Reducing the Risks of Fluid Ingress and Microbiological Contamination in Bed and Stretcher Support Surfaces
May 10, 2017 | Evaluations & Guidance
Bed and stretcher systems consist of a bed or stretcher frame, a support surface, and in some cases a compressor unit to inflate and maintain a powered support surface. A support surface consists of a mattress and a mattress cover; the mattress may be powered (air, air-foam hybrid) or nonpowered (foam/gel, air-foam hybrid), and the mattress cover may be removable or nonremovable.
Manufacturers and rental companies can supply all or part of a bed or stretcher system. For facilities that own most of their bed and stretcher frames, it is common practice to buy support surfaces from different vendors than their primary bed or stretcher frame vendor. Bed and stretcher frames and support surface components have different expected service lives, disparate inspection intervals, and different cleaning and disinfection materials and procedures. These factors make the care and maintenance of bed and stretcher systems difficult for end users—including dealing with body fluid and microbiological contamination.
Body fluid contamination of mattresses can occur during patient care if the mattress cover's integrity is compromised (Sehulster et al. 2003, Yu et al. 2016). In 2013, FDA published a Safety Communication—Damaged or Worn Covers for Medical Bed Mattresses Pose Risk of Contamination and Patient Infection—regarding the problem of fluid ingress in bed support surfaces. It reported that in the two-year period from 2011 to 2013, FDA received 458 reports associated with medical bed mattress covers failing to prevent blood and other body fluids from leaking into mattresses.
In March 2017, ECRI Institute searched FDA's Manufacturer and User Facility Device Experience (MAUDE) database and found the following:
- Four reports of patient bloodborne pathogen (BBP) exposure from contaminated support surfaces—patients were lying on an...