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Tag: medical device recalls

Dec
18

Be prepared: Lithium-ion batteries pose severe recall challenges for medical devices

The reduced size, weight and power consumption of lithium-ion (Li-ion) batteries has been a boon for medical device manufacturers seeking to create more portable and convenient products. But the efficiency gains of Li-ion batteries are tempered by the increased safety risks and regulatory concerns the technology poses. As multitudes of viral videos confirm, products with Li-ion rechargeable batteries have the potential to overheat, explode and catch fire.

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Aug
29

The FYI on UDI

It has been five years since the Food and Drug Administration (FDA) released a final rule establishing a unique device identification (UDI) system for the medical device industry. The benefits are numerous and include more accurate reporting of adverse events, a reduction in medical errors, and more effective management of medical device recalls.

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Nov
02

Budgeting for a Pharmaceutical or Medical Device Recall

It’s budgeting season, and most leaders are hoping and planning for a banner year. New product developments. Innovative strategies. Expanded market share. Everyone hopes they will avoid any sort of crisis in the coming year, and as a result, few plan for one. But one of the most disruptive crises medical device and pharmaceutical companies will face is also among the most likely – product recalls. Consider this: Through Q3 2017, 144 companies experienced more than one pharmaceutical or medical device recall.

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Aug
11

Device Disconnect: UDI and EHR Challenges in Medical Device Recalls

Medical device manufacturers have worked to meet the Food and Drug Administration’s (FDA’s) stricter regulations for Unique Device Identification (UDIs) every year since September 2014. Now humans and computers can access vital product information like never before, all from the special barcodes on the latest medical devices.

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Jun
01

How Outdated Data Impacts Medical Device Recalls

A medical device recall that affects only the provider and physician level sounds like it should be a simpler process than one that impacts the patient level. But these recalls can still involve serious pitfalls, especially when it comes to data – specifically, outdated data.   While a brick-and-mortar hospital doesn’t change sites often, smaller clinics and other facilities may move locations much more frequently.

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