Interesting Discussion Compliance with regulations in exceptional circumstances


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There are some inherent things all regulatory frameworks for medical devices deal with. And like any system, there are the familiar and often used parts and subsystems that are regularly exercised and tested, and there's the systems that you know you might need but that don't often get the chance to be tested. The latter often suffers from budget-cuts, lack of appropriate training and irregular maintenance or scrutiny under the guise that "nothing has changed since last time".

Now, humanity's encounter with SARS-CoV-2 and its resulting CoViD-19 is straining our society. I am hesitant to call this a black swan event as pandemics and extreme demands are foreseeable, though it is definitely an outlier when it comes to the likelihood of foreseeable circumstances. Thus I'm not surprised by the inertia of activating existing systems, re-configuring systems to be suitable and dealing with the lack of comprehension of the issue's nature and nuance derived from (sometimes knowingly chosen) uncertainty.

We might not get the chance to assign enough importance to certain related issues before they're swept away by more urgent issues, and eventually we will speed by to get back to business as usual once we can (as habits dictate).

The first case I'm putting up for discussion is based on the following information: Italian hospital saves Covid-19 patients lives by 3D printing valves for reanimation devices
  1. Is this counterfeit in action when its knowingly requested, made and tested? Would you report these?
  2. Could you make a rationale for not taking action as a manufacturer (putting aside that someone's public relations department went the self-damaging route of patents as the main reason to not share information)?
  3. What is the value in a cease-and-desist field safety notice that is practically standard action in such a case?
  4. Should risk management files be updated to deal with a "fleet" level impact of events (availability of spares in this case) for matters of vitality-critical devices, even if the scope of risk management doesn't usually consider going beyond ergonomics and human factors of a single device or at least its replacement/maintenance for continuous service.
  5. Do the 3d print manufacturers understand that - in printing a part essential to a medical device's intended use - they've taken it upon themselves to comply with the regulations and all that comes with it?
  6. Do hospitals know to revert these uncertified but understandable fixes to certified components? Would their maintenance records show this?
  7. If particles are observed in the patient, and cause problems (biocompatibility or otherwise) who is responsible to investigate and take action.
  8. Can the public understand that the exceptions made to the rule here come with long-term risks, and it's not only evil capitalism that wants us to return to the controlled order?
  9. Can politics get to grips with the dichotomy they've faced and now present to the public, or will this be an embarrassing episode forgotten while we forge ahead with the existing 'tough' regulation?
  10. Will we see the regulations updated to be clearer on when to go into a special public emergency mode, what to do and how to return to normal?
Take all, any or none of the points and let's discuss (and remember, this is just one of the cases we'll see).


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The second case is based on the request as mentioned in: Coronavirus: PM urges industry to help make NHS ventilators - BBC News

  1. Does suddenly allowing new personnel, in a new location (let's assume they'll use existing stock of parts and materials as a best case), to produce complex and critical devices fit in anything under our existing framework to manage risks?
  2. Do politicians realize that such suggestions (probably well-intentioned and possibly only to project a do-good image) might create unrealistic expectations of what is needed to produce a device.
  3. Could we come up with alternatives that have less risk and the same appeal?
Take all, any or none of the points and let's discuss (and remember, this is just one of the cases we'll see).


Super Moderator
Tough questions, indeed. You certainly don't want to tell a dying patient that they can't have treatment because it'll take 6 months (which would be rushing it through these days!) to get a replacement part cleared. On the flip side, you don't want someone 3D printing something that unwittingly is incompatible (with human touch, with gasses / fluids contacting, etc.) just because it's the most convenient or cheapest option. Nor do you want to give a license to experiment on humans at will under the guise of a crisis.

Since only the manufacturers know of how things are made, what material is used, what works / doesn't work, etc., it would be reasonable to first try going through them for replacement parts. They should at least understand the associated risks. This would require regulatory bodies to grant some flexibility. When hours matter, you don't want to delay. They would likely have to release and test in parallel.

I don't see this / a similar situation being addressed in the manufacturer's risk file. It would likely be cost-prohibitive to establish the effectiveness of such controls. I work with a number of small companies / inventors and the cash is barely there enough to get clearance and into production. In an ideal world, there would be contingency planning for shortages but it would be difficult to know where to draw the line.

The point about ensuring end users recognize the short-term, emergency use only need is an excellent one. Again, if this could be coordinated with the manufacturers & distributor, it might be at least manageable.

Interesting discussion, for sure. Doctors can use devices in unintended ways / outside of the indications for use if they feel, in the practice of medicine, it will be in their patients' best interest. Extraordinary times call for extraordinary measures. How to do that safely is the challenge.


Starting to get Involved
After just reading the 3D printing story, my kneejerk reaction as an RA professional (second) and a human being (first) is:

If I were the device manufacturer, I would have called an emergency meeting between SMEs at the hospital and the manufacturer to get everyone knowledgeable and on the same page with respect to the risk-benefit ratio of 3D printing these parts. Presumably the manufacturer has better insight into things like biocompatability and materials integrity characteristics; whereas the hospital can provide better information on what happens if patients don't have access to these parts.

Assuming risk-benefit bore out that more harm would come from NOT printing the parts, ultimately I would have likely (at least) surrendered the drawings/CAD/whatever files to the hospital or (at most) helped with the additive manufacturing process (assuming we're in a position to afford to do so).

Regulatory exposure would be the least of my concerns, to be honest. If you can demonstrate that you followed the spirit of the regs and made a good faith effort to do what you believed to be the right thing the right way in a national crisis... no reasonable high-level regulator is going to come down on you.

Larger concern is (1) lawsuits down the road when the parts don't perform the spec (and they won't) and (2) assuming the parts have some novel, proprietary design; harm to your business down the road when competitors get a hold of your tech. It sounds crass, but I know I'm not the one signing checks for hundreds of employees.

It's easy for me to say I would sign off on handing over the files. There may have been a good public safety reason for not doing so. Luckily I've never been put in such a situation.


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The practice of medicine in certain regions does allow for off-label use, if the physician can properly explain why he thinks it will benefit the patient while there are no other options, and the patient consents to the uncertainty. It's an odd and often overlooked (uncomfortable) spot versus the rules for how a manufacturer is expected to act in such cases, but the practitioner's exemption is there with good reason: sometimes you're just stuck within the box and you might need to look outside of it. It's seldomly a stand-alone decision, usually there's some peer review going on, even if it is after the fact.
The FDA's guidance on availability versus non-compliance implies the company can bring forward arguments (especially the scientifically substantiated kind) but should not decide in a void. It doesn't go into how parties new to the game should deal.
I think that for vitality supporting devices continuity of supply of consumables or parts that are known to not last the full life of the device as a whole is something to be expected. To expect an amount that exceeds any condition of 'normal use' to be prepared I do regard as folly. But to have a contingency plan ready when a device runs out of parts, and you cannot supply at a device level with low occurrence is not a strange expectation, and having some contingency plan with public relations effort would fall under your remaining residual risk. I would advocate having an outline of it ready and played consequences over some tabletop simulations.

As for getting people to understand it was exceptional, that's easy. But lay man's explanations of the purpose of each item that can be widely distributed and understood without aid and in the relatively short attention span of people will be a challenge.

While I think the intent of the controls placed upon companies does take priority over requirements for specific implementation, it is exactly that intent which is often not worded explicitly enough to fall back onto it. Many a word is spent on the intent to provide high-quality care without undue risk, and that's about it. The levels are left dynamic/vague, and with that the ability to link your actions to any definite intent of the regulations. While I agree many people would not take issue with it, some would. Especially as some consequences will only occur after the crisis is over, and with indeterminate traceability cannot be shown or might not be accepted to have occurred in the crisis.

Like you I would have helped with the best-can-do rendition of the part (including traceability and records in the DHR to serve maintenance with the validated and certified part as soon as possible), put in place a field safety notice in cooperation with the additive manufacturers such that the risks are clear, and instructing hospitals to note the use of such a special part in the patient's file for later investigations. Reverse-engineering is always a risk, but given it was reproduced with an amount of effort a volunteer force could muster, the amount of 'hard' protection against a determined competitor was low anyway and the reliance on copyright or patent to defend is a last resort. Oddly enough, the MDR protects against it, as compatibility of such items (this one technically becoming an accessory) must be explicitly shown - something any notified body should throw doubts on if the company cannot show it will be able to keep up with the changes of the original to which they don't have intimate access.


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Tossing into the mix: the EU's official answer is Commission Recommendation (EU) 2020/403.
In summary:
  1. It targets SARS-CoV2 and CoViD-19 relevant Personal Protective Equipment (PPE) and Medical Devices (Not IVD (tests)!).
  2. It allows non-CE marked products on the EU market after the applicable Essential Requirements (EU MDD) /General Safety &Performance Requirements (EU MDR) have been verified by a Notified Body
    • Thus without other matters such as CE-mark being present, a full technical file or a fully certified QMS etc.
  3. The expectation is that after that expedited clearance allows initial distribution during the crisis, the remainder of the conformity assessment route is still followed.
  4. There are some further pathways for governments to ease the way of entering devices into their market.
  5. The recommendation also instructs Notified Bodies to prioritize the products relevant for the crisis.
    • This can impact the other products which might be hit by the EU MDR deadline coming up. Some people surmise that some of the governmental options provided through this recommendation could be applied as temporary solutions for the EU MDR bottleneck as well, but there's no idea if that will happen.
Note: the Dutch standards organization has released some standards relevant to certain medical device products for free after registration in their on-line platform.
Point 2 is of interest: a case of paradox inducing the need for the most professional of judgement for Notified Bodies. Often you cannot prove to a Notified Body that you've met the ER/GSPR without the substantiation in a technical file and the controls in place through suitable and effective QMS.

Thus it seems to become to recommend to "work harder".
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