There is plenty of data collection to test the safety of many various devices, but why isn’t more being done for lifesaving medical devices?
As the New York Times reported:
Defibrillators implanted in nearly 200,000 patients were recalled in 2011 because of a faulty part. More recently, the Essure birth control device implanted in women’s fallopian tubes has been associated with pain and deaths. Improper handling of duodenoscopes — used by doctors to examine the small intestine — was linked to hundreds of cases of antibiotic-resistant infections in 2013 and 2014.
The Brookings Institution reported that medical devices contribute to about 3,000 deaths each year in the United States — but that number could be lower than what’s accurate, considering how medical device safety is currently being tracked in comparison to things like pharmaceuticals.
Prescribed drugs are always included in medical claims data, like those made public by the Medicare program. This is not this case with devices.
Although hospitals, nursing homes and medical device manufacturers must notify the FDA if there are problems with a device, doctors and nurses are not. As a result, the FDA has characterized the data collected as potentially “incomplete, inaccurate, untimely, unverified or biased.”
So, maybe devices should be treated and regulated just like prescription drugs are. The FDA has established the Sentinel Initiative to mine medical data to confirm or clear suspected problematic drugs, but the same has not been done for devices yet because unique device identifiers are not required to be included in standardized medical claims data.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
One solution would be including many other devices that have bar codes similar to those on drug packaging and suitable for tracking (high-risk devices already have this). But this is a pricey endeavor, as the Times noted.
The price tag for a medical device surveillance system that relies on such data is about $50 million a year. This does not include the one-time costs hospitals would have to pay to adapt to the system. Even at a multiple of the price, however, if it saved only a few tens of lives — and chances are it would save many more than that — it would be considered cost-effective. The defective defibrillators cost Medicare an estimated $287 million. The Inspector General of the Department of Health and Human Services, Daniel Levinson, says that faulty medical devices have cost taxpayers billions of dollars.
It’s unfortunate that risking people’s lives is a matter of where others are willing to put money in, but unfortunately, that is the reality. It just makes sense to collect data in this way and to make devices safer, but it will take some significant initiative for it to be a regular practice.
Photo: Flickr user jazbeck
