Devices

Groups Issue Facility Device Rep Reentry Guidance

The American Hospital Association, Association of periOperative Registered Nurses, and AdvaMed have issued a document with reentry guidance for healthcare facilities and medical device representatives. “The following principles are intended to guide facilities, healthcare personnel, and medical device representatives as they adopt access policies that support safe reentry of medical device representatives into the facility,” the paper says. “These considerations are not a substitute for guidance or requirements from state or federal government authorities.”

The document covers (1) all areas of hospitals and other healthcare facilities; (2) Covid-19 testing and screening; (3) elective surgical procedures and personal protective equipment (PPE); (4) crisis-level emergency surgical procedures and PPE; and (5) training and education regarding Covid-19 safety and precautions.

The groups say their recommended framework calls for hospitals to be the primary provider of PPE to control for potential contamination so that PPE is prioritized to providers where it is most needed. The guidance accounts for crisis capacity situations by allowing company representatives to be the back-up providers of their PPE for emergency procedures. It also recommends against Covid-19 diagnostic testing of asymptomatic medical device company representatives so that diagnostic testing resources can be prioritized for patients, symptomatic health care workers, and those with known or suspected exposures, consistent with CDC and other clinical guidelines.

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