A Quality Issue That Deserves Some Attention

For the summer I’m working as an intern at a medical device management company called Access MediQuip. My project for the summer is to create a well-researched report outlining the trends of the implantable medical device industry. Throughout my research I’ve come across some pretty interesting information.

I was completely unaware of how many products are recalled by device companies (or the FDA) in a given year. Already in 2010 there have been 23 recalls posted on the FDA’s website (2010). Comparing the list of recalls in recent years to that of 2001 to 2005, it appears that the number is growing and not declining. A Supreme Court ruling in 2008 could be the reason why.

In 2007 about 235,000 people were affected by the recall of MedTronic’s Sprint Fidelis. This is an accessory device called a lead that wires a defibrillator to the patient’s heart. In 2005, Guidant Corporation, had a similar recall due to defective defibrillators. At the time, both companies were facing a barrage of lawsuits from angry patients that had been affected by the potentially faulty devices. Because the devices had been approved by the FDA, going through the pre-market approval process, the Supreme Court ruled in 2008 that manufacturers are protected from lawsuits pertaining to malfunctioning devices. This is provided the company was not already aware that the products were unsafe.

So the injustice begins. Not only are there several thousand individuals still implanted with the Sprint Fidelis and other potentially faulty devices, but these people will not be entitled any recompense for the trouble and stress. It gets better. Patients that need to have the device removed because of its potential hazard are not guaranteed any reward by the manufacturer to help pay for corrective surgery costs. History reveals that manufacturers are not at all generous when it comes to financing what they’ve screwed up. Some will only pay for the actual device, not the cost to have the procedure done and many have refused even that. That leaves someone else to foot the bill. Sometimes it’s the private insurer, sometimes it’s the patient, and many times it’s the taxpayers. The implantable device demographic is largely an elderly population, meaning that most will qualify for Medicare.

I’m very surprised that this issue hasn’t garnered more attention. Not only does it unnecessarily increase healthcare costs, but it poses a huge quality problem for the patients. Judging from the increasing list of recalls from the FDA, it doesn’t appear that the quality issue will improve any time soon. Maybe that’s because device manufacturer’s have the protection of the Supreme Court on their side. What real incentive do they have to improve quality if there are no real consequences for the lack thereof? You would think that declining sales would provide enough motivation, but in the research I’ve seen manufacturer’s still manage to make huge profits even in the midst of recalls. I’m not saying that devices need to be perfect, because every product purchased is subject to some level of malfunctioning. However, device makers need to get some more skin in the game. The government needs to raise the stakes on companies by creating penalties for a certain percentage of faulty products and requiring device makers to pay for their mistakes instead of shifting the cost to taxpayers, patients, and private insurers.


References
(2010). List of Device Recalls. Retrieved July 13, 2010 from http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/default.htm