What does FDA Clearance mean?
DermaTherapy has FDA clearance as a Class I medical device for atopic dermatitis, eczema and psoriasis, and pressure sores. DermaTherapy is the first and only bedding to achieve this distinction. Technical classifications for DermaTherapy include:
- Class I medical device for use by people in hospital, healthcare or home settings who are susceptible to or may have atopic dermatitis, the most common form of eczema. (Reg. K061242)
- 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)
What sort of testing has been done for skin sensitivity?
We have had the fabric and bedding tested numerous times for skin sensitivity as it may relate to concerns from psoriasis/eczema sufferers. These tests included analyses of skin irritation, skin sensitization, and cytotoxicity. In all such testing, DermaTherapy showed passing results, with no cytotoxicity or sensitivity for at-risk skin. The FDA reviewed our test results and found them to pass standards for medical devices used in contact with the skin. In fact, the FDA cleared DermaTherapy as a Class I Medical Device for use by people suffering from psoriasis, eczema and atopic dermatitis. Results are available upon request.
- 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
What is the fabric made from?
DermaTherapy fabrics are woven from 50% polyester and 50% nylon yarns.
What makes DermaTherapy sheets easier to clean?
DermaTherapy fabrics have a special soil-release treatment that leaves the linens clean and fresh, wash after wash. The continuous filament thread used in the fabric makes it stain-resistant. DermaTherapy sheets should be washed separately to avoid lint contamination.
Are DermaTherapy sheets hypoallergenic?
Yes, the fabric’s continuous-filament threads are naturally hypoallergenic.
Are DermaTherapy sheets antimicrobial?
Yes, all DermaTherapy fabrics have an antimicrobial treatment to maintain freshness, dramatically reducing the opportunity for bacteria to grow and spread.
What does “moisture-wicking” mean?
DermaTherapy fabrics are woven of fibers with unique cross sections that create micro-channels. These micro-channels carry--or “wick”--moisture away from skin.
How does DermaTherapy control the temperature and climate of the bed?
DermaTherapy fabrics are cool to the touch and, through the use of unique micro-fibers, keep you from getting too cold or too hot throughout the night. In addition, DermaTherapy fabrics wick away moisture and, because the fabric dries faster than cotton bedding, keep the bedding climate consistent.
Why is DermaTherapy the standard-in-care for people with skin conditions?
DermaTherapy fabrics are woven from a strong, continuous-filament yarn that creates a consistently smooth, silk-like surface. Our fabrics are lint free, and release almost no lint or contaminating particles that can irritate the skin and infiltrate pores. Friction and skin abrasiveness are virtually eliminated.
Have DermaTherapy sheets been tested in hospitals and long-term care facilities?
DermaTherapy linens have been used in 14 trials in both hospital units and long-term care facilities. These trials have shown the effectiveness of DermaTherapy as both a preventative and remedial treatment for pressure ulcers. All trials saw a reduction in the number of patients with facility- and hospital-acquired pressure ulcers. For further reading, please refer to clinical references involving DermaTherapy. Additional studies are available upon request.
- Prospective, Nonrandomized Controlled Trials to Compare the Effect of a Silk-Like Fabric to Standard Hospital Linens on the Rate of Hospital-acquired Pressure Ulcers. Coladonato J, Smith A, Watson N, Brown AT, McNichol LL, Clegg A, McPhail L, Griffin T, Montgomery TG. J Ostomy Wound Management 2012; 58(10):14-31.
- A Retrospective, Nonrandomized, Before-and-After Study of the Effect of Linens Constructed of Synthetic Silk-like Fabric on Pressure Ulcer Incidence. 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.
- A Randomized, Controlled Study to Assess the Effect of Silk-like Textiles and High-absorbency Adult Incontinence Briefs on Pressure Ulcer Prevention. Twersky J, Montgomery T, Sloane R, Weiner M, Doyle S, Mathur K, Francis M, Schmader K. J Ostomy Wound Management 2012;58(12):18–24.
- Use of a Silk-like Bedding Fabric in Patients with Atopic Dermatitis. Eleanor JK, Christopher BY, Fabian T Camacho, Fleischer AB. Pediatric Dermatology Vol. 25 No. 4 439–443, 2008.
What is DermaTherapy’s return policy?
All DermaTherapy linens meet the strictest standards of quality as defined by our stringent ISO 9001 certification. You can expect to realize the mitigating benefits of our products within 2–3 weeks. Should you become dissatisfied with your purchase for any reason, Precision Fabrics Group will accept a return within 30 days of date-of-purchase. We cannot accept returns after 30 days for any reason other than manufacturer’s defects. Returns will be refunded in the original method of payment. Please allow 10 business days for shipping and processing.
All DermaTherapy linens include a one-year warranty against manufacturer defects. For return authorization, please contact Customer Service at 844-DERMA44 (844-337-6244). You will be provided with a return shipping label and a full refund or exchange of your defective product, less return shipping expense. Please note that we cannot accept returns or exchanges of items purchased from third-party retailers.
Are there any limitations to shipping?
All orders will be shipped using United Parcel Service (UPS). A shipping rate will be automatically calculated by UPS before you confirm the purchase of an order and added to your total charges. A physical street address is required for UPS delivery. We cannot accept a shipping address containing a P.O. Box number. Shipping options include Ground, Next Day Air, and Second Day Air.
Please note that orders placed after 1pm on Friday will not be processed until the next business day. Should you choose overnight shipping, your order will arrive on the second business day.
Once your order is shipped, you will receive an email confirming shipment, along with tracking information.
Note for orders shipped to Canada: CANADIAN DUTIES AND TAXES ARE NOT INCLUDED.
Do DermaTherapy products come with any warranty?
Precision Fabrics Group, Inc. (PFG) warrants to the original purchaser or user that accompanying product will be free from defects in materials and workmanship for a period of one year from the date of the original sales invoice. If, during the warranty period, the product is found to be defective because of defects in the materials or workmanship, it will be replaced without charge. Notice of a claim under this warranty must be given promptly in writing, in no case later than 45 days after the discovery of the defect. Defective products must be returned, along with the invoice, prepaid to PFG at the address stated below. PFG will prepay shipping charges for the replaced product. This warranty will become void if the product shows signs of careless handling or if the product is ripped or torn. In addition, product must be cleaned in accordance with PFG's Care & Use Instructions. Buyer's recovery for any claim shall be limited to what the buyer paid for the product(s). Any implied warranties shall be limited to the duration of the one year limited warranty. In no case will PFG be liable for incidental or consequential damages, whether such damages are claimed on account of the breach of warranty, breach of contract, negligence or strict/product liability, including without limitation, damage to property other than the product or economic losses. Some states do not allow limitations on implied warranties or the exclusion or limitations of incidental or consequential damages, so the above limitation or exclusion may not apply to you. This warranty gives you specific legal rights, and you may also have other rights that vary from state to state. All claims relating to the limited warranty should be addressed to: Precision Fabrics Group, Inc. c/o Customer Service Department, 301 North Elm Street, Suite 600, Greensboro, NC 27401.
For acne relief, do I only need to purchase the pillowcase?
If the acne is limited to the face, the pillowcase will be a sufficient solution. If acne is affecting other areas of the body, we recommend purchase of a full set of sheets.
Do I need to do anything with the sheets before putting them on my bed?
We recommend that you wash your new sheets before the first use. Wash and dry the sheets on low-to-medium heat. Once washed, put on your bed and enjoy!
How long will it take to see results for my skin conditions?
Initial results are typically seen within 2-3 weeks.
Are there special care and use instructions for DermaTherapy sheets?
No special laundering is required. Your DermaTherapy bedding may be machine washed and dried on low-to-medium heat. It’s recommended that you wash your bedding before use, and linens should be washed separately from other laundry.
- Do not use fabric softener or a dryer sheet as this may inhibit the wicking properties.
- If bleach is needed, use only non-chlorine bleach.
- Do not dry clean.
Are DermaTherapy sheets ever covered by Medicare or Medicaid?
While DermaTherapy sheets are not covered by either Medicare of Medicaid, you may be eligible for reimbursement for the cost of sheets from a Flexible Spending Account (FSA). Please note DermaTherapy can not guarantee reimbursement from a FSA. While we’re happy to make our customers aware of the potential for reimbursement, it remains the purchaser’s responsibility to confirm if their acquisition qualifies and, if necessary, to obtain a letter from a doctor to support their claim.