Hospital Bed Mattress Covers: FDA Safety Guidance (and What Facilities Should Do)

Mattress covers are a key infection-prevention barrier in hospitals, long-term care, ambulatory settings, and home care. When a cover is worn, punctured, or degraded, blood and body fluids can seep into the mattress core—creating hidden contamination that may expose the next patient. The FDA issued safety communication to highlight this risk and to reinforce practical steps for inspection, cleaning, and timely replacement.

Why it matters

Hospital beds are regulated medical devices, and their mattresses are used across many care environments. Covers are designed to keep fluids out of the mattress core; some include antimicrobial coatings and may be described as water-resistant, waterproof, or water-repellent. The challenge is that a cover’s protective performance can decline over time—often faster than the mattress itself.

In its 2013 safety communication, the FDA described hundreds of reports of fluids penetrating mattress covers. The document notes that between January 2011 and January 2013 the agency received 458 reports of cover failures leading to fluid ingress, with contributing factors such as small holes or tears, zipper failures, and improper cleaning or laundering. Because contamination can remain inside the mattress and be difficult to detect, routine inspection and prompt removal from service are essential infection-control practices.

What to inspect (quick checklist)

• Inspect the outer surface for cuts, tears, cracks, pinholes, snags, worn seams, and any staining.
• Routinely remove the cover to examine the inside surface and the mattress core for wet spots, discoloration, odor, or material breakdown.
• Check all sides and the bottom—damage often appears where the mattress rubs against frames and rails.
• Pay special attention to zippers and closure areas; failures here can allow fluid ingress.
• Remember that dark-colored covers can hide damage; “looks fine” is not a substitute for a hands-on check.

Cleaning and handling

For covers that are intact and in good condition, clean and disinfect them exactly as the manufacturer instructs (including product selection, dilution, contact time, and laundering parameters, if applicable). Avoid practices that degrade the material over time, and ensure staff know that you should never insert needles through a mattress cover—even a small puncture can compromise the fluid barrier and undermine infection control.

Build an inspection and replacement program

The FDA recommends developing a routine inspection plan rather than relying on ad hoc checks. At a minimum, define (1) how often mattresses and covers are inspected, (2) who performs the inspection (and how they are trained), (3) what findings require immediate removal from service, and (4) how results are documented. Include expected lifespan guidance for both the mattress and the cover (covers may need replacement sooner) and establish a clear process for contacting the manufacturer when you have maintenance, cleaning, or durability questions.

When to remove a cover or mattress from service

Remove and replace any mattress cover that is damaged, worn, or visibly stained. If fluids have penetrated the cover or the mattress shows wet spots, staining, or other signs of contamination, remove the mattress per facility procedure and manufacturer guidance. Quick triggers for removal include:

• Any tear, crack, pinhole, seam failure, or zipper failure
• Stains you cannot remove per the manufacturer’s cleaning instructions
• Wet spots or discoloration on the inside surface of the cover or on the mattress core
• Any known puncture (including from needles) or suspected fluid ingress

Reporting and resources

If you identify recurring cover failures, suspected fluid ingress, or adverse events, document the details (device and cover manufacturer, model information, and what occurred) and report concerns through the FDA’s MedWatch program in line with your organization’s reporting process. The FDA also provides a free safety poster that facilities can post to reinforce correct inspection and handling practices.

Bottom line: treat mattress covers as a critical barrier device. Frequent hands-on inspection (including removing the cover), manufacturer-aligned cleaning, and immediate replacement of damaged or stained covers can reduce the chance of hidden contamination—and help protect every patient who uses the bed next.