Precision Fabrics has partnered with Standard Textile, a global supplier of hospital linens with U.S., to test DermaTherapy. After 11 clinical trials at several hospitals showed incidences of pressure ulcers were reduced by 65%-80%, the Food and Drug Administration (“FDA”) in June certified DermaTherapy as a medical device. It’s a first for a bed sheet, and it flips conventional thinking: Instead of sheets and pads protecting the mattress, they protect the patient. What the company found during the trials is that so-called pressure ulcers aren’t caused by pressure at all but rather by what happens when moisture, friction and shear of bed linens interact with skin. The short fibers of cotton break down with use and become abrasive.
The Centers for Medicare and Medicaid Services (“CMS”) estimate that hospital-acquired pressure ulcers add about $11 billion to the nation’s health care bill each year. CMS will not reimburse hospitals for treating bed sores since they are considered avoidable. These wounds generally occur on patients who are in frail health and can lead to rapid decline and death. Precision’s patented fabric has carbon channels and antimicrobial characteristics to reduce odor and static, and a treatment to repel stains.
With the FDA approval, the company hopes that it can change the mindset of hospital and nursing home managers to view bed sheets as part of patients’ treatment rather than as housekeeping items. The company’s headquarters in Greensboro, North Carolina, turned to Moses Cone Hospital for its first trials in the renal unit and then the surgical intensive care unit. The company is looking forward to other hospitals and long-term care centers seeing the benefits of the fabric and is preparing for a run on sheets. Consumers can directly purchase DermaTherapy online as well, with twin sets running $109 and king size $149.