In the May 2011 edition of the Journal of Medical Device Regulation, AMDR President Dan Vukelich wrote a letter to the editor in response to a previously published article, written by Peter Schroeer (Eucomed Reuse Task Force and Johnson & Johnson), calling the reprocessing industry “risky.” Mr. Vukelich took this opportunity to set the record straight on the major issues surrounding reprocessing and express his strong support (similar to Mr. Schroeer) for the implementation of an industry-wide regulatory framework in the European Community:
It is imperative that people examine all of the facts and scientific evidence, so that readers and policymakers recognise the unsubstantiated claims, scare tactics or innuendo being advanced by companies with an economic and environmental agenda that differs from current reprocessing customers. That said, AMDR agrees with Mr. Schroeer and Eucomed that ‘Europe needs to prioritise patient-safety unambiguously’. We agree that European patients deserve to know that reprocessed medical devices are just as safe and as effective as original equipment. In fact, the AMDR urges international legal and regulatory bodies, including the European Union, to consider implementing legislative and regulatory requirements to ensure that all reprocessed devices are safe and effective for patients…
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AMDR would also like to thank Victoria Clark, Editor of JMDR, for the opportunity to publish this responsive letter.