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
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
- Is this counterfeit in action when its knowingly requested, made and tested? Would you report these?
- 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)?
- What is the value in a cease-and-desist field safety notice that is practically standard action in such a case?
- 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.
- 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?
- Do hospitals know to revert these uncertified but understandable fixes to certified components? Would their maintenance records show this?
- If particles are observed in the patient, and cause problems (biocompatibility or otherwise) who is responsible to investigate and take action.
- 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?
- 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?
- 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?