Re: [Docket No. 02N-0456] Determining Hospital Procedures for Opened-But-Unused, Single-Use Medical Devices; Requests for Comments and Information (67 Federal Register 55269), August 28, 2002.
Liberty Place, Suite 700
325 Seventh Street, NW
Washington, DC 20004-2802
(202) 638-1100 Phone
Tuesday, November 26th 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
Dear Dr. McClellan:
The American Hospital Association (AHA), the Association of Professionals in Infection Control and Epidemiology, the American Society for Healthcare Central Service Professionals (ASHCSP), and the Federation of American Hospitals (FAH) are 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. To help in preparing our comments, we worked together to survey our memberships using a jointly-designed instrument called the “Special Hospital Survey: Practices Associated with ‘Opened-But-Unused’ Single-Use Devices.” Based on our research and knowledge, we do not believe there is a need for further FDA regulation in this area.
It is common in hospitals that a sterile single-use device (SUD) is opened in preparation for a medical procedure 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 provide written instructions on how to conduct these activities. If this is the case, third-party reprocessors and hospitals will follow these instructions. However, if there are no instructions provided by the original equipment manufacturers, then 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. Another typical scenario occurs in the context of assembling custom surgical packs. Sterile processing professionals assemble, wrap and sterilize these packs, which may consist of many devices labeled for single-use.
We are 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, provided that the standard processes of cleaning/decontaminating, resterilizing and repackaging are properly conducted. There is strong evidence that the bioburden or contamination levels of micro-organisms on reusable medical devices/instruments is relatively low (orders of 1-2 logs).1,2 Items in which the original seal has been opened, but are unused, are several tiers removed from the potential for contamination as compared to reusable devices. We believe this already 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. Our organizations believe hospitals can uphold the essential goal of safety, without resorting to regulatory requirements that might unnecessarily strain the resources of health care providers.
Finally, we continue to believe that FDA does not have jurisdiction under the Federal Food, Drug, and Cosmetic Act to regulate hospital procedures for handling sterile single-use devices that have never been used in a patient, even if the device package was opened. While the agency has the authority to regulate the manufacture of medical devices, it does not have the authority to regulate the practice of medicine.
However, because there is not a great deal of information available on these practices, our organizations worked together to develop a survey to examine current hospital practices. A representative group of 675 hospitals responded to our survey. While detailed results of our survey are contained in Appendix A, 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.
· Of hospitals that use resterilized OBU SUDs, most (56 percent) 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, our survey data indicate that very few hospitals would resterilize devices opened within a sterile field and 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 practice, 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, we are impressed with the lack of any reported adverse events associated with the resterilization of OBU SUDs. However, we are not surprised 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.
Further, based on responses from this survey, 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.
However, we continue to believe that of greater concern is the lack of standards for original equipment manufacturers that would make the “single use” label meaningful, evidence-based and standardized. Although original equipment manufacturers 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 original equipment manufacturers 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 original equipment manufacturers describe as “single use.” In addition, as noted above, some original equipment manufacturers 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 original equipment manufacturers to provide resterilization instructions for SUDs.
In summary, we believe our letter and supporting information 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 direct any questions regarding this letter to Roslyne Schulman, AHA’s senior associate director for policy development, at (202) 626-2273.
1 Chu NS, Chan-Myers H, Ghazanfari N, Antonoplos P.Levels of naturally occurring micro-organisms on surgical instruments after clinical use and after washing. Am J Infect Control 1999 Aug;27(4):315-9.
2 Rutala WA, Gergen MF, Jones JF, Weber DJ.Levels of microbial contamination on surgical instruments. Am J Infect Control 1998 Apr;26(2):143-5.
Charles N. Kahn, II
Bryant C. Broder, ACSP