Besluit medische hulpmiddelen

Reactie

Vraag2

The Association of Medical Device Reprocessors (AMDR) is appreciative of the time and effort the Dutch Ministry has invested.

Respectfully, AMDR strongly objects to the inclusion of the prospective list of devices prohibited from reprocessing. AMDR agrees that medical device exposure to prions may necessitate special precautions, but our responsibilities as manufacturers include having proper cleaning and sterilization validations to assess for this, and any other iatrogenic concern. Such a list sets a dangerous precedent, prospectively, or before evidence has been evaluated, declaring what can and cannot be done. We therefore urge the removal of this article.

First, inclusion of a prohibited lists ignores reprocessors’ expertise. Professional reprocessing firms, under the oversight of Notified Bodies and Member States’ Competent Authorities, have far more expertise in evaluating whether medical devices may be reprocessed. Medical device reprocessors are the medical technology industry’s leading experts in the fields of medical device cleaning, sterilization and functional performance testing.

Second, inclusion of a prohibited list does not address patient safety. AMDR member reprocessors do not currently reprocess any of the devices noted in the draft list. However, no such prohibition exits for hospital reuse of reusable devices that may come into contact with the same tissues noted in the proposed list. Therefore, real risk of prion exposure, if it is a serious one, lies with what hospitals are already doing with their own instruments and in their own reprocessing departments – not with commercial reprocessors.

Third, a prohibited listed is unduly burdensome. Earlier drafts of the EU MDR did contemplate inclusion of a “negative list” of devices. Ultimately this approach was rejected. The MDR already subjects reprocessors to all manufacturer requirements, and so Member States adopting further negative lists would place additional burdens on industry that is unnecessary and does not advance patient safety. Having each EU Member State decide what cannot be professionally reprocessed would be unduly burdensome to both every Health Ministry in the EU and industry and needlessly restricts trade and competition.

We thank you for your consideration

Bijlage