Aesthetic medecine : obligations for practitionners

Every practitioner in the Aesthetic medicine field must follow specific rules (traceability for ex.) during a consultation prior to any cosmetic injection. A breach of these rules can be problematic when facing a prosecution for a medical complication induced by an aesthetic procedure.

The three main obligations are:

1- A comprehensive information shall be given to the patient prior to any procedure. Indeed, the patient shall be informed of the type of procedure he is going to sustain. The precise modalities and potential complications of every procedure shall be explained. The patient must then sign a consent form which has to be included into the medical file and stored by the practitioner.

2- Pre – procedure pictures have to be taken prior to any treatment. These pictures must be static and dynamic (The patient shall be frowning, smiling, lifting his eyebrows up) . These pictures can help the practitioner diagnose a facial abnormality or asymmetry prior to the procedure. It also allows to show the patient the effects of the rejuvenating treatments and to compare between the « before » and « after » pictures of his face.

3-The last important obligation is traceability. The traceability is the ability to follow a product at the various stages of its production, its transformation and commercialization. The collection of the traceability of any product used is a fundamental part of the medical care of patients. This is particularly true in the field of aesthetic and anti-aging medicine, where practitioners are regularly required to inject their patients with neuromodulators (botulinum toxin) or wrinkle fillers.

The scandal of PIP breast implants, revealed in 2010, has led health authorities in many countries to look into the modalities of care for surgical patients and aesthetic medicine. The case of PIP implants is linked to the PIP manufacturer’s use of a non-compliant silicone gel in the manufacture of aesthetic breast prostheses and reconstruction. This has led health authorities to advocate the removal and change of these implants in all implanted patients. This scandal was an important source of anxiety for the patients implanted at that time and forced the plastic surgeons to find, in their respective databases, the identity of the patients concerned in order to contact them and to take care of them in relatively short lead times.

Following the case of PIP, recommendations have been enacted, particularly emphasizing the need for an optimal traceability in surgery and aesthetic medicine and anti-aging. These recommendations have been implemented in France in 2012, by the Senate Committee “health, beauty, a priority: security”, chaired by Chantal Jouanno and Bernard Cazeau, and England in 2013 by the Commission chaired by Professor Sir Bruce Keogh. These recommendations particularly insisted on 2 basic elements: on the one hand the obligation for the practitioner to save references of the products used and on the other hand the implementation of logistics to quickly extract the information relating to the traceability from the database “patients”. The Commission led by french senators Chantal Jouano and Bernard Cazeau advocated the issuance to any patient with an injection notebook that such a health book, would include all of the made acts and implanted product references. Furthermore, it should be noted that in the UK, any patient with facial rejuvenation procedures was to receive, on the part of the practitioner, a report of injection with the references of the products used.

iRejuvenation by AmedSU is an iPad application that allows aesthetic practitioners to fulfill their obligations.The application has been developed with the help of several aesthetic practionners. Indeed, In the design of the iRejuvenation application, the AMedSU team has been particularly attentive to :

Patients information and the collection of consents by adding dedicated consents with comprehensive information concerning complications of aesthetic medicine in the app. These consents can be signed within the app and are automatically stored into the patient’s medical file.

Including in the app a specific picture-tool with face masks which allows to take and store standardized pictures of patients. An outstanding comparison tool allows the analysis of the evolution of patients facial features through time. With this picture tool, the app is able to create a « cosmetic time line » for every patient.

Establishing an optimal collection of traceability tool that has been integrated into the first version of the application. Thus, practitioners have both a specific tab in each patient file where they can fill in the references, batch number and date of expiry of any product used. They have also a powerful search engine to find a specific product or to retrieve a list of patients who received any particular batch number. This allows the iRejuvenation application to be in line with the latest recommendations in force and ensure practitioners and their patients an optimal collection of the traceability of the products used.

The next evolution of the management function of traceability in the iRejuvenation application will be the option to simply scan the injected product references. This development will be possible during the next implementation of universal identification elements.

By the way, IRejuvenation also includes medical questionnaires which help the practitioners to screen the patients medical history in order to detect any contraindications to cosmetic injections. For instance, a patient with a history of myasthenia shall not be proposed to have botulinum toxin injections.

This app comprises an aesthetic reporting tool which allows to precisely mark on patients faces the site of every injection as well as the injected quantities of every product.

iRejuvenation is available on the App Store and can be downloaded for free and tested with up to 5 patients before buying it.

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