As many of the readers already know, when Dr. D has some down time he partakes in a practice the doctor affectionately calls “Drink’n & Think’n”—and not necessarily in that order. While the doctor was reviewing the FDA’s weekly enforcement reports, it was quite shocking to see the number of Class I Recalls being initiated by device establishments. Now granted, the FDA’s enforcement reports are less than sprachgefühl (look-it-up) pieces of literature. However, they contain a plethora of information required for raising awareness associated with serious device issues. For example, the following establishments have executed Class I recalls, which have been posted in the FDA’s Enforcement Reports during the previous four weeks:
- Week of June 10 – Synovis Surgical Innovations (a Baxter company)
- Week of June 17– Maquet Cardiovascular, HeartWare, and Zimmer
- Week of June 24– HeartWare (continuation of previous recall)
- Week of July 1 – Maquet Critical Care
Please keep in mind, according to the agency “Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.” Enjoy!
What’s Up Doc?
There is no doubt the doctor’s friend, Mr. Murphy, is alive, well, and lurking in the corners of every device establishment in the world. As a result of his presence, it is inevitable that most firms will eventually face a “Recall” (Dr. D’s favorite 6-letter word). However, sometimes Mr. Murphy needs some help. The doctor believes there just might be an underlying trend associated with product quality, and not necessarily a good one, impacting the safety and efficacy of finished medical devices. That being said, Dr. D believes it is appropriate to at least formulate, postulate, reiterate, speculate, and regurgitate (enough “ate’s” for you) some questions and provide some perceived insight behind the Class I recall trend.
- Are quality organizations continuing to shrink under the guise of continuous quality improvement (code word for need to cut overhead)?
- Is there too much of a reliance on outsourcing manufacturing operations without proper oversight by the establishments that actually own the quality and regulatory responsibilities?
- Are there too many shortcuts being taken when pursuing design verification and validation activities?
- Are processes being properly validated?
- Are suppliers being appropriately evaluated and managed?
- Are devices being introduced into commerce without being properly vetted prior to clearance or approval by FDA?
- Is the product labeling or instructions for use too confusing?
- Is product training an issue with clinicians?
- Has Mr. Murphy grown too powerful, not unlike the Wizard of Oz (just kidding)
Dr. D’s Insight into Recalls
Before alienating some of the readers, Dr. D would like to go on record as stating the vast majority of recalls are not premised on malicious activities pursued by medical device establishments. As the doctor stated earlier, Mr. Murphy is alive and well, so unfortunate circumstances, accidents if you will, are bound to happen. Please note, the majority of recalls are typically driven by product performance issues that can quickly be resolved. However, Class I Recalls and to some extent Class II Recalls, pose an additional risk—regulatory risk. You see, the agency actually does pay close attention to Class I and Class II recalls and the activities subsequently pursued to remedy the recall and correct product deficiencies. Unfortunately, a device establishment’s competitors are also taking full-advantage of the recall by offering to fill a product void, if the recall results in a significant interruption in a healthcare provider’s supply-chain.
The doctor thinks some of the causes driving these recalls can be placed into one gigantic category summed up by the 1980 hit song by Queen and David Bowie, “Under Pressure”. Device establishments are under a tremendous amount of pressure from investors, healthcare providers, patients and competitors to design, develop and release the next wonder device to commercialization. Did Dr. D mention investors? Seriously, when project timelines become compressed and the proverbial heat has been turned up in the kitchen, mistakes are made. In some cases, mistakes can all but kill a project launch or even worse, result in a regulatory nightmare, as regulators attempt to decipher the data submitted in support of a 510(k) or PMA. In fact, serious regulatory issues plaguing a device establishment can put the entire organization in jeopardy, especially if quality and regulatory issues result in an agency warning letter or consent decree.
Getting back to the point, some of the issues relating to the recalls mentioned at the beginning of this article include: (a) connector wear; (b) battery failures that fail to actuate an alarm; (c) excessive force damaging a connector; (d) surface contamination due to a process monitoring issues; (e) a locking device that can accidently be released; and (f) difficulty in determining the smooth from the rough-side of a patch. Seriously, these are the issues that have been identified, at least initially, by the manufacturers. So now Dr. D will place each of these failure modes into a category premised on the information available from the FDA’s website. Please note; this is purely conjecture on the part of Dr. D, but it is intended to highlight what can happen if the appropriate attention to detail is not pursued.
- Connector wear – possible issues with design V & V studies
- Battery failure – possible issue with product aging studies (real time or accelerated)
- Excessive force damaging a connector – possible design issue (wrong connector selected)
- Surface contamination – possible process validation and/or QC issues
- Locking device that can be released – possible design issue
- Difficulty in ascertaining the correct surface – possible design issue or even a product labeling/IFU issue
The doctor is sure the readers can develop some hypotheses of their own; however, it is Dr. D’s opinion each one of these issues, identified as a recall catalyst, could have been prevented. Maybe a few more weeks of product testing; maybe one more inspector on the manufacturing line; or maybe one additional clinical site may have made the difference. Then again, maybe not. Regardless, product performance issues were the underlying cause of the uptick in Class I Recalls, and product performance issues could have been prevented (Dr. D’s opinion).
For this week’s guidance, the doctor will not leave any takeaways but would like to reinforce one salient concept. Product performance issues, regardless of the cause, will eventually result in product corrections and removals (a nice way of saying recall). Product performance issues can be prevented. In fact, it is incumbent upon all device manufacturers to do everything in their power to ensure that the devices they design, develop, manufacture and enter into commerce are always safe and effective in their intended use. In closing, thank you again for joining Dr. D; and I hope you find value in the guidance provided. Until the next installment of DG, cheers from Dr. D. and best wishes for continued professional success.
Code of Federal Regulation. (2014, April) Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office.
Code of Federal Regulation. (2014, April) Title 21 Part 806: Medical devices; reports of corrections and removals. Washington, D.C.: U.S. Government Printing Office.
Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation –21 CFR, Part 820. Charleston, SC: Amazon.
Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon.
It is important to realize that FDA classifies the recall, not the manufacturer. An increase in the proportion of Class I recalls could result from a different view of severity over time by the classifiers.
It would be interesting to do a longitude analysis of the recall classes. Each week the Enforcement Report (which by the way now has a nice format) has, I estimate, 20 to 25 recalls. It would be interesting to see if the distribution by class has changed over time; the previous 5 years should tell the story.
The recently published guidance on distinguishing enhancements from recalls has, I suspect, raised awareness for manufacturers about the need to file Part 806 reports, the primary source of device recalls. It would be interesting to see of there is a statistically significant increase in the total number of voluntary recalls after the publication date.
Dan, nice hearing from you. Yes, you are correct the FDA’s recall categories are premised on risk to the general public (driven by device issues). I thought it might be a nice touch to share the concept that no manufacturer is immune from the dreaded recall process. I do hope the guidance drives better establishment awareness. Scouring the warning letter database will point to ongoing compliance issues associated with Part 806 compliance. Time will tell. Best Regards, Dr. D
What actions does the FDA take against these establishments that have the dangerous class 1 recalls? Fines, Prison, Tar and Feather?
Is a recall class based purely on the possible health risks of the device?
Does the FDA consider general wear and tear of the device, such as the connectors vs. an establishments incompetents in development or ambiguity in the device instructions when taking action?
Corey, great questions. In most cases (Dr. D’s opinion), recalls are a result of device manufacturers performing inadequate verification and validation testing through the design and development of their products. Speed to market is becoming a reality in the device industry. The FDA will take the time and visit a device manufacturer that has announced, is currently navigating, or completing a Class I recall. There are no fiscal penalties until the federal courts and DOJ get involved, but this typically does not happen unless the manufacturer truly fails to remedy product and quality compliance issues. However, if it is determined that some level of malfeasance has occurred, steep fines and potential prison time could become a reality for device establishments and their chief jailable officers. Be Well, Dr. D