Docket Management
Docket: 02N-0456 - Determining Hospital Procedures for Opened-But-Unused, Single-Use Medical Devices
Comment Number: EC -27

Accepted - Volume 1

Comment Record
Commentor Mr. Raymond Sweeney Date/Time 2002-11-26 14:53:17
Organization Healthcare Association of New York State
Category Association

Comments for FDA General
1. General Comments November 26, 2002 The Honorable Mark McClellan, MD, PhD Commissioner of Food and Drugs Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Re: [Docket No. 02N-0456] Determining Hospital Procedures for Opened-But-Unused, Single-Use Medical Devices; Request for Comments and Information (67 Federal Register 55269), August 28, 2002 Dear Commissioner McClellan: On behalf of more than 200 hospitals and health systems in New York State, the Healthcare Association of New York State (HANYS) is pleased to provide the Food and Drug Administration (FDA) with comments on its request for information on determining hospital procedures for opened-but-unused (OBU) single-use medical devices. Based on our communication with our hospital membership we do not believe there is a need for further FDA regulation in this area. It is a common practice in hospitals that in preparation for a medical procedure a sterile single-use device (SUD) is opened but, for a variety of reasons, is not subsequently used. Typically, these “opened-but-unused” devices are cleaned/decontaminated, resterilized and repackaged either at the hospital or through a third-party reprocessor. Some original equipment manufacturers (OEMs) provide written instructions on how to conduct these activities. If this is the case, third-party reprocessors and hospitals follow these instructions. However, if the OEM does not provide instructions, it is appropriate for the reprocessor/hospital to develop their own written policies and protocols for each step of the process based on standard principles. Often SUDs labeled for single-use are part of surgical packs put together by sterile processing professionals who assemble, wrap, and sterilize these packs. HANYS is pleased that the FDA has historically recognized that this practice does not provide a public safety concern and has excluded it from regulation. It is essential that health care facilities be permitted to continue to conduct these activities without being subjected to burdensome, costly, and unnecessary regulation. We are aware of no scientific evidence that would establish a public health risk associated with the cleaning, resterilization, and repackaging of OBU SUDs. Since they have not, by definition, been previously used on a patient, the use of these devices should pose no risk of patient-to-patient infection, if the standard processes of cleaning/decontaminating, resterilizing, and repackaging are properly conducted. There is strong evidence that the bioburden or contamination levels of microorganisms on reusable medical devices/instruments is relatively low (orders of 1-2 logs). , Unused items for which the original seal has been opened are several tiers removed from the potential for contamination as compared to reusable devices. We believe this offers a substantial margin of safety. Proper cleaning/decontamination practices, sterilization and resterilization processes have been routinely performed for many years on a wide variety of medical devices – both reusable and single use. HANYS believes hospitals can uphold the essential goal of safety, without resorting to regulatory requirements that might unnecessarily strain the resources of health care providers. Because there is not a great deal of information available on these practices our colleagues at the American Hospital Association (AHA), the Association of Professionals in Infection Control and Epidemiology, the American Society of Healthcare Central Services Professionals (ASHCSP), and the Federation of American Hospitals worked together to develop a survey, “Special Hospital Survey: Practices Associated with ‘Opened-But-Unused’ Single-Use Devices,” to examine current hospital practices. A representative group of 673 hospitals responded to the survey. Some of the key findings are: · Only 25 percent of hospitals used resterilized OBU SUDs. · Most hospitals either have their own written policies/procedures for handling OBU SUDs or rely on the policies of third-party reprocessors. · Most hospitals (56 percent) that use resterilized OBU SUDs rely on third-party reprocessors; only 16 percent indicate that they resterilize OBU SUDs within the hospital. · No hospitals responding to the survey indicated that they have had any adverse patient outcomes associated with the use of hospital-resterilized OBU SUDs. In general, the AHA, et al. survey data indicate that very few hospitals would resterilize devices in which there was visible contamination. A majority of hospitals are willing to resterilize only devices that were opened outside a sterile field or opened within a sterile field but without visible contamination. However, it must be clarified that, as a matter of principle, proper cleaning, decontamination, and repackaging of potentially contaminated devices precede sterilization and include standard quality control processes, such as biological indicators and other sterilization cycle monitors. Most importantly, there was a lack of any reported adverse events associated with the resterilization of OBU SUDs. This is not surprising given the low percentages of hospitals resterilizing these devices as a whole, combined with what we know of the low relative risk of contamination in these instances, as noted above. This risk appears negligible in contrast to the real risks of adverse events associated with medical devices related to use, and supports the observations by many, including the FDA, that OBU SUDs contribute little-to-nothing to endemic complications of health care and do not warrant further regulation and associated expenditures. Precipitated by their work on the survey instrument, the ASHCSP will be undertaking another initiative to develop a model policy for distribution to its member organizations. This model policy will be based, in part, upon the written policies received from survey respondents. We are hopeful that this step will further assure the safety of resterilizing OBU SUDs. HANYS is greatly concerned by the lack of standards for OEMs that would make the “single use” label meaningful, evidence-based, and standardized. Although OEMs have a financial incentive to label devices “single use,” we understand that the FDA believes that it does not have the statutory authority to require OEMs to justify this labeling. We hope that the FDA would support legislation that would give the agency the statutory authority to provide for “truth in labeling” for devices that OEMs describe as “single use.” In addition, as noted above, some OEMs do provide instructions for resterilizing their SUDs. Hospitals are appreciative of this sort of guidance when it is available and we would urge the FDA to encourage other OEMs to provide resterilization instructions for SUDs. In summary, we believe our letter and referenced AHA, et al. led survey results provide compelling evidence that patient safety and care are in no way compromised by the practice of reuse/resterilizing of “open-but-unused” single-use devices in our nation’s hospitals. We hope the FDA will also determine that there is no need for further regulation in this area. Thank you for the opportunity to comment on this important issue. We look forward to working with the FDA in the future and we are available to discuss in more detail the results of our survey upon request. Please contact me if you have any questions or comments. Sincerely, /s/ Raymond Sweeney Executive Vice President

EC -27