Medical Device News International exposé of the harm caused by poorly tested medical devices.

Sidney Vianna

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#1
I receive updates from the ICIJ - The International Consortium of Investigative Journalists - a serious entity, in my estimation. The last email I received from them forewarns us that on Sunday, November 25th, 2018, they will release an exposé of the harm caused internationally by poorly-tested medical devices.
Business is booming for the $400 billion industry responsible for producing devices that can save and transform lives. But people around the globe have shared shocking stories of harm caused by faulty products as regulators watch on.
We’ve sifted through millions of records, documents and files related to the industry. We’ve spoken with patients and their families, with doctors, surgeons, academics, regulators and the industry, too.

We can’t wait to share more with you on Sunday. So stay tuned.
 
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Marcelo

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#2
Seems like the continuation of the Netflix documentary...hope that they put a more complete information (including benefits and a clear understanding of the the way regulatory requirements are applied), otherwise it will be only another "shocker" that does not resolve anything (and only get the common population more concerned than they should).
 

Sidney Vianna

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#3
If the regulatory process is failing to prevent unsafe medical devices from reaching the market, something needs to be done. The way I see it, investigative journalists will always have their limitations.

But, by exposing the flaws, and warning consumers and patients, pressure builds up through the political process to crack down the regulatory bodies so improve the approval process.

The current situation related to the Medical Devices Notification Bodies, all stretched for resources and under increased oversight is due, in part, to similar exposés of the abuses made in some eastern european countries and the lack of proper monitoring onto some shady NB’s.
 

Marcelo

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#4
If the regulatory process is failing to prevent unsafe medical devices from reaching the market, something needs to be done. The way I see it, investigative journalists will always have their limitations.

But, by exposing the flaws, and warning consumers and patients, pressure builds up through the political process to crack down the regulatory bodies so improve the approval process.
The problem is the understanding of what an unsafe medical devices is. Medical devices regulations do not require 100 % safe medical devices because this is impossible to achieve. They usually require devices whose benefits outweigh their risks. This is a complex issue which require understating of factos such as the types and magnitudes of benefits the device offer, likelihood of patients experiencing one or more benefits, patient perspective on benefit, how alternatives solutions are in relation to the proposed device, including availability, besides factors related to risk (and these are only a few factors I mentioned). And also post-marketing surveillance considerations for all of these.

This means in practice that medical devices will have risks, including side effects. My concern is that most of the discussion (and I cite again the Netflix documentary) seem to focus only on the part of side effect and adverse events, without considering the myriad of other factors that have to be taken into account to decide if a device is safe or not (and most of the time this is because either the people discussing do not understand the regulations, or lack information or all the factors, or both - the latter is usually the case) and thus it's not a real technical discussion.

The current situation related to the Medical Devices Notification Bodies, all stretched for resources and under increased oversight is due, in part, to similar exposés of the abuses made in some eastern european countries and the lack of proper monitoring onto some shady NB’s.
Yes (although it's really a small part, but who do not follow the historical development of the regulations or understand the regulations tend to think that they played a bigger part than they really have), however, this is not the same as the situation I mentioned before. For once, Notified Bodies are not responsable for defining if a device is safe or not. They are responsible for verifying if a conformity assessment process was followed. For most this seems like the same, but it's not the same and is part of the problems mentioned (such as the PIP and eastern european countries).

I'm not saying that investigations and exposés are not necessary (I think they are), but when you make those, the discussion is more complex that it seems.
 

Marcelo

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#6
Well, I've read some of the articles (will need some time to read them all), but as expected, the ones directly related to "unsafe" seems to fall exactly where I mentioned before: focusing only on problems and not in the more benefit/risk balance that I mentioned before.
 

Sidney Vianna

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#7
but as expected, the ones directly related to "unsafe" seems to fall exactly where I mentioned before: focusing only on problems and not in the more benefit/risk balance that I mentioned before.
Indeed, Marcelo. That's what an expose' is: Focusing on the problems so actions are sought.

Imagine if the commercial aviation sector had the same approach, and fatal aircraft crashes were treated as "tolerable risk". One of the purposes of an expose' is to bring awareness to the population so the level of risks are widely known and acceptance of failures continues to be lowered.

Acceptance of failure is something that decreases continually over time and, obviously, the medical device industry has to react accordingly. One of the components of the external context of organizations that organizations have to be aware of and respond accordingly.
 

Marcelo

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#8
Indeed, Marcelo. That's what an expose' is: Focusing on the problems so actions are sought.
So, what is the problem? I agree that that bringing awareness is important, but the way it's done is by trying to pass the idea that there IS a problem, and I'm not sure there is.

Acceptance of failure is something that decreases continually over time and, obviously, the medical device industry has to react accordingly.
This is already expected (for years now), but the "exposé"implies that it's not expected and thus all regulatory systems are in fail.
 

Mark Meer

Trusted Information Resource
#10
If the regulatory process is failing to prevent unsafe medical devices from reaching the market, something needs to be done...
I agree with Marcelo, that such "exposés" have to be treated with care, and not simply be an amalgamation of anecdotes. As Marcelo points out, the medical sector is all about risk-benefit, and focusing on individual cases bears a risk of stoking consumer panic (where only harm is considered, and not benefits).

I think it's a mistake to think that the regulatory process will ever "prevent [all] unsafe medical devices from reaching the market" (or that this is the purpose). If this were the expectation, then there will always be "something...to be done" - which leaves us where? Ever more strict regulations?
 
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