The Association for the Advancement...

The Association for the Advancement of Medical Instrumentation (AAMI) and the US provisions and Drug Administration (FDA), held a colloquy May 5 to 6, 1999 in Arlington, Va, to discuss the controversial make subordinate of reusing single-use devices. In developing the conversation AAMI collaborated with several organizations, including the American Society of Healthcare Central Service Professionals (ASHCSP), Association of Disposable Device Manufacturers, Association of Medical Device Reprocessors (AMDR), Association for Professionals in Infection ascendency and Epidemiology, ECRI, Health Industry Manufacturers Association, International Association of Healthcare Central Service Material Management (IAHCSMM), Medical Device Manufacturers Association (MDMA), and AORN. AORN also endorsed the conference

The goal of the two-day parley was to provide a foundation for forming public health policy decisions forward the reuse of single-use devices when multiple patients are involved. The reuse of hemodialyzers was not discussed.

talk PROCEEDINGS

In his opening remarks, AAMI President Michael Miller, JD CAE, said that the talk was being held to bring together diverse collections to reach consensus on issues surrounding the muse of single-use devices. He reiterated that AAMI is a neutral organization and is not an advocate or proponent of any position upon the issue.

Larry Kessler ScD director of the FDA's office of surveillance and biometrics, serv as moderator and facilitator. After discussing several metaphors that could be used to describe the issue, he conclud with a metaphor to describe the solution--the image of a patient in a boat being ventureed in one direction by all of the issue's stakeholders. He added that the reuse of single-use devices is a public health issue that has drawn increased interest from various parties.

The talk featured many different perspectives onward the issue, with presentations from representatives of the FDA, ECRI, Center for Disease direction and Prevention, the Joint Commission forward Accreditation of Healthcare Organizations, AMDR, and MDMA. Several ethicists and hospital infection check specialists, along with a director of perioperative services, an epidemiologist, and an Illinois state senator, readyed their different perspectives. Additional sessions included the positions and views of AORN, ASHCSP, and IAHCSMM as well as of original device manufacturers and reprocessors. A panel of lawyers discussed various liability issues. The presentations conclud with a session in succession standards and regulations, including 510(k) and premarket approval (PMA) considerations.

Participants were able to make comments [i]or[/i] remarks and ask questions after each presentation. In summation of the conference's first day, Dr Kessler outlined the following outcomes

* Public bear upon and patients' right for information are important.

* The FDA requires to take a significant part in this issue.

* The health care financial climate hints that reuse of single-use devices will continue in the short name and is likely to continue in the drawn out term.

* Reprocessing requires special care.

* More scientific data am a high priority.

CONSENSUS AND PLANS

upon the final day, stakeholder representatives identified three elucidation issues to recap the parley and provide direction to the FDA. The issues included

* patient safety, including enforcement of 510(k) and PMA;

* the importance of mutual cooperation, consistency, and tracking outcomes; and

* the ne to challenge manufacturers to be more environmentally friendly and to provide better instructions, distinct labeling, and specific guidelines for reprocessing.

a consensus was reached on the fact that the reuse of single-use devices is an economical issue. Dr Kessler said that the FDA acknowledges that there may not be a blanket approach to the reuse of these devices, still that guidelines need to be considered device through device and facility by facility. a certain quantity of stakeholders suspect that most existing validations are marginal at best and would not support premarket clearance or approval. This is a mixed problem that does not have a simple solution. Regarding regulation, the FDA clinchs that there needs to be a flush playing field for stakeholders, reprocessing guidelines and standards, specific criteria, and consistent definitions. It became clear that the issue is pertinacious and solutions cannot be delayed.

At the conclude of the conference, Dr Kessler thanked the audience members for their participation. He announced that the FDA will continue its commitment to the issue of reusing single-use devices and indicated that there would be a summary of the conversation on the FDA web site at www.fda.gov. Dr Kessler also said that the FDA will consider the discussion and dialogue heard at the interview to develop a policy that will harbor public health without creating unintended negative circumstances.

AORN President Patricia Seifert, RN MSN CNOR, CRNFA, personateed AORN on the panel and readyed some concerns that health care facilities should consider before making decisions regarding reprocessing devices (see "Clinical Issues" May 1999) AORN does not have an official position upon the practice of reprocessing and reusing single-use devices.