World Health Organization · 1st WHO edition, 2016 · 118 pages
Comprehensive guidance for establishing and operating sterile services departments and reprocessing medical devices safely.
- Issuer
- World Health Organization
- Edition
- 1st WHO edition, 2016
- Audience
- SSD managers, infection prevention and control staff, hospital administrators, biomedical engineers, health facility planners
- Evidence
- Expert consensus and international standards (ISO, EN); not GRADE-rated
- Reviewed
- 23 Oct 2026 · GMJ
What this guideline says
GMJ summary
This 118-page manual provides comprehensive guidance on establishing, operating and maintaining sterile services departments (SSDs) and decontamination processes in health-care facilities. It covers the complete decontamination life cycle: from point-of-use preparation, cleaning, inspection, assembly, packaging, sterilization (steam, ethylene oxide, hydrogen peroxide plasma), to storage, transport and quality assurance.
The guideline emphasizes that cleaning is the most critical first step—instruments cannot be sterilized without thorough cleaning. It specifies validation requirements for all sterilization processes (installation qualification, operational qualification, performance qualification), staffing levels and training curricula, physical infrastructure requirements including unidirectional workflow from dirty to clean areas, and quality management systems including tracking and traceability.
Special sections address endoscope reprocessing, chemical disinfectants (concentrations and contact times for glutaraldehyde, peracetic acid, hydrogen peroxide, chlorine compounds), dental practice, the controversial issue of reprocessing single-use devices, and occupational health and safety for SSD staff including appropriate personal protective equipment for each task.
Key points
For clinicians — doses and thresholds as stated in the guideline
- All medical devices must be thoroughly cleaned before any disinfection or sterilization; cleaning cannot be validated but requires clear standard operating procedures with complete immersion in detergent solution and brushing of all surfaces including lumens.
- Steam sterilization requires validation with three consecutive successful cycles demonstrating installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ); parametric release criteria must be documented for at least 5 years.
- Sterile services departments must have physical separation between dirty and clean areas with unidirectional workflow, negative pressure (20 air changes/hour) in the decontamination area and positive pressure (12–20 air changes/hour) in clean areas, and dedicated gowning points.
- Water quality for steam sterilizers: bacteria <200 cfu/mL, total organic carbon <1.0 mg/L, hardness <1.0 ppm CaCO₃, chloride <1.0 mg/L, iron <0.2 mg/L; reverse osmosis recommended for final rinse.
- High-level disinfection for semi-critical devices (endoscopes, respiratory equipment): glutaraldehyde 2% for 20 minutes at 20°C, ortho-phthalaldehyde (OPA) 0.55% for 12 minutes at 20°C, peracetic acid 0.2% for 12 minutes, or hydrogen peroxide 7.5% for 30 minutes.
- Personal protective equipment in decontamination area: heavy-duty domestic gloves, waterproof gown, visor or mask with goggles, hair cover, closed shoes; in inspection/assembly/packing area: hair cover only; when loading/unloading sterilizers: heat-resistant gloves.
- Flexible endoscope reprocessing: bedside pre-clean, leak test, manual cleaning of all channels with enzymatic detergent and brushing, first rinse, high-level disinfection (minimum 20 minutes glutaraldehyde 2% or automated endoscope reprocessor), second rinse with sterile/filtered water, drying with medical-grade compressed air, storage hanging vertically.
- Staffing ratio: approximately one SSD staff member per 3,000 surgical operations per year or per 1,500–2,000 instrument trays processed per year; three-tier training curriculum (basic entry, intermediate supervisor, advanced manager level).
Summary of antimicrobial activity of commonly-used disinfectants and recommended concentrations
Table extracted from the guideline
| Disinfectant | Concentration | Bacteria | Mycobacteria | Viruses | Fungi | Spores | Contact time |
|---|---|---|---|---|---|---|---|
| Glutaraldehyde | 2% | +++ | +++ | +++ | +++ | +++ (3–10 h) | 20 min (HLD) |
| Ortho-phthalaldehyde (OPA) | 0.55% | +++ | +++ | +++ | +++ | + | 12 min (HLD) |
| Peracetic acid | 0.2% | +++ | +++ | +++ | +++ | +++ | 12 min (HLD) |
| Hydrogen peroxide | 7.5% | +++ | +++ | +++ | +++ | +++ | 30 min (HLD) |
| Chlorine (hypochlorite) | 0.1% (1,000 ppm) | +++ | + | +++ | ++ | + | 10 min |
| Alcohol (ethanol/isopropanol) | 70–90% | +++ | +++ | +++ | ++ | – | Contact only |
Source: World Health Organization, Decontamination and Reprocessing of Medical Devices for Health-care Facilities. Reproduced in summary form.
From the guideline
Verbatim
“Cleaning is the first and most essential step before any process of disinfection or sterilization can be carried out.”
Editor’s perspective
Why this matters for Georgia and the region
Prof. Giorgi Pkhakadze, MD, MPH, PhD
Editor-in-Chief, Georgian Medical Journal · Chair, Public Health Institute of Georgia · WHO consultant, health and migration
As WHO consultant and chair of the Public Health Institute of Georgia, I recognise that this guideline addresses a critical gap in our region: most Georgian health facilities lack purpose-built sterile services departments, and reprocessing is often performed by untrained staff in corridors or operating-theatre annexes without validation or quality control. While Georgia has made impressive progress in infection control—for example hepatitis C elimination since 2015 and UHC reforms since 2013—surgical site infections remain a burden partly due to inadequate instrument reprocessing. The single most important recommendation for our context is establishing the unidirectional workflow with physical separation of dirty and clean zones and investing in water treatment, because Tbilisi and regional municipal water rarely meets the <1.0 ppm hardness standard required for steam sterilizers. Implementation will require a phased national plan starting with regional referral hospitals, a certification programme for SSD personnel (currently non-existent), and regulatory oversight by the Health Care Quality Assurance Service—simply translating this manual without infrastructure investment and workforce development will not improve patient safety.
ORCID 0000-0001-7609-4515 · Perspective written for the GMJ Guidelines Library, 23 Oct 2026
Applicability
Georgia and the South Caucasus
This guideline is highly relevant for Georgia and the South Caucasus as many health-care facilities lack dedicated sterile services departments or operate informal decontamination areas without validation, quality assurance or trained staff. Implementation requires significant infrastructure investment (separate dirty/clean areas, washer-disinfectors, validated autoclaves, water treatment systems), workforce development (three-tier training curriculum for SSD staff who are often untrained nurses or cleaners), and quality systems (tracking, traceability, parametric release, documentation for 5 years). National programmes should prioritize: (1) establishing at least one model SSD per region with validated processes, (2) developing national training and certification for decontamination staff, (3) ensuring water quality meets steam sterilizer requirements (often unmet in facilities with hard municipal water), and (4) implementing infection prevention and control oversight of all reprocessing including in primary care, dental clinics and endoscopy units where unvalidated practices are common.
Questions this guideline answers
Quick answers
Can I soak instruments in chlorine or other disinfectant before cleaning?
No. Soaking in disinfectant before cleaning is not recommended because: (1) disinfectants are inactivated by blood and organic matter, (2) chlorine corrodes instruments, (3) it may contribute to antimicrobial resistance, and (4) it gives false reassurance while biofilm can form in the disinfectant solution itself. Always clean first with detergent and water; disinfection or sterilization comes after thorough cleaning.
What water quality do I need for steam sterilizers?
Steam condensate should meet: bacteria <200 cfu/mL, total organic carbon <1.0 mg/L, hardness <1.0 ppm CaCO₃, total dissolved solids <0.4 mg/L, chloride <1.0 mg/L, iron <0.2 mg/L, and be colourless and clear. Hard water deposits minerals on instruments, damages them, blocks valves and reduces sterilization efficacy. Use reverse osmosis or water softening if your municipal supply does not meet these criteria; at minimum use treated water for the final rinse.
Can single-use devices be reprocessed and reused?
The WHO guideline advises extreme caution. Reprocessing single-use devices (marked with the ⊗ symbol) is only acceptable if: (1) a national policy explicitly permits it, (2) the device manufacturer provides reprocessing instructions, (3) the facility has the technical capacity to validate cleaning and sterilization for that specific device, (4) the device integrity and function can be verified after reprocessing, and (5) medico-legal liability is clear. In general, it is not recommended due to safety risks, especially for catheters, tubing and complex devices.
How often should sterilizers be validated?
Sterilizers require full validation (IQ, OQ, PQ with three consecutive successful cycles) before first use, after any repair or major maintenance, when packaging material or load composition changes substantially, and at least annually. Daily quality checks include: Bowie-Dick test for pre-vacuum autoclaves, biological indicators (spores) for at least one cycle per day, chemical indicators (preferably Class 5 integrators) in every load, and documentation of physical parameters (temperature, pressure, time) for every cycle with parametric release.
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- Issuer
- World Health Organization
- Type
- Guidance (normative)
- Edition
- 1st WHO edition, 2016
- Replaces
- Sterilization Manual for Health Centers (PAHO, 2009)
- Status
- Current
- Published
- 2020-11-18
- Languages
- English; separate translations available
- Scope
- Global, all health-care settings with surgical or invasive procedures
- Audience
- SSD managers, infection prevention and control staff, hospital administrators, biomedical engineers, health facility planners
- Pages
- 118
- Licence
- © WHO and PAHO 2016; all rights reserved
- ISBN
- 9789241549851
- Evidence
- Expert consensus and international standards (ISO, EN); not GRADE-rated
- Record history
- Created 23 Oct 2026 · updated 23 Oct 2026 · next check Apr 2027
World Health Organization, Pan American Health Organization. Decontamination and reprocessing of medical devices for health-care facilities. Geneva: World Health Organization; 2016. 118 p. ISBN 9789241549851.GMJ Guidelines Library records are original summaries written by the GMJ editorial team from the issuer’s published document and reviewed by a physician. They do not replace the full guideline. The document is the copyright of its issuer and is linked, not hosted. Spotted an error or a newer edition? Tell the Guidelines Desk.
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