33 results

• Medical Device Shortages Pose a Serious Risk for Pediatric Patients: FDA

  January 21, 2025

  Martha Garcia

  The FDA has issued warnings about the potential impact of medical device shortages on pediatric patients, who often cannot use adult-sized devices as substitutes, which was highlighted by supply chain problems during the COVID-19 pandemic.

• FDA to Hold Town Halls on Ethylene Oxide Sterilization Following Toxic Leaks

  January 26, 2024

  Martha Garcia

  The FDA is holding a series of virtual town halls to discuss ethylene oxide and its use in sterilizing medical devices following a series of leaks and exposure lawsuits.

• FDA Encourages Vaporized Hydrogen Peroxide for Medical Device Sterilization, Amid Ethylene Oxide Safety Concerns

  January 11, 2024

  Martha Garcia

  The FDA has issued updated guidance approving the use of vaporized hydrogen peroxide as a viable means of sterilizing medical devices, in an effort to move the industry away from its reliance on ethylene oxide.

• FDA Releases New Industry Guidelines for Securing Medical Devices Against Cybersecurity Threats

  September 28, 2023

  Martha Garcia

  The FDA has issued new guidelines on how medical device manufacturers should secure internet-connected devices from cybersecurity risks.

• Recalled Medical Devices Fast-Tracked Through FDA Approval Process Were Often Based on Flawed, Older Designs: Study

  January 16, 2023

  Irvin Jackson

  Researchers warn that FDA devices fast-tracked through the approval process are often based on older devices which were recalled themselves, increasing the chances of the new device also being recalled by a factor of six.

• Security Gaps in 150,000 Infusion Pumps Makes Them Vulnerable to Hacking: Report

  March 23, 2022

  Irvin Jackson

  A new report reveals that many medical devices, especially infusion pumps, still have cybersecurity gaps identified years ago which could be exploited by malicious hackers.

• Conflicts of Interest Rampant In Healthcare Industry, Requiring Oversight: Study

  November 16, 2021

  Russell Maas

  A new study reveals the potential extent to which the medical device and pharmaceutical industries are influencing important health care decisions and how they can conflict with patient needs.

• FDA Guidance Seeks To Prevent Electromagnetic Interference Between Medical Devices

  November 17, 2020

  Martha Garcia

  A proposed FDA guidance seeks to prevent medical devices from causing electromagnetic interference with other medical devices, which could create a safety risk for patients.

• FDA Relies Too Heavily On Post-Marketing Adverse Event Reports To Identify Drug, Medical Device Problems: Study

  September 29, 2020

  Irvin Jackson

  A new study warns the FDA may rely too heavily on adverse events to discover potentially life-threatening problems with approved medical devices.

• Sterigenics Faces Ethylene Oxide Exposure Lawsuit Filed By Georgia Plant Employees

  May 26, 2020

  Irvin Jackson

  Workers at a medical device warehouse in Georgia have filed a lawsuit against Sterigenics and ConMed, saying they were unwittingly exposed to high levels of a toxic, cancer-causing gas.