Information Gaps in Medical-Device Materials
Deconstructing Devices field work in action with Millie Marriott Webb.
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At HSS 2026, Millie Marriott Webb presented research on gaps in the information available about materials used in medical devices as part of Plastic Amnesias II, chaired by Anne Kveim Lie.
The presentation examined ISO 13485 and ISO 10993, the international standards developed during the 1990s which govern quality management and biocompatibility for medical devices. The standards require manufacturers to test medical plastics for biocompatibility and maintain detailed records about components, materials and suppliers so that faults can be identified and devices recalled. However, the regulatory system is less able to capture harms that emerge slowly, during manufacturing or after disposal.
Marriott Webb considered why material information recorded by manufacturers remains difficult to access, even though it could help identify harmful plastics and question misplaced assumptions of safety. With technologies such as digital product passports now making greater transparency possible, the presentation asked what institutional barriers continue to prevent this knowledge from supporting patient safety, repair and material recovery.
