Reprocessing of “Single-Use” Cardiac Devices: Regulations Coming to Europe?



Daniel Vukelich
President, Association of Medical Device Reprocessors, USA

KEY WORDS: Reprocessing, single-use devices, cardiac devices, European Union regulations, safety, environmentalism, cost-savings

Objective: This session will provide an overview of the reprocessing of “single-use” devices (SUDs), including cardiac devices such as electrophysiological and diagnostic imaging catheters. The session will include an update on current European Union efforts to regulate SUD reprocessing as part of the forthcoming EU-wide Medical Device Regulation. The session will also provide a summary of the safety, cost-savings, and environmental benefits of regulated reprocessing, including a discussion of regulations and experience for SUD reprocessing from the U.S. and Germany.

Methods: Worldwide, healthcare providers are struggling to find safe, reliable, and affordable solutions to reduce the financial and environmental burden of providing excellent care. One solution hospitals utilize is to reuse devices, like electrophysiological and diagnostic imaging catheters, labeled for “single-use.” Though regulated by FDA in the U.S., the European Union does not currently regulate SUD reprocessing, leaving the matter to individual Member States.

As the U.S. and Germany have long had regulations in place that allow for SUD reprocessing, this session will evaluate the U.S. and German experience. With the EU Commission, Parliament, and Council now considering legislation to harmonize medical reprocessing requirements across the EU, evaluation of the existing evidence on SUD reprocessing safety and effectiveness is critical.

Results: Regulated SUD reprocessing stopped inappropriate SUD reuse, held SUD reprocessors equivalent to manufacturers, and resulted in hospitals having access to safe, regulated, lower-cost, and environmentally responsible reprocessed SUDs.

Conclusions: Europe should adopt high standards for SUD reuse, including cardiac devices, to stop inappropriate hospital reuse and regulate entities that do reprocess.

Key Message: When regulated, SUD reprocessing can be safe, lower-cost, and environmentally responsible.