- Email: [email protected]
Reuse of disposable medical devices in Canadian hospitals
B. A. Camp&M, R.N., B.&N., CIC G. A. Wells, B&z, MSc., Ph.D. W. N. Palmer, B.A. D. L. Martin, M.B.A., FACHE Ottawa,
Ontario,
Canada
A survey of all Canadian hospitals was undertaken in 1986 to determine the extent of the reuse of disposable medical devices meant for “single use only.” It was found that 41% of hospitals regularly reused disposable medical devices, and reuse was significantly higher in hospitals with more than 200 beds. Only 38% of hospitals that regularly reused had written procedures for reuse, and 32% indicated a mechanism for determining the number of times a device was reused. Cost analysis studies had been undertaken by only 29% of regular reusers, and items of respiratory therapy equipment were the most commonly reused devices. (AM J INFECT CONTROL 1987;15:196-200)
The issue of whether to reprocess and reuse disposable medical devices meant for “single use only” has been surrounded by controversy. Arguments for and against reprocessing and reusing single-use items have been summarized in in the literature.‘, ’ Other issues implicated the practice of reuse such as those of a legal, ethical, and economic nature have also been discussedJ The safety and efficacy of dialyzer reuse has been supported by several major studies,4-6 and standards have been prepared for the reuse of hemodialyzers ?, 8 However, recent reports of bacteremia associated with reuse of disposable hollow-fiber hemodialyzers may require a review and reassessment of this practice.9 Studies done on the reuse of disposable syringes and needles by patients with diabetes have indicated that this practice may be safe.“-13 The From the Division of Hospital Epidemiology and the Division of Biometrics, Bureau of Communicable Disease Epidemiology, Health Protection Branch, Health and Welfare Canada; the Health Care Section, Health Division, Statistics Canada; and the Health Services and Promotion Branch, Health and Welfare Canada. Reprint requests: B. Campbell, Nurse Consultant, cable Disease Epidemiology, Laboratory Centre Control, Ottawa, Ontario, Kl A OL2 Canada.
196
Communifor Disease
reuse of disposable arterial pressure domes have been associated with epidemic bacteremia,14 and endotoxin reactions have been associated with the reuse of cardiac catheters.” A study by Jacobson et al.,” however, found no statistically significant difference in adverse reactions associated with cardiac catheter reuse. Using previously implanted pacemakers produced no complications that could be attributed to reuse. l7 It is important to note, however, that devices such as dialyzers are reprocessed and reused in the same patient, whereas-other single-use medical devices may be reprocessed for reuse on subsequent patients. Karki and Mayer’* have suggested that each institution should establish an interdisciplinary committee to identify and weigh all the risks and benefits that might result from reuse. Reichert” not only provides steps for developing a protocol for reuse but also provides one of the few examples if not the only example, of a cost analysis study done by a supply processing department. MayhalF reviews the few published reports and studies available on the reuse of medical devices, and Greene? provides historical and current aspects of the reuse of disposable medical devices. Although this literature, along with guide-
Volume October
15 Number
5
Reuse of disposable
1987
lines and recommendations for the reuse of disposable medical devices, has been published,22-26 many hospitals are still unsure of how to proceed with this practice, or whether they should proceed with it at all. The Health Services Directorate of Health and Welfare Canada, through a Sub-Committee on Institutional Program Guidelines, provides guidelines for a number of special care facilities and services in Canadian hospitals. In March 1984, this Sub-Committee formed a working group to establish guidelines for the reuse of disposable medical devices. This was a direct result of pressure from Provincial Ministries of Health and hospitals seeking guidance in the practice of reuse. This working group included representatives from industry, infection control, medicine, hospital administration, and the central service department. After several meetings the working group decided that developing guidelines from available literature and the experience of the members of the working group was clearly impossible. With the possible exception of hemodialyzers, little scientific evidence exists that confirms the safety, efficacy, and cost-effectiveness of reuse. Although the working group was fairly certain that a reasonable number of hospitals were practicing reuse, there was no documentation indicating the extent of reuse in Canadian hospitals, and there were no reported legal cases in Canada dealing with reuse of disposable medical devices. In early 1985 it was decided that Canadian hospitals be surveyed regarding their reuse practices to provide information that would assist in the development of appropriate guidelines and indicate future areas of research. Specifically, this survey would provide figures on the extent of reuse in Canadian hospitals and indicate the devices most commonly reused. Survey results indicating the number of Canadian hospitals reusing disposable medical devices, those with written policies pertaining to reuse, and the devices reused are presented in this paper. MATERIAL
AND METHODS
With use of a list of Canadian hospitals and special care facilities prepared by Statistics Canada,*’ a one-page questionnaire was sent to
medical
devices
197
Table 1. Response rates by hospital type Hospitals
N
General <200 beds General 2200 beds Long-term care Specialty hospital Other public hospital Private Federal
643 206 154 38 14 58 125
Total
1238
NO. responding
574
%
194
89 94
134 34 5 37 87
87 89 36 64 70
1065
86
the administrators of all Canadian hospitals in March 1985 (N = 1238). The questionnaire requested information as to whether hospitals reprocessed or reused disposable medical devices. The hospitals then indicated which disposable medical devices listed on the questionnaire they either reprocessed or reused. Hospitals also indicated whether they had mechanisms in place to determine the number of times disposable medical devices were reused, whether they had written procedures for the practice of reuse, and whether they had undertaken any cost analysis studies. A letter accompanying the questionnaire suggested that it be filled out by the central service manager in cooperation with the infection control nurse or practitioner, if the hospital had one. Past survey experience28 has shown Canadian infection control practitioners to be high respondents to questionnaires, and it was believed that their involvement would help prompt a high response rate. Although the response rate was very high by early April, a mail follow-up was sent and a telephone validation was done as necessary. All manual and computer editing, as well as computer processing, was carried out by Statistics Canada. Statistical comparisons of the qualitative data collected were made by various chisquare test procedures. In particular, for fourfold tables the chi-square with Yates’ continuity correction was used and for 2 x k contingency tables in which the k groups fall in natural order, a test for trend as well as differences in the proportions was done. For the purpose of this survey reprocessed was defined as the resterilization of medical devices labeled “disposable: single use only.” These devices had been opened but not used on a patient. Reused was defined as the cleaning and repro-
138
American INFECTION
Campbell et al.
Table 2. Canadian hospitals reprocessing and reusing disposable medical devices
Extent
Never Emergency Occasionally Regularly
Reprocessed (n = 1031) W) 51
2 16 31
T&l@ 3. Reprocessing disposable devices by hospital type Reused (n = 1037) w
50 1 8 41
cessing of used medical devices labeled “disposable: single use only.” The term generul hospital refers to hospitals that provide for the diagnosis and short-term treatment of patients for a wide variety of diseases or injuries. Long-term care facilities include both the rehabilitation hospitals (including convalescent) and extended-care hospitals (including chronic). RLWLTS Of the 1238 hospitals surveyed, 1065 responded, yielding a response rate of 86%. Response rates for specific hospital types are provided in Table 1. Overall, 31% of responding hospitals indicated that they reprocessed regularly, and 41% indicated that they regularly reused disposable medical devices (see Table 2). This article is restricted to the results obtained in three types of hospitals: the general hospitals with fewer than 200 beds, general hospitals with more than 200 beds, and finally the long-term care facilities. These hospital types all had response rates in excess of 86%. The percentage of hospitals reprocessing and reusing changes substantially when we look at the size and type of hospital (see Tables 3 and 4). Only 27% of general hospitals with fewer than 200 beds reprocess regularly, whereas 66% of general hospitals with more than 200 beds reprocess regularly. Of the long-term care facilities only 14% reprocess. The statistical test for differences in proportions indicated that reprocessing was significantly higher in general hospitals with more than 200 beds (p < 0.001). When we look at hospitals reusing medical devices the percentages become higher still. For
medical
Hospital
Repr-iw
Never Emergency Occasionally Regularly
General aoo beds (n = 556) (W
52 4 17
27
Jounai of CONTROL
type
General
Long-term
2200 beds (n = 191) w
10 4 22 66
(n :2,, VW
78 1 i :4
example, 38% of hospitals with fewer than 200 beds regularly reuse, whereas 86% of hospitals with more than 200 beds regularly reuse. The long-term care facilities reused very little, with only 16% indicating that they regularly reused. Reuse is also significantly higher in general hospitals with more than 200 beds, again by the statistical test for differences in proportions (p < 0.001). It was found that only 38% of hospitals that regularly reused disposable medical devices had written procedures for reuse. A mechanism for determining the number of times that items were reused was reported by 32% of regular reusers, and 29% indicated that they had undertaken cost analysis studies. The type and size of hospital did not appear to make any appreciable difference in these percentages. Disposable devices most commonly reused by those hospitals classified as regular reusers were the respiratory therapy items (see Table 5). Anesthesia breathing circuits were regularly reused by 70% of hospitals with more than 200 beds and 67% of hospitals with fewer than 200 beds. More critical devices were used less frequently by hospitals that reuse regularly. Cardiac catheters, for instance, were reused by 20% of the larger hospitals but by only 7% of the smaller hospitals.
This survey provides unique data regarding the practice of reprocessing and reusing disposable medical devices in Canadian hospitals. It is clear from these data that a large enough
Volume
15 Number
October
1987
Table devices
5
Reuse of disposable
4. Reusing by hospital
disposable type Hospital General
Reusing
Never Emergency Occasionally Regularly
medical
Table 5. Regular hospital
use of medical
General
(regular
199
by
Hospital type reusers n = 377)
Long-term
2200 beds
csre
(n = 557) w
(n = 192) W
(n = 130) rw
a 0 6 86
devices
devices
type
type
<200 beds
50 2 10 38
medical
General
General
<200 beds
,200 beds
Devices
(n = 212) (=a
(n = 165) (xl
Bain circuits Nebulizers-humidifiers Endotracheal tubes Other breathing circuits Transducer domes Cardiac catheters Arterial catheter needles
67 61 19 47 7 7 0
70 71 13 58 a 20 a
78 1
5 16
number of hospitals are reusing to warrant further investigation into the safe and efficacious practice of reuse. Reuse was significantly higher in the larger hospitals, although the reasons were outside the scope of this survey. It is likely, however, that more sophisticated disinfection and sterilization procedures are available in these facilities. For example, ethylene oxide sterilization is often not available to the smaller hospitals. If reuse could be proved to be safe and costeffective for individual devices, smaller hospitals might improve their ability to disinfect and sterilize or be prepared to purchase this capability from larger hospitals. This would mean savings to the smaller hospitals and increased revenue for larger facilities. That long-term care facilities reused very little is not surprising. These facilities likely do not use many of the devices that would be reused in the larger facilities nor would the required equipment or personnel be available for reprocessing. Considering the controversy surrounding reuse, it is surprising that only 38% of regular reusers had written procedures. This may be caused by the lack of documentation regarding any Canadian court cases resulting from reuse. Federal legal counsel used by the working group were not able to find any specific reported cases in Canada dealing with reuse of a disposable medical device. However, legal counsel did point out that there were a number of cases in the product liability field concerning the failure of a purchaser to follow the manufacturer’s directions for use of the product that might be
worthy of consideration.23 It is somewhat disconcerting that so many regular users (68%) had no way of determining the number of times an item was reused, which may be caused by the difficulty in determining how long an item may be safely reused. This is not surprising when we consider the lack of scientific evidence indicating whether specific disposable medical devices will function safely or as intended after disinfection and sterilization. Cost was undoubtedly a major impetus behind reuse. Therefore, it is indeed surprising that 71% of regular reusers had made no attempt to look at whether it was a cost-effective practice. Because this study indicates the extent to which various devices were being reused, further studies may now be done to determine which devices would be the most cost-effective to reuse. Specific devices could then be further studied to determine whether and how they are altered by disinfection and sterilization, whether they are safe to reuse, and if so, how many times may this be done. In summary, 41% of Canadian hospitals regularly reuse medical devices meant for single use only. It is clear from the controversy in the literature that only scientific studies will provide us with the evidence to support or condemn this practice. The identification of the most frequently used items indicates the devices on which studies would be most beneficial, and it is clear that hospitals require more specific guidelines regarding reuse.
Amencan
200
Campbell et al.
Until further scientific evidence regarding reuse becomes available, the following recommendations are suggested: 1. The cost-effec&eness of reuse should be determined. 2. The manufacturer should be contacted regarding directions for reprocessing and sterilization of the particular disposable device to be reused. 3. Written procedures for reusing disposable medical devices must be available in facilities where reuse is undertaken. 4. Criteria for determining how many times a disposable item may be reused should be developed. 5. A method for controlling and documenting the number of times that a disposable device is reused should be developed. 6. Periodic review of reuse should be undertaken by hospitals practicing reuse. R6ferences 1. Institute for Health Policy Analysis. Reuse of disposable medical devices in the 1980s: based on the proceedings of an international conference March 29-30, 1984. Washington, DC.: Institute for Health Policy Analysis, Georgetown University, 1984. 2. James KL, Roach C. Reusing disposables: examining the risk and benefits. Hospital Infection Control 1982; 9:113-32. 3. Association for the Advancement of Medical Instrumentation. Reuse of disposables. Implications for quality health care and cost containment. Arlington, Va.: AAMI, 1983. 4. Jacobs C, Brunner FP, Chantler C, et al. Combined report on regular dialysis and transplantation in Europe, VII, 1976. Proc Eur Dial Transplant Assoc 1977;14: 3-69. 5. Levin N. Dialyzer reuse in a hospital. Dialysis and Transplantation 1980;9:40-6. 6. Wing AJ, Brunner FP, Brynger H, et al. Mortality and morbidity of reusing dialyzers. Br Med J 1978;2:853-5. 7. National Kidney Foundation. Revised standards for reuse of hemodialyzers. NAPHT News May 1984:6. 8. Greenough A, Cockcroft PM, Bloom A. Disposable syringes for insulin injection. Br Med J 1979;1:1467-8. 9. Bacteremia associated with reuse of disposable hollowfiber hemodialyzers. MMWR 1986;35:417-9. 10. Hodge RH Jr, Krongaard L, Sande MA, Kaiser DL. Multiple use of disposable insulin syringe-needle units. JAMA 1980;244:266-7.
INFECTION
11.
12.
13. 14. 15. 16.
17.
18
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
Journa!
ot
CONTRO!
Oli JM, Gugnani HC, Ojiegbe GC. Multiple use of ordinary disposable syringes for insulin injections. Br Med J 1982;284:236. Stratchclyde Diabetic Group. Dispusablc or not1disposable syringes and needles for diabetics? Br Mcd J 1983;286:369-70. Stepanas TV, Turley H, Tuohy EA. Reuse of disposable insulin syringes. Med J Aust 1982;1:311-3. Sterilization and disinfection of hospital supplies. MMWR 1977;26:266. Endotoxic reactions associated with the reuse of cardiac catheters-Massachusetts. MMWR 1979;2825-7. Jacobson JA, Schwartz CE, Marshall HW, Conti M, Burke JP. Fever, chills, and hypotension following cardiac catheterization with singleand multiple-use disposable catheters. Cathet Cardiovasc Diagn 1983;9: 39-46. Havia T, Shuller H. The re-use of previously implamed pacemakers. Stand J Thorac Cardiovasc Surg [Suppl] 1978;22:33-4. Karki M, Mayer C. Assessing reuse of disposables: an interdisciplinary challenge for the 1980’s. Med Instrum 1981;14:153-5. Reichert M. Appropriate reuse of single-use medical devices: a case study. Journal of Hospital Supply, Processing and Distribution 1985;3:30-6. Mayhall CG. Commentary: types of disposable medical devices reused in hospitals. Infect Control 1986;7: 491-4. Greene VW. Reuse of disposable medical devices: historical and current aspects. Infect Control 1986;7: 508-13. Association of Operating Room Nurses. Standards uf technical and aseptic practice: operating room. Denver: AORN, 1975. Joint Commission on Accreditation of Hospitals. AMH186 accreditation manual for hospitals. Chicago: JCAH, 1985. Garner JS, Favero MS. Guideline for handwashing and environmental control. Centers for Disease Control, Public Health Service, U.S. Department of Health and Human Services, Atlanta, 1985. Food and Drug Administration. Reuse of medical disposable devices. FDA Compliance Policy Guide 7124, 23: Nov. 11. 1977. Working Group on the Reuse of Disposables. The reuse of disposables: an information report. Ottawa: Health and Welfare Canada, 1985. Statistics Canada, Health Division, Institutional Statistics Section. List of Canadian hospitals and special care facilities. Ottawa: Statistics Canada, 1983. Campbell BA, McCunn SM, Trotman M, Wells GA. The infection control practitioner in Canadian hospitals with more than 200 beds. AM J INFECT CONTROL 1986; 14:224-8.
Ontario,
Canada
A survey of all Canadian hospitals was undertaken in 1986 to determine the extent of the reuse of disposable medical devices meant for “single use only.” It was found that 41% of hospitals regularly reused disposable medical devices, and reuse was significantly higher in hospitals with more than 200 beds. Only 38% of hospitals that regularly reused had written procedures for reuse, and 32% indicated a mechanism for determining the number of times a device was reused. Cost analysis studies had been undertaken by only 29% of regular reusers, and items of respiratory therapy equipment were the most commonly reused devices. (AM J INFECT CONTROL 1987;15:196-200)
The issue of whether to reprocess and reuse disposable medical devices meant for “single use only” has been surrounded by controversy. Arguments for and against reprocessing and reusing single-use items have been summarized in in the literature.‘, ’ Other issues implicated the practice of reuse such as those of a legal, ethical, and economic nature have also been discussedJ The safety and efficacy of dialyzer reuse has been supported by several major studies,4-6 and standards have been prepared for the reuse of hemodialyzers ?, 8 However, recent reports of bacteremia associated with reuse of disposable hollow-fiber hemodialyzers may require a review and reassessment of this practice.9 Studies done on the reuse of disposable syringes and needles by patients with diabetes have indicated that this practice may be safe.“-13 The From the Division of Hospital Epidemiology and the Division of Biometrics, Bureau of Communicable Disease Epidemiology, Health Protection Branch, Health and Welfare Canada; the Health Care Section, Health Division, Statistics Canada; and the Health Services and Promotion Branch, Health and Welfare Canada. Reprint requests: B. Campbell, Nurse Consultant, cable Disease Epidemiology, Laboratory Centre Control, Ottawa, Ontario, Kl A OL2 Canada.
196
Communifor Disease
reuse of disposable arterial pressure domes have been associated with epidemic bacteremia,14 and endotoxin reactions have been associated with the reuse of cardiac catheters.” A study by Jacobson et al.,” however, found no statistically significant difference in adverse reactions associated with cardiac catheter reuse. Using previously implanted pacemakers produced no complications that could be attributed to reuse. l7 It is important to note, however, that devices such as dialyzers are reprocessed and reused in the same patient, whereas-other single-use medical devices may be reprocessed for reuse on subsequent patients. Karki and Mayer’* have suggested that each institution should establish an interdisciplinary committee to identify and weigh all the risks and benefits that might result from reuse. Reichert” not only provides steps for developing a protocol for reuse but also provides one of the few examples if not the only example, of a cost analysis study done by a supply processing department. MayhalF reviews the few published reports and studies available on the reuse of medical devices, and Greene? provides historical and current aspects of the reuse of disposable medical devices. Although this literature, along with guide-
Volume October
15 Number
5
Reuse of disposable
1987
lines and recommendations for the reuse of disposable medical devices, has been published,22-26 many hospitals are still unsure of how to proceed with this practice, or whether they should proceed with it at all. The Health Services Directorate of Health and Welfare Canada, through a Sub-Committee on Institutional Program Guidelines, provides guidelines for a number of special care facilities and services in Canadian hospitals. In March 1984, this Sub-Committee formed a working group to establish guidelines for the reuse of disposable medical devices. This was a direct result of pressure from Provincial Ministries of Health and hospitals seeking guidance in the practice of reuse. This working group included representatives from industry, infection control, medicine, hospital administration, and the central service department. After several meetings the working group decided that developing guidelines from available literature and the experience of the members of the working group was clearly impossible. With the possible exception of hemodialyzers, little scientific evidence exists that confirms the safety, efficacy, and cost-effectiveness of reuse. Although the working group was fairly certain that a reasonable number of hospitals were practicing reuse, there was no documentation indicating the extent of reuse in Canadian hospitals, and there were no reported legal cases in Canada dealing with reuse of disposable medical devices. In early 1985 it was decided that Canadian hospitals be surveyed regarding their reuse practices to provide information that would assist in the development of appropriate guidelines and indicate future areas of research. Specifically, this survey would provide figures on the extent of reuse in Canadian hospitals and indicate the devices most commonly reused. Survey results indicating the number of Canadian hospitals reusing disposable medical devices, those with written policies pertaining to reuse, and the devices reused are presented in this paper. MATERIAL
AND METHODS
With use of a list of Canadian hospitals and special care facilities prepared by Statistics Canada,*’ a one-page questionnaire was sent to
medical
devices
197
Table 1. Response rates by hospital type Hospitals
N
General <200 beds General 2200 beds Long-term care Specialty hospital Other public hospital Private Federal
643 206 154 38 14 58 125
Total
1238
NO. responding
574
%
194
89 94
134 34 5 37 87
87 89 36 64 70
1065
86
the administrators of all Canadian hospitals in March 1985 (N = 1238). The questionnaire requested information as to whether hospitals reprocessed or reused disposable medical devices. The hospitals then indicated which disposable medical devices listed on the questionnaire they either reprocessed or reused. Hospitals also indicated whether they had mechanisms in place to determine the number of times disposable medical devices were reused, whether they had written procedures for the practice of reuse, and whether they had undertaken any cost analysis studies. A letter accompanying the questionnaire suggested that it be filled out by the central service manager in cooperation with the infection control nurse or practitioner, if the hospital had one. Past survey experience28 has shown Canadian infection control practitioners to be high respondents to questionnaires, and it was believed that their involvement would help prompt a high response rate. Although the response rate was very high by early April, a mail follow-up was sent and a telephone validation was done as necessary. All manual and computer editing, as well as computer processing, was carried out by Statistics Canada. Statistical comparisons of the qualitative data collected were made by various chisquare test procedures. In particular, for fourfold tables the chi-square with Yates’ continuity correction was used and for 2 x k contingency tables in which the k groups fall in natural order, a test for trend as well as differences in the proportions was done. For the purpose of this survey reprocessed was defined as the resterilization of medical devices labeled “disposable: single use only.” These devices had been opened but not used on a patient. Reused was defined as the cleaning and repro-
138
American INFECTION
Campbell et al.
Table 2. Canadian hospitals reprocessing and reusing disposable medical devices
Extent
Never Emergency Occasionally Regularly
Reprocessed (n = 1031) W) 51
2 16 31
T&l@ 3. Reprocessing disposable devices by hospital type Reused (n = 1037) w
50 1 8 41
cessing of used medical devices labeled “disposable: single use only.” The term generul hospital refers to hospitals that provide for the diagnosis and short-term treatment of patients for a wide variety of diseases or injuries. Long-term care facilities include both the rehabilitation hospitals (including convalescent) and extended-care hospitals (including chronic). RLWLTS Of the 1238 hospitals surveyed, 1065 responded, yielding a response rate of 86%. Response rates for specific hospital types are provided in Table 1. Overall, 31% of responding hospitals indicated that they reprocessed regularly, and 41% indicated that they regularly reused disposable medical devices (see Table 2). This article is restricted to the results obtained in three types of hospitals: the general hospitals with fewer than 200 beds, general hospitals with more than 200 beds, and finally the long-term care facilities. These hospital types all had response rates in excess of 86%. The percentage of hospitals reprocessing and reusing changes substantially when we look at the size and type of hospital (see Tables 3 and 4). Only 27% of general hospitals with fewer than 200 beds reprocess regularly, whereas 66% of general hospitals with more than 200 beds reprocess regularly. Of the long-term care facilities only 14% reprocess. The statistical test for differences in proportions indicated that reprocessing was significantly higher in general hospitals with more than 200 beds (p < 0.001). When we look at hospitals reusing medical devices the percentages become higher still. For
medical
Hospital
Repr-iw
Never Emergency Occasionally Regularly
General aoo beds (n = 556) (W
52 4 17
27
Jounai of CONTROL
type
General
Long-term
2200 beds (n = 191) w
10 4 22 66
(n :2,, VW
78 1 i :4
example, 38% of hospitals with fewer than 200 beds regularly reuse, whereas 86% of hospitals with more than 200 beds regularly reuse. The long-term care facilities reused very little, with only 16% indicating that they regularly reused. Reuse is also significantly higher in general hospitals with more than 200 beds, again by the statistical test for differences in proportions (p < 0.001). It was found that only 38% of hospitals that regularly reused disposable medical devices had written procedures for reuse. A mechanism for determining the number of times that items were reused was reported by 32% of regular reusers, and 29% indicated that they had undertaken cost analysis studies. The type and size of hospital did not appear to make any appreciable difference in these percentages. Disposable devices most commonly reused by those hospitals classified as regular reusers were the respiratory therapy items (see Table 5). Anesthesia breathing circuits were regularly reused by 70% of hospitals with more than 200 beds and 67% of hospitals with fewer than 200 beds. More critical devices were used less frequently by hospitals that reuse regularly. Cardiac catheters, for instance, were reused by 20% of the larger hospitals but by only 7% of the smaller hospitals.
This survey provides unique data regarding the practice of reprocessing and reusing disposable medical devices in Canadian hospitals. It is clear from these data that a large enough
Volume
15 Number
October
1987
Table devices
5
Reuse of disposable
4. Reusing by hospital
disposable type Hospital General
Reusing
Never Emergency Occasionally Regularly
medical
Table 5. Regular hospital
use of medical
General
(regular
199
by
Hospital type reusers n = 377)
Long-term
2200 beds
csre
(n = 557) w
(n = 192) W
(n = 130) rw
a 0 6 86
devices
devices
type
type
<200 beds
50 2 10 38
medical
General
General
<200 beds
,200 beds
Devices
(n = 212) (=a
(n = 165) (xl
Bain circuits Nebulizers-humidifiers Endotracheal tubes Other breathing circuits Transducer domes Cardiac catheters Arterial catheter needles
67 61 19 47 7 7 0
70 71 13 58 a 20 a
78 1
5 16
number of hospitals are reusing to warrant further investigation into the safe and efficacious practice of reuse. Reuse was significantly higher in the larger hospitals, although the reasons were outside the scope of this survey. It is likely, however, that more sophisticated disinfection and sterilization procedures are available in these facilities. For example, ethylene oxide sterilization is often not available to the smaller hospitals. If reuse could be proved to be safe and costeffective for individual devices, smaller hospitals might improve their ability to disinfect and sterilize or be prepared to purchase this capability from larger hospitals. This would mean savings to the smaller hospitals and increased revenue for larger facilities. That long-term care facilities reused very little is not surprising. These facilities likely do not use many of the devices that would be reused in the larger facilities nor would the required equipment or personnel be available for reprocessing. Considering the controversy surrounding reuse, it is surprising that only 38% of regular reusers had written procedures. This may be caused by the lack of documentation regarding any Canadian court cases resulting from reuse. Federal legal counsel used by the working group were not able to find any specific reported cases in Canada dealing with reuse of a disposable medical device. However, legal counsel did point out that there were a number of cases in the product liability field concerning the failure of a purchaser to follow the manufacturer’s directions for use of the product that might be
worthy of consideration.23 It is somewhat disconcerting that so many regular users (68%) had no way of determining the number of times an item was reused, which may be caused by the difficulty in determining how long an item may be safely reused. This is not surprising when we consider the lack of scientific evidence indicating whether specific disposable medical devices will function safely or as intended after disinfection and sterilization. Cost was undoubtedly a major impetus behind reuse. Therefore, it is indeed surprising that 71% of regular reusers had made no attempt to look at whether it was a cost-effective practice. Because this study indicates the extent to which various devices were being reused, further studies may now be done to determine which devices would be the most cost-effective to reuse. Specific devices could then be further studied to determine whether and how they are altered by disinfection and sterilization, whether they are safe to reuse, and if so, how many times may this be done. In summary, 41% of Canadian hospitals regularly reuse medical devices meant for single use only. It is clear from the controversy in the literature that only scientific studies will provide us with the evidence to support or condemn this practice. The identification of the most frequently used items indicates the devices on which studies would be most beneficial, and it is clear that hospitals require more specific guidelines regarding reuse.
Amencan
200
Campbell et al.
Until further scientific evidence regarding reuse becomes available, the following recommendations are suggested: 1. The cost-effec&eness of reuse should be determined. 2. The manufacturer should be contacted regarding directions for reprocessing and sterilization of the particular disposable device to be reused. 3. Written procedures for reusing disposable medical devices must be available in facilities where reuse is undertaken. 4. Criteria for determining how many times a disposable item may be reused should be developed. 5. A method for controlling and documenting the number of times that a disposable device is reused should be developed. 6. Periodic review of reuse should be undertaken by hospitals practicing reuse. R6ferences 1. Institute for Health Policy Analysis. Reuse of disposable medical devices in the 1980s: based on the proceedings of an international conference March 29-30, 1984. Washington, DC.: Institute for Health Policy Analysis, Georgetown University, 1984. 2. James KL, Roach C. Reusing disposables: examining the risk and benefits. Hospital Infection Control 1982; 9:113-32. 3. Association for the Advancement of Medical Instrumentation. Reuse of disposables. Implications for quality health care and cost containment. Arlington, Va.: AAMI, 1983. 4. Jacobs C, Brunner FP, Chantler C, et al. Combined report on regular dialysis and transplantation in Europe, VII, 1976. Proc Eur Dial Transplant Assoc 1977;14: 3-69. 5. Levin N. Dialyzer reuse in a hospital. Dialysis and Transplantation 1980;9:40-6. 6. Wing AJ, Brunner FP, Brynger H, et al. Mortality and morbidity of reusing dialyzers. Br Med J 1978;2:853-5. 7. National Kidney Foundation. Revised standards for reuse of hemodialyzers. NAPHT News May 1984:6. 8. Greenough A, Cockcroft PM, Bloom A. Disposable syringes for insulin injection. Br Med J 1979;1:1467-8. 9. Bacteremia associated with reuse of disposable hollowfiber hemodialyzers. MMWR 1986;35:417-9. 10. Hodge RH Jr, Krongaard L, Sande MA, Kaiser DL. Multiple use of disposable insulin syringe-needle units. JAMA 1980;244:266-7.
INFECTION
11.
12.
13. 14. 15. 16.
17.
18
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
Journa!
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CONTRO!
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