The Association of Medical Device Reprocessors (AMDR) applauds the Swedish National Board of Health and Welfare (Socialstyrelsen) on its thorough and evidenced report of December 2020: Prerequisites for Reprocessing and Reusing Disposable Medical Devices (original here, AMDR’s English version here). . .
AMDR therefore welcomes and appreciates the credible work taken on by the Swedish National Board of Health and Welfare. The content, credibility and thoroughness of this investigation is perhaps unparalleled in Europe thus far and AMDR believes Sweden’s findings can be used as a basis for other Member States to expedite their own “opting in” to allow such products. The Socialstyrelsen concluded that reprocessing and reuse “of disposable medical devices that take place according to a validated protocol, according to current law in the field, can be considered patient safe.” Ultimately, the report concludes that there should be no prohibitions or restrictions regarding external reprocessing (according to article 17.4) of the EU Medical Device Regulation. . .
View AMDR’s full response here.
English translation courtesy of AMDR.