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

1.1 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 not applicable to benchtop vacuum sterilisers, which are classified as Porous Load Sterilisers.

1.2 In implementing these management policies and operating procedures, NHS Fife shall ensure decontaminated, sterile instruments are provided at all times and at reasonable, effective cost, while complying with current legislative standards.

1.3 The aim of this policy is to ensure that:-

a. 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;

b. All personnel connected with instrument reprocessing, whether NHS employees or contract personnel, are suitably qualified and trained for their responsibilities;

c. Sterilisers in the first place will be purchased from those available on National Contract as administered by Health Facilities 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;

d. Sterilizers 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:

e. 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;

f. Sterilisers are subject to a documented scheme of periodic tests at intervals described in SHTM 2010;

g. Sterilisers are subject to a documented scheme of preventive maintenance;

h. Procedures for production, quality control and safe working are documented and adhered to in light of statutory requirements and accepted best practice;

i. Procedures for dealing with malfunctions, accidents and dangerous occurrences are documented and adhered to;

j. All acquisition, replacements and relocation of transportable (benchtop) sterilisers, must be notified to the Estates Officer – Decontamination, and the Decontamination Maintenance and Testing Manager;

k. 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

Applicable to all NHS Fife owned premises and those where NHS Fife services are delivered.

3. RESPONSIBILITY

The responsibilities of various personnel are briefly described below. For a more comprehensive explanation of responsibilities, refer to SHTM 2010: Part 1 and SHTM 00

3.1 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 may be delegated to an appropriately senior manager but the Chief Executive remains accountable to the Board.

3.2 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.

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

3.4 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 Health Facilities Scotland.

3.5 The Decontamination Maintenance and Testing Manager (or Estates Officer – Decontamination) is a post created by NHS Fife and is designated by management to manage the validation, maintenance and periodic testing of (benchtop) sterilizers.

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 with regard to 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.

3.10 The Estates Officer (Decontamination) is defined as the person designated by management to be responsible for the auditing processes that ensure all 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.

4. OPERATIONAL SYSTEM

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

4.2 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

4.3 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.

4.4 Unwrapped Instrument and Utensil Steriliser Logbook

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 be kept with the steriliser at all times including when the steriliser is sent off site for repair and or relocation.

5. RISK MANAGEMENT

The key risks involved in implementation of this policy are:-

5.1 Lack of staff awareness of this policy, resulting in non-compliance

5.2 Lack of robust organisational arrangements around policy implementation

5.3 Failure to implement and maintain the required procedures associated with the policy

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.

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

6. RELATED DOCUMENTS

• NHS Fife SOP – Fault Reporting for Dental Decontamination Equipment
• Standard Operating Procedures (SOPs) for infection Control practice including decontamination are contained in NHS Infection Control Manual.

7. REFERENCES

The following list is representative of the legislation and guidance available and is by no means exhaustive:

• Scottish Health Technical Memorandum 2010: Sterilisation (Parts 1-6) and Best Practice Guidance
• Scottish Health Technical Memorandum 00: Best Practice Guidance for Healthcare Engineering
• Scottish Health Technical Memorandum 2031: Clean Steam for Sterilisation and Best Practice Guidance
• National Health Service Scotland Decontamination Guidance version 1 1999
• MDA Device Bulletin MDA DB2002 [06]: Benchtop Sterilisers The Purchase, Operation and Maintenance of Benchtop Steam Sterilisers
• MDA Device Bulletin: Update sheet for DB2002 [06] Benchtop Steam Sterilisers – Guidance on Purchase Operation and Maintenance
• Health and Safety at Work act 1974
• Management of Health and Safety at Work Regulations 1999 & 2003
• Workplace (Health, Safety and Welfare) Regulations 1992
• Provision and Use of Work Equipment Regulations 1998
• Pressure Systems Safety Regulations 2000
• Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 2013
• Control of Substances Hazardous to Health Regulations 2002
• Electricity at Work Act 1989
• NHS Fife Infection Control Manual
• NHS Fife SOP – Maintenance and Testing of Unwrapped Instrument and Utensil Sterilisers (Type N sterilisers)
• NHS Fife SOP – Management of Unwrapped Instrument and Utensil Sterilisers (Type N sterilisers)
• NHS Fife SOP – Fault Reporting for Dental Decontamination Equipment

Related Publications

See Also
Subjects

• Estates, Facilities and Capital Services
• Policies