Reuse of coronary angioplasty balloon catheters: yes or no?

In the last decade, the reuse of percutaneous transluminal coronary angioplasty (PTCA) equipment has been repeatedly discussed in the cardiological and infection control literature. Interest in this problem is growing since the frequency of PTCA procedures is increasing and cost containment in health care has been recognized as a necessity even in industrialized countries. Single-use devices in medicine were first developed in order to diminish the cost of reprocessing multi-use products. New materials have now permitted wider use of single-use products at lower cost compared with the cost for reprocessing and repackaging of multi-use devices. However, the development of expensive and highly sophisticated catheters in cardiology has raised costs to the point where the debate over reuse has once again arisen. The designation ‘single use device’ denotes exclusively the manufacturer’s definition and not the intended purpose as per legislation. In general, manufacturers are not interested in the reprocessing of their single use devices and hence refuse to give any information as to whether and how their single use devices can be reprocessed and resterilized. A company, for example, can decide to designate a stainless steel forceps for single use only, even though it can be safely resterilized. Different institutions and countries have adopted contradictory policies toward reuse. While Canada seems to be in the forefront of implementing a reuse policy, hospitals in the United States tend to fear legal consequences. In most countries, the legal situation is often vague. Although the reuse of angioplasty balloon catheters is common practice in many countries, surprisingly few clinical studies on the reuse of PTCA equipment are available.