How sensitive does chemical characterization of medical devices need to be? Calibration of analytical evaluation thresholds with the carcinogenic potency database.

Chemical characterization is a component of the safety evaluation of medical devices. An analytical evaluation threshold (AET) is recommended to calculate the required analytical sensitivity. There is a lack of consensus whether to use 1.5 or 120 µg/day in calculating the AET with the lower value often requiring sensitivities beyond analytical capabilities. The Carcinogenic Potency Database (CPDB) was reviewed to compare risks associated with using either value to calculate an AET. The TD50s for non-Cohort of Concern (non-COC) substances in the CPDB were used to extrapolate the doses to an excess cancer risk of 10-5 and calculate the total doses. The number of non-COC substances that would exceed this risk using an AET calculated using 1.5 µg/day or 120 µg/day were then compared. From the 199 substances evaluated, only two posed an excess risk at an AET calculated with 1.5 µg/day and only seven more with 120 µg/day. Furthermore, over 95 percent of non-COC substances would not pose an excess cancer risk using an AET calculated with 120 µg/day. Based on our evaluation, an AET based on 120 µg/day is protective and practical for chemical characterization of short and long-term medical devices.

A Critical Review of a Recommended Analytical and Classification Approach for Organic Fluorinated Compounds with an Emphasis on Per- and Polyfluoroalkyl Substances.

Organic fluorinated compounds have been detected in various environmental media and biota. Some of these compounds are regulated locally (e.g., perfluorononanoic acid maximum contaminant level in drinking water by the New Jersey Dept. of Environmental Protection), nationally (e.g., perfluorooctanoic acid maximum acceptable concentration in drinking water by Health Canada), or internationally (e.g., Stockholm Convention on Persistent Organic Pollutants). Globally, regulators and researchers seek to identify the organic fluorinated compounds associated with potential adverse effects, bioaccumulation, mobility, and persistence to manage their risks, and, to understand the beneficial attributes they bring to products such as first responder gear, etc. Clarity is needed to determine the best analytical method for the goal of the analyses (e.g., pure research or analysis to determine the extent of an accidental release, monitoring groundwater for specific compounds to determine regulatory compliance, and establish baseline levels in a river of organic fluorinated substances associated with human health risk prior to a clean-up effort). Analytical techniques that identify organic fluorine coupled together with targeted chemical analysis will yield information sufficient to identify public health or environmental hazards. Integr Environ Assess Manag 2021;17:331-351. © 2020. W.L. Gore & Associates Inc. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC).