The following post was written by AMDR President Dan Vukelich for the Protect Our Savings blog:

 

The European Union (EU) does not currently have a comprehensive regulatory framework for the reprocessing of “single-use” devices (SUDs). In 2007, the European Parliament identified medical device reprocessing as an issue in need of additional clarification and instructed the European Commission (Commission) to take steps to address the issue. In response to this request, the Office of the Directorate General for Health and Consumers (DG SANCO), a regulatory authority within the Commission, will soon be releasing a proposal to address the reprocessing issue as part of its larger effort to revise the regulatory framework for all medical devices throughout Europe.

Fundamentally, AMDR expects that the Commission will propose that SUD reprocessing must meet medical device manufacturer requirements (i.e., the reprocessor or refurbisher must obtain a European “CE mark,” like any other medical device manufacturer, prior to placing the device on the market). AMDR agrees with this very high standard for medical device reprocessing as it would make unvalidated, unregulated reprocessing of SUDs (including such reuse by hospitals) illegal across the EU, ensuring the same high standard of patient protection across all Member States.

AMDR is aware that some original equipment manufacturers (OEMs) are still proposing that the EU ban reprocessing altogether, or adopt standards that even exceed OEM requirements. AMDR believes that the EU’s current Medical Device Directive (MDD), or set of requirements for all medical device manufacturers, alreadyprovides the regulatory framework for reprocessors/refurbishers to come to market, which includes meeting the MDD’s Essential Requirements and demonstrating compliance with the Conformance Assessment (same as is required of any other manufacturer). Based on the extensive experience in the United States, AMDR believes that there is no difference in process between these reprocessed/refurbished devices and the original, provided that all of the CE mark processes (e.g., design control, risk assessment, validation and control of processes) are fulfilled.

Additionally, as with all other provisions of the forthcoming Medical Device Regulation, AMDR agrees with OEMs that the regulations must be applied consistently, EU-wide. This includes consistent application of the reprocessing provisions. The Parliament’s original goal of addressing reprocessing as part of the revision of the medical device framework was to “harmonize” the policy across all of Europe. Giving Member States the autonomy to continue with their own, separate reprocessing policies not only fails to address the original issue, but also fails to address patient safety concerns and creates an additional market barrier for commercial reprocessors. We believe a CE-marked device – regardless of its manufacturer – entitles the manufacturer to market the product across the EU, and Member States should not be allowed to prohibit such devices.

AMDR wants to ensure that European hospitals have access to safe, regulated, lower-cost, environmentally-friendly and CE-marked reprocessed/refurbished medical devices. Products that not only ensure patient safety but also serve to reduce the cost of health care are rare and should be available to all hospitals in Europe. In the coming months, we anticipate that the Commission will release its draft, and later this fall, the European Council will be asked to approve the proposal. After approval from the Council, we understand the European Parliament will debate the proposed new framework. AMDR plans to work with its allies and fellow stakeholders throughout this process and will provide updates to its members, other stakeholders and the public as these activities continue to play out in the coming months.

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