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FDA: Keep an eye on mattress cover damage

Friday April 19, 2013
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The Food and Drug Administration has issued an alert about the dangers posed by damaged or worn covers on medical bed mattresses.

From January 2011 to January 2013, the FDA received 458 reports associated with the failure of medical bed mattress covers to prevent fluid ingress, which 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 have indicated that if blood and body fluids from one patient penetrate a mattress, they can subsequently 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.

A medical bed mattress cover provides outer protection to a medical bed mattress by preventing blood and body fluids from entering the inside of the mattress. 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 varies from manufacturer to manufacturer. In addition, the expected life of a medical bed cover may differ from that of the mattress itself.

The FDA recommends the following steps:

• 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.

• Immediately replace any medical bed mattress cover with visible signs of damage or wear to reduce the risk of infection to patients.

• Do not stick needles into a medical bed mattress through the mattress cover.

Medical literature shows that damaged and 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 healthcare providers, healthcare facility staff and caregivers. The FDA will continue to monitor this issue and keep the public informed if new information becomes available.

For more information, visit www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm348016.htm.


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