News Articles
May 13, 2011
How to Handle a Medical Device Recall
By: Denise Odenkirk and Tom Kozenski
MDDI
To manage a recall effectively, speed and inventory visibility are key.
Product recalls are challenging for any manufacturer, but when it comes to medical devices and life sciences, speed is of the essence. Any delay in a product recall—whether due to sterility concerns, patient safety, expiry date, or product efficacy—can literally mean the difference between life and death.
More than 1000 medical devices were recalled for potential safety problems in the first half of 20091. Of those, more than 100 Class I recall notices were distributed for defects serious enough to cause a reasonable probability of adverse health consequences and death. Yet many medical device and life science manufacturers still rely on monolithic enterprise resource planning (ERP) systems that actually slow their ability to track and manage recalls. Some don’t even have a warehouse management system (WMS) in place to help them understand where product is in the supply chain.
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