Anyone know of ISO 14971 litigation for negligence?

[RansomEli]

I am researching whether any ISO 14971 lawsuits have been filed in the US. I am particularly interested if any hospitals have been sued for negligence over not purchasing medical devices that were not 14971-compliant.

Does anyone have any info on this subject?

Thank you.

 

[Ronen E]

I am researching whether any ISO 14971 lawsuits have been filed in the US. I am particularly interested if any hospitals have been sued for negligence over not purchasing medical devices that were not 14971-compliant.

Does anyone have any info on this subject?

Thank you.

How would such compliance be proven? It's not common to get certified to ISO 14971 and the FDA doesn't even require such compliance across the board.

 

[sarahstec]

You may have more luck finding litigation against hospitals for using products that have already been recalled. For negligence there would need to be a duty present first, and hospitals don't have the duty to follow or use 14971.

I agree with Ronen - 14971 isn't a requirement for compliance, and a hospital wouldn't be able to verify if the manufacturer followed 14971 without examining the manufacturer's intellectual property (the QMS and the tech file). So I would be surprised if you found something.

A hospital's regular duty of care would, however, arguably require it to monitor product recalls/expiration dates to ensure that it's not using a potentially unsafe product. Good luck!

 

[Julie O]

The only way I see this happening would be if the hospital's own policies or procedures prohibited the purchase of medical devices that were not 14971 compliant. As noted, that would be hard to verify, so this scenario does not seem likely to me.