The medical device manufacturer Bard Peripheral Vascular, a division of CR Bard, was cited by the US Food and Drug Administration (FDA) for serious quality system violations, including failing to report patient deaths, while holding an active ISO 13485 certificate issued by BSI and accredited by the Standards Council of Canada (SCC).

CR Bard has since been investigated for as many as 27 patient deaths surrounding its faulty vena cava filters, used to prevent blood clots from traveling into the heart. The company has been accused of having intentionally ignored patient deaths and keeping the defective products on the market for years.

In July 2015, the FDA issued Bard an 11-page “warning letter” citing serious quality system violations at the company’s Tempe Arizona plant, along with its Queensbury NY plant. The letter included citations indicating Bard had failed to classify at least one patient death, and another seven were misclassified so as not to mention they involved “serious injuries.”

Complaint (b)(4) for a G2 Filter, embolization of a detached filter arm with associated areas of hemorrhage and necrosis in the right lung was filed as a malfunction Medical Device Report [MDR] and should have been filed as a death.

The report then cited multiple quality system violations, including:

  • Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints as required by 21 CFR 820.198(a)
  • Failure to validate, with a high degree of assurance and approve according to established procedures, a manufacturing process that cannot be fully verified by subsequent inspection and testing, to ensure the process will continue to meet specifications as required by 21 CFR 820.75(a)
  • Failure to establish and maintain procedures for acceptance of incoming product and to inspect, test or otherwise verify incoming product as conforming to specified requirements as required by 21 CFR 820.80(b)
  • Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50.

These violations came about as a result of an FDA inspection of the Tempe facility conducted between November 2014 through January 2015. According to the official ISO 13485 certificate issued by BSI, and accredited by SCC, the Tempe facility received an updated ISO 13485 certification in September of 2013, which was set to expire in September of 2016, thus covering the period of time before and after the FDA report. The BSI website shows the Tempe facility is still listed as ISO 13485 certified.

SCC accredits BSI to issue ISO certifications and holds the final responsibility to ensure BSI certificates are issued in a competent and objective manner. SCC has also granted BSI accreditation under the Canadian Medical Devices Conformity Assessment System (CMDCAS), and that logo also appears on the Bard ISO 13485 certificate. SCC is a member of the International Accreditation Forum (IAF).

The 2016 ISO 13485 certificate was signed by BSI’s Reg Blake, a prominent member of the Independent Association of Accredited Registrars (IAAR) and a member of ANAB’s Accreditation Council.

The discovery marks yet another example of how IAF accreditation bodies, and their accredited registrars, have been found to have issued allegedly competent and trusted ISO certifications to companies later found to have killed customers or members of the public. Such certifications have been found to have been granted to the companies responsible for the Takata airbag deaths, the Deepwater Horizon disaster, and the Space Shuttle Columbia explosion.