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Packaging for medical devices such as endoscopes plays a key role in patient safety. A panel of experts recently addressed the issue in a webinar, “Single-use Endoscopes: Critical Safety and Regulatory Considerations for Manufacturers.”
Sponsored by Sterigenics and Nelson Labs, the webinar considered product and packaging design for single-use endoscopes, as well as microbiological testing and process validation approaches that ensure an appropriate sterility assurance level for packaged scopes.
Endoscopes are tubular instruments used to examine the inside of the body and, in some cases, aid in performing a biopsy or surgery. Single-use endoscopes have been available for more than 20 years, but their popularity has grown considerably in the past five years as costs have gone down and quality perceptions have improved.
Although single-use endoscopes create more waste than reusable endoscopes, the reusable instruments are much more likely cause hospital-acquired infections.
In 2022, the FDA issued a safety communication encouraging healthcare facilities to shift from reusable duodenoscopes to instruments that are either fully disposable or have disposable components. The goal of the guidance was to reduce contamination and the risk of infection.
Comparing single-use to reusable endoscopes, webinar speaker Grégory Grams, Sterigenics’ technical director, ethylene oxide (EO), for Europe, Middle East, Africa, and Asia (EMEAA), said the waste per 1,000 procedures is 1.3 tons for single-use endoscopes vs. 0.3 tons for reusable endoscopes.
However, the contamination risk level — patient risk of infection, that is — is 6% to 20% with reusable endoscopes vs. less than 0.5% for single-use endoscopes.
For reusable endoscopes “that are being reprocessed, there is no sterility assurance level,” Grams explained. “There is a bioburden reduction and disinfection, but we don’t have a sterility assurance level, and the [contamination] risk remains quite important” with these instruments.
In contrast, the EO sterilization process for single-use endoscopes can be validated, providing a sterility assurance level. EO does not degrade the endoscopes, has a good diffusion coefficient, and can be used to sterilize large volumes of endoscopes.
In addition to sterilization-process validation, packaging-materials validation is essential to ensure that pack materials perform well under harsh sterilizer conditions.
Packaging validation includes integrity tests, such as bubble emission and dye migration, as well as strength assessments, including burst and seal-strength testing. In addition, accelerated aging and real-time aging tests can provide shelf-life data for packaging materials.
Nelson Labs’ packaging validation matrix shows how various combinations of packaging materials perform on integrity and strength tests when subjected to EO and other sterilization methods. The matrix also shows microbial barrier options for the materials combinations, including microbial ranking and aerosol filtration (ASTM F2638).
Watch the on-demand webinar above.
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