FDA Warns That Damaged, Worn Covers for Medical Bed Mattresses Pose Risk

The Food and Drug Administration (FDA) is alerting healthcare providers that damaged or worn covers for medical bed mattresses can allow blood and body fluids to penetrate medical bed mattresses, posing a risk of infection to patients.

A medical bed mattress cover provides outer protection to a medical bed mattress by preventing blood and body fluids from entering the inside (inner core) of the mattress. Types of mattresses may include alternating pressure (ac-powered) air flotation mattresses, non-powered flotation mattresses, and other mattresses that are part of hospital beds. Medical bed mattress covers may be coated with or contain a substance that kills viruses or bacteria or prevents bacterial growth. There are multiple terms used to describe medical 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).

Medical bed mattress covers, whether water-resistant, water-proof, or water-repellent, may lose their effectiveness over time. The duration of time that a medical bed mattress cover is expected to last (expected life) varies from manufacturer to manufacturer. In addition, the expected life of a medical bed cover may differ from that of the mattress itself. For example, a medical bed mattress may have a longer expected life than the mattress cover.

From January 2011 to January 2013, the FDA received 458 reports associated with medical bed mattress covers failing to prevent blood and body fluids from leaking into the mattress (fluid ingress). Fluid ingress may occur if mattress covers become worn or damaged from small holes or rips in the fabric or from incorrect cleaning, disinfecting and laundering procedures. The zipper on the cover may also allow fluid to penetrate the mattress. Some reports indicate that if blood and body fluids from one patient penetrate a mattress, they can later leak out from the mattress when another patient is placed on the bed. Patients are at risk for infection if they come into contact with blood and body fluids from other patients.

Medical literature shows that damaged and wet (soiled) mattresses can be a source of contamination during infection outbreaks. The FDA is concerned that fluid ingress from worn or damaged medical bed mattress covers may be widespread and largely under-recognized by health care providers, health care facility staff, and caregivers.

Recommendations:

Inspect

Regularly check each medical bed mattress cover for any visible signs of damage or wear such as cuts, tears, cracks, pinholes, snags or stains.
Routinely remove the medical bed mattress cover and check its inside surface. Once the mattress cover is removed, inspect the mattress for wet spots, staining, or signs of damage or wear. Check all sides and the bottom of the mattress.
Be aware that it may be difficult to identify damaged or soiled mattresses because mattress covers tend to be dark in color.

Remove and Replace

Remove any damaged, worn or visibly stained medical bed mattress according to the healthcare facilitys procedures and manufacturers instructions.
Immediately replace any medical bed mattress cover with visible signs of damage or wear to reduce the risk of infection to patients.

Maintain

Clean and disinfect undamaged medical bed mattress covers according to the manufacturers guidelines.

Develop an Inspection Plan

Check the expected life of the medical bed mattress and the mattress cover. Create an inspection plan for all medical bed mattresses in your facility. Contact the medical bed mattress cover manufacturer for any additional questions.

The FDA will continue to monitor this issue and keep the public informed if new information becomes available.

Source: FDA