General Policy
Estates, Facilities and Capital Services
GP/S3
Estates Officer (Decontamination)
Decontamination Safety Group
Director of Property Asset & Estates
01 August 2006
07 July 2025
07 July 2027
5.1

GENERAL NOTE

NHS Fife acknowledges and agrees with the importance of regular and timely review of policy statements and aims to review policies within the timescales set out. New policies will be subject to a review date of no more than 1 year from the date of first issue.

Reviewed policies will have a review date set that is relevant to the content (advised by the author) but will be no longer than 3 years.

If a policy is past its review date then the content will remain extant until such time as the policy review is complete and the new version published, or if national policy or legislative changes are made

1. FUNCTION

  • This policy describes the procedures required to ensure that Unwrapped Instrument and Utensil Sterilisers owned and used by NHS Fife staff are operated safely and effectively and in compliance with existing legislation and standards. It is also applicable to benchtop vacuum sterilisers, which are classified as Porous Load Sterilisers.
  • In implementing these management policies and operating procedures, NHS Fife shall ensure decontaminated, sterile instruments are always provided and at reasonable, effective cost, while complying with current legislative standards.
  • The aim of this policy is to ensure that: -
  1. Sterilisation, as part of the decontamination process, is carried out in compliance with the laws issued by the UK and Scottish Parliaments, policies and guidance of Scottish Executive Health Departments and the guidance, directives and advice issued by NHS Fife Infection Control Manual.
  2. All personnel connected with instrument reprocessing, whether NHS employees or contract personnel, are suitably qualified and trained for their responsibilities.
  3. Sterilisers in the first place will be purchased from those available on National Contract as administered by NHS Scotland. They will conform to legal requirements, the minimum specifications set out in British and European standards and any additional requirements of the Scottish Executive Health Department.
  4. Sterilisers are to be installed and safely operated with regard to proper functioning, safety of patients, personnel and environmental protection. Consideration of the location of the steriliser to include such points as dirty to clean flow, ventilation and the proximity and effect on fire detector heads etc.
  5. Newly installed sterilisers are subject to a documented scheme of validation comprising installation checks and tests, commissioning tests and performance qualification tests before they are put into service.
  6. Sterilisers are subject to a documented scheme of periodic tests at intervals described in the Scottish Health Technical Memorandum 01-01 (SHTM 01-01) and Scottish Health Technical Memorandum 01-05 (SHTM 01-05).
  7. Sterilisers are subject to a documented scheme of preventive maintenance.
  8. Procedures for production, quality control and safe working are documented and adhered to considering statutory requirements and accepted best practice.
  9. Procedures for dealing with malfunctions, accidents and dangerous occurrences are documented and adhered to.
  10. All acquisition, replacements and relocation of transportable (benchtop) sterilisers, must be notified to the Estates Officer – Decontamination.
  11. Records in the form of the Unwrapped Instrument and Utensil logbooks are retained for a minimum of 13 years after the demise of the steriliser. In the event of closure of a facility, the records must be forwarded as soon as practicably possible to the User for collation prior to storage.

2. LOCATION

2.1 This policy is applicable to all NHS Fife owned premises and those where NHS Fife services are delivered.

2.2 This policy relates to Unwrapped Instrument and Utensil [benchtop] sterilisers only, it does not relate to vacuum sterilisers.

3. RESPONSIBILITY

The responsibilities of various personnel are briefly described below. For a more comprehensive explanation of these responsibilities refer to SHTM 01-05: Part A and SHTM 00

3.1 Chief Executive

The Chief Executive of NHS Fife has overall executive responsibility for ensuring that effective arrangements are in place to manage all safety, health and risk matters within NHS Fife. This responsibility has been delegated to an appropriate senior manager, the Director of Property & Asset Management, but the Chief Executive remains accountable to the Board.

3.2 The Director of Property & Asset Management is the Executive Lead for Health and Safety and is responsible for:

  • Making sure that the Board regularly reviews the effectiveness of this policy and by considering NHS guidance, that the policy continues to meet legislative requirements.

3.3 Management is defined as the owner, occupier, employer, general manager, chief executive or other person who is ultimately accountable for the sole operation of its premises.

3.4 The User (Manager) is defined as the person designated by management to be responsible for the day-to-day management of the sterilizer.

3.5 The Authorizing Engineer (Decontamination) is defined as a person designated by management to provide independent auditing and advice on sterilizers and sterilization, and to review and witness documentation on validation. The current provider of the Authorised Engineer (Decontamination) for NHS Fife is NHS Scotland.

3.10 The Authorised Person (Decontamination) (or Estates Officer - Decontamination) is designated by management to manage the validation, maintenance and periodic testing of (benchtop) sterilizers as well as the responsibility for the auditing processes that ensure all the decontamination equipment throughout NHS Fife is being properly managed, maintained, tested and validated. The Estates Officer (Decontamination) will act as a source of initial guidance on all decontamination technical matters.

3.6 The Maintenance Person or Competent Person (CPD) - (Sterilizers) is defined as the person designated by the Estates Officer – Decontamination to carry out maintenance and testing duties on sterilizers and can be an NHS member of staff or an appointed contractor.

3.7 The Operator (Clinician) is defined as any person, nominated by the User, with the authority to operate a steriliser, including the noting of steriliser instrument readings and carrying out simple housekeeping duties. This would normally be a clinician or their supporting staff.

3.8 The Competent Person (Pressure Vessels) is defined as a person or organisation designed to exercise certain legal responsibilities regarding the written scheme of examination of any pressure vessel associated with sterilisation. 

3.9 The Microbiologist (Steriliser) is defined as the person designated by management to be responsible for advising the user on microbiological aspects of the sterilisation of non-medicinal products.

4. OPERATIONAL SYSTEM

4.1 Unwrapped Instrument and Utensil [benchtop] sterilisers are designed to process unwrapped solid instruments only and must not be used to:

  • Re-process single use items
  • Re-process hollow or wrapped items.

4.2 Benchtop sterilisers are used to process unwrapped surgical instruments and utensils intended for immediate use by means of direct saturated steam contact. These sterilisers are therefore for clinical use only within the immediate environment in which the instruments are to be used.

4.3 Unwrapped Instrument and Utensil Steriliser Logbook

4.3.1 The User has the responsibility for ensuring the recommended documentation is complete and applicable to the relevant steriliser. The logbook used in NHS Fife is as supplied by Health Facilities Scotland. The logbooks must always be kept with the steriliser at all times including when the steriliser is sent off site for repair and or relocation.

4.6 Incident Reporting

4.6.1 Any incident which involves a steriliser and which compromises safety must be reported in the first instance to the Estates Officer (Decontamination). The Estates Officer (Decontamination) will determine the action to be taken and if necessary, seek guidance from the Authorising Engineer (Decontamination) on the appropriate actions to be followed.

4.6.2 All reportable incidents are to be recorded in the steriliser logbook (PHR1) and entered into the Datix reporting system in accordance with NHS Fife policy GP/I9

4.7 Review

4.7.1 This Policy is to be formally reviewed periodically by the NHS Fife Decontamination Group and an agreed minute of the review is to be retained.

5. RISK MANAGEMENT

The key risks involved in implementation of this policy are:

  • Lack of staff awareness of this policy, resulting in non-compliance.
  • Lack of robust organisational arrangements around policy implementation.
  • Failure to implement and maintain the required procedures associated with the policy.

6. RELATED DOCUMENTS

This section details the documentation relating to this Policy. It is recommended that this document is read in conjunction with the following:

  • NHS Fife SOP – Maintenance, Testing and Validation of Dental Decontamination Equipment.
  • Standard Operating Procedures (SOPs) for infection Control practice including decontamination are contained in NHS Infection Control Manual.

7. REFERENCES

7.1 Statute, Legal and Guidance

Health and Safety at Work act 1974

The Electricity at Work Regulations 1989.

Provision and Use of Work Equipment Regulations 1998.

Workplace (Health, Safety and Welfare) Regulations 1992

Pressure Systems Safety Regulations 2000

Management of Health and Safety at Work Regulations 1999

Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 2013

Control of Substances Hazardous to Health Regulations 2002

Available online at www.legislation.gov.uk

Safe use of work equipment, Provision and Use of Work Equipment Regulations 1998. Approved Code of Practice and Guidance L22.

Electricity at Work: Safe working practices HSG 85.

The Electricity at Work Regulations 1989, Guidance HSR25.

Maintaining portable electrical equipment. HSG107.

Available online at HSE: Information about health and safety at work

7.2 NHS Requirements

NHS Scotland has published Scottish Health Technical Memoranda (SHTM) and other guidance documents which contain policy and procedural guidance. This list is not exhaustive.