Conference Agenda

The ISO 14801 standard test is repeatedly criticized for not reflecting the actual conditions and loads realistically enough to which dental implants are exposed (e.g. during chewing).

The aim of this paper is to provide a brief review of the test parameters of the ISO standard and to compare them critically with the parameters that prevail in vivo.

The research revealed significant simplifications of the test conditions, which can partly be justified with better reproducibility and comparability. Nevertheless, the realization remains that the test deviates considerably from real physiological loading conditions and should be adapted accordingly or supplemented by further tests.

Functionality of state-of-the-art medical devices often depends on high-end materials. Today, a large spectrum of medical devices like heart valves, vascular grafts, sutures or endoscopic devices consist of or incorporate fluoropolymers like polytetrafluoroethylene (PTFE). Fluoropolymers offer unique mechanical, electrical and chemical properties. Based on their chemical constitution, fluoropolymers are assigned to the group of per- and polyfluorinated substances (PFAS). The aim of the current restriction proposal within Europe (EU) is to limit and/or fully ban the persistent PFAS substances known as forever chemicals. The restriction proposal concerns all PFAS substances beyond further subdividing and evaluating their hazardous potential and with just short-term derogations depending on the application.

The consequences of the impending restriction proposal on PFAS is shown from a medical device industry viewpoint. Literature data on annual material consumption and supply chain are collected and evaluated, especially pointing to future problems assuming an entry into force of the pending restriction proposal. Furthermore, the short derogation times are contextualized with current timelines of Medical Device Reg-ulation (MDR) approval processes to highlight the impact on product availability assuming a PFAS ban. Selected examples of affected products illustrate, how patient treatment options are limited by the PFAS restriction.

It can be clearly shown that the PFAS restriction will crit-ically affect the medical device sector through collapsed sup-ply chain and insufficient derogation times for product approvals, thus limiting the availability of medical products and set-ting back the gold standards in medical treatment.

Fatigue behaviour is a crucial aspect of mandatory mechanical tests for regulatory purposes, aimed at determining the load at which the bone plate withstands under a specific number of cycles, known as the runout condition. However, current test standards, such as ASTM F382, provide setup configurations without explicit guidelines on required fatigue strength. The determination of the minimum level of in vivo performance that the plate must fulfil remains an open issue, which is frequently addressed by the direct comparison with predicate devices. To address this gap, this study proposes an in silico framework to estimate maximum stress on implanted femoral plates for comparison with four-point bending tests described in the ASTM standard, deriving appropriate safety factors. As case studies, three femoral plates were assessed, and results showed safety factors above 1.4, indicating the reliability of the implanted plates.

Patient-reported outcomes (PROs) are used in clinical trials to provide valuable evidence on the impact of treatment on patients’ symptoms, function and quality of life. High-quality PRO data from trials can inform shared decision-making, regulatory and economic analyses and health policy. The heterogeneity between the patient groups and the associated differences in morbidity and quality of life can be taken into account by standardization to the general population. As a result, our study shows that despite the retrospective design with the corresponding level of evidence, mesh repair of a ventral hernia leads to an equivalent result compared to tissue hernia surgery.