Different regulatory framework for medical devices and drugs in the European Union: Impact on clinical research and health technology assessments.

OBJECTIVES: Understanding whether the regulatory framework in the European Union creates different standards for medical devices and drugs, assessing whether there is evidence on the impact of those standards on clinical and HTA research, and reflecting on findings in order to propose legislative changes for promoting a more efficient allocation of resources in the healthcare systems. METHODS: Reviewing and comparing the legal framework for the approval of medical devices and drugs in the EU, with a particular focus on the changes brought by Regulation (EU) 2017/745. Investigating the available information on manufacturer sponsored clinical studies and HTA-supported recommendations for medical devices and drugs. RESULTS: The review of the legislation identified different standards for approval of devices and drugs on their quality, safety, and performance/efficacy dimensions and fewer manufacturer sponsored clinical studies and HTA-supported recommendations for medical devices versus drugs. CONCLUSIONS: Policy changes could be implemented in order to promote an integrated evidence-based assessment system for a better allocation of resources in healthcare, namely: a consensual classification of medical devices from an HTA perspective, which could be used as a guide for generating outcomes in clinical investigation, and the adoption of conditional coverage practices including mandatory post-approval evidence development for performing periodic technology assessments.

Use of a Bipolar Device (LigaSure) to Seal the Appendiceal Stump in Pediatric Laparoscopic Appendectomy: 10-year Latin-American Experience.

BACKGROUND: Closure of the appendiceal stump is a critical step during an appendectomy. There is a lack of knowledge about the feasibility of using electrosurgical devices for the occlusion of the appendix. This study aims to determine the safety of this technique in pediatric patients. METHODS: We performed a cross-sectional analytical study in patients less than 18 years of age treated at Hospital Militar Central Colombia between 2012 and 2021. Our institution's ethics committee approved the study. We analyzed the data using SPSS 22 statistical program. We present frequencies for qualitative variables and measures of central tendency or dispersion for quantitative variables depending on the distribution measured by the Kolmogorov-Smirnov test. In addition, we measured the association of nominal variables with the Chi-square test or Fisher's exact test. For numerical variables, the difference of means with the Student's t-test or the difference of medians with the Mann-Whitney U test. RESULTS: We treated 209 patients. One hundred sixteen (55.5%) were boys, and the mean age was 9.7 years (SD 3.2). The median intraoperative time was 60 min, and the hospital stay was 2.8 days on average. There were no cases of stump leakage, and only two patients (1%) had an organ-space surgical site infection, which was unrelated to the closure technique. We found no association between procedural complications and appendicular status (p = 0.450). CONCLUSIONS: Our research suggests that using a bipolar sealing device (Ligasure, Medtronic, USA) for appendiceal stump closure in pediatric patients undergoing laparoscopic appendectomy is feasible and should be further studied. TYPE OF STUDY: Treatment study. LEVEL OF EVIDENCE: Level III.

Titanium dioxide nanotubes added to glass ionomer cements affect S. mutans viability and mechanisms of virulence.

This in vitro study evaluated the impact of TiO2 nanotubes (n-TiO2) incorporated into glass ionomer cement (GIC) on Streptococcus mutans (S. mutans) characteristics at cellular and molecular levels. n-TiO2, synthesized by the alkaline method (20 nm in size), was added to Ketac Molar EasyMix® at 0%, 3%, 5%, and 7% by weight. S. mutans strains were cultured on GIC disks with addition or not of n-TiO2 for 1, 3, and 7 days and the following parameters were assessed: inhibition halo (mm) (n=3/group); cell viability (live/dead) (n=5/group); cell morphology (SEM) (n=3/group); and gene expression by real-time PCR (vicR, covR, gtfB, gtfC, and gtfD) (n=6/group). The data were analyzed by the Kruskal-Wallis test, repeated-measures ANOVA or two-way ANOVA, and Tukey's and Dunn's post-hoc tests (α=0.05). The agar diffusion test showed a higher antibacterial property for 5% n-TiO2 compared with 3% and 7% (p<0.05) with no effect of time (1, 3, and 7 days). The cell number was significantly affected by all n-TiO2 groups, while viability was mostly affected by 3% and 5% n-TiO2, which also affected cell morphology and organization. Real-time PCR demonstrated that n-TiO2 reduced the expression of covR when compared with GIC with no n-TiO2 (p<0.05), with no effect of time, except for 3% n-TiO2 on vicR expression. Within-group and between-group analyses revealed n-TiO2 did not affect mRNA levels of gtfB, gtfC, and gtfD (p>0.05). Incorporation of n-TiO2 at 3% and 5% potentially affected S. mutans viability and the expression of key genes for bacterial survival and growth, improving the anticariogenic properties of GIC.

Titanium dioxide nanotubes added to glass ionomer cements affect S. mutans viability and mechanisms of virulence

Abstract This in vitro study evaluated the impact of TiO2 nanotubes (n-TiO2) incorporated into glass ionomer cement (GIC) on Streptococcus mutans (S. mutans) characteristics at cellular and molecular levels. n-TiO2, synthesized by the alkaline method (20 nm in size), was added to Ketac Molar EasyMix® at 0%, 3%, 5%, and 7% by weight. S. mutans strains were cultured on GIC disks with addition or not of n-TiO2 for 1, 3, and 7 days and the following parameters were assessed: inhibition halo (mm) (n=3/group); cell viability (live/dead) (n=5/group); cell morphology (SEM) (n=3/group); and gene expression by real-time PCR (vicR, covR, gtfB, gtfC, and gtfD) (n=6/group). The data were analyzed by the Kruskal-Wallis test, repeated-measures ANOVA or two-way ANOVA, and Tukey's and Dunn's post-hoc tests (α=0.05). The agar diffusion test showed a higher antibacterial property for 5% n-TiO2 compared with 3% and 7% (p<0.05) with no effect of time (1, 3, and 7 days). The cell number was significantly affected by all n-TiO2 groups, while viability was mostly affected by 3% and 5% n-TiO2, which also affected cell morphology and organization. Real-time PCR demonstrated that n-TiO2 reduced the expression of covR when compared with GIC with no n-TiO2 (p<0.05), with no effect of time, except for 3% n-TiO2 on vicR expression. Within-group and between-group analyses revealed n-TiO2 did not affect mRNA levels of gtfB, gtfC, and gtfD (p>0.05). Incorporation of n-TiO2 at 3% and 5% potentially affected S. mutans viability and the expression of key genes for bacterial survival and growth, improving the anticariogenic properties of GIC.