Chapter 8 – More Immediate Actions by the FDA to Increase Medical Supplies
The COVID-19 outbreak has created shortages of medical supplies such as gloves, masks, hand sanitizer, and respiratory ventilators (the last essential for treatment of critical care patients). The restrictions on plants that sterilize medical products with ethylene oxide (see my previous posts here and here) are not making the supply situation any easier. The FDA has taken a number of actions in the past 2 weeks to alleviate the supply shortage, including:
- Accepting the first master file for the Ethylene Oxide Sterilization Master File Pilot Program,
- Issuing a temporary policy for preparation of alcohol-based hand sanitizer,
- Expanding the availability and capability of non-invasive remote monitoring devices such as thermometers, electrocardiograph monitors, and stethescopes for use during the pandemic, and
- Issuing guidance to enable manufacturers to make minor modifications to their ventilator devices (such as substitution of motors or tubing material) to improve the availability of these devices.
It’s not hard to envision additional updates, given the expanding scope of the challenges. Keep an eye on the FDA’s COVID-19 webpage for the latest updates
Reach out to me if you want to know more or discuss your medical product development challenges.
Text Copyright © 2020 Katrina Rogers
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