Cardiac Catheter Reuse in An Era of Reform: Cost-Efficiency and Regulatory Policy in the Face of Scientific Uncertainty

Abstract

Cardiac catheters have become an essential element of current cardiovascular practice with several hundred thousand used each year in both diagnostic and angioplasty procedures. Uke many other disposable devices they are also increasingly being reused as hospitals attempt to cut costs.' The general progression of device reuse seems to follow rather directly the rise in the expense of medical equipment and procedures. For example, in 1976, only 14% of United States' hospitals reported reusing single-use devices, while in 1982, 90% of hospitals admitted practicing reuse.2 As for the government's regulation of such reuse, 1981 saw the FDA issuing guidelines practically proscribing the reuse of catheters when their average cost was only $10-$25.~ Even as late as 1987, however, only 2.4 full-time FDA employees and $19,000 were dedicated to monitoring the reuse of nondurable devices.4 The General Accounting Office concluded that the FDA knew of less than 1% of medical device problems occurring in hospitals.5 On the heels of the longstanding debate about the reuse of hemodialyzers and the Safe Medical Devices Act of 1990 and 1992 Medical Device Amendments, it appears as if the FDA is more receptive to tightening regulatory control over medical device reuse.