Fall MedAccred Management Council Meeting Update

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Fall MedAccred Management Council Meeting Update

12 October 2015

On October 1, 2015, the MedAccred Management Council (MMC) meeting was hosted by Philips HealthTech at their facility in Andover, MA.  Mr Venky Gopalaswamy, Vice President – Quality Systems and Supplier Quality at Philips HealthTech welcomed participants and strongly expressed his ongoing support for the program and its continued development.

Representatives from thirteen different organisations attended, including Philips HealthTech, Medtronic, Stryker, DePuy Synthes, Vention Medical, Paulo Products, Solar Atmospheres, RTE Sales, Global Technologies and Techmetals.

At the meeting, key discussion points included:

  • The initial results of research into FDA recalls which have involved critical processes and could potentially have been mitigated by the MedAccred program.
  • An interactive session run by Stryker on the FDA Quality System Regulation Preamble (21 CFR Part 820).
  • MedAccred’s 2015 accomplishments including the completion of audit criteria in 5 critical process areas along with initial audits and the first accreditation. In addition MedAccred has been highlighted at numerous Medical Device Conferences and in key industry publications.
  • Development of the MedAccred program strategy for 2016 which includes ongoing dialogue with the FDA and focusing on a strong educational outreach program to continue to build industry participation to improve device quality, reduce recalls and improve patient safety.

Based on their discussions, the MMC also made some key decisions regarding future opportunities for the program. The MMC decided to conduct further research into creating a Batteries Task Group based on the findings of a preliminary survey to establish interest. The potential focus of this activity would be on implantable and rechargeable batteries.

In addition, it was decided that the sub-team of the MMC charged with looking at Process Validation will be assessing the need to include additional general audit criteria to cover Process Failure Modes and Effects Analysis (PFMEA).  This group has also been asked by the MMC to provide training on Process Validation to key MedAccred stakeholders.

Meeting minutes will be issued later this month.

The next MedAccred Management Council meeting will take place via teleconference on Wednesday, 11 November 2015, 11:00am – 12:00pm EST. The next face-to-face meeting is scheduled for Wednesday, 2 December 2015, 8:00am – 5:00pm EST to be held at PRI Headquarters in Warrendale, PA, USA.

For more information, please contact MedAccred@p-r-i.org