 35 6 2 2 Factors affecting equipment failures 36 6 2 3 Inspection and return to service 37 6 3 Reporting 37 6 4 Safety 37 7 Concluding remarks 39 References 40 Useful resources 41 Appendix Sample policies and procedures 43 Appendix A 1 Risk based biomedical equipment management programme 44 Appendix A 2 Initial testing and evaluation 48 Appendix A 3 Inspection and preventive maintenance procedure 50 Appendix A 4 Work order system for corrective maintenance 52 Appendix A 5 Corrective actions id
94. or demonstration is tested prior to its use in the hospital unless an emergency dictates otherwise In this instance the user should ensure with reasonable certainty that the equipment is in safe working condition before operating If the equipment is to remain in the hospital subsequent to its emergency use it must be safety tested by the clinical engineering department 1 All electrical equipment that passes the clinical engineering safety inspection will have a clinical equipment maintenance sticker affixed in a visible location or equivalent indicating that it has been inspected and is safe for use in the hospital Certain battery operated devices may be excluded from the preventive maintenance programme and will not have a sticker affixed Devices included in the programme but that do not require regular preventive maintenance will also receive a PM Exempt sticker 2 Any equipment that fails the clinical engineering safety inspection will be returned to its originating source with a description of the failure Such equipment device will be prohibited from being used in the facility until it has been repaired and satisfactorily passes the safety inspection C Equipment intended for use in a clinical laboratory application Vendor provided equipment in exchange for the purchase of reagents or consumables must be approved by hospital management the clinical laboratory or pathology department manager and safety tested prior to
95. orrect trigger and response time Cycle alarms and verify correct operation of audio and visual indicators Verify correct operation of all buttons controls displays and or indicators Verify correct operation of unit in all functional modalities Clean exterior of unit including all accessories cables controls and displays Medical equipment maintenance programme overview 5 Pump infusion FDA risk 2 Safety insp yr 2 Programme risk score Perf insp yr 2 Risk group Patient support PM checks yr 2 Procedure l Inspect exterior of equipment for damage or missing hardware 2 Inspect the power cord strain relief and plug s for any signs of damage 3 Turn unit off open user accessible covers and inspect unit for damage 4 Clean unit interior components and exterior with vacuum or compressed air 5 Inspect interior for signs of corrosion or missing hardware Repair as required 6 Inspect electrical components for signs of excessive heat or deterioration 7 Perform battery operation test 8 Test instrument service test mode 9 Verify pressure calibration 10 Perform auto pinch off test 11 Verify rate accuracy 12 Verify correct operation of all buttons controls displays and or indicators 13 Verify correct operation of unit in all functional modalities WHO Medical device technical series 63 64 Appendix B 6 X ray system mobile FDA risk 11 Safety insp yr 1 Progra
96. ower cord has a cut in the covering the technician should follow these steps a Perform the preventive maintenance procedure b Complete the PM work order form c Affix an updated sticker on the device Note if the PM work request is completed in a month after the scheduled month the technician will date the sticker to correspond with the month the work request was completed The due date should reflect the next due date based upon the last due month and the appropriate interval for the device d Initiate a corrective work order request affix a label to the device indicating it is out of service and inform the user department of the delay in return to service of the device 2 problem is determined to be minor the preventive maintenance procedure can be completed and the device can be returned to service e g a hose bracket for an anaesthesia machine is broken or a cosmetic label has fallen off the technician should follow these steps a Perform the preventive maintenance procedure Medical equipment maintenance programme overview b Complete the PM work order form c Affix an updated maintenance sticker on the device Note if the PM work request is completed in a month after the scheduled month the technician will date the sticker to correspond with the month the work request was completed The due date should reflect the next due date based upon the last due month and the appropriate interval for the device d Retu
97. plan for the equipment in a given clinical department to be inspected at the same time This works very well for equipment that does not move from the department Another approach would be to schedule inspection of equipment of a given type e g defibrillators simul taneously For preventive maintenance equipment may be scheduled by calen dar dates depending on the manufac turer s recommendation e g once every 3 months etc Alternatively it can be scheduled by hours of usage e g for volume ventilators In this case creat ing a method for the users to commu nicate the device s elapsed usage time to the clinical engineering department is important See section 5 3 8 for more on effective communication Because they are unscheduled CM activities will increase or decrease with demand Therefore it is important to have a pri oritization scheme in place so that CM resources are directed toward the most critical needs see section 5 3 4 for more information on prioritization For IPM the workload is best sched uled over the calendar year so that the work schedule and staff capacity can be aligned However during vacation or holiday periods where staffing levels in the department may be reduced consid eration can be given to reduce the IPM workload by moving IPM inspections to another time Measuring the workload created by scheduled IPM helps identify where adjustments may be needed Ap pendix C explains how the
98. pplicable standards Therefore it is often necessary to test the utility infrastructure rather than to assume it is functioning appropriately 6 2 3 Inspection and return to service After completion of repair it is essential to conduct a performance and safety inspection and in some cases a re calibration may be required These activities will measure the performance of the device and allow for any adjustments necessary to return the equipment to full functionality Once this is complete the device may be returned to use in patient care 1 Itis important for clinical engineers and biomedical equipment technicians to have a working knowledge of utility systems and facility infrastructure An article that provides an overview of these topics can be found in Issue 4 of Revista Ingenieria Biom dica Colombia http revistabme eia edu co numeros 4 index html 6 3 Reporting For IPM activities the technician typically has a detailed checklist to follow in order to record the results Having such a checklist also serves as a reminder of each step in the IPM process and thus helps avoid skipping or overlooking specific steps Recording measurements and documenting the final results either as pass fail or numeric values aids in the execution of future maintenance work including repairs Having the last few sets of IPM checklists on hand for reference during maintenance is extremely helpful for decision making For example
99. r basic computer resources Administrator Plan for transportation among hospitals and clinics Administrator transport services officer Plan for service request dispatching and clerical support Administrator Human resources Identify current human resources one engineer and a few technicians with varying skills Clinical engineering department manager Plan additional general and specialised training for technicians Plan management training for the engineer Develop links to external resources Clinical engineering department manager administrator Medical equipment maintenance programme overview 4 Managing maintenance programme within a regional health system Personnel management CMMS assigns scheduled and unscheduled work using defined protocols e Monitor hours worked by the technical staff and timely completion of scheduled and unscheduled work assignments Clinical engineering department manager Technical personnel document work on work order forms and in the CMMS software Technician Financial management Monitor costs associated with service contracts and with work carried out by technical staff Compare costs to budget review variances plan for future budgets Clinical engineering department manager Operational management Develop procedures and schedules for inspection and preventive maintenance
100. r the inspections and maintenance performed and any other important observations 7 When the IPM is completed successfully the equipment will receive an IPM sticker or other identification denoting its maintenance status 8 When the IPM and documentation is completed the work order will be updated in the records and or the CMMS 9 f scheduled work cannot be completed i e parts are needed equipment is in use equipment cannot be located the reason is documented on a work order This work will be followed up at a later date 10 When scheduled maintenance is performed by an outside vendor the biomedical engineering department will notify the vendor and schedule the maintenance service When maintenance and documentation is completed the work order is subsequently updated in the records and or the CMMS Medical equipment maintenance programme overview 11 12 13 14 15 Life support equipment due for maintenance but still in use by patients will be scheduled for maintenance after it is removed from the patient The technician will work closely with the clinical department to schedule the maintenance as soon as possible Equipment scheduled for IPM but which cannot be located can be identified as could not locate only after a concerted effort to locate the device has been made the equipment owners have made every attempt to locate it and the biomedical engineering supervisor manager has approved the device to
101. re carefully maintained Typically test equipment can be used for about seven years Highly specialized items such as troubleshooting software and laptop computers to connect to computer based laboratory or imaging equipment may have a shorter useful lifespan because the laboratory and imaging technology changes so quickly Medical equipment maintenance programme overview Tools and in particular test equipment must themselves be appropriately maintained They should be kept in good physical condition calibrated at appropriate intervals and repaired as required Where resources are constrained creativ ity is required establishing a network of technicians and engineers may mean that tools can be shared Facilities with few financial resources can consider rent ing or sharing expensive test equipment and tools with other hospitals in the sur rounding area Medical instrumentation in the developing world recommends a minimum set of tools and test equip ment for low resource settings 2 These recommendations represent the most basic level of investment in tools and test equipment that can enable meaningful service for medical devices Initial funding to start a programme is necessary but so too is providing additional ongoing funding to purchase calibrate and service test equipment for new medical equipment the hospital may acquire in the future or for test equipment needed to expand the scope of the maintenance progr
102. re type and multiplying it by the estimated time it is possible to determine an estimated total workload for the IPM programme Administrative time to create the IPM forms preparation time Medical equipment maintenance programme overview in getting ready to do inspections time to obtain the equipment to be inspected either bringing it to a central work area or going to the location of the equipment time to document the work done and re order PM parts used are all activities that should be added to the total workload calculation An example can be found in Appendix Direct maintenance costs can be difficult to estimate initially but will improve with time and experience Service contract costs however can be determined by negotiation with external service providers These types of services can be acquired on a time and materials basis or by contracting over a set period at a fixed rate In either case the cost must be planned in advance and included in related budgets Section 5 2 1 discusses further the issues surrounding engagement of service vendors The cost of service ratio is a useful measure in determining the financial effectiveness of a maintenance programme This ratio is calculated by dividing the total annual cost of operating a medical equipment maintenance programme by the value initial cost of medical equipment in the inventory In the United States for example the cost of service ratio is between 5
103. rn the unit to service e Initiate a corrective work order for eventual follow up action when the device is available and take appropriate actions to complete the request problem is determined to be more than minor and the preventive maintenance procedure cannot be completed e g the flow control module on a mechanical ventilator is damaged the technician should follow these steps a Initiate a corrective work order referencing the preventive work request number affix a label to the device indicating it is out of service and inform the user department of the delay in return to service of the device b Complete the preventive maintenance work order and must reference the corrective work order number c Upon completion of the corrective action resume the preventive maintenance procedure document that a preventive maintenance procedure was completed and then complete the corrective work request d Affix an updated maintenance sticker on the device Note the completion date will be the date the PM work request documentation is completed in the work order system For example a PM work request was completed in October and the CM work request was opened and carried over into November The PM sticker should reflect the October date coinciding with the PM work order The due date should reflect the next due date based upon the last due month and the appropriate interval for the device The technician will complete the CM work order and
104. romote efficiency Typically technical personnel will be assigned a combination of IPM and CM responsibilities However there may be cases where emphasis on one or the other types of maintenance WHO Medical device technical series 23 24 activities is appropriate Section 5 3 3 specifically discusses the various aspects of scheduling maintenance activities Personnel management also includes monitoring service vendors when maintenance must be outsourced see 5 2 1 below It is important to monitor the productivity of internal and outsourced technical personnel on a regular basis When applied to individual in house technicians productivity monitoring can identify those technicians needing additional support or training When applied to the maintenance programme as a whole productivity monitoring can identify opportunities to improve the cost effectiveness of the programme More details on performance monitoring and improvement are found in sections 5 4 and 5 5 The most important aspect of personnel management is the ability to ensure adequate training Training on new equipment as well as routine refresher training on existing hardware is necessary to ensure that technical staff are capable of properly maintaining and repairing the medical equipment included within the scope of the programme Section 5 2 2 discusses training in further detail 5 2 1 Service vendors As mentioned it is often not possible to provid
105. s are often used interchangeably Clinical engineering Engineer technician or team of engineers technicians responsible for the management and department group maintenance of medical equipment Depending on the context and country this department or team may be referred to by a wide variety of names Some alternative names include biomedical engineering department medical equipment maintenance department medical equipment management unit etc In this document we refer most often to clinical engineering department Common descriptive The terminology used to describe a device Using common universal descriptive names from a single nomenclature internationally accepted source is key to comparing inspection procedures inspection times failure rates service costs and other important maintenance management information from facility to facility Although manufacturers have specific names for devices it is important to store the common name of the device as listed in the nomenclature system e g nomenclature name electrosurgical system monopolar bipolar vendor name for the device electrosurgical generator vendor model name Radiolase Corrective A process used to restore the physical integrity safety and or performance of a device after a failure maintenance CM Corrective maintenance and unscheduled maintenance are regarded as equivalent to the term repair This document uses these terms interchangeably
106. s parts is an option if the quality and characteristics of each part is carefully analysed Purchasing generic parts from specialty medical equipment parts suppliers who do the engineering analysis and guarantee the parts they sell is a reasonable solution in many cases but associated risks e g loss of manufacturer guarantee non compliance with equipment specifications that leads to device failure must be carefully considered beforehand Operation and service manuals Ideally the maintenance programme will have an operation user manual and a service manual for each model of medical equipment The operation manual is valuable not only for equipment users but also for equipment technicians who need to understand in detail how the equipment is used in clinical practice The service manual is essential for inspection preventive maintenance repair and calibration Unfortunately operation manuals and service manuals are not always available or may be in a language not spoken by equipment technicians Therefore it is important that a clinical engineering department take steps that allow them access to such manuals For existing equipment the manuals may be borrowed from other local hospitals or obtained online Clinical engineering department managers should if possible have access to high speed Internet service for this purpose Manuals or advice may be found among the wider health technology management community s
107. safety of the patient and the user proper training is critical for both the user and the technical staff The technical staff and the clinical engineering department manager have dual responsibility for ensuring that the technical personnel as well as the clinical users are informed trained and versed on their specific responsibilities Training and education is not a one time activity but a continual process Enabling staff to see that learning is important and a constant feature of their job will improve reliability and success in future problem solving This section describes the training of technical personnel and section 5 3 9 briefly discusses user training Training of technical personnel can be provided inside the health care organization through e Self study gt reading the equipment service and training manuals using additional self study materi als provided by the manufacturer gt using materials provided by a third party e One to one training provided by a more experienced person from inside the organization This may be a clinician teaching biomedical equipment technicians how the device works for example or a technician who is familiar with the device guiding others about maintenance and operation e The biomedical equipment techni cian taking part in a education class for nurses or other clinical users to learn about the operation of the equipment e The clinical engineering department bringing i
108. signage should be posted tag out Furthermore personnel should be aware prior to performing maintenance work of particular medical technologies that may present special hazards such as chemical hazards from chemotherapeutic agents and from other sources radiation hazards from radiation generating equipment and radiopharmaceuticals magnetic field hazards from magnetic resonance imaging MRI equipment hazards from compressed gas cylinders etc Training in personal protective equipment PPE and techniques that will allow technical personnel to work safely in hazardous conditions are critical It is preferable to have PPE readily available within the clinical engineering department for hazardous maintenance Following maintenance especially after procedures that may have affected the safety features of a medical device technical personnel should verify that the device is safe to use mechanically and electrically Particular attention is given to electrical safety for medical devices such that ground resistance and leakage currents are measured to ensure that they are within applicable limits In the absence of electrical safety test equipment technical personnel must Medical equipment maintenance programme overview rely on careful repair techniques and simple electrical tests to verify device integrity Clinicians should be advised to check the settings of the device and to perform basic operational checks prior
109. stem in this technical series is a good resource when ready to implement such a system as it provides details on the key elements of an effective CMMS In cases where a CMMS may not be possible or is not necessary e g health centre small hospital ntroduction to medical equipment inventory management in this technical series is a good resource on getting started with tracking current inventory and equipment maintenance in a paper based way 5 3 7 Tags and labels It is good practice to label each piece of medical equipment with a unique identification number This number will be used by the users to communicate with the medical equipment maintenance department so there is no confusion about which specific piece of equipment is being reported When doing IPM procedures a label indicating the date the work was done and the procedure that was performed Medical equipment maintenance programme overview should be applied to the equipment for two reasons e communicate with clinicians and others that the device was recently inspected or maintained e To identify to IPM technicians which devices have been completed and which are still due for IPM When taking power measurements on equipment that have an output the measurements are recorded on the inspection form but many hospitals also choose to record these readings on a sticker which is placed on the equipment for future reference See Appendix D 2 and Appendix E for
110. t training in electronics biomedical equipment technology or a related field is required Experience At least three years experience as a biomedical equipment technician or a minimum of five years experience in electronic mechanical or electromechanical repair or equivalent preferably in a healthcare setting Medical equipment maintenance programme overview Appendix G 3 Biomedical equipment technician senior level Job description Performs tasks involving the installation and maintenance of therapeutic diagnostic and monitoring medical equipment These activities include 6 Being able to consistently perform a wide variety of routine complex and Specialized tasks associated with the installation maintenance and repair of a wide range of clinical equipment including life support equipment Training mentoring and guidance to entry level and mid level technicians Conducting training sessions for department staff covering safe operation and maintenance of equipment for entry level and mid level technicians Assisting in developing technical specifications for equipment purchases Routinely coordinating and managing projects performing any necessary communication and follow up with the department Leadership and prioritization of work in the absence of the manager Education Two year degree or equivalent training in electronics biomedical equipment technology or a related field is required Experience Requires a
111. tenance interval of six months Devices with average or minimal requirements values of 3 2 or 1 are scheduled for preventive maintenance annually e Devices with an EM number of 15 or above will be scheduled for inspection at least every six months Devices with an EM number of 19 or 20 will be given an inspection interval of four months Devices not included in the programme All patient care related equipment including therapeutic monitoring diagnostic or analytical equipment not included in the programme because it did not receive an EM number of 12 or above may still be included in the hospital s biomedical equipment inventory and be covered on a repair only basis Medical equipment maintenance programme overview Equipment classification examples Anaesthesia machine Anaesthesia vaporizer 5 3 15 5 enflurane ethrane Arthroscopic surgical unit 4 2 13 Breast pump Aspirator mobile Blood warmer Bone saw Blood pressure module Camera video medical 3 12 Cast cutter 4 3 7 N Cast cutter vacuum 2 3 5 N Cardiac output computer 3 2 12 Computer micro pc 3 1 5 N Cryosurgical unit 4 3 15 5 Defibrillator monitor 5 4 18 5 Electrocardiograph 3 channel 3 5 16 5 Endoscopic video system 3 3 12 Electrosurgical unit 4 3 16 5 Fetal monitor 3 3 13 Humidifier heated 3
112. tives is to ensure improved access quality and use of medical products and technologies This objective together with the World Health Assembly resolution formed the basis for establishing the Global Initiative on Health Technologies GIHT with funding from the Bill amp Melinda Gates Foundation GIHT aims to make core health technologies available at an affordable price particularly to communities in resource limited settings to effectively control important health problems It has two specific objectives e to challenge the international community to establish a framework for the development of national essential health technology programmes that will have a positive impact on the burden of disease and ensure effective use of resources tochallenge the business and scientific communities to identify and adapt innovative technologies that can have a significant impact on public health To meet these objectives WHO and partners have been working towards devising an agenda an action plan tools and guidelines to increase access to appropriate medical devices This document is part of a series of reference documents being developed for use at the country level The series will include the following subject areas policy framework for health technology medical device regulations health technology assessment health technology management needs assessment of medical devices medical device procurement medical equipment don
113. to medical technology Similarly technicians receive technical training with a primary focus on medical equipment maintenance Biomedical or clinical engineers come into the position Medical equipment maintenance programme overview after completion of a four to five year bachelor s degree progamme while biomedical equipment technicians often come into the position with two year s post graduate training and a degree or certificate in biomedical electronics or biomedical equipment technology Alternatively particularly in countries with fewer specialized training programmes engineers and technicians may be trained in a related field such as industrial engineering or electrical technology and have taken certificate courses received training or completed an apprenticeship enabling them to work in the area of medical equipment Engineers or technicians must have this additional training because medical equipment is highly specialized and if improperly maintained or repaired may have adverse consequences on human life This type of engineer or technician is usually easier to find in the employment marketplace but will need more supervision and training to effectively accomplish their work Overtime and with experience technicians may become qualified to take a position as a biomedical equipment technician However for engineers to become qualified as a biomedical or clinical engineer they must receive the relevant higher edu
114. ture Study prepared for the European Commission 2005 WHO Medical device technical series e Introduction to medical equipment inventory management Geneva World Health Organization 2011 Computerized maintenance management system Geneva World Health Organization 2011 e Medical device donations considerations for solicitation and provision Geneva World Health Organization 2011 Medical equipment maintenance programme overview Appendix Sample policies and procedures The following samples are provided to support the development of medical equipment maintenance policies and procedures in a hospital health centre or other health facilities The samples should be adapted and modified according to the specific needs and circumstances of any given institution the relevant resource context and local environment A 1 Risk based biomedical equipment management programme A 2 Initial testing and evaluation A 3 Inspection and preventive maintenance procedure A 4 Work order system for corrective maintenance A 5 Corrective actions identified during preventive maintenance A 6 Infection control WHO Medical device technical series 43 44 Appendix 1 Risk based biomedical equipment management programme Equipment inclusion criteria have been developed to evaluate each piece of equipment in use at a hospital or health facility The following details a modified version of the Fennigkoh and Smith model see reference 6 wh
115. ty of each clinical engineering technician to follow up on such situations as needed and personally contact the request originator or department manager if necessary WHO Medical device technical series 53 54 5 Corrective actions identified during preventive maintenance The clinical engineering department performs preventive maintenance procedures on a timely basis as part of the hospital s equipment management plan Corrective actions arising during preventive maintenance procedures will be documented appropriately Purpose To ensure corrective actions are performed and documented appropriately when found during preventive maintenance procedures Procedure A No problem found during preventive maintenance of a medical device 1 Once the preventive maintenance procedure is performed the technician will complete the preventive maintenance work order form 2 The technician will affix an updated maintenance sticker or other record of inspection on the device Note if the PM work request is completed in a month later than the scheduled month the technician will date the sticker to correspond with the month the work request was completed 3 The technician will return the device to service B Problem found during preventive maintenance of a medical device 1 If a problem is determined to be minor the preventive maintenance procedure can be completed and the device cannot be returned to service e g a p
116. uch as the Infratech mailing list For new equipment it is important that these manuals are included as part of the purchase agreement All manufacturers who sell equipment are required to provide detailed IPM procedures for use by those who buy their equipment These procedures are usually written very clearly and in many cases with illustrations for performing complete and appropriate IPM However manufacturers may not provide specific IPM procedures maintenance and service manuals troubleshooting guidelines parts lists and schematics unless the owner requires them to do so at the time of purchase Even if the hospital staff does not plan to do maintenance on a particular piece of equipment having maintenance and service manuals enables the hospital to provide the manuals to external maintenance providers or do the repairs themselves in the future if circumstances change For donated equipment when manuals have not been provided and due to the age or type of equipment are impossible to access the instincts and know how of the staff will be the primary resource However 2 Instructions on how to join the Infratech listserv are found at http infratechonline net page 4 38 WHO Medical device technical series 20 the clinical engineering department should consider developing their own guidelines and emphasizing the importance of including operation and service manuals with every donation Developing countries shou
117. ufficient familiarity with the equipment or because of resource constraints the clinical engineering department manager may prefer to modify what equipment to inspect how often maintenance should be performed and what parts should be replaced Before changing the inspection frequency of a medical device the manager should consider the regulatory environment the physical environment the level of user training the reliability of the equipment the frequency of use how much wear the equipment receives during normal use and the number and types of technical staff available This information could then be presented to a multidisciplinary safety committee if available or hospital management to make the final decision In this way the decision making responsibility is soread to a broader group of interested parties When the clinical engineering department is unfamiliar with the equipment it is best to simply follow the manufacturer s recommendations and adjust the procedures and frequency only after familiarity increases Where a level less than the manufacturer s specification is determined this should be noted in the equipment s maintenance record 5 3 3 Scheduling maintenance Efficient use of technician time will reduce down time of equipment and minimize overall expenses The most appropriate method for scheduling maintenance in a particular health care facility should be chosen For inspections one approach is to
118. with an adequate level of IPM Devices excluded are those for which there is no evidence that they benefit from scheduled IPM Resource based prioritization This methodology uses any of the three prioritization models see above in combination with knowledge about the staffing and resource levels of the particular facility or region in order to define maintenance priorities In this way the devices with the highest risk most important to the work of the hospital or that are maintenance critical would be maintained first and other devices with a lower prioritization rank would be maintained if resources permitted In addition to these methods priority may be given to IPM and CM of equipment that generates revenue for the health care organization The same is true when the non availability of equipment incurs higher costs for the organization due to the costs of temporary rental of replacement equipment for example 5 3 5 Keeping records The record for each device should include identifying data such as a brief descrip tion manufacturer model serial number and location see ntroduction to medical equipment inventory management in this technical series for more details It is helpful to also include data regarding the time and expense of providing scheduled and unscheduled maintenance services for the device These data are typically contained in work order records that pro vide documentation of every maintenance t
119. y Inis Communication We would like to thank Aditi A Sharma for assistance in proofreading and Karina Reyes Moya and Gudrun Ingolfsdottir for administrative support throughout the development of this document Declarations of interests Conflict of interest statements were collected from all contributors and reviewers to the document development No conflicts of interest were declared WHO Medical device technical series Acronyms and abbreviations AAMI ACCE BMET CIMV CM CMMS ECG EM FDA GIHT HEPA HTM IPM ISO MRI NFPA PM PPE SIMV TAGHT UPS WHO Association for Advancement of Medical Instrumentation American College of Clinical Engineering biomedical equipment technician conventional intermittent mandatory ventilation corrective maintenance computerized maintenance management system electrocardiograph equipment management Food and Drug Administration Global Initiative on Health Technologies high efficiency particulate air health health care technology management inspection and preventive maintenance independent service organization magnetic resonance imaging National Fire Protection Association preventive maintenance personal protective equipment synchronized intermittent mandatory ventilation Technical Advisory Group on Health Technology uninterruptable power supply World Health Organization Medical equipment maintenance programme overview Executive summary Medical devices are assets that dire

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