Microneedle systems as medical devices for esthetical treatments: A risk assessment approach.

BACKGROUND: Microneedling devices are being used as a surgical technique without a clear regulatory category. They can become dangerous considering that these kind of devices can easily be bought and used by nonqualified people. AIMS: Our aim has been to demonstrate that microneedling devices used in dermatological surgery are Medical Devices according to the current regulations. PATIENTS/METHODS: After a thorough review in the European Union and USA medical device classification, we consider microneedling systems as Class II (US) or IIa (EU). RESULTS: Therefore, they must follow the regulations established for medical devices. A risk assessment has also been made, in which the technical and scientific deficiencies in their design and manufacturing have been recognized in addition to including compulsory information for the regulatory agencies and most importantly for the final user. CONCLUSION: It can be concluded that microneedling is an interesting tool in dermatology although more information related to its safety needs to be submitted. In addition, its use by nonprofessional people does not guarantee the safety of the user.

Nail dryer devices: a measured spectral irradiance and labelling review.

The popularity of nail beauty has increased during the last few years in Spain, as well as in other countries. Nowadays there are a large number of nail dryer devices in the market with ultraviolet (UV) fluorescent lamps, light emitting diodes (LED) or a combination of both. The different spectral emissions of each individual nail dryer device require particular nail polishes, which are polymerized by specific wavelengths and a controlled exposure time to achieve the desired results. We have measured and analyzed the emission of 28 nail dryer devices currently in use in Spanish beauty centers. The emission of each individual nail dryer device showed a particular spectral distribution and maximum intensity, especially those with fluorescent lamps or LED/UV combinations. About 30% of the devices emitted more UV-A radiation than that received in Barcelona at solar noon in summer. Nevertheless, in all cases the erythemal irradiance was low, similarly to ambient values at solar noon in winter or when the solar altitude is low. The erythemal doses corresponding to a typical session were, therefore, lower than those received from sunlight at summer midday at equivalent exposure times. The biological irradiances for photoaging (skin sagging and elastosis) showed high variability depending on the device, especially for fluorescent lamps. Since the emission of LED-based devices is centered in the visible region, erythemal and photoaging irradiances were low. An analysis of the labelling showed that 85% of the devices had a visible label, although 23% contained some errors, according to the EN 60335-1 guideline.

Soft and hard tissue management in the treatment of a discolored single tooth in the esthetic zone.

When treating the color of a single tooth in the esthetic zone, it is a complex task to achieve the same visual effect as the rest of the teeth. In addition to the problem of the clinical crown color, if the patient has a thin periodontal biotype it is necessary to manipulate both the hard and soft tissue to achieve a good esthetic result. To change the biotype, a connective tissue graft needs to be performed. The graft must be stabilized exactly where it is needed, and the recipient area modified. The tooth needs to receive an adequate preparation so as to make the restoration thick enough to naturally mask the treated tooth, while also ensuring long-term stability.

Ultraviolet spectral distribution and erythema-weighted irradiance from indoor tanning devices compared with solar radiation exposures.

Concern regarding the impact of indoor tanning devices on human health has led to different regulations and recommendations, which set limits on erythema-weighted irradiance. Here, we analyze spectral emissions from 52 tanning devices in Spanish facilities and compare them with surface solar irradiance for different solar zenith angles. Whereas most of the devices emitted less UV-B radiation than the midday summer sun, the unweighted UV-A irradiance was 2-6 times higher than solar radiation. Moreover, the spectral distributions of indoor devices were completely different from that of solar radiation, differing in one order of magnitude at some UV-A wavelengths, depending on the lamp characteristics. In 21% of the devices tested, the erythema-weighted irradiance exceeded 0.3Wm(-2): the limit fixed by the European standard and the Spanish regulation. Moreover, 29% of the devices fall within the UV type 4 classification, for which medical advice is required. The high variability in erythema-weighted irradiance results in a wide range of exposure times to reach 1 standard erythemal dose (SED: 100Jm(-2)), with 62% of devices requiring exposures of <10min to reach 1 SED. Nevertheless, the unweighted UV-A dose during this time period would be from 1.4 to 10.3 times more than the solar UV-A dose.

Indirect porcelain veneers in periodontally compromised teeth. The hybrid technique: a case report.

The loss of periodontal structure causes an esthetic problem for many patients, especially when the esthetic zone is compromised. Among the various types of solutions is the use of composite resins. While this procedure is not aggressive towards tooth structure, it does require the clinician to have a precise technique, and demands strict longterm maintenance. 1 Another way of treating the compromised teeth is with porcelain veneers. This procedure is especially difficult, however, if carried out on periodontal teeth, as it requires preparation along the roots. 2 The intention of the hybrid technique described in this article is to combine both of these procedures in order to obtain a less aggressive treatment with precise management of the soft tissue and an adequate esthetic outcome. The hybrid technique consists of enlarging the root portion of the teeth with composite resin to obtain a less aggressive tooth preparation, and thereafter placing porcelain veneers.