Report on investigation of ISO 10993-12 extraction conditions.

The international standard ISO 10993-12 describes extraction conditions for generating extracts of medical devices to be used in testing of biological safety. Questions about the adequacy of the extraction conditions (and their variations) for hazard identification drove the development and execution of a round robin study. Four relevant device materials were each evaluated by four laboratories following an established protocol that specified multiple options of extraction solvent, temperature, duration, and ratio of solvent volume to quantity of test article. The resulting samples were analysed by three instrumental methods to identify and quantify extracted organic and elemental substances; however, quantification was not achieved due to lab resource constraints, and only numbers of compounds were reported. Results showed an increased number of volatile organic compounds extracted with organic solvents; however, no clear effect of varying the other extraction parameters could be discerned. Quantification of a small subset of analytes showed sensitivity that may be adequate for hazard identification. An unplanned post hoc comparison of results across labs showed differing numbers of compounds detected; however, fundamental differences in sample preparation and specific analysis methods as well as lack of quantification render the results poorly suited to either exonerate or indict the adequacy of chemical characterization as practiced by the participating laboratories.

Advancing medical device innovation through collaboration and coordination of structured data capture pilots: Report from the Medical Device Epidemiology Network (MDEpiNet) Specific, Measurable, Achievable, Results-Oriented, Time Bound (SMART) Think Tank.

The Medical Device Epidemiology Network (MDEpiNet) is a public private partnership (PPP) that provides a platform for collaboration on medical device evaluation and depth of expertise for supporting pilots to capture, exchange and use device information for improving device safety and protecting public health. The MDEpiNet SMART Think Tank, held in February, 2013, sought to engage expert stakeholders who were committed to improving the capture of device data, including Unique Device Identification (UDI), in key electronic health information. Prior to the Think Tank there was limited collaboration among stakeholders beyond a few single health care organizations engaged in electronic capture and exchange of device data. The Think Tank resulted in what has become two sustainable multi-stakeholder device data capture initiatives, BUILD and VANGUARD. These initiatives continue to mature within the MDEpiNet PPP structure and are well aligned with the goals outlined in recent FDA-initiated National Medical Device Planning Board and Medical Device Registry Task Force white papers as well as the vision for the National Evaluation System for health Technology.%.