The FDA's Regulations Should Be Reprocessed

June 1, 2001

The FDA's Regulations Should Be Reprocessed

The FDA's Regulations Should Be Reprocessed

By Nathan L. Belkin, PhD

ANALYSIS& OPINION ONE OF THE MOST CONTROVERSIAL ISSUES discussed today focuses onthe reuse of a myriad of devices that have been identified as single-use-devices(SUDs). Aside from questions regarding SUDS being safe to use following theirreprocessing, the bottom-line objective of the healthcare provider is a matterof economics.

Whether or not providers' fiscal condition is attributable to theimplementation of the Balanced Budget Amendment of 1997 that reduced the rate ofreimbursement for hospital services, a recent report from the Robert WoodJohnson Foundation indicates that one third of all US hospitals are failingfinancially. The study further indicates that another third are on the other endof the scale, and that the remaining third are barely making it.1

Provided the cost of reprocessing an item is less than that of itsacquisition, the economic benefits are assured. As one time, virtually all ofthe medical devices that were used were reusable and were routinely and safelyprocessed in-house. History indicates that the single-use-only concept was firstintroduced in the early 1960s. At that time, the items were marketed on thebasis of their efficiency, ease of use, and economics.

Nevertheless, the thought of using a device once and discarding it wasinitially not readily accepted by the healthcare community. Retrospectively, itcould perhaps be that the idea was regarded as unduly expensive and wasteful.

However, with the government's reimbursement system predicated on a cost-plusbasis, the cost of a SUD was irrelevant. Thus, the popularity of a large varietyof single-use items that rapidly became available increased dramatically. Unliketheir reusable counterparts in which the reprocessing costs were part of afacility's operating expenses, the SUDs were patient-charge items on a cost-plusbasis. As such, their use was actually skewed by being viewed as revenuegenerators.

Today, on the other hand, the financial status of the US healthcare deliverysystem can no longer afford the luxury of using something once and thendiscarding it. The for-single-use-only label is not a requirement of the Foodand Drug Administration (FDA). Its use actually originated prior to theformation of the federal agency and has self-perpetuated. To identify a productin that manner is a decision made by the manufacturer-not the FDA. By the sametoken, it is not a requirement associated with obtaining the agency's marketingapproval. What it does mean is that hospitals are more than likely wastingbillions of dollars a year on readily reusable medical devices.

The question that logically arises, therefore, is that if the only differencebetween those that were used then and those being used today is the language onthe package that reads "For single-use only," why shouldn't they bereused today? Apparently not-according to the FDA.

The FDA's Regulations

The agency's recent regulations on the reprocessing of SUDs considerhospitals that reprocess these devices the same as the original equipmentmanufacturer (OEM). According to these regulations, hospitals now will berequired to comply with the same rules that govern the OEM as well as thethird-party processors. These requirements include the premarket requirements ofeither a 501K (premarket notification) or a PMA (premarket approval). Inaddition, non-premarket requirements for all entities include registration as areprocessor, medical-device reporting and tracking, product corrections andremovals, quality system programs, and labeling. 3

FDA officials acknowledges that the hospital's biggest task will bethat of complying with those rules.3

According to a report recently released by the Government Accounting Office(GAO), approximately 30% of the hospitals they surveyed were reusing SUDs.However, the percentage of beds they represent is unknown. Despite the intensityof the pressures on hospitals to contain and reduce their costs, FDA regulationswill simply add another burdensome and costly layer of administrative functionsupon them or discourage them entirely from continuing to reprocess them as theyhave been doing.

In terms of the products being suitable for another use. It has recently beenreported that for a period of approximately three and a half years (August1996-December 1999), the FDAs medical device reporting (MDR) system documented245 adverse events associated with the reuse of SUDs.4 Compared tothe 100,000 MDR reports that the FDAQ receives on a yearly basis,5the nominal number of reports associated with the reprocessed devices isexemplary. It also should be noted that the Centers for Disease Control andPrevention (CDC) has few reports of adverse outcomes associated with the reuseof those devices.3

Why then is it necessary for the agency to impose these regulations on thosefacilities for the devices that they have been reprocessing? Why can't theysimply be "grandfathered" the same way that a myriad of other deviceswere categorized in 1976 when the agency first came into being?

For example, the Cleveland Clinic Foundation has retrospectively studied3,000 electrophysiology mapping and 2,000 reference ablation procedures-of which97% used one or more reprocessed nonlumen catheters-and found not one infection.4Why should they now have to comply with the new regulations for these items?

Is it the agency's intent to have the facility cease reprocessing? All thingsconsidered, would that be fiscally prudent for hospitals to do so? Not verylikely according to a GAO report. It notes that independent reprocessing firms'fees are about half the price of new items, while in-house reprocessing of somedevices cost less than 10% of the price of new devices.5

Admittedly, there are many in-house Central Service (CS) or SterileProcessing Departments (SPD) that have neither the qualified personnel norproper equipment to render the SUDs suitable for reuse. However, they have theoption of outsourcing for the reprocessing services that are available from anyone of the 13 identified reprocessors that can enable them to realize someeconomic relief. On the other hand, those that do have the reprocessingcapability and have been utilizing it to the complete satisfaction of themembers of their infection control and medical/clinical staffs and withoutcompromising the quality of care provided to their patients, why should they nowhave to sacrifice part of the economic benefits that they have accrued fromdoing so? Perhaps it's the FDA's regulations that should be reprocessed.

Nathan Belkin, PhD, worked in the healthcare industry for more than 40years. He has been publishing medical articles since 1966. He is now retired inClearwater, Fla.

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