FDA regulation of single-use device reprocessing amounts to fiscal irrationality, contend advocates - Brief Article

Free enterprise is not a term that accurately describes our health care system, and because many entities--both individual and institutional--regulate the sales and marketing of medical devices and med-surg supply products, it is impossible to pinpoint with any accuracy why costs continue to spiral out of control.

Ongoing increases are attributable to wide-ranging decisions too diverse to enumerate, but which, in sum, add up to fewer goods and services at more cost.

A case in point: the U.S. Food and Drug Administration's (FDA) decision to regulate the re-use of medical devices.

At first glance, such a decision may seem trivial. According to June 2000 Senate testimony by a United States General Accounting Office (GAO) official, there are between 80,000 and 100,000 different medical devices currently in use, generating $56 billion in sales revenue per year.

But the seemingly innocuous determination following that Senate testimony to regulate the re-use of some of those devices provides an insight into the fiscal irrationality of one aspect of our health care system.

The FDA conclusion reads as follows:

"The evidence suggests that some SUDs [single-use devices] can be safely reprocessed if appropriate cleaning, testing and sterilization procedures are carefully followed. However, SUD reprocessing is not invariably safe, and relatively little is known about the practice of SUD reprocessing in health care facilities.

For this reason, the FDA has taken steps to increase its oversight of SUD reprocessing. Nonetheless, the new framework is cumbersome and will be difficult to implement."

Jumping in head first

Although the FDA admits it does not know much about the practice, it intends to regulate reprocessing in a way the agency itself acknowledges will be cumbersome.

How much does this decision needlessly increase health care costs? It is impossible to say with precision, but the testimony referenced above provides evidence that the cost increase is substantial.

It states, for example, that without benefit of FDA regulation, 20-30% of U.S. hospitals have been reprocessing so-called SUDs. The FDA has no definition for an SUD except that a manufacturer classifies it that way.

Many devices are clearly reusable, such as blood-pressure cuffs.

According to GAO Senate testimony, savings from the re-processing of medical devices is significant.

The GAO estimates that the cost of reprocessing can be less than 10% of the price of a new device. For frequently reused devices such as an electrophysiology (EP) catheter (a device inserted into the heart to correct cardiac rhythm disorders), this amounts to a savings of over $900 per device.

Catheters demonstrate some of the misperceptions concerning the reuse of medical devices. There is no heightened risk of infection with the reuse of an EP catheter, but manufacturers have labeled them single-use devices.

According to the GAO, "One study of more than 14,000 EP procedures found that the overall rate of patient infection was very low and did not differ between clinical centers that reused EP catheters and centers that used each catheter only once."

Adding to the burden

Despite this unregulated success story of medical cost control--and despite the FDA's admitted lack of knowledge in the area of reuse of medical devices--the agency began the regulation that is now ongoing.

Putting aside the question of how the FDA will regulate an area of which it knows little, this decision will put a huge burden on both the FDA and the hospitals that reuse medical devices.

The language in the GAO Senate testimony is graphic on this subject:

"The potentially large number of ... applications and ... facilities to inspect could overburden the FDA's already stretched resources."

Indeed, the GAO acknowledges that an undesired effect on already-stretched FDA resources would be to decrease the resources available for review of new medical devices that are in line to enter the market.

Surely, the FDA decision turns common sense on its head: In order to regulate an activity that has been proceeding with few, if any, problems, the FDA is going to stretch its resources in such a way that may slow new, helpful medical devices on their way to the patients that need them.

In other words, the new policy of regulation of an area without regulatory need is causing human as well as economic costs.

The policy of regulation without need should be looked at critically by a non-partisan committee of medical professionals, insurers and politicians with a view toward creating a system that enhances efficiencies such as the reuse of medical devices.

Ronald S. Katz and Robert D. Becker are partners in the San Francisco office of the international law firm of Coudert Brothers. They can be reached at 415-986-1300, or at www.coudert.com.

COPYRIGHT 2001 J.B. Lippincott Company
COPYRIGHT 2001 Gale Group