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Comparative cost-efficiency of the EVOTECH endoscope cleaner

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1. did not permit a comparison on this macro level In addi tion with a macro level examination of endoscopy clinic efficiency comparing different reprocessors such a study could determine staff s ability to perform other clinical duties while still ensuring efficient reprocessing of endo scopes Finally the full impact of failed cycles could be incorporated where if the EVOTECH ECR fails during a cycle because a connection was not made properly the computer notifies the technician right away with a visual and auditory signal along with the reason for the failed cycle With the immediate notification the con nection can be rectified and the cycle can be re started The AER in use at this study site did not have a signal to notify the operator of a poor connection The impact of these additional efficiencies or safety features with EVOTECH ECR compared with an AER could not be incorporated into the present study but should be con sidered in future research The present study was also limited in its ability to examine the impact of other potential advantages of the EVOTECH ECR over AERs First the long term use of the EVOTECH ECR rather than an AER may reduce the cost related to the number of scopes required annually With wear and tear on endoscopes associated with manual brushing 20 21 scopes may have to be replaced and or repaired more frequently Second the EVOTECH ECR records information about the doctor patient scope type and
2. median followed by interquartile range For all the ana lyses p lt 0 05 was considered as statistically significant All cost figures are reported in Canadian dollars Results The total numbers of each scope type that were evalu able for the analysis are shown in Table 2 One cycle of each reprocessor type was excluded because the cycles had to be repeated due to human error in connecting the tubing For the EVOTECH ECR the cycle was auto matically interrupted after 13 minutes due to a detected disconnection in an endoscope connector The connec tion was fixed and the cycle was repeated The lost time was therefore between 14 15 minutes For the AER a similar poor connection was discovered by the user but only after the completion of the cycle because the AER did not have an alarm or other signal to indicate when the tubing disconnected from the scope After the poor Forte and Shum BMC Gastroenterology 2011 11 105 Page 5 of 10 http www biomedcentral com 1471 230X 11 105 Table 2 Mean total reprocessing time and time savings with the EVOTECH ECR Colonoscope Gastroscope Bronchoscope EVOTECH ECR umber of scopes 21 9 4 edian time mins per scope 3742 37 22 36 04 inter quartile range 36 72 37 63 36 65 37 38 35 69 36 58 Manual cleaning plus AER umber of scopes 23 16 8 edian time mins per scope 49 88 44 27 42 43 inter quartile range 49 42 51 12 42 71 45 37 41 70 43 81 Difference between EVOTECH
3. 00002 and 1 54 minutes for each bronchoscope p 0 0485 Cycle reprocessing with EVOTECH ECR required between 20 to 30 less time than manual cleaning plus AER despite the fact that a large portion approximately 2 3 minutes per cycle of the technician s labour was spent entering the identification information for the operator physician and patient data not shown with EVOTECH ECR These activities were not per formed with the AER although a technical manual for Medivators DSD 201 indicates that this information can be collected 14 Time Savings with EVOTECH ECR The daily savings in labour and total reprocessing time are presented in Table 4 The time savings achieved on a daily basis with the EVOTECH ECR were 6 2 hours for total cycle time and 1 8 hours of direct labour time Labour Cost Savings with EVOTECH ECR The value of the total time saved every day with EVO TECH ECR 6 2 hours was 138 41 per day and 35 987 per year The value of the direct labour time saved every day with EVOTECH ECR 1 8 hours was 39 07 per day and 10 159 per year Table 3 Labour only time involved in reprocessing with each reprocessor type Colonoscope Gastroscope Bronchoscope EVOTECH ECR Median time mins per scope Ta 7 07 5 89 interquartile range 6 57 7 48 6 50 7 23 5 54 6 44 Manual cleaning plus AER Median time mins per scope 9 88 9 27 7 43 interquartile range 9 42 11 12 7 71 10 37 6 70 8 81 Difference b
4. operator allowing improved tracking of information in case of a system failure Third there is less environmental impact with the Page 9 of 10 EVOTECH ECR because an AER requires the use of more disposable supplies in the manual cleaning step While this study predicts significant savings in terms of human labour it is unknown whether in practice those savings could be redistributed to other functions within the clinic or hospital or whether 25 more scopes could actually be reprocessed in a day without the need to expand the physical structure of the labora tory Future research could examine precisely how the time and cost savings with the use of EVOTECH ECR could be realized through shifting personnel responsibil ities For example at the study site personnel in the endoscopy reprocessing unit utilize any downtime dur ing the automated portion of the reprocessing cycle to assist other staff to prepare beds and the operatories where the endoscopy procedures take place It is possi ble that the total number of personnel employed in the gastroenterology clinic could be reduced through effi ciencies like these Conclusions In summary the EVOTECH ECR was more efficient and less costly to use for the reprocessing of endoscopes than manual cleaning plus AER as shown in actual prac tice in a busy endoscopy unit in Canada Although the cost of consumable supplies required to reprocess endo scopes with EVOTECH ECR was slightly high
5. 6 34 561 570 Page 10 of 10 20 Thomas LA Care and handling of the flexible endoscope http www educationaldimensions com eLearn endoscope damage php Accessed April 20 2011 21 Canada Endoscope Corporation Troubleshooting common flexible endoscope problems http canadaendoscope ca services troubleshooting Accessed April 20 2011 Pre publication history The pre publication history for this paper can be accessed here http www biomedcentral com 1471 230X 11 105 prepub doi 10 1186 1471 230X 11 105 Cite this article as Forte and Shum Comparative cost efficiency of the EVOTECH endoscope cleaner and reprocessor versus manual cleaning plus automated endoscope reprocessing in a real world Canadian hospital endoscopy setting BMC Gastroenterology 2011 11 105 Submit your next manuscript to BioMed Central and take full advantage of e Convenient online submission e Thorough peer review e No space constraints or color figure charges e Immediate publication on acceptance e Inclusion in PubMed CAS Scopus and Google Scholar e Research which is freely available for redistribution Submit your manuscript at www biomedcentral com submit BioMed Central
6. ECR and Manual cleaning plus AER mins 12 46 6 31 5 66 p value lt 0 0001 lt 0 0001 0 0040 Wilcoxon rank sum test connection was discovered the connection was repaired and the cycle was restarted The lost processing time was estimated at 35 5 minutes 35 minutes to repeat the cycle plus 0 5 minutes to open the reprocessor and dis cover and fix the improper connection In addition a total of 14 14 cycles were excluded from the analysis because due to the timing of staff breaks either the first or second phase of the cycle could not be timed Time Consumed in Reprocessing Scopes The total time to reprocess all scope types was signifi cantly shorter in the EVOTECH ECR compared with manual cleaning plus AER The differences in median time to reprocess each scope in the EVOTECH ECR ver sus manual cleaning plus AER were 12 46 minutes per colonoscope p lt 0 0001 6 31 minutes per gastroscope p lt 0 0001 and 5 66 minutes per bronchoscope p 0 0040 The average total number of minutes required to reprocess each type of scope along with the time differ ence between the reprocessor types are shown in Table 2 The total labour time spent on each scope type was also similarly shorter for the EVOTECH ECR Table 3 The differences in median labour time to reprocess each scope in the EVOTECH ECR versus manual cleaning plus AER were 2 61 minutes for each colonoscope p lt 0 0001 2 20 minutes for each gastroscope p 0
7. Forte and Shum BMC Gastroenterology 2011 11 105 http www biomedcentral com 1471 230X 11 105 p BMC Gastroenterology RESEARCH ARTICLE Open Access Comparative cost efficiency of the EVOTECH endoscope cleaner and reprocessor versus manual cleaning plus automated endoscope reprocessing in a real world Canadian hospital endoscopy setting Lindy Forte and Cynthia Shum Abstract Background Reprocessing of endoscopes generally requires labour intensive manual cleaning followed by high level disinfection in an automated endoscope reprocessor AER EVOTECH Endoscope Cleaner and Reprocessor ECR is approved for fully automated cleaning and disinfection whereas AERs require manual cleaning prior to the high level disinfection procedure The purpose of this economic evaluation was to determine the cost efficiency of the ECR versus AER methods of endoscopy reprocessing in an actual practice setting Methods A time and motion study was conducted at a Canadian hospital to collect data on the personnel resources and consumable supplies costs associated with the use of EVOTECH ECR versus manual cleaning followed by AER with Medivators DSD 201 Reprocessing of all endoscopes was observed and timed for both reprocessor types over three days Laboratory staff members were interviewed regarding the consumption and cost of all disposable supplies and equipment Exact Wilcoxon rank sum test was used for assessing differences in total cycle reprocessing
8. al cleaning plus AER disinfection The purpose of this economic evalua tion was to determine the cost efficiency of using the EVOTECH ECR versus an AER disinfection process from the perspective of hospital decision makers mana ging operating budgets by comparing the annual utiliza tion costs including labour and consumable supplies involved in using each reprocessor type in an actual clinical practice setting in Canada Methods Time and Motion Study A time and motion study was conducted at a Canadian hospital to collect data on the personnel resources and consumable supplies costs associated with the use of EVOTECH ECR Advanced Sterilization Products ASP a unit of Johnson amp Johnson Medical Products and Medivators Reprocessing Systems DSD 201 Auto mated Endoscope Reprocessor AER Minntech Cor poration Following a pre study visit where the disinfection process was observed a data collection form was developed to objectively capture the time involved in each stage of the reprocessing procedure and to quantify the disposable equipment supplies con sumed The reprocessing of all colono gastro and broncho scopes by two technicians in the endoscopy unit were then observed over three days during two vis its Three stopwatches were used to simultaneously col lect all scope reprocessing times as outlined in Table 1 A wet leak test was not routinely performed for endo scopes to be reprocessed with the EVOTECH ECR beca
9. al day was calcu lated by multiplying the number of each scope type by the observed average number of minutes per scope Savings in time related to technician labour and reprocessing cycle time were calculated by subtracting the total time for a typical day using only manual cleaning plus AER from the total time for a typical day using only the EVOTECH ECR Value of the Time Saved The scope reprocessing time saved was multiplied by a technician wage of CDN 22 20 per hour including bene fits Human Resources Department L H6pital Maison neuve Rosemont Statistical Analysis A scope reprocessing cycle was considered evaluable for the analysis if both phases of the reprocessing i e man ual cleaning leak testing and removal from the reproces sor were captured In some cases due to the timing of lunch breaks or the start of the cycle occurring too late in the day the first or second phase of the cycle was not timed and therefore the cycle was excluded from the analysis Endoscopic Retrograde Cholangiopancrea tography ERCP scopes were also excluded because there were too few processed 2 in the ECR and 1 in the AER during the timeframe of the study SAS version 9 2 SAS Institute Cary NC was used for the statistical analysis Exact Wilcoxon rank sum test was used for assessing the difference in total time spent on colono gastro and bronchoscopes between EVOTECH ECR and manual cleaning plus AER Data were presented as
10. ards set for rou tine manual cleaning in at least 99 to 100 of cleaning cycles 12 Combined the research suggests that EVO TECH ECR s automated process is at least as effective as manual cleaning plus AER and when the value of human labour involved in the cleaning and reprocessing procedures is included use of EVOTECH ECR is also cost saving Within the scope of this study it was not possible to determine whether EVOTECH ECR would be more effi cient and less costly to use than all other AERs on the Canadian market nor was it possible to determine if EVOTECH ECR would be less costly in countries out side of Canada It should also be noted that there are some cases in which automated cleaning in EVOTECH ECR is not possible For example EVOTECH ECR can not be used to reprocess double biopsy channel scopes and ultrasound scopes In addition in cases where endo scopes are used for emergency procedures or where reprocessing is delayed for more than one hour manual cleaning of the endoscopes to be reprocessed with EVO TECH ECR is still required 12 Therefore in these relatively infrequent scenarios the cost of reprocessing in the EVOTECH ECR could be higher than the cost with manual cleaning plus AER because the labour cost savings associated with the avoidance of manual clean ing would not be realized Future research could be con ducted over a time period long enough to ensure that the rare incidences where manual cleaning of
11. c personnel time is saved on a daily basis when the EVOTECH ECR is used rather than a reprocessor that requires manual cleaning of endoscopes For each endoscope processed EVOTECH ECR saved a total of 12 5 minutes per colo noscope 6 3 minutes per gastroscope and 5 7 minutes per bronchoscope compared with manual cleaning plus AER The significant per cycle time savings was seen despite the 2 3 minutes required every cycle for the technician to enter identification information for the operator procedure physician and patient a feature that was not employed with the AER in use in the study clinic Had this feature been activated an even greater time difference between the EVOTECH ECR and the AER reprocessing cycles could be expected Over the course of a day the per scope time savings translated into a savings of 6 2 hours of time spent in the reprocessing laboratory and almost 2 hours of tech nician direct labour time alone The analysis showed that the value of the time saved would be about 35 987 per year in a technician s salary alternatively 25 Forte and Shum BMC Gastroenterology 2011 11 105 http www biomedcentral com 1471 230X 11 105 Page 7 of 10 Table 5 Cost of consumables involved in reprocessing endoscopes with manual cleaning plus AER Cost per Scope Cost per Year Multiuse brushes Sterilization of multiuse brushes Test strips Fibertech Enzymatic soap 4L Cidex OPA in AER for automated endoscope c
12. cal to do so With the requirement to concurrently monitor all of the activities of two laboratory technicians simultaneously employing a total of up to 8 reprocessing bays it was determined that there would be too much error intro duced if more than three stopwatches requiring different start stop and re start times were used Instead for the EVOTECH ECR an average cycle duration was calcu lated based on the read outs produced following each cycle According to the EVOTECH ECR Technical Man ual 13 individual cycle durations can be between 30 and 33 minutes The average cycle duration for the EVOTECH ECR cycles observed during the study was 31 minutes The high level disinfection phase was 5 minutes 20 seconds at 50 C followed by two 45 second tap water rinses at 35 C With the Medivators DSD 201 AER there was a variance in cycle time depending upon the scope type The total cycle lengths displayed on the unit were assumed as follows colonoscope 40 minutes gastroscope 35 minutes bronchoscope 35 minutes According to the clinic s practice the AER was pro grammed to soak all scopes in high level disinfectant for 5 minutes at 28 29 C The total reprocessing time for colonoscopes was 5 minutes longer because the AER was programmed to perform two tap water rinses The time involved in all procedures that were com mon to both reprocessor types e g gross pre cleaning in operatory rooms walk from operatory to endoscope reprocess
13. data collection even though a recent study has shown that the manual leak test may not be required 12 Second the hospital selected for the comparison of the reprocessors was par ticularly efficient in the manual cleaning process due to Page 8 of 10 the use of an in house developed non commercial flushing device The device conducted the enzymatic and water flushes of the endoscope channels through an automated process without the need for clinic personnel to change hosing and or attach and remove sources of detergent or water as required Third all of the recom mended steps for reprocessing of endoscopes with EVO TECH ECR were timed including the entry of operator physician and patient identification for every cycle there was no recording of this information in the AER A limitation of the study is the fact that an evaluation of the effectiveness of reprocessing scopes in EVOTECH ECR versus manual cleaning plus AER could not be incorporated in conjunction with the time and motion study However other published references have demon strated that cleaning in the EVOTECH ECR is non inferior to manual cleaning using worst case conditions for the EVOTECH ECR and best case conditions for manual cleaning and according to standards set in con sultation with the FDA based on published literature 13 In addition a recent Canadian publication showed that the use of EVOTECH ECR to clean endoscopes in actual practice met or exceeded stand
14. e EVOTECH ECR was demonstrated to be 99 to 100 effective in meeting or surpassing the cleaning endpoints set for protein hemoglobin and bioburden residuals in a recent study of actual clinic use and simu lated use 12 The authors of the efficacy study con cluded that the EVOTECH ECR is an effective automated approach that ensures surfaces and channels Page 2 of 10 of flexible endoscopes are adequately cleaned after hav ing only a bedside pre cleaning consisting of a flush with enzymatic detergent solution through all channels and wiping of the exterior of the insertion tube using a cloth moistened with the same enzymatic detergent With EVOTECH ECR manual cleaning is not required except in cases where reprocessing is delayed for more than one hour or in emergency situations where patients are not properly prepped prior to the procedure Based on this research the FDA concluded that manual clean ing of endoscopes is not required prior to processing in the EVOTECH ECR as long as a cycle including a wash stage is selected The wash stage completed in the EVO TECH ECR eliminates tedious manual brushing of the endoscopes and results in cleaning that is safe fast and consistent each time While it appears that the EVOTECH ECR would save valuable time and effort on the part of staff responsible for reprocessing endoscopes there are no studies quan tifying the total time required to reprocess endoscopes with EVOTECH ECR compared to manu
15. ed completely i e if a technician was asked to leave the endoscope reproces sing activity to attend to something else otherwise normal conversation and the negative impact that this would have on a technician s speed and efficiency was included for both the EVOTECH ECR and the AER cycles equally The impact of technicians efficiencies during the manual cleaning step required with the AER only was incorporated when it occurred For example at the study site a semi automated cleaning process was in place whereby following a wet leak testing and man ual brushing of the endoscope channels a machine developed by engineers at the hospital was connected to the endoscope to complete the enzymatic and tap water flushes Efficiencies in the process occurred when tech nicians were able to initiate the draining of the sink before the enzymatic flushing process was fully complete such that the tap water rinse could start immediately without the need to wait for the sink to drain After each scope was placed in a separate basin of each reprocessor type the actual durations of the Forte and Shum BMC Gastroenterology 2011 11 105 http www biomedcentral com 1471 230X 11 105 various phases of the reprocessing period i e the leak test pre rinse wash rinse disinfection final rinse and alcohol flush stages for EVOTECH ECR and the disin fection rinse alcohol flush and air purge for the AER were not timed because it was not practi
16. end of the article 2011 Forte and Shum licensee BioMed Central Ltd This is an Open Access article distributed under the terms of the Creative C BioMed Central Commons Attribution License http creativecommons org licenses by 2 0 which permits unrestricted use distribution and reproduction in any medium provided the original work is properly cited Forte and Shum BMC Gastroenterology 2011 11 105 http www biomedcentral com 1471 230X 11 105 Background Endoscopes are medical devices consisting of a long thin flexible or rigid tube equipped with a light and a video camera and are critical tools used in the screening and diagnosis of medical conditions such as cancer breathing disorders internal bleeding and stomach ulcers Endoscopes are also used to guide biopsies and laparoscopic surgery thereby avoiding the need for more invasive procedures It has been estimated that about 17 million gastrointestinal endoscopic and 500 000 flexible bronchoscopic procedures are performed each year in the United States 1 2 During endoscopic procedures the scopes come into contact with mucous membranes and bodily fluids and therefore must undergo thorough reliable cleaning and high level disinfection between uses 3 4 The cleaning and disinfection process requires meticulous labor intensive manual cleaning followed by high level disin fection When conducted according to guidelines devel oped by the Society of Gastroenterology N
17. endo scopes to be reprocessed with EVOTECH ECR could be included in order to examine the impact that the Forte and Shum BMC Gastroenterology 2011 11 105 http www biomedcentral com 1471 230X 11 105 additional cleaning time would have on the overall cost comparison of EVOTECH ECR vs an AER The present study was designed to determine effi ciency and cost on a micro or per cycle basis while not interrupting the usual clinic practice where both repro cessor types were used continuously each day Conse quently the ability of the study to project overall costs or savings to the endoscopy department with the use of EVOTECH ECR versus manual cleaning plus AER on a more macro level was limited Future research could monitor the use of EVOTECH ECR compared with manual cleaning and reprocessing with an AER by repeating the study on one day with the use of EVO TECH ECR only and another day with an AER only A study of this design would allow researchers to deter mine the full length of time used to clean and disinfect an equivalent number of scopes taking into considera tion the fact that each of the reprocessors can clean two endoscopes concurrently and thus the difference in total reprocessing time required with the two reproces sor types would be less than the 6 2 hours reported in this study The clinic set up at this study site where both reprocessor types were used continuously each day to keep up with the demand for clean endoscopes
18. er than with manual cleaning plus AER the value of the signifi cantly shorter labour time with EVOTECH ECR more than offset the additional consumables cost Further research should be done to determine if the increased efficiency with EVOTECH ECR would permit endoscopy clinics to realize even further cost savings by shifting endoscopy laboratory personnel responsibilities Acknowledgements The authors would like to thank the Sterile Processing Department SPD at L H pital Maisonneuve Rosemont Montreal Canada for performing the endoscope reprocessing and assisting in the collection of consumable cost data The authors would also like to thank Ying Qi biostatistician Toronto Canada for planning and performing all of the statistical data analysis Author details VALORE Research Toronto Ontario Canada Johnson and Johnson Medical Products Department of Health Economics amp Outcomes Research Markham Ontario Canada Authors contributions All authors have read and approved the final manuscript CS was responsible for the study concept and provided direction for the conduct of the data collection LF designed the study and data collection forms performed all data collection interpreted the data and wrote the manuscript with input from CS LF had independent control over the study methods and collection of the data Advanced Sterilization Products personnel provided assistance with the editing of the manuscript Competing in
19. es used in reprocessing scopes and the additional labour involved in equipment maintenance for the AER and the EVO TECH ECR respectively Total per Cycle Cost Savings with EVOTECH ECR The total per cycle cost of consumables and labour for maintenance was slightly higher for EVOTECH ECR versus the AER 8 91 versus 8 31 respectively Including the cost of labour consumed in reprocessing scopes the per cycle and annual costs of using the EVOTECH ECR was less than the cost of using the AER 11 50 versus 11 88 as shown in Table 7 With a cost savings of 0 38 it was estimated that the hospital would save 3 920 per year to reprocess the 10 316 endoscopes used annually Efficiency With shorter cycles in EVOTECH ECR the total per scope time saved would be 374 minutes per day With a weighted average total reprocessing time of 38 minutes per scope for all scope types processed in EVOTECH ECR an additional 9 84 scopes could be processed every day and 2 558 additional scopes could be processed each year This represents an increase of 25 additional scopes each day 9 84 40 This study examining the cost efficiency of EVOTECH ECR versus manual cleaning plus AER captured the time consuming and labor intensive efforts required for the critical cleaning and disinfection of endoscopes dur ing actual gastroenterology clinic practice in a high volume Canadian hospital The investigation demon strated that a substantial amount of clini
20. etween EVOTECH ECR and Manual cleaning plus AER mins 2 61 2 20 1 54 p value lt 0 0001 0 00002 0 0485 Wilcoxon rank sum test Forte and Shum BMC Gastroenterology 2011 11 105 http www biomedcentral com 1471 230X 11 105 Page 6 of 10 Table 4 Average daily total reprocessing and personnel labour times Colonoscopes Gastroscopes Bronchoscopes Typical average number of scopes per day 22 14 4 Total reprocessing time EVOTECH ECR Average time per scope mins 38 22 37 92 36 99 Total daily reprocessing time mins 839 518 151 Manual cleaning plus AER Average time per scope mins 50 29 44 24 42 64 Total daily reprocessing time mins 1104 604 174 Difference between EVOTECH ECR and Manual cleaning plus AER Savings in total reprocessing time with EVOTECH ECR mins 265 86 23 Total daily time savings for reprocessing all scopes 374 minutes 6 2 hours Labour only time EVOTECH ECR Average time per scope mins 7 22 6 92 5 99 Total daily labour time mins 159 95 24 Manual cleaning plus AER Average time per scope mins 10 29 9 24 7 64 Total daily labour time mins 226 126 31 Difference between EVOTECH ECR and Manual cleaning plus AER Savings in total reprocessing time with EVOTECH ECR mins 67 32 7 Total daily time savings for reprocessing all scopes 106 minutes 1 8 hours Consumables and Additional Hospital Personnel Time Discussion Utilized in Reprocessing Tables 5 and 6 show all of the consumabl
21. ing laboratory disposal of sterile tray liner cleaning of endoscope trays preparation of endoscope trays for next procedure was not collected as the pro cess was the same for both reprocessor types Calculation of Scope Processing Times The total time taken for reprocessing was calculated by adding the observed time for the manual cleaning leak testing standard reprocessing time for each scope type and removal of scopes from the reprocessors An aver age time for each type of scope reprocessed with the ECR versus manual cleaning plus AER was calculated by adding the total time separately for all colono gastro and broncho scopes for each reprocessor and then dividing the total by the number of each type of scope The average time per scope was calculated without and with the standard cycle reprocessing times to obtain the time for the personnel labour only and the total time including automated high level disinfection The total number of scopes processed annually by the hospital in the Sterile Processing Department was available for the most recent full year From April 1 2008 to March Page 4 of 10 31 2009 the endoscopy unit at L H pital Maisonneuve Rosemont reprocessed 5 780 colonoscopes 3 550 gastro scopes and 1 058 bronchoscopes A typical day was cal culated by dividing the total number of each scope type by 260 clinic days per year The number of minutes taken in the reprocessing of all scopes for a typic
22. leaning Labour to change Cidex after every 45 cycles 70 alcohol for alcohol flush Cidex OPA in ultrasonic device to clean multiuse brushes Blue wipes to dry endoscopes after manual cleaning Blue wraps to cover brushes to be autoclaved at the end of each day Small filter 6 per year Ultra filter replacement every 2 years Ultra filter cleaning 3 times per year labour Ultra filter cleaning 3 times per year Cidex Total annual consumables cost Cost of consumables per scope 1 11 broncho 15 860 21 1 59 colono gastro 0 14 1 443 00 1 21 12 465 17 0 70 7 207 53 4 15 42 822 86 0 09 933 02 0 006 62 05 0 03 284 58 0 29 3 037 03 0 004 38 27 0 009 90 00 0 04 425 00 0 03 360 00 0 07 700 50 85 729 23 8 31 Annual cost of disposable brushes would be much higher at 82 528 A less costly disinfectant such as glutaraldehyde may be used if glutaraldehyde was used the disinfectant cost would be lower more scopes could be reprocessed annually at the same labour cost While the cost of consumable supplies required for endoscope processing and reprocessor maintenance was slightly higher with EVOTECH ECR 8 91 vs 8 31 per scope the reduced labour cost more than offset the higher cost of consumed and dis posable supplies such that the total per scope costs were 11 50 with EVOTECH ECR and 11 88 with manual cleaning plus AER On average endoscopes are used up to 1200 times a
23. nnually 14 Great care must be taken during cleaning because they are fragile and expensive to replace There must also be certainty that infectious agents are destroyed to prevent cross contamination from one patient to another Thus the demand for rapid turnover of endoscopes must be balanced with the need to ensure patient health Despite the availability of state of the art equipment highly technical cleaning solutions and detergents and guidelines for the Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes 4 human error has led to the potential spread of infection through endoscopes that weren t adequately cleaned 9 10 15 17 Recent surveys report that manual cleaning is inade quately performed at least some of the time 7 8 18 Other published reports suggest that the time spent and steps taken to manually clean flexible endoscopes in clinic practice are highly variable and can range from 4 to 25 minutes 19 Moreover the time taken to manu ally clean endoscopes according to guidelines may be up to five fold higher than the time taken spent manually cleaning endoscopes in usual clinic practice 19 To Table 6 Cost of consumables involved in reprocessing endoscopes in EVOTECH ECR Cost per Scope Cost per Year Cidex OPA for automated single use cleaning of each endoscope 7 75 79 912 68 Labour to change the Cidex 0 02 168 10 70 alcohol for internal flush of each endosc
24. ope 0 03 310 27 Cidezyme for automated daily disinfection of the EVOTECH ECR 0 89 9 174 31 Labour to perform auto disinfection cycle 0 003 28 86 1 um External Pre Filter 0 09 225 00 0 2 um Internal Evotech Machine Filter 0 33 825 00 0 2 um External Hybrid Carbon Filter 0 16 400 00 0 2 um External Membrane Filter 0 32 800 00 Labour to change filters 0 02 49 95 Total annual consumables cost 91 894 17 Cost of consumables per scope 8 91 Forte and Shum BMC Gastroenterology 2011 11 105 http www biomedcentral com 1471 230X 11 105 Table 7 Total per cycle and annual costs of labour plus consumables EVOTECH Manual cleaning plus ECR AER Annual cost of 91 894 17 85 729 23 consumables Annual cost of labour 26 695 03 36 854 22 Total annual cost 118 589 20 122 583 45 Total cost per cycle 11 50 11 88 Does not include personnel labour time elapsed during cycle processing as employees could be available to work on other tasks while a scope is in the reprocessor Does not include acquisition cost of either processor achieve reliable consistent results and minimize the chance of cross contamination manufacturer and SGNA guidelines must be meticulously followed By removing the manual cleaning step the EVOTECH ECR s automated cleaning process can not only mini mize the likelihood of human error but also increase clinic efficiency and decrease overall costs This study was the first to directl
25. processing of flexible gastrointestinal endoscopes Gastroenterol Nurs 2006 29 42 48 5 Mehta AC Prakash UBS Garland R et al Prevention of flexible bronchoscopy associated infection Chest 2005 128 1742 1755 6 Spach DH Silverstein FE Stamm WE Transmission of infection by gastrointestinal endoscopy and bronchoscopy Ann Intern Med 1993 118 117 128 7 Alfa MJ Olson N Degagne P Jackson M A survey of reprocessing methods residual viable bioburden and soil levels in patient ready endoscopic retrograde choliangiopancreatography duodenoscopes used in Canadian centers Infect Control Hosp Epidemiol 2002 23 198 206 8 Moses FM Lee JS Current GI endoscope disinfection and QA practices Dig Dis Sci 2004 49 1791 1797 9 Bronowicki JP Venard V Bott C Monhoven N Gastin Chon L Hudziak H Rihn B Delano C LeFaou A Bigard MA Gaucher P Patient to patient transmission of hepatitis C virus during colonoscopy N Engl J Med 1997 337 237 40 0 Agerton T Valway S Gore B Pozsik C Plikaytis B Woodley C Onorato Transmission of a highly drug resistant strain strain W1 of Mycobacterium tuberculosis Community outbreak and nosocomial transmission via a contaminated bronchoscope JAMA 1997 278 1073 7 1 Food and Drug Administration 2008 http www accessdata fda gov cdrh_docs pdf8 K082392 pdf Accessed April 20 2011 2 Alfa MJ Degagne P Olson N Fatima Correction EVOTECH endoscope cleaner and reproces
26. sor ECR simulated use and clinical use evaluation of cleaning efficacy BMC Infectious Diseases 2010 10 291 3 Advanced Sterilization Products The EVOTECH Endoscope Cleaner and Reprocessor Product Monograph December 2008 4 Minntech Corporation Business Group Medivators Reprocessing Systems User Manual Single shot Generator Kit for DSD 201 DSD 91E Endoscope Reprocessors 50090 946 Revision A 2003 5 Canadian Broadcasting Corporation Dirty endoscopes used at Victoria hospital 2010 http www cbc ca canada british columbia story 2010 04 22 bc victoria hospital dirty endoscopes html ref rss Accessed August 2010 6 Kozarek RA Bronowicki J P Bigard MA Transmission of Hepatitis C Virus during Colonoscopy New Engl J Med 1997 337 1848 1849 7 US Food and Drug Administration the Centers for Disease Control and Prevention and the Department of Veterans Affairs Preventing Cross Contamination in Endoscope Processing Safety Communication from FDA CDC and the VA 2009 http www fda gov MedicalDevices Safety AlertsandNotices ucm190273 htm Accessed July 16 2010 18 Ofstead CL Wetzler HP Snyder AK Horton RA Endoscope Reprocessing Methods A Prospective Study on the Impact of Human Factors and Automation Gastroenterology Nursing 2010 33 54 19 Alfa MJ Olson N Degagne P Automated washing with the Reliance Endoscope Processing System and its equivalence to optimal manual cleaning Am J Infect Control 200
27. t reprocessing adapter tubing to connection port in basin x Place lid closure on reprocessor x x Program and start cycle X X Phase 2 Removal of scopes from reprocessor at conclusion of cycle Enter operator identification x x Open reprocessor lid x x Disconnect color coded tubing from scope x Disconnect reprocessing adapter tubing from connection port in basin with manual check to ensure connections x were properly placed Return accessories and scope to Cleanascope transport tray for next procedure or to the storage cupboard if the x x scope is not required in the short term Included all steps involved in preparing scope for reprocessing and then starting the reprocessing cycle The EVOTECH ECR performs an automated wet and dry leak test A manual leak test according to the endoscope manufacturer s instructions is also recommended Thus although it may not be required with EVOTECH ECR a manual wet leak test was incorporated in the analysis Although the Medivators DSD 201 was capable of recording the same information this procedure was not in place at the study site Included all steps required to remove scope from reprocessor and replace scope in storage testing in EVOTECH ECR the time required for the manual wet leak was incorporated in the total per scope labour times for EVOTECH ECR Timing was paused during the data collection period if a technician was distracted by conversation such that the normal activity was stopp
28. terests CS is an employee of Johnson and Johnson Medical Products LF is an employee of VALORE Research VALORE Research received funding Forte and Shum BMC Gastroenterology 2011 11 105 http www biomedcentral com 1471 230X 11 105 including the article processing charge for the study provided by Johnson and Johnson Medical Products a division of Johnson and Johnson Canada VALORE Research had independent control over the methods of the study and had the right to publish the analysis regardless of its results VALORE Research will not gain or lose financially from the publication of this manuscript Received 7 December 2010 Accepted 3 October 2011 Published 3 October 2011 References 1 Seeff LC Richards TB Shapiro JA Nadel MR Manninen DL Given LS Dong FB Winges LD McKenna MT How many endoscopies are performed for colorectal cancer screening Results from CDC s survey of endoscopic capacity Gastroenterol 2004 127 1670 1677 2 Ernst A Silvestri GA Johnstone D American College of Chest Physicians Interventional pulmonary procedures Guidelines from the American College of Chest Physicians Chest 2003 123 5 1693 1717 3 Society of Gastroenterology Nurses and Associates Guideline for the use of high level disinfectants and sterilants for reprocessing of flexible gastrointestinal endoscopes Gastroenterol Nurs 2003 27 198 206 4 Society of Gastroenterology Nurses and Associates Standards of infection control and re
29. time Results Endoscope reprocessing was significantly shorter with the ECR than with manual cleaning followed by AER The differences in median time were 12 46 minutes per colonoscope p lt 0 0001 6 31 minutes per gastroscope p lt 0 0001 and 5 66 minutes per bronchoscope p 0 0040 Almost 2 hours of direct labour time was saved daily with the ECR The total per cycle cost of consumables and labour for maintenance was slightly higher for EVOTECH ECR versus manual cleaning followed by AER 8 91 versus 8 31 respectively Including the cost of direct labour time consumed in reprocessing scopes the per cycle and annual costs of using the EVOTECH ECR was less than the cost of manual cleaning followed by AER disinfection 11 50 versus 11 88 Conclusions The EVOTECH ECR was more efficient and less costly to use for the reprocessing of endoscopes than manual cleaning followed by AER disinfection Although the cost of consumable supplies required to reprocess endoscopes with EVOTECH ECR was slightly higher the value of the labour time saved with EVOTECH ECR more than offset the additional consumables cost The increased efficiency with EVOTECH ECR could lead to even further cost savings by shifting endoscopy laboratory personnel responsibilities but further study is required Correspondence lindy forte sympatico ca VALORE Research Toronto Ontario Canada Full list of author information is available at the
30. urses and Associates 3 4 manual cleaning is highly effective in reducing bioburden on endoscopes failure to perform good manual cleaning can result in a failure in disinfec tion increasing the risk of patient and staff exposure to microorganisms including pathogens 5 6 Because the results of this time consuming process are dependent upon technique and method outcomes can be variable 7 8 With the need to reprocess endoscopes quickly to meet the demand in busy clinics reprocessing personnel are under pressure to make the cleaning and disinfecting process as efficient as possible Research has shown that manual cleaning practices vary from one facility to another whereby one survey showed that only 43 of centers were fully compliant with national guidelines 7 As a result the SGNA states that inadequate cleaning of endoscopes has been one factor cited in transmission of infection by flexible endoscopes 3 There are also reports in the literature of patient to patient transmission of serious infection following inade quate cleaning of endoscopes 9 10 The need for a more automated reliable cleaning and disinfection process led to the development of the EVO TECH Endoscope Cleaner and Reprocessor ECR which was the first system to receive U S Food and Drug Administration approval to eliminate manual pre cleaning of the endoscope prior to its automated high level disinfection processing 11 The effectiveness of th
31. use the EVOTECH ECR performs automated wet and dry leak tests Because some sites may choose to perform the manual wet leak test in addition to the leak Forte and Shum BMC Gastroenterology 2011 11 105 http www biomedcentral com 1471 230X 11 105 Table 1 Steps observed in the reprocessing of endoscopes Page 3 of 10 EVOTECH Manual ECR cleaning plus AER Phase 1 Preparation of scopes for reprocessing Fill sink with water x x Clean valves x x Remove suction air water and biopsy valves in sink brush the valves and other removable parts place valve parts in the reprocessor Manual wet leak test X x Add enzymatic detergent to sink x Brush internal channels three times each x Connect cleaning adapters tubing to scope x Flush interior of scope with enzymatic detergent using hospital developed automated flushing system x Drain sink of enzymatic detergent X Rinse interior of scope with tap water using hospital developed automated flushing system X Rinse exterior of scope with tap water spray X Drain sink and remove scope from sink X x Dry exterior of scope with a blue wipe x Walk from sink to reprocessor with scope X x Place scope in an unoccupied basin of reprocessor x Xx Connect colour coded connecting tubing to scope according to specific scope connection diagram X Enter identification data for operator physician scope type procedure and patient X Connec
32. y compare the effi ciency and cost of reprocessing endoscopes with EVO TECH ECR versus manual cleaning and reprocessing with an AER in an actual Canadian clinic practice Strengths include the fact that the study was designed from the perspective of hospital administrators responsi ble for operating budgets interested in the costs and benefits of using a newer reprocessor relative to their existing equipment as such actual clinic procedures were recorded by an unbiased third party observer and actual clinic methods and costs were incorporated However it should be noted that the study did not examine differences in acquisition and maintenance contract costs of EVOTECH ECR vs AERs which may be important for capital purchasing departments The relative acquisition cost of the two reprocessor types could not be included because comparative pricing was not publicly available in Canada Another strength of the study lies in the design of the investigation where bias against manual cleaning plus AER was avoided for three main reasons First the time required to conduct a manual leak test of all scopes to be reprocessed in the EVOTECH ECR as per the EVO TECH user manual was included Because the EVO TECH ECR conducts an automated wet and dry leak test some users may not perform a manual leak test as per endoscope manufacturers instructions To be con servative the time required to perform a wet leak test was included in the EVOTECH ECR

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