European Association for Medical Device Reprocessing

Reprocessing of Single-use Medical Devices (SUDs)

The techniques for reprocessing medical devices currently labelled “single-use” have seen considerable progress over the last years. Although some national regulations have changed to accommodate these improvements, the European framework has not. EAMDR is concerned with providing a clear update of the implications for safety, costs and practices in the health care system, the various regulatory frameworks and the future scenarios in this domain. Please find below a list of policy challenges in the field of “single-use” medical devices:

Safety for Patients and User

For safety reasons, many medical devices are only suitable for single use before disposal. However, due to recent technological progress, up to 16% of those currently labelled “single-use” could be safely reprocessed, allowing significant cost savings and wider application of these (some life-saving) devices.

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Labeling: The meaning of the label Single-Use

Historically, manufacturers have been allowed to declare devices as “single-use” or “multiple-use” as they see fit. Medical devices were assigned one of these categories according to whether the manufacturer felt able to guarantee the hygienic and functional quality for one or several uses.

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Uncontrolled reprocessing: Enormous risk due to uncontrolled reprocessing

Of course the most significant objection to reprocessing, understandably, is the issue of patient safety. This is the foremost concern, not only of citizens and patients, but also of medical practitioners, and reprocessors, throughout Europe.

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Liability: More safety through a clear regulatory framework

Improving patient safety is EAMDR’s first objective, and this is of course the utmost concern of practitioners, reprocessors and the relevant authorities. For effective regulation, all risks must be managed, and the liabilities must be clearly defined and brought in line with the regulatory framework.

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Public Health Expenditures: Balance between safety and cost-savings

It is EAMDR’s position that the proposed reforms would provide a win-win solution; where the healthcare system benefits from cost savings, with no additional risk to patient safety.

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Resource Efficiency: Responsibility for the environment

In addition to the economic savings and the improvement in healthcare provision, there is also the added advantage that reprocessing considerably reduces the impact of medical technology production on the environment.

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Lack of Consistent Regulation: Improved safety through a Europe-Wide regulation

The largest single obstacle to a European solution to this problem is the lack of consistent regulation across Europe. Each country has a different approach to the safe reprocessing of medical devices.

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Following the recent adoption of the revised Medical Devices Directives, the European Commission has undertaken a public consultation on the reprocessing of medical devices. As requested by the European Parliament, the Commission has to submitted the report on reprocessing based on an assessment of the current practices and their real costs as well as existing national regulations and market studies. The final report you can find here.