Philips Healthcare Trick or Treat

Joe Hage

🔥 Find me at MedicalDevicesGroup.net 🔥

November 2017

< 1 min reading time

Just after Halloween, the FDA issued a Consent Decree to Philips Healthcare for a number of egregious violations involving their external defibrillators. Philips had “tricked” industry by consistently providing unsafe defibrillators so the FDA “treated” them to a cease and desist order through a mandate from a federal judge. What amazes me is that a company with the size and resources of Philips could allow such a systemic breakdown in their quality system to escalate to the point where the FDA, in the interest of public safety, had to issue them an order to cease and desist manufacturing. I discuss this breakdown in my recent blog post http://wp.me/p6wmF6-ek. To me, this reflects a lack of accountability from executive management and a cultural breakdown. Despite a long history of problems with the defibrillators causing patient death, Philips did not take proper actions to fix the problem so FDA had to intervene. What are your thoughts on how executive management and company culture impact the efficacy of the quality system?

If you have not been scared enough by Halloween, read this consent decree announcement made by the FDA on November 1 to Philips Healthcare concerning quality control issues with their automatic ext…

source: https://www.linkedin.com/groups/78665/78665-6336223760735100930

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Posted by Joe Hage

Asked on November 14, 2017 12:00 am

121 views

	Private answer Shawn Fetz I would agree, executive accountability and a breakdown of the quality system. It begs the question for all manufacturers: How are you measuring yourself internally and externally? Where is your bar set? Marked as spam Report spam
	Private answer Numerous violations....You would of thought one would have been enough to throw up some red flags as to the quality control issues. Marked as spam Report spam
	Private answer Our quality manager is effectively using this as "scare" tactics internally. To use another Halloween themed word. Marked as spam Report spam
	Private answer Shawn Fetz great feedback I think metrics in medical device companies often create undesired behaviors that compromise quality and patient safety. What measure to you find the most helpful in measuring the right things and create positive behaviors? Marked as spam Report spam
	Private answer Jonathan Jurgaitis good for your quality manager! Better to learn vicariously than live through something like this. If you get to live that is. Some patients didn't. Marked as spam Report spam
	Private answer Margarethe Boisserie Michelle Lott , RAC : I presume that they are ISO 13485 certified ? If so, did this breakdown impact the validation of their QMS ISO cert. , i.e. suspension or withdrawal ? Thanks. Marked as spam Report spam
	Private answer How could everyone have looked the other way? Where is the accountability? Oversight? Marked as spam Report spam
	Private answer Sad. This shows the importance of keeping FDA strong and staffed to appropriate levels which is not happening at several federal agencies. Marked as spam Report spam
	Private answer Julie Omohundro Executive management is accountable to the company’s shareholders. Without being able to crunch the numbers, I don't think I'm in a position to say whether those interests were well or poorly served. An effective quality management system is one that gives the company effective control over its quality outcomes. Without knowing what quality outcomes the company was aiming for, I don't think I'm in a position to say whether its QMS was functioning effectively or not. Marked as spam Report spam
	Private answer Julie Omohundro What would be really interesting to know is whether the company's manufacture of these defibrillators would have met the quality metrics being proposed under the "Case for Quality" as a justification for reduced regulatory oversight. Marked as spam Report spam
	Private answer No doubt that executive management must be accountable for public safety demands; but we all have an impact. So what can you and I do today to flag potential quality issues? Marked as spam Report spam
	Private answer Shawn Fetz Internal metrics: unit and $ scrap rate, NCR per period of time. Effectiveness of CAPA and training effectiveness. External metrics: number of complaints, type of complaints, who is complaining: users, distributors, patients. Those are on the top of my head. Marked as spam Report spam
	Private answer Hany M. EL Debeky I miss your point from the post. There is a big difference between violating QSR requirements and product recall due to field failures and complaints. In Philips case it is about violating QSR requirements and no incidents or near-miss cases, unless I am unaware of them. Marked as spam Report spam
	Private answer Julie Omohundro "Specifically, the complaint alleged that, while Philips initiated corrective and preventive action in response to complaints involving certain resistor failures during the use of the HeartStart HS1 and FRx defibrillators, Philips’ corrective actions did not fully address the problem with the devices in the field and Philips continued to receive complaints about the failure.' Marked as spam Report spam
	Private answer Shawn Fetz Julie, you bring a good point, a point of contention for some: management beholden to shareholders and not the patients. Maybe medical companies should not be publicly traded. Not something to be discussed here but still an interesting discussion. Marked as spam Report spam
	Private answer @Hany m. Hany M. EL Debeky A quick Review of the MAUDE database indicates 180 deaths associated with Philips defibrillator since 2016. If you search all event types just for the month of October 2017, you get the message "500 records meeting your search criteria returned. The results are incomplete - please narrow your search." The incidents were enough to get FDA's attention just not Philips executive management. Marked as spam Report spam
	Private answer Roger Cepeda, JD, MBA, RAC The article resonated with me as I've seen two major examples of the same thing in my own past (consent decree and market withdrawal), where large companies ended up with catastrophic FDA problems even though lack of resources was not the issue. I agree there is a difference between "paperwork" part 820 violations and user complaints or patient injury. But that distinction is exactly how these stories happen. Sadly, patient injury is the "easy" scenario, as the economic impact to sales is immediate. When the problems are not affecting sales or clinicians/customers aren't complaining, it's much harder to make the internal budget argument for investing in QA/RA. The FDA is similar, in that most of their authority and legal changes arose from public health crises, from Upton Sinclair's "The Jungle" through the New Engl Compounding Center, etc. Marked as spam Report spam
	Private answer It's not a hard thing to do. But staff's qualities must be improved. Strengthening safety education, especially to improve staff's sense of responsibility and career quality is the basic guarantee of safety production. They are what we always do at APT Mold to ensure making high-quality prototyping and tooling. Marked as spam Report spam
	Private answer Ryan Mikulich I spent one year with Philips, in a different division than the defibrillators are sold. This doesn’t shock me one bit. Organization was very messy and no one seemed to have a clue about basically anything. Marked as spam Report spam
	Private answer My only question is “What took the FDA so long? I too have been through a market withdrawal and a consent decree. The fault lies with the leadership who do not grasp their full responsibility when they launch and support products into the medical device space. CAPA is only as good as the people who conduct it and the leaders who review and approve it. When root causes go beyond the device and the process, to the management and the leadership, everyone wants to rush a fix to the field. I just hope Philips takes a closer look at how this happened. Marked as spam Report spam
	Private answer Margarethe Boisserie Ryan Mikulich This is scaring ! Michelle Lott , RAC : They are still certified to ISO 13485 and ISO 9001 Is that "normal" that : - The ISO 3rd party Auditor's obviously found the QMS compliant to the Std.'s - The consent decree has no influence/impact to the validity of the ISO certs either ------- Remember the PIP Scandal in France they produced with Industrial Silicon whilst under valid ISO cert. Marked as spam Report spam
	Private answer Ginger Cantor This was the same at GE Healthcare in the mid 2000s. Ignore the quality issues for years to cut costs related to an acquisition, then have the laid off quality folks whistleblow on you, and voila! Consent decree in the making. Marked as spam Report spam
	Private answer I'm pleasantly surprised by the comments here - I've only "lurked" until now as I had concerns that some in the device industry are more interested in profits than realities that might limit those profits. So, now I gather the courage to hope that a few of you kind souls ("maybe medical companies shouldn't be publicly traded" - just one of the interesting comments, wow !) might read my book on medical devices - see the reviews of The Danger Within Us at www.jeannelenzer.com - Marked as spam Report spam
	Private answer Art Pichierri Julie, what was the 'corrective action' implemented? Replacement/exchange or? Marked as spam Report spam
	Private answer Chea Kunwon,ASQ-CQA, PPI A great way to improve Medical Device Industry Marked as spam Report spam
	Private answer In my experience problems like this come straight from the top. I worked at one company where the President did not care about quality, just shipments/revenue, so the Production VP and his people did not care either. This lead to inconvenient production tests being skipped or falsified and lots of sub-par products shipped to customers. Management was also mystified at the lack of repeat business. The basic desire for quality products costs nothing, and doing things correctly is ultimately cheaper and more profitable than angry customers, failed audits, and recalls. Marked as spam Report spam

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Philips Healthcare Trick or Treat

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