Prantl, L. and von Fritschen, U. and Liebau, J. and von Hassel, J. and Baur, E. M. and Vogt, P. M. and Giunta, R. E. and Horch, R. E. (2016) Concept for a National Implant Registry to Improve Patient Safety. HANDCHIRURGIE MIKROCHIRURGIE PLASTISCHE CHIRURGIE, 48 (6). pp. 320-329. ISSN 0722-1819, 1439-3980
Full text not available from this repository. (Request a copy)Abstract
Since the introduction of silicone implants, several events have led to considerable uncertainty among the patients, public, and users. So far, however, the necessary steps to significantly improving patient safety have not been taken in any of these cases. Requiring stricter approvals for medical devices, improving monitoring by the regulatory authorities and the revision of the Medical Devices Directive are all initial steps in the right direction towards a change in policy, but are insufficient as an early warning system. After the introduction of registers was announced in the coalition agreement, the German Society of Plastic, Aesthetic and Reconstructive Surgeons (DGPRAC), in close consultation with the Ministry of Health, has developed a concept which is presented here. The need for a uniform and legally binding central register for breast implants is fully supported by the entire medical profession. According to the concept presented by the DGPRAC, three data qualities would be applicable: Safety data (mandatory), physician information (voluntary) and research data (optional, except if safety related). The public authorities are creating a unified, secure entry portal for all professional associations concerned. This register is based with the professional associations, and from there the mandatory security data will be forwarded to the public authorities. Decoding of the identity of the patient and doctor would only occur in specifically defined emergency situations such as product recalls. Automated tools in the security database provide early detection of problems, so that rapid clarification is possible in consultation with the professional associations, manufacturers and possibly patients. This concept as proposed by the DGPRAC has thus far been very positively received in all discussions between the various parties concerned.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | LARGE-CELL LYMPHOMA; BREAST DEVICE REGISTRIES; LATE UNILATERAL HEMATOMA; CAPSULAR CONTRACTURE; INTERNATIONAL IMPORTANCE; SMOOTH SILICONE; LATE SEROMA; WOMEN; AUGMENTATION; RECONSTRUCTION; national legally binding central implant register; coalition agreement; early warning system; one-portal-solution; safety data; physician data; research data |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Mund-, Kiefer- und Gesichtschirurgie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 04 Apr 2019 07:29 |
| Last Modified: | 04 Apr 2019 07:29 |
| URI: | https://pred.uni-regensburg.de/id/eprint/3829 |
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