| Title: | Screening for extractables in additive-manufactured acrylonitrile butadiene styrene orthopedic cast |
| Author(s): | Nahan K; Sussman EM; Oktem B; Schultheis L; Wickramasekara S; |
| Address: | "Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA. Fischell Department of Bioengineering, Robert E. Fischell Medical Device Institute, University of Maryland, 8278 Paint Branch Drive, College Park, MD, 20742, USA. Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA. Electronic address: Samanthi.Wickramasekara@fda.hhs.gov" |
| DOI: | 10.1016/j.talanta.2019.120464 |
| ISSN/ISBN: | 1873-3573 (Electronic) 0039-9140 (Linking) |
| Abstract: | "The use of additive-manufactured components in medical applications, specifically medical devices (e.g., orthopedic casts), has increased in recent years. Such devices may be fabricated at the point of care using consumer-grade additive manufacturing. Limited studies have been conducted to evaluate the extractable substances of these devices. Chemical characterization followed by toxicological risk assessment is one means of evaluating safety of devices. This study was designed to determine the extractables profile of additive-manufactured materials according to filament grade and post-processing method. Feedstocks for additive manufacturing were tested as filament and manufactured casts, while the cast from consumer-grade filament (CGF) was post-processed. Samples were extracted using three solvents of varying polarities. Extracts were analyzed by gas chromatography/mass spectrometry (GC/MS) and liquid chromatography/mass spectrometry (LC/MS) techniques. In GC/MS analysis, isopropanol extracts generated fewer compound identifications for USP Class VI filament (USPF)-based casts (3) compared with the respective filament (17) while hexane generated the most compound identifications for the finished cast manufactured from CGF. CGF was found to have the highest number of nonvolatile extractables for isopropanol (15) and hexane (34) by positive ion LC/MS. Additionally, CGF produced more non-polar extractables in hexane than the USPF. A known polymer byproduct and potential genotoxicant, styrene acrylonitrile (SAN) trimer, was one of the compounds identified in both GC/MS and LC/MS at quantities ranging from 19 to 270 mug g(-1). Overall these results suggested that the extractables profile was affected by the filament material, printing procedure, and post-processing method" |
| Keywords: | Acrylic Resins/*analysis Butadienes/*analysis *Orthopedic Equipment Polystyrenes/*analysis Solid Phase Extraction Volatile Organic Compounds/analysis 3D printing Acrylonitrile butadiene styrene (ABS) Additive manufacturing Chemical characterization Extrac; |
| Notes: | "MedlineNahan, Keaton Sussman, Eric M Oktem, Berk Schultheis, Lester Wickramasekara, Samanthi eng Netherlands 2020/03/03 Talanta. 2020 May 15; 212:120464. doi: 10.1016/j.talanta.2019.120464. Epub 2019 Oct 31" |
