Tag: FDA medical device safety

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FDA Expands Early Alert Program for High-Risk Device Issues

The initiative provides faster notifications on potentially high-risk removals or corrections for all medical devices.

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EPA: Chemical in Medical-Device Cleanser Poses Cancer Risk

The U.S. EPA is alerting residents who reside near certain commercial sterilizing plants of the health risks EtO emissions can cause.

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Certain Karl Storz Urological Endoscopes Have Changed Reprocessing Methods, Says FDA

The FDA is aware that the current reprocessing instructions for certain urological endoscopes manufactured by Karl Storz are being updated.

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FDA Expands Early Alert Program for High-Risk Device Issues

The initiative provides faster notifications on potentially high-risk removals or corrections for all medical devices.

FDA’s Health of Women Strategic Plan to Better Inform Medical Device Research, Regulation

Jan 19, 2022

The plan seeks to strengthen regulatory science and identify current and emerging issues in medical device research and regulation for women’s health.

Unpacking Averages: Likelihood of FDA Medical Device Inspections

Jan 5, 2022

The FDA’s new medical device inspections dashboard indicates that there are county level hotspots for inspection rates, but not state or region hotspots.

FDA Warns of Medical Device Cybersecurity Vulnerability

Dec 20, 2021

FDA raised awareness of a cybersecurity vulnerability in Apache’s Log4j software library, which is used in medical devices and supporting systems.

Medical Device Development Tool Gets FDA Qualification for MR Safety

Nov 24, 2021

MED Institute obtained FDA qualification of their new Medical Device Development Tool for virtual MRI safety evaluations.

Patient Deaths Called ‘Injury,’ ‘Other’ in FDA Medical Device Database: Study

Jul 30, 2021

An analysis of the U.S. FDA’s Manufacturer and User Facility Device Experience database has discovered that medical device-associated patient deaths are being mislabeled in the system—mistakes that could impede patient care.

Who Has the Right to Repair Medical Equipment?

Jul 23, 2021

As the Right to Repair movement gains momentum, a Proto article asks, should hospitals be allowed to fix machines themselves?

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Olympus Supports New FDA Guidance on Bronchoscope Reprocessing

Olympus announces that it supports the updated safety recommendations from the U.S. FDA for bronchoscope reprocessing and single-use bronchoscopes.