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…
7.The external reprocessor shall report to the health institution any failure occurring during reprocessing that could indicate that the reprocessing cycle is no longer adequate or that the safety and performance of single-use devices already released for use cannot be guaranteed anymore. If failure occurs, adequate corrective and preventive measures shall be taken immediately. The health institution shall inform the competent authority accordingly and the public list referred to in Article 4(7) shall be updated.
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