On November 20, 2017, the FDA updated its information regarding cleaning procedures for covers for hospital bed mattresses. The FDA issued a safety communication in 2013 alerting health care providers, health care facility staff, and caregivers to safety concerns related to hospital bed mattress covers allowing blood and body fluids to penetrate and get trapped inside mattresses. From 2011 through 2016, the FDA received more than 700 reports of a hospital bed mattress cover failing to prevent blood or body fluids from leaking into the mattress.
FDA regulations classify hospital beds as Class I and Class II devices. A hospital bed system encompasses the bed frame and its components, including the bed side rails, head and foot board, the mattress, and any accessories added to the bed, such a detachable mattress cover.
A hospital bed mattress cover provides outer protection to a mattress by preventing blood and other body fluids from entering the inside (inner core) of the mattress. Such covers may be coated with or contain an antimicrobial solution that kills germs (viruses or bacteria) or prevents bacterial growth. There are multiple terms used to describe hospital bed mattress covers: water-resistant (keeps liquid away from the material), water-proof (prevents liquid from entering inside the material), or water-repellent (keeps liquid away from the material and prevents liquid from entering inside the material). Covers are usually detachable from the mattress or the mattress lining, meaning that they can be removed or replaced.
Over time, hospital bed mattress covers can wear out and allow blood and body fluids to penetrate and get trapped inside mattresses. If blood or body fluids from one patient penetrate and get absorbed in a mattress, the fluids can leak out the next time the mattress is used. Coming into contact with these fluids poses a risk of infection to patients using the bed.
The FDA’s new recommendations were based on guidelines for environmental infection control in health care facilities issued by the CDC. The recommendations were intended to help health care providers, health care facility staff, and caregivers ensure hospital bed mattress covers are safe for use in health care settings.
First, the FDA recommended that facilities using hospital bed mattress covers develop an inspection plan for all hospital bed mattresses and mattress covers in each facility. Developing an inspection plan should include checking the manufacturers’ guidelines for an expected life time on the hospital bed mattress and mattress covers, following any additional recommendations listed there, and contacting the mattress cover manufacturer with any additional questions.
Second, the FDA recommended that facilities using hospital bed mattress covers inspect all hospital bed mattresses and mattress covers in each facility. Inspections should include regularly checking each hospital bed mattress cover for any visible signs of damage or wear such as cuts, tears, cracks, pinholes, snags, or stains. Also, inspections should include routinely removing the hospital bed mattress cover and checking the inside surface. Once the mattress cover is removed, all sides and the bottom of the mattress should be inspected for wet spots, staining, or signs of damage or wear. The FDA warned that it may be difficult to identify damaged or soiled mattresses without removing the mattress covers first. Mattress covers tend to be dark in color, making it hard to see what lies underneath.
Third, the FDA recommended that facilities using hospital bed mattress covers remove and replace hospital bed mattresses and mattress covers as needed. Facilities should remove any damaged, worn, or visibly stained hospital bed mattress according to the health care facility’s procedures and manufacturer’s instructions. Additionally, facilities should immediately replace any hospital bed mattress cover with visible signs of stains, damage, or wear to reduce the risk of infection to patients.
Fourth, the FDA recommended that facilities using hospital bed mattress covers maintain hospital bed mattresses and mattress covers. Facilities should clean and disinfect undamaged hospital bed mattress covers according to the manufacturer’s guidelines. The FDA warned that needles should not be stuck into a hospital bed mattress through the mattress cover.
See the FDA Hospital Bed Mattress Cover medical device information page
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