Medical device reprocessing - Letters - Letter to the Editor

AORN Journal, March, 2003 by Nathan L. Belkin

The article on the reprocessing of single-use devices (SUDs) ("Medical device reprocessing--An alternative," [Opinion] September 2002, page 406) focuses on the subject from the perspective of a third-party reprocessor. As a cost-conscious, quality-oriented health care consumer, I believe that there are a number of questions that the author did not address that are worthy of the perioperative nurse's consideration.

For example, although identified by the original equipment manufacturer as being for "single use only," many of the items have been and still are being reprocessed in-house for yet another use. The question that logically arises, therefore, is why does the US Food and Drug Administration (FDA) continue to permit the items to be identified as SUDs? Why not require the manufacturer to identify them for what they are--reusable? If an item is truly, as alleged, designed for "single use only," then does it not appear to be reasonable to believe that if it were reprocessed, it would not be suitable for another use?

Hospitals have been reprocessing (eg, cleaning, disinfecting, sterilizing) a myriad of reusable medical devices for more than a half a century without the need for the intervention of any regulatory federal agency at any time. So why now? Furthermore, because the alleged SUDs have proven themselves to be reusable, the next question that logically arises is why is it necessary for in-house reprocessors to be subjected to the same regulations as the third-party reprocessors?

It has recently been reported that one-third of our nation's hospitals are struggling to stay fiscally afloat and that another third are barely scraping by. (1) These institutions can simply no longer afford the luxury of using any reusable item once and then throwing it away. Nevertheless, an FDA official has observed that it is because of the high cost of reprocessing under their regulations that "the hospital's task will be that of complying with our rules." (2)

Is that really the agency's intent--to discourage health care providers from reusing devices that the manufacturer has identified as allegedly being for single use only? If so, what justification do they have for doing that? Certainly it cannot be on the basis of the number of adverse events reported through the agency's Medical Device Reporting system. (3) Incidentally, it is worthy of note that according to a General Accounting Office report, the independent reprocessing firms' fees are about one-half the price of a new item, while in-house reprocessing of some devices costs less than 10% of a new one. (4)

This brings up the final question. The FDA's regulations do not appear to be in the interest of either the patients' welfare or the economic state of affairs of our nation's health care providers, so who do they benefit? The answer is self-evident.

NOTES

(1.) "Money crunch: One-third of US hospitals face financial ruin," Health Facilities Management 13 (June 2000) 6.

(2.) P A Perry, "Decision time: Reuse regs force go/no go decisions," Materials Management in Healthcare 9 (September 2000) 20.

(3.) C Lewis, "Re-using medical devices: Ensuring safety the second time around," FDA Consumer 34 (September/October 2000) 7; G Pugliese, M S Favero, "GAO issues report on reuse of single-use medical devices," Infection Control and Hospital Epidemiology 21 (September 2000) 574.

(4.) "GAO report sheds light on reuse," Materials Management in Healthcare 9 (July 2000) 9.

NATHAN L. BELKIN
PHD
CLEARWATER, FLA