Question: I have been hired by physician anesthesiologists who request that I wash and reuse supposedly disposable single-use equipment such as endotracheal tubes and breathing circuits. What is the current standard of practice on this issue and what are the safety and liability implications of doing this? A CRNA
Answer: Safety, liability, and cost-effectiveness must be addressed in determining whether to reuse a medical device which has been designed and manufactured for one-time use. The American Society for Hospital Central Service Personnel has published Guidelines for the Reuse of Disposable Medical Devices with the objective of establishing procedures to ascertain whether any device labeled “single-use-only” can be adequately reprocessed’ (1) These guidelines are only an outline of considerations for the development of future policies and procedures. The issue of whether and when to reprocess a single-use device has yet to be resolved by consensus.
Greene has reported the results of an informal survey taken at the International Conference on the Reuse of Disposable Medical Devices (2) Two hundred and four respondents reported 44 disposable devices as being correctly reused, with hemodialyzers, cardiovascular catheters and guide wires, respiratory therapy breathing circuits, biopsy needles, cautery devices, anesthesia breathing circuits and endotracheal tubes being cited most often (3)
In a review of reuse of disposable devices at the Medical College of Virginia (4) , Mayhall has pointed out the risks associated with reuse of both anesthesia and respiratory therapy face masks, corrugated tubing and bags, airways and esophageal stethoscopes. Ethylene oxide sterilization can present a major hazard to the structural integrity of a device intended for single use, and the activated glutaraldehyds used to disinfect breathing circuits has been linked to tracheal burns (4)
In 1987, Health and We4fare Canada published the results of a survey of all Canadian Hospitals taken to determine the orient of re” of disposable equipment which showed 41% of Canadian hospitals reusing equipment intended for one-time uses, with this practice significantly more frequent in those hospitals with 200 or More beds (5). Lamentably, of the hospitals responding, only 38% used written reprocessing procedures, 68% could not provide records of the number of times an item was used, and only 29% had made any assessment of cost effectiveness. Of 165 hospitals classified as “regular reusers” (200 or more beds), 70% reused Bain circuits, 7 1 % nebulizers-humidifiers, 13% endotracheal tubes, 58% other breathing circuits, 8% transducer domes, 20% cardiac catheters and 8% arterial catheter needles(5). No specific court cases were reported from Canadian courts involving reuse of disposable medical devices, but a number of Canadian product liability cases dealt with the user’s failure to comply with manufacturer’s instructions.
The FDA Cites Lack of Data Supporting Reusing Disposables
The U.S. Food and Drug Administration (FDA), in its Compliance Policy Guide of September 24, 1987, states that “there is a lack of data to support the general reuse of disposable medical devices, including disposable guide wires and catheters. The fact that devices are labeled disposable is indicative of this lack of data. In order for a device to be considered ‘reusable’, it must be capable of withstanding necessary cleanings and restorative techniques and methods, and continue to be safe and reliable for its intended use (6). By definition, a disposable device is not intended by the manufacturer to be reused, so that, “Any institution or practitioner who resterilizes and/or reuses a disposable medical device must bear all responsibility for its safety and effectiveness (6). This FDA statement must control anesthetists’ current practice habits.
ASTM Backs FDA Stand
In recognition of the need to address this issue, in September of 1986, ASTM’s Committee F-04 on Medical and Surgical Materials and Devices organized a Subcommittee F-04.20 on Reprocessing of Medical Devices. Taking a position in conformance with the FDA’s stance that the manufacturer is responsible only for the safety and effectiveness of a device at its initial use, unless the device is clearly Libeled and designated as intended for multiple use, and that the reprocessor is responsible for reuse, Subcommittee “4.02, chaired by Mr. M.L. Bancroft of Harvard University, is currently developing a guideline document for the use of physicians, nurses, administrators, insurance carriers, patients and others for whom this question has become a significant concern.
In conformance with definitions established by the Centers for Disease Control (7)., “critical” devices are those which enter the vascular, circulatory, or central nervous systems, or any sterile cavity, “semi-critical”, those which come in contact with mucous membranes or enter a sterile cavity while passing through a non-sterile area, and “non-critical”, those which come into contact with intact skin. As Radany et. al. have pointed out (8) the monitoring of and adherence to such distinctions by nurses will be a major factor in the success or any reprocessing program.
The reuse of CDC classified critical or semicritical single-use medical devices is fraught with hazard. ASTM’s Subcommittee on Reprocessing of Medical Devices believes that it is obligatory for the manufacturer of a device intended for multiple use to provide the user with an adequately tested reprocessing protocol, as well as the actual test procedure and results. The Committee is taking a firm stance on adherence to recommended procedures by personnel responsible for reprocessing.
The reuse of disposable anesthesia devices presents a greater medicolegal hazard than other types of equipment, commensurate with the relative size of malpractice awards in anesthesiology. Consequently, anesthesia devices intended for single use are not reused in Harvard Medical School’s system of teaching hospitals (9).
In formulating a decision to reutilize a device intended for one-time use, the end-user must consider the overall quality of the sterilization/ reconditioning facilities available and his/her availability to supervise or personally undertake the reprocessing and subsequent reinspection. Written protocols for the sterilization and reconditioning must be acceptable to the manufacturer, the insurers, and the physician dispenser, for the decision to reuse an anesthesia device intended for single use is a medical one, with the attending anesthesiologist ultimately responsible for its outcome. As should be the case with the use of any controversial drug or treatment, the decision to employ a reprocessed single-use item should be communicated by the anesthesiologist or his representative to appropriate non-physician staff by written policy memorandum agreed upon by the hospital administration. At the same time, it is incumbent on the CRNA or other non-physician staff member to voice his argument against the use of a particular reprocessed device in writing to an appropriate authority, even though he agrees to proceed as instructed (Table 1).
Table I Reuse of Disposable Anesthesia Equipment Physician Checklist
- Will the reuse program conform to FDA guidelines?
- Does the Anesthesiology Department have written policy and procedures on the reuse of disposable equipment? Has the hospital administration approved these procedures in writing?
- Have the sterilization/reconditioning procedures specified been adequately tested, and has a regular review program been established?
- Does the liability insurance document accurately reflect hospital departrnental policy on reuse?
- Does the anesthesia equipment conform to ISO and ASTM standards?
- Have the CRNAs and other appropriate non-physician personnel agreed in writing to the reuse policies and procedures?
Answer provided by Ms. Debra Milamed, M.S. and John Heffley-Whyte M.D.; Department of Health Policy and Management; Harvard School of Public Health at the VA Medical Center; Boston, MA 02132.
- American Society for Hospital Central Service Personnel. Guidelines for the reuse of disposable medical devices. Infed. Control 7(11): 562, 1986.
- The Institute for Health Policy Analysis, Georgetown University Medical Center: Reuse of Disposable Medical Devices in the 1980’s. Proceedings of an International Conference, March 29-30, 1984, Washington, D.C. Washington, D.C.: Institute for Health Policy Analysis, Georgetown University Medical Center, 1984.
- Greene, VW.: Reuse of disposable medical devices; historical and current aspects. Infect. Control 7(10): 508-513, 1986.
- Mayhall, C.G.: Types of disposable medical devices reused in hospitals. Infect Control 15(5): 196-200, 1987.
- Campbell, BLA., Wells, G.A., Palmer, W.N., and Martin, D.L.: Reuse of disposable medical devices in Canadian hospitals. Am. 1. Infection Control 15(5): 196-200, 1987.
- Food and Drug Administration. Office of Enforcement, Division of Compliance Policy. Associate Commissioner for Regulatory Affairs. Compliance Policy Guide 7124.16. Washington, D.C.: U.S. Government Printing Office, September 24, 1987.
- Centers for Disease Control. Center for Infectious Diseases, Hospital Infections Program. Guidelines for Handwashing and Hospital Environmental Control.
- Radany, M., Perry, S., and McCallum, D.: Is it safe to reuse disposables Am. 1. Nursing 87(l): 35-38, 1987.
- Hedley-Whyte, I.: Medicolegal and infection risks of reuse of single-use supplies and equipment in anesthesiology. In Reuse of Disposable Medical Devices in the 1980s. Proceedings of an International Conference, March 29-30, 1984, Washington, D.C. Washington, D.C.: Institute for Health Policy Analysis, Georgetown Medical Center, 1984, p. 149-155.
- Springfield, V.A.: National Technical Information Service (PB85-923404), 1985.