On June 7, 2018, the U.S. Food & Drug Administration (FDA) announced the Agency’s recognition of the ISO 18562 series - Biocompatibility evaluation of breathing gas pathways in healthcare applications as FDA-CDRH Recognized Consensus Standards in the Federal Register.
Product submissions to the FDA for devices with breathing gas pathways may now leverage testing and declarations of conformity to the ISO 18562 series to speed product review. By testing products for chemical emissions into the breathing air stream, manufacturers can demonstrate that their products will not expose patients to toxic levels of chemicals that may cause harm. Although many of the materials used in respiratory devices may pose minimal risk when incorporated into products intended for general use, their inclusion in breathing gas pathway expands the scope of potential safety considerations and considerations can include:
- Breakdown or decomposition of device materials attributable to heat or wear during normal device operation or the migration of chemicals from internal device components into the patient breathing air path
- For components that handle humidified air, additional consideration is required for VOCs and heavy metals that may leach into condensate and then be inhaled by the patient
- For components in direct contact with external or internal human tissues, such as cannulas, breathing masks or intubation mechanisms, traditional biocompatibility assessments for extractables and leachables, sensitization, cytotoxicity, and irritation must still be considered.
The regulatory approval process for medical devices is complex and not always well defined. Most medical device premarket reviews conducted by the FDA fall under its 510(k) Premarket Notification program. In addition to the device description, equivalent devices, software, and performance testing information, the FDA 510(k) submission must include data regarding the biocompatibility of any patient contacting materials (directly or indirectly).
UL provides testing and exposure assessment according to the ISO 18562 guidelines for manufacturers to help ensure the safety of the patient airstream in many types of devices, patient interfaces, and accessories. The test methods and risk assessment requirements in these standards apply to all medical devices, parts, and accessories that may contact the breathing gas pathway. Products that should be tested include: ventilators, anesthesia workstations (including gas mixers), breathing systems, oxygen conserving equipment, oxygen concentrators, incubators, nebulisers, low pressure hoses, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, mouth pieces, resuscitators, breathing tubes, breathing systems filters and Y-pieces as well as many accessories.
UL also offers GREENGUARD Certification which provides a framework for managing compliance throughout the product lifecycle, including evaluation of material changes and process improvements. Medical devices with gas pathways that maintain GREEENGUARD Certification have been subject to third-party review and are better positioned to satisfy regulatory requirements regarding biocompatibility in the U.S., the European Union and other major medical markets.
For more information about testing to ISO 18562 visit: https://services.ul.com/service/iso-18562-voc-and-particle-testing-for-medical-devices/
For more information about GREENGUARD for Medical Devices, visit https://industries.ul.com/environment/certificationvalidation-marks/greenguard-certification-program
For any questions, please contact us at [email protected].