Can The Medical Dermaroller ® Devices Be Reused? - Patient

Can Medical Dermaroller ® Devices Be Reused? 

This is the most frequently asked question and source of confusion after patients or consumers have conducted their online research on micro-needling devices. The confusion is due to the fact that most micro-needling sellers, web-sites, and bloggers either state or imply that the devices can be reused. Their statements and implications are in direct conflict with FDA established guidelines and regulations regarding disposable medical devices.

In order to answer whether or not a micro-needling device can be reused we first need to understand the significant differences between cleaning, disinfecting and sterilizing.

Cleaning

Means that dirt, debris and other elements have been removed by washing with soap for example.

Disinfecting

Means that the number of microorganisms has been lowered but are still present.

Sterilizing

Means that all microorganisms have been killed. Sterilization is a surgical standard that ensures the absence of any microorganisms.

Some manufacturers of micro-needling devices claim that their devices are gamma ray sterilized upon arrival for medical use. This is a very important point. This safety factor is a requirement by the FDA that ensures that infections do not occur since medical micro-needles will penetrate deeply into the skin. Logically then, if it is deemed important by the FDA for the medical micro-needling devices to arrive sterilely packaged prior to use, sterility should be equally as important if the devices are to be reused. That stands to reason, does it not? Let's continue.

All medical micro-needling devices have virtually the same components: 1) a plastic roller, 2) micro-needles which differ in shapes, sizes and composition depending on the manufacturer, and 3) to keep the needles properly aligned either glue is used or the needles are embedded directly into the plastic roller. In order for a medical device to be deemed reuseable and in order to assure sterility after the initial use of a device, it has to be re-sterilized. One method of sterilization involves the use of an autoclave during which the temperature generated is so high that it damages and alters the integrity of the plastic roller thus affecting the alignment of the micro-needles. The second method is by exposing the medical device to radiation called gamma rays. Although autoclaves are commonly available in medical offices, gamma ray emitting radiation equipment is not. Third, there are chemical solutions capable of sterilizing medical tools. Most of these solutions can damage the roller. Thus, they also can't be relied upon for sterilizing the medical micro-needling devices. 

If all micro-needling devices were made of metal, then all microorganisms and contaminants could be removed by either autoclaving or by disinfecting and then re-sterilizing them with gamma rays. This would certainly simplify matters.

However, a very critical element remains to be considered: the sharpness of the micro-needles. How can the micro-needles be assured to retain their sharpness and efficacy if reused?  The answer is simple. You can't. There is no currently available method of re-sharpening the tiny needles in medical micro-needling devices. They are intended to be disposable.  Therefore, medical micro-needles can not be re-sharpened and medical micro-needling devices cannot be re-sterilized by any commonly available methods.

For the reasons outlined above, Dermaroller ® medical devices are designed to be disposable and for single use only. Dermaroller® does not recommend reusing their micro-needling medical/surgical devices.  Ensuring the effectiveness of the medical devices is critical. Patient safety is considered paramount.  Dermaroller ® does not consider your health and welfare a subject of sales gimmicks!! With certainty the FDA does not consider our legitimate concerns as sales gimmicks either. Note that other manufacturers recommend using alcohol or similar substances, as do some medical professionals, as a methods of ensuring sterility and safety after the initial use. Please beware.

Medical Dermaroller ® devices are sold only to medical professionals. Every Medical Dermaroller ® device that is sold to a medical professional comes individually packaged. It has a bar code that tracks the model type, manufacturing date, expiration date, where it was bought, type of sterilization method used and lot number. This is a mandatory requirement for Dermaroller ® in order to meet stringent CE quality approval in Europe and in the US. The FDA and the European Union have different requirements. Dermaroller ® meets or exceeds the requirements for both. Dermaroller® goes the extra distance to make sure that the patient and the medical professional are safe and protected.

Become involved in your care. Demand the best. Demand Dermaroller ® medical micro-needling devices.

 

 

Testimonials
"I chose Dermaroller ® due to it's impecable reputation and widespread use throughout Europe. I have seen Dermaroller ® time and time again win awards for standard of care. "
Ira Lee NP
Dermaroller Practitioner
See More Testimonials >
"As a integrative doctor when I saw what the Dermaroller ® was doing with my patient's energy and the increases blood flow to her face I knew that this was an amazing device. The women that I trained on had major acne scars. "
Jorge Moreno DO
Dermaroller Practitioner
See More Testimonials >
"My client's, co-workers, and myself are amazed and thrilled with my results. "
Maggie Griffith , HairArts Spa
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"I recommend Dermaroller treatments to my friends all the time. "
Tammy H , Medical Dermaroller Patient
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FAQs

"Where do I go to see if a micro-needling company is Registered with the FDA?"
"Am I safe even if a micro-needling company claims that it is FDA registered?"
"Can any one perform medical micro-needling?"
"Can I achieve the same results if I use a micro-needling device at home?"
"There are a lot of companies claiming to be FDA Approved. Is Dermaroller® FDA Approved?"
"If I use my micro-needling device more frequently will I achieve better results?"
"Are thinner needles like acupuncture needles better?"
"Are all micro-needling device needles engineered the same?"
"If a roller has more and longer needles, will I get better results?"
"Can micro-needling devices be cleaned or sterilized for repeated home use?"
"Can a medical micro-needling device be reused?"
"Is the Dermaroller® a CE marked medical device? Are any of the alternative skin needle-rollers CE marked?"
"Why should I use a trained practitioner and an authorized Dermaroller® Clinic?"

Testimonials

I chose Dermaroller ® due to it's impecable reputation and widespread use throughout Europe. I have seen Dermaroller ® time and time again win awards for standard of care.

As a integrative doctor when I saw what the Dermaroller ® was doing with my patient's energy and the increases blood flow to her face I knew that this was an amazing device. The women that I trained on had major acne scars.