The FDA has issued a warning letter to Orchid Orthopedic Solutions, a major design and manufacturing outsourcer in the orthopedic medical device space, for alleged violations including unsanitary water used to clean implants. The letter, dated May 13 and released today, says the company’s facility at 23149 Commerce St., Farmington Hills, Mich. failed to adequately […]
FDA
Former Olympus exec gets probation for allowing faulty device sales
Olympus’ former top regulatory official has dodged a prison term for failing to file adverse event reports with the FDA regarding infections connected to contaminated duodenoscopes, according to published reports. Hisao Yabe, 64, and Tokyo-based Olympus (TYO:7733) both entered guilty pleas in December in U.S. District Court in Newark, N.J. for failing to file the […]
Zeller Power earns first FDA warning letter over UDI compliance
An FDA inspection netted Zeller Power Products (Wallace, Idaho) a warning letter citing quality violations that led to adulterated defibrillator batteries. Specifically, the agency discovered during its Nov. 6-9, 2018 inspection of that the firm didn’t have design validation documentation for its automated external defibrillator battery. The design validation documentation was needed to justify the […]
How should medtech manufacturers cope with sterilization plant closures?
The sudden closure of a medical device sterilization plant in February and a second plant closure planned for later this year have raised questions about the effects on medtech manufacturers. Medical Design & Outsourcing asked Dan Fowler of WuXi AppTec about the implications and options for the industry. MDO: What can medtech manufacturers do to mitigate the impact of the […]
Louisiana prisoners to get non-FDA-approved BioCorRx implant
BioCorRx (OTC:BICX) has begun a controversial pilot program to provide soon-to-be-released Louisiana prison inmates an opioid addiction treatment implant that has not been approved by the FDA. The pilot, announced last week, has drawn praise from corrections officials and concern from prisoner advocates and some medical professionals, according to a report in The Advocate, a Baton Rouge, La. newspaper. Ten […]
Aethlon Medical wins FDA nod for Hemopurifier cancer trial
Aethlon Medical (NSDQ:AEMD) said today that it won an investigational device exemption from the FDA for an early feasibility study of its Hemopurifier device in patients with head and neck cancer in combination with the standard pembrolizumab (Keytruda) care. San Diego-based Aethlon said the small trial will enroll 10 to 12 patients with advanced head and […]
FDA Form 483s could get easier for medical device companies: Here’s how
FDA in the U.S. is setting up a formal way for medical device companies to get nonbinding feedback about Form 483s, which raise potential manufacturing process problems. FDA is taking comments through today about the draft guidance, which it issued Feb. 19 under a requirement in the FDA Reauthorization Act of 2017. The proposed process […]
FDA bans Boston Sci, Coloplast sales of pelvic mesh
The FDA has ordered Boston Scientific (NYSE:BSX) and Coloplast — the only remaining companies that sell pelvic mesh in the U.S. — to immediately halt sales and distribution of those products. The two companies have not demonstrated a “reasonable assurance of safety and effectiveness for these devices” used to treat pelvic organ prolapse (POP) since the […]
More device shortages pegged to sterilization plant shutdown
More medtech companies are experiencing shortages of medical devices due to the sudden closure in February of a Sterigenics sterilization plant. Officials from Cardinal Health (NYSE:CAH), and Guerbet (EPA:GBT) have written letters to customers indicating that certain devices are already in short supply or may experience shortages, Medical Device & Outsourcing has learned. The letter from Cardinal Health (Dublin, […]
EO plant shutdown leads to pediatric breathing tube shortage
The February shutdown of an ethylene oxide (EO) sterilization plant has produced the first temporary medical device shortage, according to the FDA. The device in short supply is the Bivona tracheostomy tube manufactured by Smiths Medical and used by many pediatric patients. The FDA anticipates the tube will be made available again the week of April 22, according to […]
FDA warns against unapproved concussion diagnosis devices
The FDA today warned consumers against using medical devices purported to assess head injuries, saying tht only five companies are cleared to market such devices in the U.S. and that they should only be used by physicians. “The FDA has identified several manufacturers that were marketing medical devices for concussion diagnosis, treatment or management without […]