FDA Guidelines for Reprocessing of Single-Use Medical Devices does not include Medical Microneedling
Dermaroller ® Warns: FDA does not approve the reuse of Single-Use Only medical micro-needling devices.
Jan. 3, 2012 - PRLog -- Billions are spent annually by US consumers in their pursuit of skin rejuvenation, acne scar solutions, and anti-aging procedures. Yet, the esthetics industry is by and large unregulated. Medical esthetics however, is regulated by ethical standards and established FDA guidelines.
Annually many novel medical esthetics tools are developed that fall outside FDA surveillance. Many of these tools are sterilely packaged and are designed for Single-Use Only (SUO) due to concerns regarding contamination, and patient health and safety concerns. In the field of medical micro-needling manufacturers, including domestic and those based in China, Korea and the UK, continue to disregard not only FDA guidLelines, but the health and safety of the US consumer. The list of the offenders includes online derma roller sellers which also sell directly to the public.
The FDA has stated that “Reprocessing and reusing single-use devices (SUDs) can save costs and reduce medical waste. But before medical devices can be reprocessed and reused, a third-party or hospital re-processor must comply with the same requirements that apply to original equipment manufacturers.”
In other words, the FDA wants to be able to assure that before any SUO device is reused, it has to conform and be in the same condition as in the original form including sterility and safety. Generally, most SUO medical devices cannot be re-sterilized for various reasons. Medical micro-needling devices belong in this category because they penetrate the skin and due to their material composition. Micro-needling devices with needle lengths of 0.5 mm or longer are for SUO, disposable and are not to be reused. Medical offices, medical spas, etc. do not have the equipment necessary for proper decontamination of SUO devices nor are they capable of complying with FDA regulations that deal with the reprocessing of SUO micro-needling devices.
Treatment decisions are usually made by medical providers which depend on what appears on the available medical literature. Unlike consumers, rarely do medical providers rely on internet-only based “medical” information. Dermaroller ® wants the consumer to be aware of the unsafe practices being promoted by other derma roller manufactures, online sellers that sell directly to the public, and by some medical spas and medical providers.
Phillip Terrazas, Sales Director for Cynergy explains: “If the excuse for reusing an unsterile medical micro-needling device which is designed for SUO is to cut your cost of treatment, think twice. Your health is at risk. Be aware that alcohol does not sterilize anything. If you are considering a medical micro-needling procedure for the treatment of acne scars, burn scars, stretch marks, wrinkling or hyperpigmentation, look for an educated, quality medical provider who considers your health and safety paramount. You need to ask if the medical micro-needling devices are being reused.”
For further information on what are differences between Cleansing and Sterilizing a Micro-Needling Device or to find a Dermaroller ® Trained Provider for the solutions to acne scars or natural face lift, please visit www.dermarollerus.com
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Based in Germany, Dermaroller ® has been in the United States since 2003. The U.S. branch of the company, Dermaroller ® US, is the only skin micro-needling company with both a medical director and a pharmacist on staff to answer clinical questions. It also has a staff that supports, educates, and promotes the legal, proper, and most efficient and ethical way to use and apply skin micro-needling devices.
Cynergy, LLC is the exclusive U.S. distributor of Dermaroller ®. To learn more please visit Dermaroller US Website or if you are a medical professional and want to be a Trained Dermaroller Provider please visit Dermaroller Training