Everyone knows that the number of medical device recalls is on the rise. Here are two telling examples of the growth. In 2003 a total of 604 recalls were reported to the FDA, while last August a single manufacturer recalled 233 products. In 2010 a single recall—metal-on-metal hip implants—led to revision surgery for thousands of patients.
Hospitals are caught in the middle. Too often their tracking systems can’t keep up with the growing volume of recall notices. And it’s not merely a matter of volume. Tracking is much more complicated than may appear at first blush. Consider, for example, the fact that implant devices are often stocked on consignment, appearing on the hospital’s purchase history only after being implanted in patients. So a hospital can’t—at least, can’t reliably—identify recalled devices simply of the basis of purchase history.
How serious is the safety problem for hospitals? So serious that it made the Top 10 Health Technology Hazards for 2015 list released by the ECRI Institute, a nonprofit organization dedicated to studying the safety and effectiveness of medical products.