Standard operating procedure

Decontamination & Sterile Services Procedure

A standard operating procedure for the safe decontamination of reusable medical and surgical instruments at [Organisation Name], covering cleaning, disinfection, inspection, steam sterilisation, storage, traceability, and the routine testing and validation of decontamination equipment.

For Private Healthcare ClinicRef BS-PH-SOP-003See a sample (PDF) →
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  • Editable Microsoft Word (.docx)
  • Mapped to the CQC standards
  • Optional 3-monthly updates

What's inside

This standard operating procedure is fully drafted and structured, ready to brand and complete for your service. It covers:

  • 1. Purpose
  • 2. Scope
  • 3. Definitions and abbreviations
  • 4. Responsibilities
  • 5. Equipment and materials
  • 6. Procedure
  • 7. Records
  • 8. Related documents
  • 9. Review and version control
  • 10. Disclaimer

Legislation & standards it maps to

  • Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 - Regulation 12 (Safe care and treatment)
  • Health and Social Care Act 2008: Code of Practice on the prevention and control of infections and related guidance (the Hygiene Code)
  • Health Technical Memorandum 01-01: Management and decontamination of surgical instruments used in acute care
  • Health Technical Memorandum 01-06: Decontamination of flexible endoscopes (where flexible endoscopes are used)
  • Medical Devices Regulations 2002 (SI 2002/618, as amended)
  • Control of Substances Hazardous to Health Regulations 2002
  • Health and Safety at Work etc. Act 1974

Who it applies to

All clinical and support staff at [Organisation Name] who use, handle, clean, disinfect, sterilise, transport, store or track reusable medical and surgical instruments, including doctors, surgeons, dentists where applicable, nurses, healthcare assistants, decontamination operators and the staff responsible for infection prevention and control, equipment and procurement.

Glossary

Plain-English explanations of the technical terms and legislation used in this document.

Autoclave
A machine that sterilises instruments using saturated steam under pressure; a bench-top steriliser is a small autoclave used within a clinic.
Blood-borne virus (BBV)
An infection such as hepatitis B, hepatitis C or HIV that can be passed on through blood.
Calibration
Checking and adjusting a machine's gauges, sensors and timers so its readings are accurate.
Care Quality Commission (CQC)
The independent regulator of health and social care services in England.
Central Sterile Services Department (CSSD)
A facility, on-site or external, that provides decontamination and sterilisation services for reusable instruments.
Cleaning
The physical removal of visible soil, organic matter and microorganisms; it must be done before disinfection and sterilisation can work.
Cleaning-efficacy test
A check confirming that a washer-disinfector is removing soil from instruments as intended.
Control of Substances Hazardous to Health Regulations 2002 (COSHH)
The law for safely managing chemicals and other hazardous substances at work.
Decontamination
The combined process of cleaning, disinfecting and, where needed, sterilising equipment so it is safe to reuse.
Disinfection
A process that greatly reduces the number of living microorganisms on an item, though it may not kill all microbial spores.
Endoscope (flexible)
A flexible tube with a camera used to look inside the body; it needs special decontamination because of its long internal channels.
Enzymatic cleaner
A detergent containing enzymes that helps break down and remove blood, tissue and other organic soil from instruments.
Fundamental standards
The minimum standards of safety and quality below which care must never fall.
Health and Safety at Work etc. Act 1974
The main law requiring employers to protect the health and safety of staff and others affected by their work.
Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
The regulations setting out the fundamental standards that registered care providers must meet.
Health Technical Memorandum (HTM)
Official Department of Health and Social Care guidance on the safe management and decontamination of medical equipment.
Hygiene Code
The Health and Social Care Act 2008 Code of Practice on the prevention and control of infections, which sets the standards providers must meet on infection control.
Infection prevention and control (IPC)
The measures used to stop infection spreading between patients, staff and visitors.
Inoculation injury
An injury, such as a needlestick or cut, that breaks the skin and could pass on a blood-borne infection.
Lumen
The hollow channel or bore running through a tube-shaped instrument, which is harder to clean than a flat surface.
Medical Devices Regulations 2002
The law governing the safety, manufacture and supply of medical devices in the United Kingdom.
Near miss
An event that could have caused harm but did not, by chance or because it was caught in time.
Performance qualification
Testing that proves a piece of decontamination equipment performs correctly and consistently in real use.
Personal protective equipment (PPE)
Items such as gloves, aprons, eye protection and masks worn to protect against harm or infection.
Porous-load (vacuum) cycle
A steam-sterilisation cycle that removes air using a vacuum so steam can reach wrapped, pouched or hollow instruments.
Process indicator
A mark or strip on packaging that changes colour to show an item has been through a sterilisation process.
Registered manager
The person registered with the regulator as responsible for the day-to-day running of a service.
Regulated activity
A type of care or treatment the law requires a provider to register with the regulator to deliver.
Reprocessing
Cleaning, disinfecting and sterilising a used device so it can be used again; single-use devices must never be reprocessed.
Revalidation
Repeating validation tests at set intervals to confirm equipment still performs to the required standard.
Safety data sheet
A manufacturer's document describing a chemical's hazards and how to use, store and dispose of it safely.
Sharps
Needles, blades and other items that can cut or puncture the skin.
Single-patient-use device
A device that may be reused on the same patient but must never be used on another patient.
Single-use device
A device intended to be used once on one patient and then discarded; it is never cleaned or reused.
Standard operating procedure (SOP)
A written, step-by-step instruction setting out how a particular task is to be carried out consistently and safely.
Steam-penetration test
A daily check (such as a Bowie-Dick type test) confirming that steam can reach all surfaces inside a steriliser load.
Sterilisation
A validated process that kills all living microorganisms, including spores, making a device free from infection risk.
Steriliser
Equipment, usually a steam autoclave, used to sterilise instruments.
Traceability
Keeping records that link each decontaminated instrument to the cycle that processed it and to the patient it was used on.
Ultrasonic cleaner
A device that uses high-frequency sound waves in a fluid to remove fine soil from instruments, especially from hinges, joints and channels.
Validation
Documented testing that proves a decontamination process reliably achieves the required result.
Washer-disinfector
An automated machine that cleans and then disinfects instruments through a controlled, validated cycle.

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