The Tip of the Spear: A Review of "The Bleeding Edge" and What's Waiting Behind Door #2


I should not have been as surprised as I was. But then the anger set in, then fear, then a few tears as the reality of the current state of our medical device industry hit me like a ton of bricks.

I'm not a surgeon or scientist. I've never been to an FDA meeting or gone through a 510K process. But I've handled more medical devices in my short career than 90% of the folks in the brand new Netflix documentary "The Bleeding Edge", so this conversation is real for me -- and if you're reading this, I'm sure it's just as real for you.

So, first for the review:


Disagreements:


1) There is a fundamental assumption in this film that regulation = safety. The film makers spend a large portion of their time focusing on how easy it is to get a medical device to market through the 510K process and predicate device "loophole" (as they call it). And as far as that goes, I'll grant that there are all kinds of holes in that process. What they failed to prove (and why I call it an assumption) is that the FDA or any governmental body can have the insight or wherewithal to properly, consistently, and 'without undue influence' regulate an industry like this. Obviously, that's not going to stop them from trying -- but I think if we learned anything about the failure of FDA regulation and regulators from this film, it's that they deserve less power not more. If there is a system, it's going to be "gamed," if there's money to be made, it's going to be made. Regulation is not the silver-bullet.


2) A number of the individuals and groups interviewed for this documentary who were harmed by medical devices had real, heart-wrenching, harrowing stories (hence the aforementioned tears). But some of the language and methods they utilized to respond to these events, I felt, were misdirected. If Essure hurt you, you have every right to be angry and respond. But if your goal is to garner support from a watching world, then "F*CK Bayer" signs and decals of a kid peeing on the word "Essure" is probably not the best way to get there. This is more a disagreement with the means rather than the message.


3) I'm not an attorney (even though I punished myself by completing a year of law school in my younger days). That being said, as is usual for many documentaries, I do not think the this film gave adequate attention to an important issue from the other side of the debate -- informed consent. No one forced these folks to use these devices. To my recollection, all of the surgeries and devices mentioned in the film related to elective procedures. Now, the argument could be made, and I think was carried this direction by the film, that patients and physicians unduly trust the FDA to be the informed part of that equation, leaving the consent part to be given by the patient. While there probably is blame due to the FDA, there should also be a level of responsibility on the part of individuals who contractually assumed that risk, and the physicians who led them there. There is failure of the process all around.


Agreements:


1) Innovation is not the same thing as improvement. If there were one word that is thebuzz word in this industry it is definitely "innovation," and I think this film did a great job at debunking the myth that innovation = good, safe, better. A surgeon in the film stated that innovation really means "untested," and again, that's true enough -- considering that existing devices will always have more real-life evidence available regarding both the risks and rewards of the particular treatment or device. While innovation is still a positive force, the idolatrous worship of innovation is dangerous for our patients and our costly for our facilities. Speaking of cost, let's talk about how much $$ device manufactures make out of releasing "next generation" devices to replace existing devices in the field that are working just fine...


2) These stories of medical device failures must be told -- because the device industry has zero incentive to tell it themselves. I know as a medical device reprocessing professional, it was powerful to hear and see these patient's stories. I've processed instruments for thousands of patients up to this point, and led departments who have processed many thousand more -- but I'm met with only a handful of patients, and never met with one who had a negative outcome such as an SSI or device complication. Lives are impacted forever by what we do, what we manufacture, and what we let into our operating rooms. These are real people, with real stories -- not just medical record numbers and case IDs. I wish there were more documentaries of this kind focused on cleaning, SSIs, and compliance break downs.


3) The vast majority of medical device professionals care about what they do. But it is also true (as the anonymous sales rep mentioned in the film) that there are far too many reps and surgeons who are unduly influenced by profit margins, corporate relationships, and greed. As was mentioned in one of our early Beyond Clean podcasts with Keerthi Kanubaddi from ReadySet Surgical, many of these vendor companies value the surgeon/vendor relationship in the tens of millions of dollars over the life of the surgeon. You can see the unfortunate implications of this staggering valuation in the ways some vendors disregard hospital policies when they deliver their surgical trays for processing, how they stash non-owned loaner trays in healthcare facilities without any type of contractual agreement for storage, and on and on. When money is the master, safety cannot help but suffer.


What's Behind Door #2


If "The Bleeding Edge" had one over-arching take away, it is that patients (and their physicians) should be empowered to ask questions regarding the safety of medical devices and receive real answers. But the reality of the "medical device problem" does not stop at the FDA and device manufacturers.

"I'm doing a study on this. It's something I feel morally obligated to do, but I just don't think I should have to be the guy to do that." - Dr. Stephen Tower, "The Bleeding Edge"

Even with "safe" devices, fully vetted by the FDA and researched accordingly -- the dirtytruth is that there is a real and present danger that patients and many physicians are still not aware of -- dirty, damaged, non-functional devices making their way into our country's operating rooms. This is the Sterile Processing challenge. And like the story of these medical devices, there are a host of victims out there suffering today from process breakdowns in this critical portion of medical device reprocessing. Infections, surgical burns, retained foreign bodies, and on and on. No one has told their story yet, but in the background of any discussion regarding safe medical devices, their voices and their experiences are beckoning the rest of us to stand up and make a difference today.


That's my opinion. What say you?


Hank Balch is the co-founder and Principal of Beyond Clean, a next generation Sterile Processing consulting firm with focus on operational improvement, accreditation survey preparedness, interim-leadership placement, and brand consulting for CS/SPD vendors. He is also the Co-Founder & Host of the Beyond Clean Podcast, a weekly international podcast discussing industry topics with the biggest names in Sterile Processing. You can find over 100 other Sterile Processing articles and commentary here, along with published articles in Becker's Hospital ReviewInfection Control TodayAAMI NewsAAMI BI&T JournalOutpatient Surgery Magazine, and contributions to Healthcare Purchasing News. Hank's CS/SPD team in Louisville, KY was named the "2016 CS/SPD Department of the Year" by HPN, he's served as the President of the South Texas Association of Sterile Processing Services and President of the Kentuckiana IAHCSMM Chapter, and was nominated for the 2017 President-Elect & 2018 President-Elect of the International Association of Healthcare Central Service Materiel Management.

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