Decontamination services by an outside provider which is not part of the parent organisation should have the following:
- ISO13485 as a legal requirement.
- a clear contract identifying a service level agreement between the two organisations, in line with HTM 01-06 requirements
- leadership for decontamination services, linking directly to the point of delivery for the endoscopes
- an in-year IHHEM audit as carried out by the AED
- an in-year IPS audit (www.ips.uk.net/professional-practice/quality-improvement-tools1/) carried out in conjunction with an infection prevention team
- clear policies, protocols and training for staff involved in the endoscope journey
- at the site assessment, evidence of safe handling, transportation and storage of endoscopes from the point at which the endoscope enters the organisation to when it leaves it, including evidence of robust tracking and traceability and adherence to the 3 hour rule.