Derivation of no significant risk levels for three lower acrylates: Conclusions and recommendations from an expert panel.

A panel of toxicology, mode of action (MOA), and cancer risk assessment experts was engaged to derive no-significant-risk-levels (NSRLs) for three lower acrylates: methyl acrylate (MA), ethyl acrylate (EA), and 2-ethylhexyl acrylate (2EHA) using the best available science, data, and methods. The review was structured as a five-round, modified Delphi format, a systematic process for collecting independent and deliberative input from panel members, and it included several procedural elements to reduce potential sources of bias and groupthink. Input from the panel for key decisions in the dose-response assessments resulted in NSRL values of 530 µg/day (330-800 µg/day), 640 µg/day (280-670 µg/day), and 1700 µg/day (1300-2700 µg/day) for MA, EA, and 2EHA, respectively. Novel to this approach were the use of nonneoplastic lesions reported at point of contact where tumors have been reported in laboratory rodents, along with nonlinear extrapolation to low doses (uncertainty factor approach) based upon panel recommendations. Confidence in these values is considered medium to high for exposures applied to the routes of exposure tested (inhalation for MA and EA, dermal for 2EHA), but confidence is considered lower when applied to other routes of exposure.

Cost-effectiveness of a new multi-lumen infusion device to reduce central venous line-associated bloodstream infections in neonates.

BACKGROUND: A new medical device was developed for multi-infusion in neonatal intensive care units (NICUs) with the aim to address issues related to drug incompatibilities and central line-associated bloodstream infections (CLABSI). AIM: To assess the cost-effectiveness of implementing this new perfusion system in a NICU setting. METHODS: We conducted a single-centre, observational study in all infants admitted to the NICU within the first 3 days after birth and who required central-venous line, to evaluate the cost and effectiveness before (Year 2019) and after (Year 2020) the implementation of the new perfusion system. We calculated the costs from the hospital perspective, and we examined the incidence of CLABSI, over a time horizon spanning from admission to NICU discharge. We measured the resource utilisation (infusion medical device, infection treating drugs and biological analyses), and valued corresponding costs using tariffs for year 2019. We calculated incremental cost-effectiveness ratio (ICER) expressed as euros per CLABSI avoided, and conducted one-way and multivariate sensitivity analyses. FINDINGS: Among 609 infants selected, clinical characteristics were similar across both periods. The CLABSI rate significantly decreased (rate ratio: 0.22; IC95% [0.07-0.56]), and total costs were reduced (from €65,666 to €63,932 per 1000 catheter days respectively; p<0.001), yielding to an ICER of €251 saved per CLABSI avoided. The majority of sensitivity analyses showed the new intervention remaining economically dominant. CONCLUSION: This single-centre study showed a significant decrease in the incidence of CLABSI without incurring additional costs. Further prospective multicentre randomised studies are needed to confirm these results in other NICU.