The FDA's Regulations Should Be Reprocessed
By Nathan L. Belkin, PhD
ANALYSIS & OPINION ONE OF THE MOST CONTROVERSIAL ISSUES discussed today focuses on the 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 their reprocessing, the bottom-line objective of the healthcare provider is a matter of economics.
Whether or not providers' fiscal condition is attributable to the implementation of the Balanced Budget Amendment of 1997 that reduced the rate of reimbursement for hospital services, a recent report from the Robert Wood Johnson Foundation indicates that one third of all US hospitals are failing financially. The study further indicates that another third are on the other end of the scale, and that the remaining third are barely making it.1
Provided the cost of reprocessing an item is less than that of its acquisition, the economic benefits are assured. As one time, virtually all of the medical devices that were used were reusable and were routinely and safely processed in-house. History indicates that the single-use-only concept was first introduced in the early 1960s. At that time, the items were marketed on the basis of their efficiency, ease of use, and economics.
Nevertheless, the thought of using a device once and discarding it was initially not readily accepted by the healthcare community. Retrospectively, it could perhaps be that the idea was regarded as unduly expensive and wasteful.
However, with the government's reimbursement system predicated on a cost-plus basis, the cost of a SUD was irrelevant. Thus, the popularity of a large variety of single-use items that rapidly became available increased dramatically. Unlike their reusable counterparts in which the reprocessing costs were part of a facility's operating expenses, the SUDs were patient-charge items on a cost-plus basis. As such, their use was actually skewed by being viewed as revenue generators.
Today, on the other hand, the financial status of the US healthcare delivery system can no longer afford the luxury of using something once and then discarding it. The for-single-use-only label is not a requirement of the Food and Drug Administration (FDA). Its use actually originated prior to the formation of the federal agency and has self-perpetuated. To identify a product in that manner is a decision made by the manufacturer-not the FDA. By the same token, it is not a requirement associated with obtaining the agency's marketing approval. What it does mean is that hospitals are more than likely wasting billions of dollars a year on readily reusable medical devices.
The question that logically arises, therefore, is that if the only difference between those that were used then and those being used today is the language on the package that reads "For single-use only," why shouldn't they be reused today? Apparently not-according to the FDA.
The FDA's Regulations
The agency's recent regulations on the reprocessing of SUDs consider hospitals that reprocess these devices the same as the original equipment manufacturer (OEM). According to these regulations, hospitals now will be required to comply with the same rules that govern the OEM as well as the third-party processors. These requirements include the premarket requirements of either a 501K (premarket notification) or a PMA (premarket approval). In addition, non-premarket requirements for all entities include registration as a reprocessor, medical-device reporting and tracking, product corrections and removals, quality system programs, and labeling. 3
FDA officials acknowledges that the hospital's biggest task will be that 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 intensity of the pressures on hospitals to contain and reduce their costs, FDA regulations will simply add another burdensome and costly layer of administrative functions upon them or discourage them entirely from continuing to reprocess them as they have been doing.
In terms of the products being suitable for another use. It has recently been reported that for a period of approximately three and a half years (August 1996-December 1999), the FDAs medical device reporting (MDR) system documented 245 adverse events associated with the reuse of SUDs.4 Compared to the 100,000 MDR reports that the FDAQ receives on a yearly basis,5 the nominal number of reports associated with the reprocessed devices is exemplary. It also should be noted that the Centers for Disease Control and Prevention (CDC) has few reports of adverse outcomes associated with the reuse of those devices.3
Why then is it necessary for the agency to impose these regulations on those facilities for the devices that they have been reprocessing? Why can't they simply be "grandfathered" the same way that a myriad of other devices were categorized in 1976 when the agency first came into being?
For example, the Cleveland Clinic Foundation has retrospectively studied 3,000 electrophysiology mapping and 2,000 reference ablation procedures-of which 97% used one or more reprocessed nonlumen catheters-and found not one infection.4 Why 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 things considered, would that be fiscally prudent for hospitals to do so? Not very likely 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 some devices cost less than 10% of the price of new devices.5
Admittedly, there are many in-house Central Service (CS) or Sterile Processing Departments (SPD) that have neither the qualified personnel nor proper equipment to render the SUDs suitable for reuse. However, they have the option of outsourcing for the reprocessing services that are available from any one of the 13 identified reprocessors that can enable them to realize some economic relief. On the other hand, those that do have the reprocessing capability and have been utilizing it to the complete satisfaction of the members of their infection control and medical/clinical staffs and without compromising the quality of care provided to their patients, why should they now have to sacrifice part of the economic benefits that they have accrued from doing so? Perhaps it's the FDA's regulations that should be reprocessed.
Nathan Belkin, PhD, worked in the healthcare industry for more than 40 years. He has been publishing medical articles since 1966. He is now retired in Clearwater, Fla.
For a complete list of references, visit www.infectioncontroltoday.com.
For a complete list of references click here