Brigitte Tag

Safety of acupuncture: results of a prospective observational study with 229,230 patients and introduction of a medical information and consent form

Background: To evaluate the safety of acupuncture in a large number of patients receiving conventional health care and, based on these results, to develop a new medical consent form for acupuncture. Methods: The prospective observational study included patients who received acupuncture treatment for chronic osteoarthritis pain of the knee or hip, low back pain, neck pain or headache, allergic rhinitis, asthma, or dysmenorrhoea. After treatment, all patients documented adverse events associated with acupuncture (defined as adverse effects). Patients who reported a need for treatment due to an adverse effect completed an additional standardised questionnaire on the most important adverse effect. Based on this data and considering ethical and legal aspects a new consent form was developed. Results: A total of 229,230 patients received on average 10.2 ± 3.0 acupuncture treatments. Altogether, 19,726 patients (8.6%) reported experiencing at least one adverse effect and 4,963 (2.2%) reported one which required treatment. Common adverse effects were bleedings or haematoma (6.1% of patients, 58% of all adverse effects), pain (1.7%) and vegetative symptoms (0.7%). Two patients experienced a pneumothorax (one needed hospital treatment, the other observation only). The longest duration of a side effect was 180 days (nerve lesion of the lower limb). The resulting medical consent form consists of five modules: Introduction to acupuncture and moxibustion, Risks of acupuncture treatment, Conditions which can increase the risk, Doctor’s statement, and Consent. Conclusion: Acupuncture provided by physicians is a relatively safe treatment and the proposed consent form could support both patients and professionals in the process of obtaining informed consent.

Obduktionen in der Schweiz, Deutschland und Österreich

Significant reasons militate for the implementation of clinical autopsies: On the part of physicians and nurses, there is quality assurance, establishment of legal certainty regarding possible accusations of medical errors and development of treatment methods. On the part of patients and their relatives, there is consolation and relief in cases of unexpected death, insight into genetic dispositions and insurance law concerns, to name only a few. However, a continuing decrease of clinical autopsies can be observed in Switzerland, Germany and Austria. The thesis asserting that the often required informed consent of the deceased during his/her lifetime or of close relatives is a crucial reason for this decrease needs to be called into question due to recent studies. Mainsprings are rather structural reasons, such as the often deficient communication with the patient or close relatives, economic reasons, namely the frequently insufficient remuneration for the clinical autopsy, organizational causes, in particular the repeatedly encountered suboptimal collaboration between the individual departments and the pathology department, the high administrative effort and probably the decreasing appreciation of the clinical autopsy.

Verordnung über das Errichten, Betreiben und Anwenden von Medizinprodukten (Medizinprodukte- Betreiberverordnung – MPBetreibV) *

(1) Diese Verordnung gilt fur das Betreiben und Anwenden von Medizinprodukten im Sinne des Medizinproduktegesetzes einschlieslich der damit zusammenhangenden Tatigkeiten.

The role of skin self-examination at the Swiss skin cancer day

BackgroundThe rising incidence of melanoma - Switzerland has the highest incidence in Europe - is a major public health challenge. Swiss dermatologist introduced the “Swiss Skin Cancer Day” (SSCD) in 2006, which provides skin cancer screening at no costs. The aim of the study was to describe the participating subjects and their motivation and investigate factors influencing the probability of a clinical diagnosis of skin malignancy.Methods150 dermatologists were involved in the SSCD in May 2012. Dermatologists were not remunerated. Participants had the opportunity to show a single skin lesion to a dermatologist at no cost. A questionnaire for each participating subject collected data about subjects’ age, sex, risk factors and reason for encounter; furthermore the dermatologist noted down clinical diagnosis and further management. We used descriptive statistics to report characteristics of participants and skin lesions. We built two multiple logistic regression models, one regarding the clinical diagnosis of skin malignancy and one regarding the further management.Results5266 subjects (55.6% female) were assessed; in 308 (5.8%) participants a clinical diagnosis of skin malignancy was found. In 1732 participants (32.9%) a clinical follow up or an excision was recommended. In the multiple logistic regression model age, sex, skin phototype and the reason for participation at the SSCD were found as significant risk factors regarding the clinical diagnosis of skin malignancy. Participants with skin cancer risk factors were more likely to get a clinical follow up recommended even if the clinical diagnosis was benign.ConclusionA self-perceived suspicious lesion was the strongest predictor for a clinical diagnosis of skin malignancy at the SSCD. This suggests that skin self-examination might also work in general population. Future research should focus on better access to a specialist in case a suspicious skin lesion was discovered. Safety and quality of the SSCD should be further investigated, especially concerning the discrepancy between the low number of malignant lesions and the high quantity of participants where further clinical examinations or interventions were recommended.

HTA and its legal issues: a framework for identifying legal issues in health technology assessment.

OBJECTIVES Legal analysis can highlight important issues that are relevant when deciding whether a medical technology should be implemented or reimbursed. Literature and studies show that even though the law is an acknowledged part of health technology assessment (HTA), legal issues are rarely considered in practice. One reason for this may be the lack of knowledge about the diversity of legal issues that are relevant for HTA. Therefore, this contribution aims primarily to identify and then explain the relevant legal issues in HTA. This study offers a framework for identifying the legal issues in HTAs in different jurisdictions and provides a basis for further research. METHODS After extensive literature search, the authors review Swiss health law to identify legal issues that are relevant to HTA. The authors then categorize these legal issues using a framework with an inside and outside perspective. Finally, they explain a selection of these legal issues with several examples. RESULTS This study reveals numerous legal issues that are relevant for HTA and underlines the necessity of incorporating legal analysis in HTAs. The suggested perspectival framework in this study provides a basis to structure the legal analysis. The identified legal issues are relevant in other countries and the perspectival framework is transferable to other jurisdictions. CONCLUSIONS The article underlines the importance of in-depth discussion about the role of law in HTA. It provides a structured overview of the legal issues in HTA and suggests a development of more concrete instruments toward a standardized legal technology assessment.

Nichtanzeige geplanter Straftaten, unterlassene Hilfeleistung oder Freispruch?

Zahlreiche Brandanschläge auf Gebäude, die Menschen zum Wohnen dienen, beschäftigen seit einiger Zeit die Gerichte. Wie aber ist zu entscheiden, wenn eine Beteiligung an einer schweren Brandstiftung nicht nachgewiesen, der dringende Beteiligungsverdacht jedoch nicht ausgeräumt werden kann? In dem Beitrag wird dargelegt, daß der Verdacht der Beteiligung an der schweren Brandstiftung einer Katalogtat i. S. von § 138 StGB sowohl die Strafbarkeit wegen Nichtanzeige geplanter Straftaten als auch die wegen unterlassener Hilfeleistung sperrt.

Verordnung über die Erfassung, Bewertung und Abwehr von Risiken bei Medizinprodukten (Medizinprodukte-Sicherheitsplanverordnung - MPSV)

vom 24.06.2002 (BGBl. I S. 2131), die durch Artikel 4 der Verordnung vom. 27.09.2016 (BGBl. I 2203) geandert worden ist.

Richtlinie 90/385/EWG

vom 20. Juni 1990 zur Angleichung der Rechtsvorschriften der Mitgliedstaaten uber aktive implantierbare medizinische Gerate (ABl. L 189 vom 20.07.1990, S. 17) zuletzt geandert durch: Richtlinie 2007/47/EG des Europaischen Parlaments und des Rates vom 5. September 2007 (ABl. L 247 21.09.2007, S. 21).

Verordnung über Medizinprodukte (Medizinprodukte-Verordnung - MPV)

Vom 20. Dezember 2001 (BGBl. I S. 3854) Zuletzt geandert durch Art. 3 der Verordnung vom 27. September 2016. (BGBl. I S. 2203).

5 Verantwortlicher für das erstmalige Inverkehrbringen

Verantwortlicher fur das erstmalige Inverkehrbringen von Medizinprodukten ist der Hersteller oder sein Bevollmachtigter. Werden Medizinprodukte nicht unter der Verantwortung des Bevollmachtigten in den Europaischen Wirtschaftsraum eingefuhrt, ist der Einfuhrer Verantwortlicher. Der Name oder die Firma und die Anschrift des Verantwortlichen mussen in der Kennzeichnung oder Gebrauchsanweisung des Medizinproduktes enthalten sein.