Medical devices are intended to help cure a patient not cause them harm, but every year in the U.S. they are to blame for at least 3,000 deaths. That’s according to a report from the Brookings Institution.
So what’s causing these deaths? Is it due to faulty medical devices being linked to infections? Unfortunately, it’s hard to pin down the exact cause sometimes because medical data is not routinely or consistently collected in the United States.
When errors are reported, the FDA states that details are often left out that would be useful in identifying the cause. For instance, when investigating the pain and deaths linked to the Essure birth control devices, the FDA said the reporting system used by health care professionals, “has notable limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data.”
The FDA relies on a variety of post-market surveillance data sources to monitor the safety and effectiveness of medical devices, but those standards aren’t mandatory across the health care industry.
In some cases, improper sterilization can lead to serious and deadly outbreaks. The duodenoscope, used to examine the small intestine, caused at least 250 cases of an antibiotic-resistant infection from 2012 through 2015 because it
Continue reading →