Regulatory Focus™ > News Articles > Deluge of Reports Prompts FDA to Issue Warning About Contamination Control Device

Deluge of Reports Prompts FDA to Issue Warning About Contamination Control Device

Posted 19 April 2013 | By Alexander Gaffney, RAC 

US Food and Drug Administration (FDA) regulators on Friday sent out a warning letter regarding a rather unusual, but serious subject: Beds.

To be more specific, medical beds, and a special type of medical device called a medical mattress cover that is used to protect mattresses from becoming contaminated.

In most facilities, medical mattress covers are used to make sure that a patient's bodily fluids don't leak into the mattress, a process called fluid ingress. The higher purpose of the covers, which are classified as medical devices, is to prevent the spread of contamination by providing a surface that can be sterilized and therefore prevent the growth of bacteria or the transmission of disease.

But the mattress covers have been failing in an alarmingly high number of cases, FDA wrote a 19 April 2013 warning to healthcare professionals.

Between January 2011 and January 2013, FDA said it received 458 reports of the devices failing to prevent fluid ingress, with the majority of the failures resulting from the general wear of the devices, the physical attributes of the device as designed, or improper cleaning procedures.

And that may just be the tip of the iceberg, FDA added. "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," the agency said. "The FDA will continue to monitor this issue and keep the public informed if new information becomes available."

Regulators advised owners of the devices to regularly check them for damage, remove them to assess the mattress of fluid ingress, and to keep needles from puncturing the cover.

The covers are currently exempt from good manufacturing practice (GMP) regulations as exempted class I medical devices, and are allowed to be marketed without 510(k) clearance, raising the possibility that FDA could elevate the requirements for the device in light of the ongoing problems.


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