On May 5-6, 1999, an AAMI/FDA Conference was held in the Washington, D.C. area on the subject of the Reuse of Single-Use Devices: Practice, Patient Safety, and Regulation. This was not the first AAMI/FDA meeting in which this topic was addressed; there had been previous conferences, documents, and correspondence relating to the issue during the past several years.This particular conference, co-sponsored by nine organizations, solicited input in order to move forward from the status quo and resolve the concerns about reuse which are now finding their way through the media into public awareness.The organizations co-sponsoring the Conference were the International Association of Healthcare Central Service Materiel Management, the Association of Operating Room Nurses, the Association for Professionals in Infection Control and Epidemiology, ECRI, the American Society of Healthcare Central Service Professionals, the Association of Disposable Device Manufacturers, the Association of Medical Device Reprocessors, the Health Industry Manufacturers Association, and the Medical Device Manufacturers Association.

Representatives were asked to participate fully and express their views on various aspects of the topic. IAHCSMM was represented by Anne Cofiell and Sue Klacik. The document which follows was presented as the official position of the Association.

The International Association of Healthcare Central Service Materiel Management (IAHCSMM) is a non-profit association with a membership of 8,500 healthcare central service/materiel management professionals from across the nation and around the world.

The IAHCSMM mission is to provide healthcare facilities and the members of the Association with organized educational opportunities, professional development, a forum for information exchange, member services in response to member-identified needs and priorities; and to represent Central Service Materiel Management in the professional community.

IAHCSMM Position Statement: The Reuse of Single-Use Medical Devices

The reuse of single-use medical devices is a very controversial, complex issue. IAHCSMM'S position is that we must always promote quality healthcare and assure patient safety with positive outcomes. These issues must not be overlooked when evaluating the legal, ethical, financial, and technical aspects of reprocessing medical devices labeled for single-use, or considering a third party reprocessing company.

The Food and Drug Administration (FDA) has made it very clear in its Compliance Policy Guide No. 7124.23 that "the institution or practitioner who reuses a disposable medical device should be able to demonstrate: (1) that the device can be adequately cleaned and sterilized, (2) that the physical characteristics or quality of the device will not be adversely affected, and (3) that the device remains safe and effective for its intended use."Reprocessing a disposable medical device requires a vast amount of testing, validation, and documentation. In today's healthcare setting, there are very few Central Service departments equipped to adequately deal with these requirements. The validated cleaning, sterilization and testing, for example, requires specialized equipment functions which are not commonly available on equipment in general use. Often the manufacturers' recommendations for reprocessing that are necessary to insure the device is returned to its initial specifications are not available. Staffing and supervision are often not adequate to insure that a quality system is in place for the reprocessing activity. It is for these reasons that the IAHCSMM discourages the practice of healthcare facilities becoming involved in the reprocessing of single-use medical devices and does not recommend it.

However, the IAHCSMM recognizes that due to the constant reductions in reimbursements, many healthcare facilities have been forced to reduce expenses without compromising quality. One cost-saving alternative some facilities have chosen is the reprocessing of specific disposables by a third party reprocessor. Of course, every healthcare facility needs to assess its own situation to determine if the cost saving potential is worth the additional risk involved.Should a healthcare facility opt for third party reprocessing, it is the position of the IAHCSMM that the reprocessing company selected shall have completed registration with the Food and Drug Administration (FDA). Other criteria that users might want to require of a third party reprocessor include:

• The ability to track the medical device through the various stages of reprocessing. Written policies and procedures for cleaning, packaging, and sterilization. Documentation available to demonstrate procedures are being properly followed. Documentation of the training and/or certification of the staff. Insurance policies with appropriate liability coverage. A willingness to provide facility tours for potential customers.
• Demonstration that the waste from the healthcare facility is properly disposed of according to local, state, and federal regulations.

The IAHCSMM also considers the decision whether or not to reprocess a single-use medical device, or use the services of a third party reprocessor, to be the responsibility of an appointed committee including administration, risk management, infection control, central service, and other appropriate departments of the facility.

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