Safety problems rightly force medical device companies to halt sales of implants like defibrillators or pacemakers, but they can take years to make themselves fully known, based largely on human oversight. The existing system counts on companies themselves or doctors handling the implants to spot any problems and report them to the FDA.
It turns out, however, that automated systems can screen hospital databases and find those flaws years ahead of time compared with the current system, according to a new study. And such a software program could allow companies to address post-marketing safety issues sooner, with all kinds of long-term implications on device safety in particular and healthcare costs in general. Bloomberg reports on the research, which tested an automated safety review software program developed by Coping Systems in Cambridge, MA.
As the Bloomberg story explains, their research focused on 2,710 patients who had defibrillator implants between November 2001 and December 2008 at several hospitals around the country. Medtronic's ($MDT) Sprint Fidelis or Quattro Secure defibrillators leads connected the patients' hearts to the devices. In testing the Coping Systems software, the researchers found that the system would have triggered an alert for the Sprint Fidelis lead two years before the company stopped selling it and 13 months after doctors implanted the first lead, the article notes. (Medtronic stopped selling Sprint Fidelis in 2007 after a number of safety concerns.)
Lead researcher Robert Hauser of the Minneapolis Heart Institute told Bloomberg that the study showed the software effectively does its intended job. He said companies should support its use because earlier safety alerts are "good for business, not to mention patients." A Medtronic, spokesman, meanwhile, is quoted in the story as stating that anything that can further device safety and reliability "is of interest" to the company. Certainly, consumer advocates question whether companies reveal safety problems when they first become known. This could also be a way to address the concern by having a way for hospitals to screen that data automatically and flag any specific problems sooner.
By the way: The Minneapolis Heart Institute and Abbott Northwestern Hospital Foundation funded the research. For study details, read the journal Circulation: Cardiovascular Quality and Outcomes.
- here's the Bloomberg story