|As the number of medical-device recalls has rapidly increased, so has the complexity of the recalls. That is raising questions about safety and risks for hospitals that mostly still track and locate faulty products manually.|
There were 1,190 recalls of medical devices in 2012, nearly double the 604 recalls reported to the Food and Drug Administration in 2003.
In August, Customed, a Puerto Rico-based supplier of surgical kits, trays and packs, recalled 233 products because of sterility issues, making it the largest single-day recall in FDA history. Other high-profile recalls, such as the removal from the market of metal-on-metal hip implants starting in 2010, led to billions of dollars in lawsuits against the manufacturers and thousands of patients having to undergo revision surgery. Other recalls have been more obscure, such as when a supplier must issue corrective language for a user manual.
Most if not all hospitals have recall management programs in place. The Joint Commission issued standards for hospital recall policies that detailed how to respond to recalls and alerts. But experts at the ECRI Institute, a not-for-profit that studies the safety and effectiveness of medical products and services, say not all hospitals are updating their programs to reflect the growth and complexity of today's recalls.
“This issue is frequently flying under the radar of executives,” said Eric Sacks, ECRI's director of healthcare product alerts. “Supply chains are becoming...