On April 6, the FDA issued new guidance on modifying devices in order to prevent a shortage of equipment and allow for safe physical distance between care providers and COVID-19 patients.
Infusion pump demand has significantly increased with the COVID-19 pandemic because many infected patients require continuous infusions of medications, nutrition, and other fluids. In order to address manufacturing limitations or supply shortages, the FDA does not intend to object to limited modifications to devices that would normally require a new FDA 510(k).
The new guidance refers to modifications to design, intended use, material, chemical composition, energy source, or the manufacturing process of a device.
Making changes to an infusion pump could allow alternate suppliers to meet required design specifications. The FDA is currently looking at mitigating the infusion pump supply issue by looking at manufactures who have not previously developed medical devices.
The agency said, "We believe this approach will help manufacturers that want to add production lines or manufacture at alternative sites which may have different manufacturing equipment to increase manufacturing capacity and supply and reduce supply chain interruptions and manufacturing bottlenecks."
The FDA is also looking into solutions to providing care to COVID-19 infected patients including remote monitoring and controlling an infusion pump without entering a patient’s room; using wired and wireless networks to transfer electronic drug libraries, using infusion pumps not intended for ground or air transport; and using infusion pumps for populations not referenced on device labeling (ex. Pediatric patients).
Large volume parenteral, syringe, patient-controlled analgesia, and ambulatory infusion pumps and their accessories are all devices covered under the guidance. The new policy applies for the duration of the crisis.
AIV, Inc. is committed to providing high quality IV pumps, replacement parts, accessories and repair service for major infusion equipment manufacturers. Learn more about AIV’s wide selection of IV pump solutions at https://www.aiv-inc.com/infusion-pump-parts.html.
About the Author
Laura Collier has a Bachelor’s Degree in Communications and a Master’s Degree in Business Administration from the University of North Florida. She is the Marketing Manager at AIV, Inc.