Devices

UDI Searches Often Come Up Empty: Blog

Cooper Union adjunct professor of biomedical engineering William Hyman says his experiment seeking information on a cardiac ablation catheter based on its unique device identifier (UDI) found that there can be too little information available. Writing in an AAMIBlog post, Hyman says FDA has said a benefit of using UDIs is that they provide “a mechanism to reduce medical errors by enabling healthcare professionals and others to more rapidly and precisely identify a device and obtain important information concerning the device’s characteristics, which also prevents confusion between similar devices that can lead to device misuse.”

He writes it is hard to imagine that a healthcare professional would have a medical device and not know what it is. But if that premise is accepted, there is still the issue that entering the UDI into the GUDID database produces too little data due to the content design of the database and how many of the data fields are actually filled in.

“It is perhaps not unusual for programs such as UDI to be accompanied by hype about how wonderful it will be,” Hyman concludes. “However, this is not the same thing as it actually being wonderful.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome