Update and next steps.
The report includes plans for establishing a unique device identifier and promotion of registries for tracking devices.
Medical Bed Mattresses: FDA Safety Communication – Damaged or Worn Covers Pose Risk of Contamination and Infection
From January 2011 to January 2013, the FDA received 458 reports associated with medical bed mattress covers failing to prevent blood and body fluids from leaking into the mattress (fluid ingress). Fluid ingress may occur if mattress covers become worn or damaged from small holes or rips in the fabric or from incorrect cleaning, disinfecting and laundering procedures. The zipper on the cover may also allow fluid to penetrate the mattress. Some reports indicate that if blood and body fluids from one patient penetrate a mattress, they can later leak out from the mattress when another patient is placed on the bed. Patients are at risk for infection if they come into contact with blood and body fluids from other patients.
Makers of all-metal, total-hip replacement products will now have to file approval applications for the strictest level of agency device review, the FDA said today in a statement on its website.
Today the U.S. Food and Drug Administration (FDA) issued a Safety Communication on metal-on-metal hip implants which includes recommendations on imaging a patient with a metal-on-metal hip implant.
A federal appeals court ruled that a drug company’s marketing of a drug “off label” which means it is marketing the drug for a use not approved by the FDA, is a matter of free speech.
AP: The Food and Drug Administration said Monday it will collaborate with medical device manufacturers on a public-private partnership designed to speed up the development of new medical technology.
Created using computer-aided design to comprise FDA’s “Virtual Family Tool,” the models are being used to assess the safety and efficacy of medical implants and devices, and radiologic imaging.