Authorising Engineer (Decontamination)
Keith Shuttleworth MIHEEM has been an Authorised Person (Sterilizers) and subsequently an AE (D) from the commencement of the IHEEM Register in 1995. His background has been as an Engineering Manager in both the NHS and the Pharmaceutical industry. He has worked with sterilization and other decontamination disciplines in a number of capacities, from a Service Provider to a User. More information about his background and experience is available on his LinkedIn Profile.
Keith has considerable experience in working with Clean Room environments (down to ISO 14644-1 Class 4) and High Purity Water systems in the Pharmaceutical, Medical Devices and Healthcare industries i.e. HTM 2030, Purified Water, Water for Irrigation and Water for Injection. He has been involved variously, with the design, construction, commissioning, validation and Project Management of a number of new or upgraded Pharmaceutical, Decontamination and Endoscopy facilities.
Also, Keith is used to working in strictly regulated environments with a range of different provides a proactive and responsive service and works closely with other professionals. Keith is Member of IHEEM, an Associate Member of the IDSC and the Central Sterilising Club in addition to organisations associated with the pharmaceutical industry.
Keith provides both contracted and ad hoc services to deal with specific challenges. Contact us for further infomation.
* The Authorising Engineer Foundation Programme Level 3 Course covered the following elements:
Unit 1. Health Organisation and organisations
Unit 2. Roles, duties and responsibilities of CPs, APs and AEs
Unit 3. Safety Culture
Unit 4. Health And Safety at Work
Unit 5. Authorising Engineers and the law
Unit 6. The principles and practice of Audit
Unit 7. Incident investigation and root cause analysis
Unit 8. Confidentiality and discretion
Unit 9. Records and record keeping
Unit 10. Principles of behavioural interviewing
Unit 11. Feedback and reporting Unit 12. Assessing competence
Unit 13. Mentoring skills
Role of the AE(D)
This role has been developed from the prior Authorised Person (sterilizer) arrangements.
This person should be fully independent of the organisation’s structure for maintenance, testing and management of the decontamination equipment.
The AE(D) should have a reporting route to the Decontamination Lead and should provide
professional and technical advice to AP(D)s, CP(D)s, Users and other key personnel involved in the control of decontamination processes.
The Institution of Healthcare Engineering and Estates Management (IHEEM) sets professional standards for their voluntary registration and for the accreditation of training courses, as has been the case for the existing AP(S) role. The Department of Health, and where applicable the relevant health estates bodies in the devolved administrations, set the technical standards asrelevant.
The principal services provided by AE(D) services are as follows:
- To provide to Management and others, general and impartial advice on all matters concerned with decontamination
- To advise Management and others on programmes of validation
- To audit reports on validation, revalidation and yearly tests submitted by the AP(D)
- To advise Management and others on programmes of periodic tests and periodic maintenance
- To advise Management and others on operational procedures for routine production
- To advise Management on the appointment of the AP(D)
- To audit the permit to work scheme for decontamination equipment as introduced by HTM01-01
- To advise on or prepare specifications for the purchase of decontamination equipment and facilities