By Jeffrey Shuren, M.D., J.D. and Thomas P. Gross, M.D., MPH
Food & Drug Administration (FDA)
FDA warns on ERCP endoscope, CRE “superbug” link
The FDA is warning that ERCP endoscopes may allow for the transmission of certain drug-resistant “superbugs,” even if the devices are properly cleaned.
The advisory was issued in the wake of news that contaminated endoscopes are suspected of causing a deadly outbreak of the superbug CRE, or carbapenem-resistant enterobacteriaceae (CRE), among patients at the UCLA Ronald Reagan Medical Center in Los Angeles.
FDA knew devices spread fatal ‘superbug’ but does not order fix
(Reuters) – U.S. health regulators have known since at least 2009 that the medical devices at the center of the "superbug" outbreak at UCLA can transmit lethal infections but have not recommended any new safety requirements, a lapse that threatens patient safety, experts in hospital-acquired infections said.
Varicose vein treatment: VenaSeal wins FDA approval
Covidien‘s VenaSeal closure system to treat varicose veins has been approved by the U.S. Food and Drug Administration, according to an agency press release.
UK appoints top med device regulator
The UK’s equivalent of the FDA has named a prominent British anesthesiologist as its top medical devices regulator.
Recent progress on demographic information and clinical trials
By Barbara D. Buch, M.D.
At FDA, one of our foremost responsibilities is to evaluate and if medical products meets the appropriate standard, to approve or clear drugs, biological products and medical devices. We know that these products are safer and more effective for everyone when they are tested in clinical trials that include diverse populations.
FDA approves Sonoma’s FibuLock Nail for ankle fractures
The FDA has approved Sonoma Orthopedic Products’ FibuLock Nail device for the repair of ankle fractures.
Sonoma said FibuLock is designed to be a less invasive and more comfortable alternative to traditional surgical plates, which are screwed directly onto the bone through a large incision. In comparison, FibuLock Nails are inserted through a small incision directly into the bone canal.
FDA warns Staar again over Calif. plant | Regulatory news for the week of February 16, 2015
Avedro wins date with joint FDA panel
Avedro said today that it won a date with the FDA next week for its corneal cross-linking technology for treating a pair of eye conditions.
A joint meeting of the watchdog agency’s Dermatologic & Ophthalmic Drugs Advisory Committee and its Ophthalmic Devices Panel is slated for Feb. 24, Boston-based Avedro said.
FDA expands indication for Medtronic’s Vertex spine implant
Medtronic (NYSE:MDT) said today that it won an expanded indication from the FDA for its Vertex spinal fixation system, covering lateral mass and pedicle screw use in the posterior cervical spine.
Medtronic said the expanded indication makes it 1 of the 1st systems cleared in the U.S. for use of screws at vertebrae C1 to C7.