Lifeloom’s bedding is engineered with DermaTherapy fabric technology, and is an FDA cleared Class I medical device for bedsores. Lifeloom bedding affords proactive skin protection with a smooth, silk-like surface, virtually eliminating skin injuries, friction and abrasiveness.
Our bedding also helps manage moisture and heat control through a technology that wicks moisture away from the skin, increasing evaporation and decreasing abrasion
Abrasive bedding can lead to painful, irritating bedsores and pressure ulcers. Our fabric uses a continuous-filament yarn to provide an ultra-smooth finish and breathability that virtually eliminates abrasiveness. When compared with standard hospital bedding for 307 patients at risk of pressure wound development in an acute-care renal unit over a six-month period, bedding made with DermaTherapy® fabric technology resulted in:
"The fabric is designed to reduce friction, which allows a patient to move easily across the bed, making it less likely that a patient’s weakened or moist skin could develop a pressure ulcer or bedsore."
Lifeloom bedding with DermaTherapy® fabric technology has FDA clearance as a Class I medical device for pressure sores. The DermaTherapy® technology is the first and only bedding to achieve this distinction. Technical indications for use of DermaTherapy® include:
* Class I medical device for use by patients who are susceptible to pressure ulcers. DermaTherapy® Bed Linens help to reduce the likelihood of patients developing pressure ulcers by reducing moisture, friction and shear on the patient’s skin. (Reg. K152884)
Lifeloom’s bedding uses DermaTherapy® fabric technology, which is woven from a strong, continuous-filament yarn that creates a consistently smooth, silk-like surface. Our fabrics are lint free and release almost no contaminating particles that can irritate the skin and infiltrate pores. Most importantly to those susceptible or experiencing bedsores or pressure ulcers, such issues are drastically reduced while moisture is wicked away from the fabric.
Lifeloom's DermaTherapy® fabric technology has been tested many times for skin sensitivity as it may relate to concerns from those suffering with bedsores and pressure ulcers. These tests included analyses of skin irritation, skin sensitization, and cytotoxicity. In all such testing, the fabric showed passing results, with no cytotoxicity or sensitivity for at-risk skin. The FDA reviewed test results and found them to pass standards for medical devices used in contact with the skin.
* Standard No. ISO 10993-5, “Biological Assessment of Medical Products, Part 5: Tests for Cytotoxicity – MEM Elution; Version 10993-5”, Standard Date 01/01/1999
* Standard No. ISO 10993-10, “Biological Evaluation of Medical Devices – Part 10: Irritation: Intracutaneous Reactivity; Version 10993-10:2002(E)”, Standard Date 01/01/2002
* Standard No. ISO 10993-10, “Biological Evaluation of Medical Devices – Part 10: Tests for Irritation and Sensitization – Maximum Sensitization
Test; Version10993-10:2002(E)”, Standard Date 01/01/2002
Lifeloom’s bedding is crafted from DermaTherapy® fabric technology, and is woven from a blend of polyester and nylon yarns.
Our FDA-cleared bedding is made in the United States.
The DermaTherapy® fabric technology is crafted from woven fibers with unique cross sections that create micro-channels. These micro-channels carry–or “wick”–moisture away from skin, keeping your skin dry and clean, critical to those susceptible to or experiencing bedsores & pressure ulcers.
Initial results are typically seen within 2-3 weeks.
All Lifeloom bedding made with DermaTherapy® fabric technology meet the strictest standards of quality as defined by our stringent ISO 9001 certification. You can expect to realize the mitigating benefits of our bedding within 2–3 weeks. Should you become dissatisfied with your purchase for any reason, Lifeloom will accept a return within 90 days of date-of-purchase. Customer is responsible for return shipping, and returns will be refunded in the original method of payment. It is recommended to use a tracking number when returning product.
All linens crafted using DermaTherapy® technology include a one-year warranty against manufacturer defects.
Freeman R, Smith A, Dickinson S, Tschannen D, James S, Friedman C. American Journal of Critical Care. 2017; 26: 474-481.
Smith A, McNichol LL, Amos MA, Mueller G, Griffin T, Davis J; McPhail L, Montgomery TG. J Ostomy Wound Management 2013;59(4):28-33.