STRUCTURAL PATIENT SAFETY FAILURES IN NON-MEDICAL AESTHETIC SETTINGS: EVIDENCE FROM A NATIONWIDE DERMAL FILLER INSPECTION PROGRAM IN SWITZERLAND TO INFORM RISK-BASED REGULATORY POLICY
Author(s)
Anita Kuduzovic, Master.
University of Geneva, Genève, Switzerland.
University of Geneva, Genève, Switzerland.
OBJECTIVES: To assess regulatory compliance in facilities performing dermal filler injections, such as hyaluronic acid, in Switzerland, compare cosmetic studios (CS) with medical practices (MP), and inform risk-based patient safety policies and regulatory oversight.
METHODS: We conducted a cross-sectional analysis of the 2024-2025 Swiss national dermal filler inspection campaign. A total of 163 facilities were included, comprising 121 CS and 42 MP; among these, 102 facilities used dermal fillers. MP served as reference category, except for confiscation (CS vs. MP). Full compliance required qualified practitioners, compliant medical devices, and adequate storage (restricted to facilities with complete data; n=82). Associations were assessed using chi-square or Fisher's exact tests (when expected counts <5), with odds ratios and Cramér's V as effect sizes. Seized-product counts were compared using the Mann-Whitney U test.
RESULTS: Full compliance was low (31.7% ; 26/82). Disparities by facility type were marked: 8.9% (4/45) of CS achieved full compliance compared with 59.5% (22/37) of MP (p<0.001; OR=15.03; 95% CI 4.45-50.85; Cramér's V=0.541). Practitioner qualification compliance was 17.2% in CS versus 97.4% in MP (p<0.001; OR=178.3; 95% CI 22.1-1440.9; Cramér's V=0.777). Storage non-compliance was also higher in CS (75.6% vs. 24.3% ; p<0.001; Cramér’s V=0.510). Medical device conformity was significantly lower in CS (50.0% vs. 73.7%; p=0.019; OR=2.80; 95% CI 1.17-6.70; Cramér's V=0.233). Confiscation rates were significantly higher in CS (46.9% vs. 13.2%; p<0.001; RR=3.56; 95% CI 1.51-8.40) and seized product volumes were also significantly higher in CS (Mann-Whitney U test, p=0.003).
CONCLUSIONS: These findings highlight substantial non-compliance in CS, particularly involving unqualified practitioners, posing preventable patient safety risks and avoidable healthcare costs. As inspected facilities were likely risk-selected, results reflect higher-risk settings rather than national prevalence estimates. Further research should explore social media monitoring to assess practitioner claims and support regulatory enforcement.
METHODS: We conducted a cross-sectional analysis of the 2024-2025 Swiss national dermal filler inspection campaign. A total of 163 facilities were included, comprising 121 CS and 42 MP; among these, 102 facilities used dermal fillers. MP served as reference category, except for confiscation (CS vs. MP). Full compliance required qualified practitioners, compliant medical devices, and adequate storage (restricted to facilities with complete data; n=82). Associations were assessed using chi-square or Fisher's exact tests (when expected counts <5), with odds ratios and Cramér's V as effect sizes. Seized-product counts were compared using the Mann-Whitney U test.
RESULTS: Full compliance was low (31.7% ; 26/82). Disparities by facility type were marked: 8.9% (4/45) of CS achieved full compliance compared with 59.5% (22/37) of MP (p<0.001; OR=15.03; 95% CI 4.45-50.85; Cramér's V=0.541). Practitioner qualification compliance was 17.2% in CS versus 97.4% in MP (p<0.001; OR=178.3; 95% CI 22.1-1440.9; Cramér's V=0.777). Storage non-compliance was also higher in CS (75.6% vs. 24.3% ; p<0.001; Cramér’s V=0.510). Medical device conformity was significantly lower in CS (50.0% vs. 73.7%; p=0.019; OR=2.80; 95% CI 1.17-6.70; Cramér's V=0.233). Confiscation rates were significantly higher in CS (46.9% vs. 13.2%; p<0.001; RR=3.56; 95% CI 1.51-8.40) and seized product volumes were also significantly higher in CS (Mann-Whitney U test, p=0.003).
CONCLUSIONS: These findings highlight substantial non-compliance in CS, particularly involving unqualified practitioners, posing preventable patient safety risks and avoidable healthcare costs. As inspected facilities were likely risk-selected, results reflect higher-risk settings rather than national prevalence estimates. Further research should explore social media monitoring to assess practitioner claims and support regulatory enforcement.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
EPH199
Topic
Epidemiology & Public Health, Health Policy & Regulatory, Real World Data & Information Systems
Topic Subcategory
Public Health
Disease
Sensory System Disorders (Ear, Eye, Dental, Skin)