The ASTM Committee F04.15.17 on Medical Device Cleaning recently held a workshop focused on the analysis of cleaning agents used for both new and reusable medical devices. The goal was to identify key topic areas requiring standardization to help ensure the development of safe, effective, and well-characterized products across the medical device industry.
The morning sessions opened with an overview of current standards for clinically used devices, such as endoscopes and surgical instruments, presented by Ralph Basile (Healthmark). Subsequent talks explored strategies for identifying manufacturing residues, addressing worst-case cleaning challenges, and defining product grouping considerations, with contributions from Ben Grosjean (Zimmer), Ramanthan Dhakshinamoorthy (Procept BioRobotics), and Sarah Frank (Johnson & Johnson).
Jeff Phillips (Alconox) and David Ruiz (Agilitti Health) led discussions on detergent composition and its impact on cleaning performance. Several presenters then examined analytical methods for evaluating cleaning agent residues, including:
- Analysis of volatile compounds by Brian Bosso (Steris)
- Spectroscopic techniques by Mayuri Kasareni (Intuitive Surgical)
- Chromatography methods by Stephen Spiegelberg, Mimoza Xheka, and Becky Bader (Cambridge Polymer Group)
Alex Freeman (Intuitive Surgical) and John Howell (Novonesis) discussed how cleaning agents interact with biological tissues, while Rob States (Cormica) presented case studies illustrating failure analyses linked to improper cleaning protocol implementation.
The workshop concluded with a panel discussion led by conference chairs Alpa Patel, Kaumudi Kulkarni, and Barbara Kanegsberg, summarizing key takeaways and identifying areas for future standardization work.
Key Insights and Next Steps
- Detergent efficacy testing: A standardized approach is needed to enable meaningful comparison of cleaning agent performance.
- Unknown composition risks: Common test methods and risk assessment frameworks should be developed to address cleaning agents with partially disclosed or proprietary formulations.
- Healthcare facility engagement: Greater collaboration with healthcare providers is essential to ensure that clinical cleaning processes meet appropriate standards. Currently, most healthcare facilities are not involved in ASTM or ISO initiatives focused on cleaning and are not subject to FDA regulation in this area. The committee plans to explore ways to involve this community more directly in future standardization efforts.