web analytics

More BS from the FDA: Medical Device Post Market Surveillance

More BS from the FDA: Medical Device Post Market Surveillance

February 23, 2015


On the heels of the DOJ’s blame game we now have the FDA discussing the national medical device post market surveillance program that started in 2012-ever heard of it? Me either.

Taken directly from Mass+Device:

In 2012, CDRH laid out a strategy to strengthen the nation’s postmarket surveillance system for devices. As described in that strategy, our vision for medical device postmarket surveillance consists of a national system that quickly identifies poorly performing devices, accurately characterizes and disseminates risk and benefit information about real-world device performance, and efficiently generates data to help support premarket clearance or approval of new devices and new uses of currently marketed devices.


Quickly identifies poorly performing devices?  Seriously? Currently 70,000 cases in federal court regarding polypropylene mesh and permanent birth control devices spanning upwards of ten years and they haven’t been pulled yet? That statement is consistent & contradictory language to action on the part of the government. Well in fairness the FDA has identified some devices (because they’re in federal court) but they just haven’t done anything productive after identifying them about pulling them from the market.

We cannot create a system like this alone. Achieving our vision for a national system requires thoughtful input and active participation from many key national and international stakeholders—now and in the future.  In 2013, after receiving public input on the 2012 strategy, we published an update that described the five major steps the FDA would take to create a National Medical Device Postmarket Surveillance System (MDS):

(1) Establish a multi-stakeholder Medical Device Postmarket Surveillance System Planning Board to identify the governance structure, practices, policies, procedures, methods and business model(s) necessary to facilitate the creation of a sustainable, integrated medical device postmarket surveillance system.

(2) Establish a unique device identification (UDI) system and promote its incorporation into electronic health information.

(3) Promote the development of national and international device registries for selected products.

(4) Modernize adverse event reporting and analysis.

(5) Develop and use new methods for evidence generation, synthesis, and appraisal.

Many key and international stakeholders?-Does that mean the makers of the devices and the doctors who are paid by those device makers? Yep that’s certainly not a design flaw.  That’s almost as good as the DOJ expecting companies to self-report when excessive devices are used (hello that’s the goal of every device maker).

Today, we are happy to announce the release of the Planning Board’s report Strengthening Patient Care: Building an Effective National Medical Device Surveillance System, which outlines recommended steps toward achieving the MDS and strategies for implementation. The report provides a pathway to realizing a national system that harnesses novel data sources, modern analytical techniques and the participation of all stakeholders to optimize patient care. Interested stakeholders will be able to share their feedback on the report through a public docket.

Fantastic! Keep announcing all these programs that have actually done nothing! Our tax dollars hard at work people.

In the coming months, we will also get reports from the Medical Device Registry Task Force. As noted in the 2013 Update, these reports will address significant issues such as defining effective registry governance and data quality practices, which will enrich the national dialogue on development of registries as a crucial source of data on device performance.

egg in face


Oh good a Task Force and here I thought this was just another pointless announcement.  Mmmm I sure hope the FDA calls on their buddies the NSA when checking out who’s on the Task Force-they certainly don’t want another egg-on-their-face episode like Dr. Andrew Brill (paid consultant for Johnson & Johnson and also on the FDA panel to evaluate among other things Johnson & Johnson products).

  • FDA. CYA. Enough said. Right?

    February 23, 2015 at 6:27 pm
  • Jan Urban

    Hmm…Stakeholders? Or do they really mean Shareholders? I guess the past failures are just that, past, set aside, forgotten.

    February 23, 2015 at 6:32 pm
  • They say stakeholders but Patient Stakeholders are not only not at the table, they are not even in the room. Like what happened when the Essure women went to Washington last month and the FDA would not even meet with them saying they had never confirmed the meeting.

    But you can be sure, Bayer (Essure manufacturer)who makes the ugly device that has hurt thousands and thousands of women is at the table anytime they want.

    February 23, 2015 at 7:49 pm

Post a Comment