Contents
- 1. Health institutions using reprocessed single-use devices s…
- 2. The serious incident report shall contain the following in…
- 3. When the health institution sends the report referred to i…
- 4. Reprocessed single-use devices involved in a serious incid…
- 5. During investigation of the serious incident, devices of t…
- 6. The health institution shall request its staff and, where…
- 7. The external reprocessor shall report to the health instit…
- 8. The health institution shall register and compile informat…
8.The health institution shall register and compile information about all incidents involving reprocessed devices and shall perform, at least annually, a critical analysis of those incidents. The critical analysis of all incidents, including the analysis of the trends of incidents, shall be transmitted to the manufacturer and, if applicable, to the external reprocessor. Upon request, the critical analysis of all incidents, including the analysis of the trends of incidents shall be transmitted to the relevant competent authority. The analysis shall be used by the health institution, and if applicable, by the external reprocessor, to improve the reprocessing cycle, to review and update the technical documentation and/or to decide to discontinue reprocessing certain types of single-use devices.
Source: EUR-Lex, © European Union, 1998-2026. Reuse authorised under Decision 2011/833/EU.