Medline Updates Guidance on Bed Recall
NORTHFIELD, Illinois—Medline has issued updated guidance on the removal, discontinuation and market exit of its brand of beds, rails, mattresses and accessories.
The updated guidance includes several changes from its earlier Oct. 14 notice announcing a voluntary recall of its Medline Brand beds and other items due to a potential fire hazard involving beds, hand-control pendants, control or motor boxes and actuators or motors. At the time, the company also announced it would be exiting the hospital bed market, the American Association for Homecare reported.
The recall impacts all Medline Brand beds, including homecare beds, bariatric beds, and long-term-care beds, and their associated pendants, accessories, replacement parts, and bed-containing order packages. The full item list can be found here.
The new announcement, posted Oct. 24, states that the affected items may remain in use in accordance with instructions listed in the announcement until the bed is repaired or replaced. It also lays out a new repair or replace procedure allowing the company to repair some beds for customers, while others will receive a replacement or a full or partial refund.
“In an effort to support continuity of care and to minimize disruptions for our customers, healthcare providers, and patients, and in consultation with the U.S. Food and Drug Administration (FDA), Medline is updating the instructions for continued use, and providing additional information about options for repair, replacement and full or partial refund of original purchase price,” Medline wrote.
The updated instructions are to:
- Unplug the beds from electrical outlets.
- When necessary adjustments to the bed need to be made, plug the bed into an electrical outlet while repositioning the patient and unplug the bed when not repositioning the patient.
- Do not use extension cords to power the bed.
- Whenever possible, have a second person available to assist with the use and movement of the bed.
The company advised durable medical equipment (DME) providers and others not to attempt to repair, modify or alter Medline Brand beds unless specifically instructed to do so by the company. Products bought in the last five years may be eligible for products bought in the last five years. Products bought more than five years ago are still covered by the recall and users should follow the updated instructions.
Other Suppliers Stepping Up
Drive Medical announced it has accelerated its bed manufacturing capacity in order to ensure continued product availability for homecare providers in the case of supply shortages. The company said it had taken practive steps several weeks ago to substantally expand manufacturing and distribution capacity to boost its supply chain, and expects “significant additional inventory” to be available beginning in mid-November, supported by a new distribution operation in Savannah, Georgia.
“Every delay in access to critical equipment ultimately affects patient care,” Drive Medical CEO Derek Lampert said in a news release “That’s why we took immediate action to expand manufacturing and distribution capabilities, helping ensure providers have the products they need to serve patients and residents without interruption.”
Contacting Medline
- To start a repair, replacement, refund, or ask questions, contact Medline Recall Customer Service, 1-800-950-0128, option 7.
- To report adverse events to Medline: [email protected], or 1-800-950-0128, option 5.
AAHomecare said it has been in communication with the FDA about this recall. The FDA shared the following contacts for reporting disruptions and adverse events:
- Disruptions in availability and shortages of medical devices can be reported directly to the Office of Supply Chain Resilience at: [email protected]. This email is the right place for healthcare providers and patients to contact us regarding shortages issues.
- In addition to contacting Medline directly, issues and adverse events with the Medline beds (or other medical products) can be reported through the FDA MedWatch program (MedWatch Online Voluntary Reporting Form).
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