Teleflex (NYSE:TFX) this week initiated a voluntary field safety corrective action in Europe for its Arrow subsidiary's multiple-lumen catheter. In a field safety notice dated March 16, Teleflex announced that Arrow is voluntarily recalling the catheter due to a potential sterility issue. The catheter's product tray may be damaged in affected … [Read more...] about Teleflex warns on Arrow multi-lumen catheter
Sterilization
FDA issues draft guidance on multi-use arthroscopy tubing sets
The FDA has issued draft guidance on arthroscopy pump tubing sets intended for multiple-patient use. Clinicians often use a single source of irrigation fluid for multiple patients without replacing the source of irrigation fluid or replacing/reprocessing the irrigation tubing system between patients. These devices are designed to deliver … [Read more...] about FDA issues draft guidance on multi-use arthroscopy tubing sets
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 … [Read more...] about EO plant shutdown leads to pediatric breathing tube shortage
How to streamline sterile package validation
The requirements for validating the back-end processes for packaging, manufacturing, sterilization and shelf life of a sterile medical device are often misunderstood. Errors and oversights can result in failed validation tests and longer-term sterile barrier reliability. Jeff Barrett, J-Pac Medical It can take nearly a year to get a validated … [Read more...] about How to streamline sterile package validation
New study demonstrates 87% of rigid containers tested allowed bacterial contamination, and more
According to a new scientific study published in the December print publication of the American Journal of Infection Control (AJIC),i 87 percent of tested sterilized rigid containers – used in the sterilization of surgical instruments – allowed ingress of aerosolized bacteria under the test conditions used. This study calls into question the … [Read more...] about New study demonstrates 87% of rigid containers tested allowed bacterial contamination, and more
