Over the past decade, recalls for dangerous or defective medical devices have exponentially risen and hospitals are having a hard time keeping track of the recalls.
The problem of recall management by hospitals is so serious that the ECRI Institute has listed “Overwhelmed Recall and Safety Alert Management Programs” as number 10 on its 2015 list of Top 10 Health Technology Hazards. ECRI – an independent nonprofit that researches practices to improve patient care – believes hospital recall systems are not keeping up with the number of medical device recalls. The ECRI report noted that in 2003 there were a total of 604 recalls reported to the FDA, but in 2012 there were over 1,190 medical device recalls. Last August nearly 233 products were recalled by a single manufacturer. The 2015 list is the first time recall management has appeared on ECRI’s list.
Hospitals are caught in the middle of regulators, manufacturers, and dangerous medical devices. While most hospitals have established recall management systems, these systems are facing the challenge of managing a growing number of complex recalls. While the FDA and the Department of Health and Human Services have attempted to provide clarification on how to handle recalls, many hospitals cannot update or adjust their recall programs fast enough. The fear is that out-of-date or overwhelmed recall systems will result in compromised patient safety.
Manufacturers of dangerous medical devices are responsible for the products within their supply chain. These billion dollar companies have complex, up-to-date systems in place that manage recalls with practiced efficiency. Unfortunately, the same cannot be said for hospitals, as the departments that use the products (clinical departments) rarely are involved in the recall process. In fact, it can take months for a recalled product to be tracked down. As such, newly recalled devices can end up in a hospital or remain in use by the facility after the announcement of a recall.
One method hospitals are pursuing is through manufacturer standardization via the FDA’s Unique Device Identification system. The UDI system allows for medical devices to be more easily identified through their distribution and use. For example, using UDI, some hospitals can now require manufacturers to label recalled devices with a standard scannable code (i.e. UDI). These codes can be incorporated into the electronic health records, thus making it easier to inform patients who have had a particular device used in the course of their treatment. Implant tracking is another possible service hospitals may employ to improve their recall systems.
Hospitals, physicians, and patients must remain vigilant in the face of thousands of medical device recalls. Hospitals and doctors have a responsibility to warn patients of recalled products and ensure their facilities do not use or maintain recalled medical devices. If you or a loved one was injured by a defective medical device, there is recourse.
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Our dangerous device attorneys can help if you or someone you care about was harmed by defective medical equipment. Lawsuits have been filed against device makers by both patients and their families seeking compensation for the injuries caused. You may be entitled to a settlement. We do not charge any legal fees unless you receive a settlement and we pay all of the case costs. If your claim is not successful for any reason, you do not owe us anything. We put it all in writing for you. Our defective medical device lawyers will help you file your lawsuit.
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