In an executive summary of its Medical Device Recall Report, the FDA revealed that the annual number of recalls increased by a staggering 97 percent from 2003 to 2012. Over the past decade, the complexity of medical device recalls increased and 1,190 recalls were reported in 2012, almost double the amount in 2003. Manufacturers maintain product liability for devices they market and have a responsibility to the public to alert of any potential hazards.
The FDA categorizes recalls into one of three classes. Class II recalls reflected the most significant increase in the recall report with a reported 1,043 recalls in 2012, up from 460 a decade ago.
The largest single-day recall occurred last August when Customed, a surgical kit provider out of Puerto Rico, recalled 233 of its products due to sterility issues. Other medical device recalls, such as metal-on-metal hip implants, have led to thousands of patients being affected and billions of dollars in lawsuits against its manufacturers.
A Modern Healthcare article reports on these recalls, their effect on hospitals, and questions whether medical providers have appropriate recall management programs in place. It references ECRI Institute experts that have determined not all hospitals are keeping up-to-date with recall programs due to the massive increase and complex nature of current recalls.
Joint Commission standards for the management of medical equipment and how to address recalls include:
- Alerting the proper staff members;
- Applying the recall notice to all medical device equipment in use or in storage; and
- Creating a tracking sheet with instructions for how to respond.
The ineffectiveness in recall management systems in hospitals has been a top recognized hazard. Although the process is time-sensitive, it can take weeks or sometimes months in order to track down every medical device during a recall.
With the number of medical device recalls continuing to rise, it is important now more than ever for efficient management programs to be modernized and made effective. In an effort to address this problem, FDA will be phasing in a unique device identification system over the next several years to help identify medical devices through their distribution and use. In the meantime, there is chance for new hazard or recall information to continue slipping through the cracks.
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