The U.S. FDA said it has become aware of the action taken by the U.S. state of Georgia against the ethylene oxide (EtO) sterilization plant operated by Becton, Dickinson & Co., of Franklin Lakes, N.J., in Covington, Ga. The FDA said it is concerned that should the facility close, "significant additional strains to the supply chain for critical medical devices may lead to shortages," including for devices used in critical care situations. The agency posted a list of devices that are sterilized at the Covington plant, which includes intravascular and biliary catheters, surgical meshes, enteral feeding tubes, brachytherapy seeds for cancer treatment, and aortic valvuloplasty balloons. The agency said it is monitoring the situation and will advise as warranted. Acting FDA commissioner Ned Sharpless said in an Oct. 25 statement that the agency is "again alerting the public to growing concerns about the future availability of sterile medical devices and impending medical device shortages." Sharpless noted that more than 20 billion devices used in the U.S. each year are sterilized with EtO, which accounts for roughly half of all devices requiring sterilization. "We anticipate a national shortage" of critical devices, Sharpless said in reference to drug-eluting coronary artery stents and instruments used in Caesarean sections, adding that the agency "share[s] the public's objective to reduce over-reliance" on EtO for sterilization. He made note of efforts undertaken by the agency and by device makers to mitigate the shortages, adding that the FDA is working with the U.S. Environmental Protection Agency. "We want to be clear that we understand that there are very real consequences that medical device shortages have on patients," Sharpless said.
The FDA said it has designated self-fitting, air conduction hearing aids as class II devices per the de novo petition by Bose Corp., of Framingham, Mass. The agency said it issued the order for this designation Oct. 5, 2018, based on the May 2018 petition, adding that the related regulation appears under Title 21, §874.3325, of the Code of Federal Regulations.
The U.K. National Institute for Health and Care Excellence said a meta-analysis of the use of MRI-guided interstitial thermal therapy (MRgLITT) for drug-resistant epilepsy demonstrated that the rate of freedom from epileptic seizure provided by was comparable to rates provided by stereotactic radiosurgery (SRS). The systematic review of 19 studies of medically refractory temporal lobe epilepsy yielded a rate of freedom from seizure of 50% (42% for SRS), and that the exclusion of a randomized, controlled trial for radiosurgery did not affect the results of the meta-analysis. NICE said in its draft health technology assessment for MRgLITT said the rates of reoperation between the two device therapies numerically favored MRgLITT (15% vs. 27% for SRS), but that 11 patients on the applicant technology required repeat treatment while another 17 underwent anterior temporal lobectomy. The analysis of 19 studies suggested that the overall rate of complications was lower in the MRgLITT group (20% vs. 32% for SRS). NICE is proposing to recommend the procedure only under clinical governance and/or in clinical trials.
Australia's Therapeutic Goods Administration has imposed a six-month suspension of the marketing authorizations for eight breast implant devices as of Oct. 25, including three implants by Allied Scientific Products Pty. Ltd., of Kolkata, India. The other companies whose products are suspended are Euro Implants Pty. Ltd., JT Medical Pty. Ltd., and Emagin Pty. Ltd.