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 more sophisticated, and they assume the management of recalls of all of those products is being managed with a similar efficiency. It's just not true.”
Effective recall management is highlighted by ECRI in its list of the Top 10 Health Technology Hazards for 2015. It's the first time ECRI has included recall management on the annual list. ECRI and other organizations such as Noblis market recall-alert systems to hospitals.
Health systems say that new tools, such as the FDA's unique device identification system, and the ongoing modernization of the hospital supply chain will help address gaps or lags in recall management programs at hospitals.
The hospital supply chain is widely seen as decades behind other industries' supply chains in technology and efficiency. Some common practices at U.S. systems mean that unauthorized or undocumented medical products can end up in a hospital without the knowledge of the supply-chain team. Such potentially risky practices include device manufacturers providing medical implants to a hospital “on consignment,” or a pharmaceutical sales representative dropping off medication samples.
It can take weeks or even months to track down every drug or device during a recall. Supply chain or clinical engineering leaders tend to be in charge of recalls. But ECRI experts and hospital officials say clinical departments need to get involved with recall management.
Some hospitals say they already have moved to improve their recall management programs. Trinity Health, a Livonia, Mich.-based health system that operates more than 80 hospitals, updated its recall management program in 2008 after realizing the frequency of recalls was increasing.