Difficult to prevent reuse of single use devices

Difficult to prevent reuse of single use devices. Need For Policy and Regulation. Er. Ajai Basil Consultant, Healthcare Technologies (Medical Devices) E-mail: ajaibasil@gmail. com Er. Ajai Basil-Radiation Safety in India 10/09/2020 1

• To reuse a single-use device without considering the consequences identified in this document could expose patients and staff to risks which outweigh the perceived benefits of using the devices. • Multiple use of single-use device affect safety, performance and effectiveness. Er. Ajai Basil-Radiation Safety in India 10/09/2020 2

Why hospital promote Reuse of Medical device • Health care organizations seeking cost savings by reprocessing • Environmental advantages • Costs of health care can be prohibitively unaffordable- LMIC Er. Ajai Basil-Radiation Safety in India 10/09/2020 3

• Hospital that reuse medical devices forgets anyone who reprocesses a single-use device and passes it to a separate legal entity (eg: an individual) for use, has the same legal obligations under the Medical Devices Regulations as the original manufacturer of the device. • No enforcement cases found on CDSCO or public domain on Hospital that reuse medical devices. • Post market or adverse event due to reprocessing? Responsibility of Manufacturer. Er. Ajai Basil-Radiation Safety in India 10/09/2020 4

Safety & Performance Issues • Device Design- Reprocessing & Validation • Potential for cross contamination • Production of residues from chemical decontamination • Material alteration • Mechanical failure • Reaction to endotoxins • Prion disease each device has unique challenges to cleaning and verification of cleanliness. Er. Ajai Basil-Radiation Safety in India 10/09/2020 5

Global Regulation • In the US, the FDA regulates which single-use devices can be reprocessed and has designated 70 such devices. • Health Canada stated that all commercial reprocessors that distribute devices to Canadian health care facilities would be required to meet the same regulatory requirements as the original manufacturer, regardless of whether they are reprocessed in Canada or outside Canada. • Australia required hospitals and third-party re-processors of single-use medical devices to conform to the same regulatory standards as the original manufacturer and to demonstrate that reprocessed devices are equally safe and perform as well as the original manufactured device EU, Middle east , other – Not legally recognized. Er. Ajai Basil-Radiation Safety in India 10/09/2020 6

Need for policy or regulation • India has no clear policy on hospital (both private and public) reusing medical devices. • No strong enforcement or previous reported enforcement to prevent reuse of medical devices. • Medical device rules 2017 - Not clear on legal obligation of reprocessing or reuse of medical devices with manufacturer or hospital. • Medical devices rules 2017 – Hospital that resale single use medical device –ISO 13485 -Schedule. Er. Ajai Basil-Radiation Safety in India 10/09/2020 7

Disclosure: No funding or grant received or any conflict of interest exist. Er. Ajai Basil-Radiation Safety in India 10/09/2020 8