Washer monitoring: A must-have for today`s best practices (Part 2)
Contents
1. Preventive maintenance One key to assuring optimal daily per formance minimizing downtime and maximizing equipment life is appropriate maintenance Performing regularly sched uled maintenance according to the manufac turer s recommended timeline is actually a way to monitor the washer By performing al _ ees Sponsored by thorough preventive maintenance the hos pital biomed professional or original equip ment manufacturer service technician can replace the washer s worn parts before they fail and look for signs of unexpected wear on larger parts which helps to ensure that the washer is performing at its best The consequences of forgoing preventive maintenance could be huge Imagine that a worn part for example a seal or bush ing fails and causes the washer to abort its cycle during peak processing hours This puts a strain on the department and could prevent surgical instruments from being turned around in time for the next surgery Since preventive maintenance is scheduled in advance it can happen during off peak hours to help reduce disruptions during the busiest time of the day Emergency maintenance can also be more expensive The total cost not only includes the actual cost of the repair and associated parts but the lost revenue associated with any downtime the costs for extra labor needed to catch up when the system is back online and the time wasted when department staff is idle waiting2. She is responsible for managing product development sales and marketing for single chamber multi chamber and cart wash ers and their accessories She has experience as a product development scientist at manufacturing companies in multiple industries Benz holds a Bachelor of Science degree in Engineering Man agement from Miami University sponsored by STERISSELF STUDY SERIES References Facilities AAMI ST79 2006 p 55 58 97 169 1 References 1 5 Food and Drug Administration Office of Device Evaluation Class II Special Controls 3 References 12 13 AORN Perioperative Standards and Recommended Practices 2012 Edition Recom Guidance Document Medical Washers and Medical Washer Disinfectors Guidance for the Medical Device mendation p 521 533 ODS and DROVE Stat RO ROCRUME WIRE USA he Daly 7 2007 Fonnar engi 2720 4 References 14 17 International Standards Organization 15883 Washer disinfectors Part 1 General 2 References 6 11 AAMI Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare requirements terms and definitions and tests 2006 Edition P 20 21 CONTINUING EDUCATION TEST NOVEMBER 2012 Washer monitoring A must have for today s best practices Part Two Circle the one correct answer 1 Process indicators for washers are designed to 7 According to AAMI guidance mechanical cleaning equipment should be tested upon installation hourly a Monitor the performance parameters of a
3. automated washing equipment and suggest that process param eter results be reviewed and documented regularly as part of an ongoing quality management program AAMI states The purpose of cleaning and rinsing is to remove all visible debris from an item and to reduce the number of particulates mi croorganisms and potential pathogens The accepted standard for the degree of clean is visibly clean To ensure that mechanical cleaning equipment is working properly and according to the manufacturer s specifications health care personnel may perform verification tests as part of the overall quality assur ance program Methods of verification include the use of devices that directly test individual instruments for residual soils challenge cleaning effectiveness with standardize test methods or measure specific key parameters to evaluate the functionality of the cleaning equipment Mechanical cleaning equipment should be tested upon installation weekly preferably daily during routine use and after major repairs Monitoring and verifying cleaning processes should be documented Some mechanical washers have digital readouts and cycle printouts that should be reviewed for each cycle and initialed Ideally cleaned medical devices should be traceable to the patients on whom they are used They also make this recommendation After completing the cleaning process per sonnel should visually inspect each item care fully to de
4. equipment to a level that renders them safe to handle by persons who will inspect and prepare them for terminal sterilization This type of decontamination equip ment can use a single chamber for rinsing clean ing and drying or can use multiple chambers i e one chamber for each phase of the cycle These phases can include an initial cool water rinse to remove protein debris an enzymatic rinse a detergent wash an ultrasonic cleaning a sustained hot water rinse a deionized water final rinse a lubrication rinse a liquid chemical germicide rinse and a drying cycle The sequenc ing and number of stages can vary among manufacturers The instrument manufacturer s instructions should be used to determine the amount of time necessary to efficiently clean and rinse the instruments The operator should ensure that the proper cycle is being used They continue A quality management program should be in place to test mechanical cleaning equip ment Mechanical instrument washers should be tested for proper functioning before initial use weekly during service and after major maintenance Adequate cleaning of surgical instruments is essential to remove or destroy microorganisms and eliminate endotoxins Testing washer decontaminators on a regular basis verifies that the equipment is function ing properly or indentifies an opportunity for corrective action Washer testing products are commercially available As mentioned prev
5. for the unit to be repaired In addition to avoiding financial conse quences the other important benefit of pre ventive maintenance is that it puts someone familiar with the washer in front of it at regularly scheduled intervals to monitor the performance of individual components The end result is that the washer is less likely to fail when you need it the most Compliance to standards yields best practices As has been stated before cleaning is a critical step in the sterile processing of reusable medical devices For this reason establishing a quality management system that incorporates equipment monitoring is recommended by many healthcare profes sional organizations No discussion of washer monitoring is complete without a review of recommenda tions from these guidance organizations and global standards like the ISO 15883 series Each has a different perspective but all offer guidance that can help departments develop washer disinfector monitoring processes that are compliant and in line with best practices Association for the Advancement of Medi cal Instrumentation AAMI While AAMI acknowledges that visual in spection is the widely accepted standard in the market today for degree of cleanliness they also provide several suggested verifi cation tests to further validate that medical STERISSELF STUDY SERIES devices have been properly cleaned and disinfected They stress the importance of regular monitoring of
6. lipids and dyes designed to represent the soils on used surgical equipment 3 A published validated cycle documents the sci entific testing process and results proving that a washer achieved the cleaning and disinfection 10 When a washer disinfector that meets the ISO standard finishes a cycle without warnings or faults the conditions were right for cleaning and for the claimed level of disinfection to occur results specified in the FDA Special Controls a True b False Guidance Document a True b False 4 Remote diagnostic monitoring is Presented by Sponsored by a An adjunct to observation by department staff b A 24 7 web based monitoring service H FA LTH CARE S If F R S c A method for identifying a part that may be PURCHASING NEWS wearing out d Away to dispatch a technician proactively e All of the above Request for Scoring Detach exam and return to 5 Performing regularly scheduled maintenance have enclosed the scoring fee of 10 Pay Continuing Education Division on a washer according to the manufacturer s able to KSR Publishing Inc We regret that KSR Publishing Inc Se tme meS adtua Via Tarm gn no refunds can be given Multiple submissions 2477 Stickney Point Road Suite 315B a True g b False may be submitted in bulk and paid with a Sarasota FL 34231 single check for the bulk sum PH 941 927 9345 Fax 941 927 9588 6 The consequences of forgoing preventive main tenance could be serious because a
7. the controller of the attainment of those process variables affecting both the cleaning and disinfection processes The standard describes sensing locations in the washer disinfector for the process parameters It even defines a method of measuring temperature in the chamber At least one temperature sensor shall be located in a position which was previously deter mined as being representative of the lowest temperature achieved within the load This shall make it possible to determine that all surfaces which are required to be disinfected throughout the load and chamber will attain the disinfection temperature for the required time This gives the user additional reas surance that the temperature achieved dur ing the thermal rinse phase is sufficient for the claimed level of disinfection to occur However if a sensor were to fail during the cycle the standard gives guidance for the washer disinfector s ability to notify the 32 November 2012 HEALTHCARE PURCHASING NEWS www hpnonline com user Failure of any sensor in a system controlling disin fection time or temperature shall cause a fault to be indi cated Again this gives the user reassurance that when a washer disinfector that meets the standard finishes a cycle without warnings or faults the conditions were right for cleaning and for the claimed level of disinfection to occur This ISO standard also dis cusses in detail the specifi
8. A worn part could fail and cause the washer to abort its cycle during peak processing hours which could prevent surgical instruments trom being turned around b Emergencymaintenancecanbemoreespensve Tile o and the total cost includes the actual cost of the repair and parts the lost revenue associated Hospital Name aaa needed to catch up when the system is back online and the staff time wasted when techni Apt Suite SSS SSS cians are idle waiting for the unit to be repaired c Without preventive maintenance at regular City State Zio o intervals the washer is more likely to fail when l no ee Daytime Phone d aandc E mail O O e All of the above www hpnonline com HEALTHCARE PURCHASING NEWS November 2012 33 Please print or type Return this page only
9. HASING NEWS www hpnonline com A washer disinfector test indicator and holder designed By to present a cleaning challenge in the chamber The most common method to evaluate the results of the cleaning process is a visual inspection sometimes involving the use of a lighted magnifying glass Healthcare personnel inspect every device for visible organic soil and contamina tion in a simple functionality check usually as part of the inspection preparation and packaging procedure Process indicators There are a number of washer indicators on the market today that are designed to moni tor the performance parameters of a washer disinfector It is important to understand that these indicators do not indicate whether instruments have been thoroughly cleaned rather they verify that critical process pa rameters have been met in all phases of the cleaning and decontamination cycle The chemical indicator substrates are often coated with proteins carbohydrates lip ids and dyes that are designed to represent the soils commonly found on used surgical VERIFY equipment These All Clean Test coating formula Code LCC012 LOT tions are designed to break down and disappear or change color when all of the key washer disin fector process pa rameters including time temperature mechanical action impingement and clean ing chemistry have been met through the cleaning and disinfection process
10. HEALTHCARE SELF STUDY SERIES sponsoras STERIS Washer monitoring A must have for today s best practices Part 2 PURCHASING NEWS November 2012 The self study lesson on this central service topic was developed by STERIS The lessons are administered by KSR Publishing Inc Earn CEUs The series can assist readers in maintaining their CS certification After careful study of the lesson com plete the examination at the end of this section Mail the complete examination and scoring fee to Health care Purchasing News for grading We will notify you if you have a passing score of 70 percent or higher and you will receive a certificate of completion within 30 days Previous lessons are available on the Internet at www hpnonline com Certification The CBSPD Certification Board for Sterile Processing and Distribution has pre approved this in service for one 1 contact hour for a period of five 5 years from the date of original publication Successful completion of the lesson and post test must be documented by facility management and those records maintained by the individual until re certification is required DO NOT SEND LESSON OR TEST TO CBSPD For additional information regarding certification con tact CBSPD 148 Main Street Suite C 1 Lebanon NJ 08833 www sterileprocessing org For more infor mation direct any questions to Healthcare Purchasing News 941 927 9345 ext 202 Learning Objectives 1 Understan
11. c requirements for establishing a cleaning validation includ ing routine testing Ultimately for the patients When the ultimate goal of a washing and disinfection protocol in a reprocessing department is to reduce the risk of infection and other adverse reactions in patients then all guidelines standards and monitoring options must be considered in order to design the optimal cleaning policies and procedures for the facility In the two parts of this self series lesson we have attempted to provide an overview of the most current monitoring capabilities and the multiple options and resources available to sterile processing de partments By selecting quality systems with automated monitoring options and applying available guidance and standards healthcare providers can incorporate the monitoring capabilities that support departmental best practices and maximize patient safety HPN Zak Harty is a product manager for washing systems at STERIS Corporation with responsi bilities for overseeing product development sales and marketing He has also served as a product manager for STERIS surgical solutions and has an extensive background in design engineering application engineering and test engineering in various industries Harty holds a Bachelor of Sci ence in Mechanical Engineering from Rensselaer Polytechnic Institute Lindsay Benz is a product manager in the Infec tion Prevention Technology division of STERIS Corporation
12. d the different methods of washer monitoring in the reprocessing department 2 Discuss the washer monitoring recommendations of industry guidance organizations 3 Discuss how to implement a monitoring process based on guidance and standards Sponsored by VAX VR_CBSPD EC AA STERIS by Zak Harty and Lindsay Benz asher monitoring has improved in recent years Like most prod ucts in the world today washer disinfectors have more technology built in than ever before This technology allows the washer disinfector to provide useful information to the user and the department manager about the cycle and any errors or faults that occur It gives the user more as surance that the critical process parameters are maintained during a cycle and that the conditions were right for cleaning and dis infection to occur Once a washer disinfector is installed in a sterile processing department there are a number of monitoring activities and practices that can be employed Additional technologies are also available that allow a system to be remotely monitored Any detected issues can elicit proactive service to maximize uptime and minimize negative impact to the department Preventative maintenance also serves as a means to monitor this type of equipment Having a trained set of eyes inspect the equipment for signs that parts need to be replaced can extend the life of the unit and reduce the likelihood that emergency service
13. during routine use and after major repairs washer a True b False b Determine whether instruments processed in the washer are clean c Represent the clinical soils found on used surgical 8 ISO sets forth several types of verification for critical process variables They include a Verification by the operator of the attainment of thermal disinfection b Verification by process record independent from the controller of the attainment of thermal disinfection condi instruments dase ae A oe cou c Verification of standardized test methods l ee panda d Verification by process record independent trom the controller of the attainment of those process variables affecting both the cleaning and disinfection processes 2 There are several ways to monitor washer e a b andd disinfector performance including f All of the above a Verification of critical process parameters by the control program Visual inspection of instruments c Remote diagnostic monitoring and preventive maintenance A d Washer process indicators c Are designed to disappear or change color when all key washer disintector process parameters have been met e aandb in the cleaning and disinfection process n All of the above d Indicate that instruments are clean l e a b andc 9 Washer indicators a Verify that critical process parameters have been met in all phases of the cleaning and decontamination cycle b Are often coated with proteins carbohydrates
14. iously under the Pro cess Indicators section of this article these washer indicators monitor the performance of automatic washing equipment by verify ing that critical process parameters have been met in all phases of the selected cycle International Standards Organization The international standard ISO 15883 goes into great detail about the monitoring capa bilities that a washer disinfector must have in order to claim compliance to the standard The level of detail is too fine to cover every point in this lesson However there are several key points that warrant attention The stan dard focuses heavily on the critical process parameters The WD shall be fitted with a means to verify and or record the attainment of the specified process conditions Based on the instruments being processed and their terminal process the standard provides rec ommendations for the amount of monitoring the washer disinfector should have The nature and extent of monitoring shall be commensurate with the intended use of the load and the risk arising from not detecting a failure to attain the specified value of one or more critical process variables Three different levels are defined 1 Verification by the operator of the attainment of thermal disinfection 2 Verification by process record indepen dent from the controller of the attainment of thermal disinfection conditions 3 Verification by process record indepen dent from
15. sinfector inoperable Visual inspection a standard practice As an added level of assurance reprocess ing professionals should visually inspect the instruments after they have been processed in the washer disinfector As AAMI states The extra assurance of validated cycles All of these important parameters need to be within the tolerances determined by the manufacturer for the cycle to be completed effectively but how does the user know that the parameters were indeed within the limits Washers with sophisticated PC controls have the ability to accurately reliably and repeatedly monitor the critical parameters of the cycle and are smart enough to alert the user when there is a risk that the process was not effective Some washer disinfector manufacturers offer even more confirmation that these critical process pa rameters are being met in the standard washer cycle This assurance is offered in the form of a published validated cycle The validated cycle documents the scientific testing process and results proving that the washer achieved the cleaning and disinfection results specified in the FDA Special Controls Guidance Document Medical Washers and Medical Washer Disintectors By comparing the manufacturer s vali dated cycle document to the Special Controls Guidance Document a user can be confident that their washer disinfector if used according to manufacturer directions is doing its job 30 November 2012 HEALTHCARE PURC
16. tect any visible soil Inspection using magnification might identify residues more readily than with the unaided eye Although validation of the cleaning process may not be realistic in health care facilities verification is possible Device manufacturers should provide any test procedures that can be easily replicated and that can help users recognize whether cleaning was effective for all device areas Such tests are particularly important for devices with components that cannot be readily inspected for cleanliness The AAMI Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities Annex D Tables 1 amp 2 pg 172 173 provides several verification tests that measure cleaning efficacy Association of periOperative Registered Nurses AORN AORN helps define the cleaning process and guides healthcare facilities to follow the medical device manufacturer s instructions for use when determining specific cleaning See SELF STUDY SERIES on page 32 VOL 36 3 8 9 2 3 9 V S Jv V E I Z a suemsuy sa Apnys as www hpnonline com HEALTHCARE PURCHASING NEWS November 2012 31 SELF STUDY SERIES sponsorea y STERIS parameters for a given device They also recommend that departments establish a quality management program to aid in moni toring the ongoing performance of auto mated washing equipment They state that Washer decontaminator cycles are intended to process instruments and
17. will impact the department In addition the standards and recommen dations provided by key professional and regulating bodies for washer disinfectors offer information to both the manufacturers and the users of these systems This gives the user extra reassurance that the conditions were right for cleaning and disinfection to occur and guidance to the department to help them verify that the process was com pleted effectively The end result of thorough washer disinfector monitoring is a more efficient department and better outcomes for patients Remote diagnostic monitoring Washer disinfectors often provide informa tion to the user by sounding or displaying alarms and warnings Although the washer s user manual may indicate the process to fol low if the washer alarms or issues a warning many times the manual is not immediately available or the alarms and warnings may go unnoticed in a busy department As an adjunct to departmental observation some systems come equipped with web based connectivity that allows linkage to a remote diagnostic monitoring service A 24 7 monitoring service can help keep track of alarms warnings or cycle aborts and will notice patterns consistent with a part need ing replacement for example Service center professionals can notify the department if abnormal washer operation is observed and can dispatch a technician proactively to the department to fix a problem before it renders the washer di
Download Pdf Manuals
Related Search