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Policy Challenges

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:

Patient and User Safety: 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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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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Perhaps 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. >> Read more
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. >> Read more
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. >> Read more
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. >> Read more
Following the recent adoption of the revised Medical Devices Directives, the European Commission has started a public consultation on the reprocessing of medical devices. As requested by the European Parliament, the Commission has to submit a report on reprocessing within the next three years, based on an assessment of the current practices and their real costs as well as existing national regulations and market studies. For this purpose, a first Questionnaire has been prepared by the competent DG Enterprise and Industry which is available on the Internet : [Link]  Interested parties have the opportunity to give their answers until July 02, 2008.