American College of Cardiology

• Reprocessing is safe. Reprocessing is a safe practice that hospitals and physicians have relied on for more than two decades. A significant body of peer-reviewed literature demonstrates that certain devices labeled as single-use can be safely and effectively reprocessed, including EP catheters used by cardiovascular specialists.

• Neither the FDA nor the CDC has found reprocessing to be unsafe. The Food and Drug Administration (FDA) n the regulatory body which has primary responsibility for the safety of medical devices n has stated that it "has been unable to find clear evidence of adverse patient outcomes associated with the reuse of a single-use device from any source." Dr. William Jarvis, chief of the epidemiology branch at the Centers for Disease Control and Prevention (CDC), stated that he "would be absolutely amazed if this [reprocessing] is a major public health problem and the [leading hospitals] have failed to realize it."

• The FDA is actively involved in regulating reprocessing. The FDA has a Compliance Policy Guide on the Reuse of Medical Disposable Devices that has been in use since 1977, and the FDA has required reprocessors to comply with its Quality System regulation since it became effective in 1997. Furthermore, the FDA has developed a proposed policy for regulating the reprocessing of medical devices labeled for single use and is currently working with physicians, hospitals, device manufacturers, and device reprocessors to refine its regulation of reprocessed devices. The FDA's proposed policy takes a risk-based approach to regulating the practice of reprocessing. The ACC would encourage Congress' deference to the FDA on the issue as the FDA continues to work to develop its regulations.

• The single-use designation is a choice made by manufacturers. The "single-use" designation on a medical device is not an FDA requirement, but rather, a manufacturer's choice. Physicians have no direct or personal financial incentives to reuse catheters. The cost of supplies for electrophysiology laboratories is paid from hospital budgets. Cardiovascular specialists may use as many as six or more EP catheters during one procedure. It is in patients' best interest if costs are not a factor in care.

 
The ACC is a 24,000-member professional medical society whose mission is to foster optimal cardiovascular care and disease prevention through professional education, promotion of research, leadership in the development of standards and guidelines, and the formulation of health care policy.

NASPE, the North American Society for Pacing and Electrophysiology, is comprised of 3,200 physicians, allied health professionals and scientists committed to the research and treatment of patients with cardiac arrhythmias. NASPE endorses this position of the ACC.