Identification of emerging safety and sustainability issues of advanced materials: Proposal for a systematic approach.

The EU Chemicals Strategy for Sustainability is a first step to achieve the Green Deal ambition for a toxic-free environment, and ensure that chemicals are produced and used in a way that maximises their contribution to society while avoiding harm to our planet and to future generations. Advanced materials are predicted to play a pivotal role in achieving this ambition and the underlying sustainability goals, and considerable efforts are invested in designing new classes of materials. Examples of such materials are metamaterials, artificially architectured materials designed to have material properties beyond those of the individual ingredient materials, or active materials at the boundary between materials and devices (e.g., new biomedical soft materials). Such innovative advanced materials raise concern about possible future safety and sustainability issues and would benefit from appropriate risk governance that promotes innovation, while pushing for safety and sustainability. To balance these aspects, a methodology is proposed for the early-stage identification of emerging safety and sustainability issues of advanced materials. As exemplified by two case studies, the methodology aims to be of use for innovators, risk assessors, and regulators. Extension of the methodology is highlighted, as well as implementation in broader initiatives like the EU's industrial policy approach.

The risk of blood exposure incidents in dental practices in the Netherlands.

OBJECTIVES: An awareness of the risk of blood-borne infections among dentists has been promoted by the Dutch Dental Association (NMT) as part of their quality and safety programme, and a nationally operating expert counselling centre was contracted to manage all reported incidents. METHODS: We analysed data on hepatitis B vaccination status, sex and age for all reported incidents recorded by this centre during 2008. We compared this with data collected at same time during a national survey to assess the performance of the centre. The number of blood exposure injuries among dentists and their assistants, and reporting behaviour, were also assessed. RESULTS: In 2008, 387 incidents were reported to the counselling centre. The percentage of high-risk incidents was 16, with a risk of hepatitis B, hepatitis C and HIV infections. In the hepatitis B cases, 12% had no or insufficient immunization. Eight per cent of those injured were unable to start HIV Post-Exposition Prophylaxis because they reported too late. Of the 1442 surveys sent, 487 (34%) were returned. Dentists estimated levels of hepatitis B vaccination at 98%. Thirty-two per cent reported to have had one or more injuries in their practice in 2008. Of these, 37% were counselled by the expert centre, 18% were counselled by others and 45% sought no medical attention. The performance of the counselling centre received a positive score (95%). A need for more information about vaccination and blood-borne infections in dentistry (52%) was reported. CONCLUSIONS: Nationwide data show blood exposure incidents occur frequently in dental settings, with a considerable number of high-risk incidents. Administering anaesthetics and cleaning-up are major risk factors. There is a need to intensify measures for safe working conditions in dental care settings in the Netherlands, irrespective of the type of dental practice.

Does evidence permeate all surgical areas equally? Publication trends in wound care compared to breast cancer care: a longitudinal trend analysis.

BACKGROUND: Evidence-based decision making has permeated the daily practice of healthcare professionals. However, in wound care this seems more difficult than in other medical areas, such as breast cancer, which has a similar incidence, variety of etiologies, financial burden, and diversity of treatment options. This incongruence could be due to a lack in quantity and quality of available evidence. We therefore compared worldwide publication trends to answer whether research in wound care lags behind that in breast cancer. METHODS: In order to assess the trends in quantity and methodological quality of publications as to wound care and breast cancer treatments, we examined relevant publications over the last five decades. Publications in MEDLINE were classified into seven study design categories: (1) guidelines, (2) systematic reviews (SR), (3) randomized (RCT), and controlled clinical trials (CCT), (4) cohort studies, (5) case-control studies, (6) case series and case reports, and (7) other publications. RESULTS: We found a 30-fold rise in publications on wound care, versus a 70-fold increase in those on breast cancer. High-quality study designs like SR, RCT, or CCT were less frequent in wound care (difference 1.9, 95 % CI 1.8-2.0 %) as were guidelines; 76 on wound care versus 231 for breast cancer. CONCLUSIONS: Publications on wound care fall behind in quantity and quality as compared to breast cancer. Nevertheless, SR, RCT, and CCT in wound care are becoming more numerous. These high-quality study designs could motivate clinicians to make evidence-based decisions and researchers to perform proper research in wound care.

The use of complementary alternative medicine (CAM) in 1 001 German adults: results of a population-based telephone survey.

AIM OF THE STUDY: The objective of this study was to evaluate the patterns of use of complementary alternative medicine (CAM) in a representative adult population in Germany. METHODS: A population-based telephone survey was conducted in Lübeck, Germany. We performed computer-assisted telephone interviews (CATI) in order to obtain information on demographics, health status, prevalence of CAM usage, motivation for using CAM, type of CAM and health problems for which CAM were used. RESULTS: 1,001 adults (median age 48 years) participated in the study (response 46.8%). 79.6% of the interviewed subjects reported health problems. The most frequently named problems were chronic pain (45.3%), circulation problems (32.9%) and colds with fever (27.8%). Non-users of CAM had a lower incidence (76.6%) of overall illness than users (83.5%) (OR 0.65, 0.47-0.89). 42.3% of the participants had used CAM. The CAM user group consisted of significantly more females (72.8 vs. 55.5%) (OR 2.32, 1.74-3.08) and involved better educated subjects (school education >12 years, 36.6 vs. 27.9%, OR 3.25, 1.35-7.81) than the non-user group. The main health problems for which CAM was used were chronic pain (36.3%), some cases of uncomplicated colds (16.9%) and for improving general health (14.7%). Three procedures accounted for the majority of usage: Acupuncture (34.5%), homeopathy (27.3%) and herbal medicine (9.7%). A large number of participants reported as the main reason for using CAM the wish to avoid drugs as much as possible (31.7%). 26.7% reported opting for CAM due to the recommendation of their physician. 23.9% gave unsatisfactory results of conventional medicine as reason for CAM usage. CONCLUSIONS: CAM is used widely for different complaints by the general population. This frequent use of CAM has implications for the health-care system and health policy.

Assessing reasonable worst-case full-shift exposure levels from data of variable quality.

Exposure assessors involved in regulatory risk assessments often need to estimate a reasonable worst-case full-shift exposure level from very limited exposure information. Full-shift exposure data of very high quality are rare. A full-shift value can also be calculated from (short term) task-based values, either derived from measured data or from models. The most simple option is to use the task based exposure levels as the full-shift value. A second option is to calculate a time-weighted average (TWA), using (reasonable worst case) estimates of the duration and the exposure level of the relevant tasks. The third option is to use a Monte Carlo analysis with estimated input distributions for exposure level and duration of exposure. If an estimated distribution of respiratory volume is also included, this leads to a distribution of inhaled amounts. The 90th percentile of such a distribution is generally substantially lower than the fixed point estimates calculated using high end values for each parameter. This technique can thus prevent unnecessary conservative estimates in risk assessment. The output distribution can also be used as valuable input to the risk management process, because it provides information on probabilities of exposure levels, that can influence the cost-benefit analysis of the risk management process. Finally, the sensitivity analysis of Monte Carlo simulation can give guidance for further studies to increase the accuracy of the exposure assessment.