| MICRONEEDLING | PEER-REVIEW Currently, the original needle roller is
increasingly being replaced by automated microneedling devices. These devices resemble micropigmentation devices. Whereby, the needle cylinder is replaced by sterile single-use needle cartridges with a range of different needle configurations. Instead of a rolling motion, the approximately 0.2 to 0.4 mm thin and very sharp needles prick into the skin using a stamp motion (back and forth motion), which is created by a swing of an electric engine in the handpiece (or pen). Depending on the chosen frequency, the devices create between 50–150 stamp motions per second. Through multiple applications with the selected cartridge, several hundred punctures per second are created. Similar to the needle roller the aim is to achieve a puncture density of 250–300 punctures per cm2
of the skin. The manual needle rollers as well as the
automatic microneedling devices allows the practitioner to control the range of integrity violation to the skin (invasiveness) through the technique of the application as well as through the choice of needle length and material. The skin integrity violation ranges from none to slight perforation of the horny layer of the epidermis (stratum corneum of the epidermis) up to a penetration of the deeper dermis (stratum reticulare of the dermis).
Medical and cosmetic microneedling The most important criterion for the definition of a medical microneedling treatment arises from the European definition of a medical or rather a medicinal treatment. The medical treatment is defined as the activities of physicians for the prevention, early diagnosis, and treatment of diseases. A disease is defined as the disruption of the function of an organ, psyche or the whole organism. The treatment of a healthy person cannot be a medical
treatment according to the above mentioned European perspective. Therefore, a medical microneedling treatment requires the treatment of a patient, which should be performed by a physician or an authorized healthcare professional. The microneedling instrument or device used for the
medical microneedling treatment requires the medical device CE marking according to European legislation. Medical devices within the scope of the Medical Device Directive 93/42/EEC (MDD) includes all instruments or devices that have been intended for use on humans for the purpose of disease treatment by the manufacturer. In the spirit of the European regulations, a medical
microneedling treatment could be performed, for example, to treat and smooth scar tissue, such as surgical scars, burn scars, and acne scars. Microneedling treatments to the skin for the purpose of
accelerated skin renewal (anti-aging), by smoothing wrinkles or skin tightening, does not count as a medical treatment in the European Union. Rather, such a
The manual
needle rollers as well as the automatic microneedling devices allows the practitioner to control the range of integrity violation to the skin through the technique of the application as well as through the choice of needle length and material.
HEINZ FREIER, DIPL.-ING, DEGEUK GmbH, Frankfurt, Germany; ANDREAS PACHTEN, PH.D, MT Derm GmbH, Berlin, Germany
email:
heinz.freier@
degeuk.de
COVER STORY
KEYWORDS Microneedling, CE Mark
prime-journal.com | October 2015
49
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