Audit Decontamination Standards in Sterile Services Departments

Sterilization and decontamination of instruments and medical devices play a very important role in the prevention of HAIs.

Indeed, defective sterilization of surgical instruments and disinfection of reusable objects including endoscopic devices, respiratory care devices, and reusable haemodialysis devices still occur in many settings and lead to HAIs.
This audit is designed to provide oversight of the management and decontamination of invasive devices in the organisation, facilitate identification of risks and track non compliances through to closure.

This Audit system has been developed for the regular audit and assessment of infection control standards and decontamination standards in Endoscopy Units

Using Medical Audits Decontamination Audit system you can audit practice against the most up to date decontamination standards as well as best practice guidelines for Infection Prevention and control in endoscopy units.

The decontamination audit system has been designed to assist identification of risks and training requirements, assess practice in relation to safe management of reusable invasive medical devices and evidence your compliance with relevant endoscopy unit standards.

Specifically designed for auditing decontamination Standards in hospitals and Central Decontamination Units, this audit system includes:
✔ Role of decontamination officer
✔ Infection Control oversight of decontamination processes
✔ Standards for endoscopy unit layout
✔ Standards for Central Decontamination Unit layout
✔ Management of reusable invasive devices across the facility
✔ Cleaning of reusable invasive medical devices
✔ Disinfection and sterilisation of medical devices
✔ Traceability standards for medical devices
✔ Staff training and education
✔ Maintenance of washer /disinfectors and autoclaves
✔ Monitoring compliance in clinical and procedure rooms

Decontamination of Reusable Invasive medical Devices (RIMD)

The term Invasive medical device is used to describe any item that penetrates the patient’s skin or body cavities. Depending on the cavity penetrated (e.g. mouth, rectum, surgical incision) the devices need to be either single use or if reusable, capable of being cleaned and then either sterilised or treated to high level disinfection.

Most surgical instruments are classed as “critical devices” as they come into contact with sterile body cavities and tissues during use and so they require sterilisation prior to reuse.

Unlike endoscopes they are rarely heat labile and the most common form of sterilisation used is autoclaving.

Best practice standards also recommend these devices and other reusable invasive medical devices such as endoscopes are tracked from patient through cleaning, disinfection and sterilisation processes and on to the next patient.


Best Practice In Management Of Reusable Invasive Medical Devices

The organisation should have a named decontamination Officer with the training and expertise to monitor decontamination services in the organisation.

This may be the Endoscopy manager, Central decontamination unit manager or a separate person with responsibility and oversite of both departments.

A decontamination committee should be in place with representation from senior management, infection prevention, microbiology, operating theatre and decontamination unit staff at a minimum.

Decontamination Standards in Hospitals

The organisation should carry out regular audits of the Central Decontamination Unit and Endoscopy unit to ensure standards are met and to identify any risks in either processing or management of invasive medical devices.

The audits should be carried out using an audit based on the most up to date best practice standards and guidelines.

All the relevant stages of the decontamination life cycle of reusable invasive medical devices should be included in the audit process to ensure compliance with best practice.

This includes reviews during any Healthcare Associated Infection incident or outbreak involving reusable invasive medical devices.

Action is taken to address any areas identified for improvement

Decontamination Standards – NHS and HSE Hospitals

This audit was designed with reference to the most up to date guidelines and has been prepared with reference to:-

  • Health Service Executive Standards and Recommended Practices for Central Decontamination Units (HSE, 2011)
  • Health Technical Memorandum 01-01: Management and decontamination of surgical instruments (medical devices) used in acute care (2016)
  • ISO 13485 -2016 Quality management system for monitoring Standards for management of reusable invasive medical devices

All our audit systems are based on best practice standards and guidelines.

They are developed in consultation with Infection Prevention experts and reference the following standards and guidance:-
✔ High Impact Interventions (NHS Improvement & IPS, 2017).
✔ Health Information and Quality Authority (HIQA) National Standards for the prevention and control of healthcare-associated infections in acute healthcare services (2017).
✔ Standard Infection Control Precautions (SIPCs) (Health Protection Scotland 2016).
✔ Code of Practice for Decontamination of Reusable Invasive Medical Devices (HSE,2012)
✔ EPIC 3 Guidelines on prevention of HCAI in England (2012).

Medical Audits Auditing and Quality Assurance Systems Provide the Technology Systems for Monitoring Infection Prevention Standards across all areas of healthcare

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Health Service Executive Code Of Practice For Decontamination Of Reusable Invasive Medical Devices
Health Technical Memorandum 01-06: Decontamination Of Flexible Endoscopes
Health Technical Memorandum 01-01: Management And Decontamination Of Surgical Instruments (Medical Devices) Used In Acute Care
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