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Tag: medical device recalls

Feb
21

Ripple Effect: When Med Device Recalls Cause Critical Shortages

A recall is bad enough, but when that recall causes a shortage of a critical medical device, the problem is compounded. That was the case with a recent recall of a device used to deliver naloxone, which is used by first responders to reverse an opioid overdose. The situation made headlines because it left first responders in some communities without an effective method of delivering the potentially life-saving drug. Recall situations put medical device manufacturers in a unique position.

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Feb
13

Q4 2016 Recall Index Highlights

Stericycle ExpertSOLUTIONS recently released its Q4 2016 Recall Index, which analyzes data from regulatory agencies to identify key recall trends. This quarter’s report reveals a mix of positive and negative trends. Check out the highlights:

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Feb
09

High Price Device: Race to Innovate Medical Devices Fuels More Product Recalls

The rapid pace of innovation in medical devices resulted in an unfortunate side effect of increasing medical device recalls in the second half of 2016. Stericycle ExpertSOLUTIONS looks at trends in this industry and others in the recently released Recall Industry Spotlight. The biannual Industry Spotlight, which examines trends in a specific industry, found that medical device recalls heated up quickly as the year progressed, increasing 44 percent from the first half of the year.

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Jan
04

FDA Finalizes Guidance on Emerging Signals

Nearly a year after the draft was issued, the Food and Drug Administration (FDA) has finalized guidance on emerging signals – when a potential problem with a medical device already on the market could alter the benefit-risk assessment among patients and their healthcare providers.

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Dec
07

21st Century Cures Act Calls for 21st Century Recall Preparation

The 21st Century Cures Act has cleared a major Senate hurdle and is expected to be signed into law by President Obama. Among other provisions, the bill will fast-track the approval process for certain drugs and medical devices. The $6.

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