The Safe Patient Project is a Consumers Union campaign focused on eliminating medical harm, improving FDA oversight of prescription drugs and promoting disclosure laws that give information to consumers about health care safety and quality.
FDA
Strengthening our National System for Medical Device Postmarket Surveillance
Update and next steps.
Categories: Medical Device Safety, Medical Devices & Drugs
Tags: FDA, medical device, UDI
Strengthening Our National System for Medical Device Postmarket Surveillance
The report includes plans for establishing a unique device identifier and promotion of registries for tracking devices.
Categories: Medical Device Safety, Medical Devices & Drugs
Tags: FDA, medical device, UDI
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.
Categories: Hospital Acquired Infections, Medical Device Safety, Medical Devices & Drugs
Tags: FDA, medical bed mattress covers, MedWatch
Consumers Union’s comments of FDA Reclassification of Metal on Metal Hip Implants
Categories: Hip and Knee Replacement, Medical Device Safety, Medical Devices & Drugs
Tags: FDA, medical device
Doctors Weigh Risks of Metal Hips as FDA Tightens Reviews
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.
Categories: Medical Device Safety, Medical Devices & Drugs
Tags: FDA, metal-on-metal hip implants
FDA Safety Communication: Metal-on-Metal Hip Implants
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.
Categories: Medical Device Safety, Medical Devices & Drugs
Tags: external, FDA, metal-on-metal hip implant
Off-Label Drug Marketing Is ‘Free Speech,’ Court Rules
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.
Categories: Medical Errors
Tags: FDA, medication, medication labels, off label
FDA pledges to work with medical device industry consortium to speed up product approvals
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.
Categories: Medical Device Safety, Medical Devices & Drugs
Tags: FDA, Medical Device Innovation Consortium
Going Virtual To Improve Patient Safety
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.
Categories: Medical Device Safety, Medical Devices & Drugs
Tags: FDA
Ethicon Endo-Surgery Circular Stapler Sets: Class I Recall – User Difficulty With Firing Stapler Devices
FDA notified healthcare professionals of a Class I Recall of these products because of difficulty users have firing the stapler devices, resulting in incomplete firing stroke and incomplete staple formation.
Categories: Medical Device Safety, Medical Devices & Drugs
Tags: FDA, recall
