I don't know how due diligence works in the US, but in Europe failure of a device that has been shown to have been designed as safe as 'reasonably practicable' then the manufacturer will not be charged with breaking the law; he may however still be ordered to pay compensation, but that would be covered by his product liability insurance. Maybe US manufacturers have had it easy and now have liability aligned with Europe. Surely an unlikely but possible random failure of a device cannot mean the manufacturer was breaking the law.
Andy From: Brian O'Connell [mailto:[email protected]] Sent: 16 June 2009 16:19 To: [email protected] Subject: Re: [PSES] U.S. Medical Device Safety Act Perhaps I did not understand the proposed legislation. My interpretation is, regardless of FDA and NRTL assessments and certification, that the failure of a fully conforming device will make the vendor subject to all manner of litigation, and that there is no such thing as all due diligence. Please comment if I am not correct. Brian > -----Original Message----- > From: Andy Clifford [mailto:[email protected]] > Sent: Tuesday, June 16, 2009 8:06 AM > To: 'Brian O'Connell'; [email protected] > Subject: RE: [PSES] U.S. Medical Device Safety Act > > Due to the new Medical Device Safety Act 2009, I might > expect the risk > assessment requirements of the 3rd edition to become more > important, since > the FDA, who may now share in a manufacturer's liability by > approving test > reports, will need more effort from manufacturers in order > to demonstrate > safety of their devices? > > Andy > > -----Original Message----- > From: Brian O'Connell [mailto:[email protected]] > Sent: 11 June 2009 21:56 > To: [email protected] > Subject: [PSES] U.S. Medical Device Safety Act > > Medical Device Safety Act of 2009 (HR 1346) > <http://thomas.loc.gov/cgi-bin/query/z?c111:H.R.1346:> > comments by medical community > <http://content.nejm.org/cgi/content/full/360/15/1550> > > The proposed bill would nullify the 2008 decision Reigel v. > Medtronic, where > the U.S. supreme court ruled that if your box is certified/tested to > required normative standards and legislation, the mfr is > generally immune > from civil litigation when the device fails through no fault > of the mfr. > (Yes I know that the case had to do with published product > data and labels) > > The new stuff required by IEC60601-1 3d ed does not matter... > > Brian - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <[email protected]> All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc Graphics (in well-used formats), large files, etc. can be posted to that URL. Website: http://www.ieee-pses.org/ Instructions: http://listserv.ieee.org/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <[email protected]> Mike Cantwell <[email protected]> For policy questions, send mail to: Jim Bacher: <[email protected]> David Heald: <[email protected]> - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <[email protected]> All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc Graphics (in well-used formats), large files, etc. can be posted to that URL. Website: http://www.ieee-pses.org/ Instructions: http://listserv.ieee.org/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <[email protected]> Mike Cantwell <[email protected]> For policy questions, send mail to: Jim Bacher: <[email protected]> David Heald: <[email protected]>
