ISSUE: GE Healthcare became aware of an incident at a VA Medical Center facility in the US. A patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. On July 03, 2013 GE notified hospitals that they were recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this recall.
FDA has created a new form for consumers to report adverse events with drugs or devices. This less technical form is part of larger FDA effort to encourage consumers to submit quality reports.
Washington Post reports: “The Food and Drug Administration is tightening standards for a wide range of medical devices — from fetal monitors used in hospitals to pacemakers implanted in people — because of escalating concerns that the gadgets are vulnerable to cybersecurity breaches that could harm patients.”
The FDA is granting money to Glaxcosmithkline – up to $200 million in 5 years- to help develop medication that can work against antibiotic resistant superbugs. Glaxcosmithkline has paid the largest health care fraud settlement in US history-$3 billion.
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.