A former member of a medical device committee representing the US to ISO Technical Committee 210, which authors the ISO 13485 standard, is at the center of an FDA investigation for having released “adulterated” medical products.
Frank Bernardo, listed as VP of Operations for Datascope Corporation, was sent an official FDA Warning Letter which detailed multiple quality system violations related to the company’s intra-aortic balloon catheter products. In one case, a failure of one such Datascope product resulted in a patient being forced back onto life support after the catheter leaked. One patient is reported to have died due to a related defect in one such product.
Datascope issued a global recall of its related catheter pumps. The FDA indicated that Datascope’s reporting of the death and other concerns related to these products was insufficient.
Mr. Bernardo was listed as a member of the Associate for the Advancement of Medical Instrumentation’s (AAMI) working group, which represented the United States on the official ANSI Technical Advisory Group to TC 210. Bernardo would have worked on the ISO 13485:2003 version of that standard; it’s not immediately clear if Mr. Bernardo is still on the US TAG.
Datascope was acquired by the Getinge Corporation. It is not known if Datascope currently holds an ISO 13485 certification.