Anyone know of ISO 14971 litigation for negligence?

R

RansomEli

#1
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.
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
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.
 
S

sarahstec

#3
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!
 
J

Julie O

#4
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.
 
Thread starter Similar threads Forum Replies Date
J Does anyone have an example of Risk-Benefit Analysis per ISO 14971? Other ISO and International Standards and European Regulations 2
R Can anyone Recommend a Webinar which addresses ISO 14971? ISO 14971 - Medical Device Risk Management 4
MDD_QNA QR Code Standard ISO/IEC 15417:2007 - Does anyone use it? Other Medical Device Related Standards 3
F Hi friends, can anyone show me an example of a procedure for ISO 13485 6.4.1 Work Environment? ISO 13485:2016 - Medical Device Quality Management Systems 2
Q Does anyone have experience implementing a QMS without ISO certification? Quality Manager and Management Related Issues 2
M Anyone Dropping IATF and going back to ISO ? IATF 16949 - Automotive Quality Systems Standard 18
R Anyone who can share a checklist for ISO 29134? IEC 27001 - Information Security Management Systems (ISMS) 7
C Will anyone please share training material for ISO:13485:2016 for best practices Training - Internal, External, Online and Distance Learning 0
N Does anyone know a registrar that offers both ISO 9001 and ISO 17020? Registrars and Notified Bodies 6
C Upgrading from ISO 9001:2015 to IATF 16949:2016 - Anyone have a gap analysis tool? IATF 16949 - Automotive Quality Systems Standard 2
S Has anyone created a Turtle Diagram reflecting the new ISO 9001:2015 Structure? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
pammesue Calibration in the UK to ISO 17025..cant find anyone ISO 17025 related Discussions 8
A Does anyone have a comparison between ISO 9001:2015 and ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 2
D Is anyone changing their ISO 14001:2004 EMS Policy? ISO 14001:2015 Specific Discussions 8
T Has anyone been through the ISO 14001:2015 process? ISO 14001:2015 Specific Discussions 12
K Can anyone recommend some good book explaining ISO/TS 16949 requirements? Book, Video, Blog and Web Site Reviews and Recommendations 9
J Anyone here use Paradigm Sofware to manage compliance with ISO standards Quality Assurance and Compliance Software Tools and Solutions 3
G Does anyone have a ISO 13485 Gap Analysis form they'd be willing to share? Quality Manager and Management Related Issues 3
G Anyone have a list of ISO 9001:2008 "Shalls"? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
J Does anyone have a summary of changes made to ISO 11137-2? Other Medical Device Related Standards 3
E Anyone have experience with UL as ISO 13485/CMDCAS and MDD registrar Registrars and Notified Bodies 17
G Can anyone outline the advantages to an organisation - ISO 9001 Benefits ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
P Can anyone give any declaration or something stating that ISO 13488 is no more ISO 13485:2016 - Medical Device Quality Management Systems 2
I Does anyone here have experience with ISO 3951? Other ISO and International Standards and European Regulations 3
D Does anyone know about an ISO 19011 Amendment? General Auditing Discussions 2
P Can anyone give Business Continuity Plan (BCP) (ISO 27001) Business Continuity & Resiliency Planning (BCRP) 10
D Does anyone know of a biocompatible ABS tested & certified to ISO 10993-1 Other Medical Device Related Standards 5
G ISO/DIS 14045 - Anyone have an early draft copy? Miscellaneous Environmental Standards and EMS Related Discussions 2
C Does anyone have an example of an ISO 14001 Internal Audit Schedule ISO 14001:2015 Specific Discussions 2
E Implementing ISO 9001 and an Example of a Quality Manual anyone? Document Control Systems, Procedures, Forms and Templates 6
G Should ISO/QMS policy be signed by the Managing Director or anyone from Top Mgt? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
E ISO 17020 and ISO 26000 - Has anyone implemented ISO 26000? Other ISO and International Standards and European Regulations 10
B Is anyone familar with ISO 10005 Guideline for Quality Plans? Other ISO and International Standards and European Regulations 2
A Does anyone know what the Canadian deviations to ISO 8185 are? Canada Medical Device Regulations 5
M ISO 9001:2008 vs. ISO 10012:2003 - Can anyone expain the need for 10012:2003 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
D ISO Team Size ranges, anyone? Misc. Quality Assurance and Business Systems Related Topics 9
J Acceptance Sampling for Bulk Materials - Anyone knowledgeable about ISO 10725? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
D Does anyone know about ISO 13485:2004? ISO 13485:2016 - Medical Device Quality Management Systems 7
A ISO 9001:2008 Assessment - Has anyone been audited yet? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 52
S Does anyone know if ISO publishes audit findings/results much like the FDA ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
R Ownership of ISO 13485:2003 company changing - Anyone to update? ISO 13485:2016 - Medical Device Quality Management Systems 5
N Does Anyone have something that shows Correlations between ISO 14001 & AS 9100? ISO 14001:2015 Specific Discussions 9
E Anyone attending the International Conference on ISO 9000 in March 2008? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
L Can anyone help me with ISO 14644? Other Medical Device Related Standards 17
Ajit Basrur ISO 15378 certification - Has anyone experience with ISO 15378? ISO 13485:2016 - Medical Device Quality Management Systems 4
P Has anyone compared ISO 19011:2002 to ISO 20000-2 (Service Management)? Internal Auditing 4
GStough Anyone Here Ever Move from ISO 9001 / ISO 13485 into AS9100? Career and Occupation Discussions 3
Manix Can anyone define an Antenna Connector DIN/ISO Standard? Other ISO and International Standards and European Regulations 0
ScottK NACE MR0175/ISO 15156 (petrochem industry). Is anyone familiar with it? Various Other Specifications, Standards, and related Requirements 2
M Anyone know what the ISO general tolerances are for blue prints? Other ISO and International Standards and European Regulations 14

Similar threads

Top Bottom