Reader’s Digest recently published an essay by Shannon Brownlee and Jeanne Lenzer about medical device dangers that manufacturers know about but don’t properly publicize. In the end, the article calls for a registry of all medical devices in the US so all defects and problems can be tracked, something like the aviation industry’s FAA database.
Short of a registry, experts want to:
* Require all cases in which a patient is seriously hurt by a Class III device to be reported to the FDA, not just those that the company decides are due to its product.
* Create an independent panel to routinely monitor the MAUDE data-base — and give the panel access to company data when there appears to be a problem with a device.
* Stop payments, often called kickbacks, from device makers to physicians and hospitals in exchange for using the company’s device.
A Medgadget alumnus, now employed in the implantable medical device industry, wrote in with the following comment:
As a guy employed by a medical device company I think It’s a relatively fair shake, at least as well as you could hope for from Reader’s Digest.
Crafting a system to opening and accurately monitor medical device safety would be functionally impossible. We (device mfgs) are required to do root cause analysis on any adverse events already, but like the article says, we tend to keep it internal as long as possible. This means a team of engineers works their ass off to get to the bottom of things and writes up a report that is reviewed and signed off by management. Unfortunately, that takes time, and inside our corporate walls we have access to only the most basic clinical info on the patient (meds, other conditions, etc…but no direct access to “the scene of the crime”).
On the clinical side, the MD’s are welcome to come to whatever conclusion s/he feels like. Based on my experience in ortho, I’ve never seen a surgeon chalk up a complication to their own butterfingers (even when that’s the case). The culture of MDs is to never admit weakness/guilt/failure/errors/lack of knowledge. I’m not saying there aren’t reasons for this (patient/staff confidence, liability), but it’s a reality. You’ll never, ever hear a surgeon say “Yep, I messed that up”.
…whereas the culture in engineering is the opposite. Improving on failures is our stock and trade. Thus, in an engineering root cause analysis, we’re likely to uncover a number of potential causes for a problem, weak spots in a design, etc. We can then investigate and “probably” rule them out. Unfortunately, given the layers of obfuscation involved, we may never know exactly what went wrong with high certainty. Oh, and by the way…these things aren’t concluded until months, if not years after the event.
The biggest problem comes when the public at large (not just the “evil media”) get hold of all of this info. It doesn’t take long for engineering analysis to be misinterpreted and distilled to “yeah, those things don’t work/are dangerous/had a bug/etc”, when in reality there’s an outside chance that under certain circumstances certain patients have a 1 in [big number] probability of complications.
So, in a world where the MD’s are guaranteed to (publicly) blame the company/device, and the public is likely to completely misunderstand any information presented, you see the disincentives to device manufacturers when it comes to publicly releasing data.
To be clear, I’m definitely not blaming docs for everything. It’s just that when something goes wrong, there’s a contrast of cultures. With engineering root cause analysis (at least internally, confidentially), it’s more like confession…my experience with clinicians is that it’s more about being hyper-defensive.
It is a reality that the public at large is extremely failure intolerant. One in thousands or tens of thousands is too frequent. Make all the arguments about it you want, but it’s my day-to-day reality, one that’s unlikely to change any time soon.