Packaging management according to the three-layer principle (SIS-TR 57:2020)

To protect sterile medical devices from contamination during storage and transport, a three-layer principle is applied. The function of each layer must be respected:
• Product packaging: Closest to the product and preserves its sterility. It must never be resealed after it has been opened.
• Department packaging: Collects and protects several product packages of the same kind against dust and external influences during storage in the unit.
• Transport packaging: Protects the goods during transport from the supplier to the receiving room at the healthcare unit. This should be a specially designated place where the outer packaging is removed in such a way that dirt from outside does not enter the healthcare unit.

Storage management, climate and order

A well-managed storage prevents the spread of infection and extends the products’ shelf life. Storage for clean and sterile materials should be placed protected from splashes, dust, and pests, and never under water or sewage pipes. Floors, walls, and shelves should have smooth, easy-to-clean surfaces.
• Zone division and separation: There should be a clear boundary between clean and unclean material. For example, clean linen storage or sterile storage should never border or be accessible via waste areas.
• Placement and cleaning: Materials must never be placed directly on the floor. Shelves are wiped with alcohol-based surface disinfectant at least once a month. Wiping/vacuuming is carried out on frequently used surfaces, and planned and completed deep cleaning is documented with date and signature.
• Climate control: In sterile storage, the temperature should be kept at a maximum of 23 °C and the relative humidity between 30–60%. This must be logged and monitored regularly. Access to sterile storage should be limited.
• Structure and FIFO: Always apply the FIFO principle (First In, First Out) so that products with the shortest shelf life are used first. Label shelves and boxes clearly (preferably with visual color coding) and avoid overfilling to ensure good ventilation and prevent packaging from being damaged.
• Specific spaces: Linen is stored in closed cabinets, separated from used linen. Cleaning and disinfection rooms should have good ventilation and be separated from clean areas. Waste storage should have sorting for household, risk and sharp waste in closable and puncture-resistant containers.
• Personal hygiene routines: Always perform hand hygiene before handling clean material. Private items (bags, cell phones, outerwear) do not belong in clean storage.

Local storage, bags and home care

When care is provided outside the central storage, special precautions are required to maintain the degree of cleanliness.
• Local storage and emergency boxes: Should only be handled with disinfected hands and have clear cleaning routines. Unused material taken out from local storage or patient rooms must never be returned to the department storage.
• Bags as mini-storages: Bags used in care work should have separate compartments for sterile, disinfected, and clean material. The bag must be wipeable or washable at 60 °C and cleaned at least once a month. Sterile products should be stored according to the three-layer principle even in the bag.
• Home care: Basic equipment such as plastic aprons, gloves, and hand disinfectant should preferably be stored in a sealed plastic box with a lid in the patient’s home. The box should be cleaned and disinfected at least once a month. Used or removed material must never be put back.

Degrees of cleanliness and use of disinfectors

Products in healthcare are classified according to how they will be used and what level of cleaning is required:
1. Sterile products: Require complete freedom from living microorganisms (used during interventions and broken skin/mucosa).
2. Disinfected products: Used on mucous membranes or damaged skin; cleaned and disinfected in a washer-disinfector.
3. Clean products: Used on intact skin and must be visibly clean.

Flush and washer disinfectors

• Flush disinfector: Used for approved reusable items such as bedpans, urine bottles, and cleaning buckets. The process takes about 10 minutes. Instruments must never be run in the flush disinfector.
• Washer disinfector: Used for cleaning and disinfection of surgical instruments. The process takes 40–60 minutes and includes washing and disinfection with hot water (85–90 °C).
• Post-treatment: After washer disinfection, the instruments should be dried with a sterile cloth and stored dry and dust-free in a covered box or a closed cabinet.

Safe unpacking of sterile goods

Strict asepsis applies when opening sterile material. If sterility can ever be questioned – consider the goods contaminated.
• Preparation: Check that the work surface is clean and dry. Perform hand disinfection. Inspect the packaging: the sterilization indicator must show an approved result, the expiration date must not have passed, and the packaging must be completely intact and dry.
• Outer packaging: Open carefully without touching or pulling the outer packaging over the sterile contents. Let any inner packaging remain on the outer layer when moved to the work surface.
• Inner packaging: Always open on a sterile surface or table. Pull or fold the edges outward and away from the contents so that they form a non-sterile edge. Never reach over the sterile contents. If a fabric package is used: fold the flaps in order – the farthest first, then the side flaps, and lastly the flap closest to you.
• Transfer: Use sterile forceps or grippers (with the tips pointed downward). Material dropped outside the sterile field is contaminated and must not be used. Avoid talking, coughing, or sneezing over the sterile field.

Documentation, responsibility and education

• Logbook and traceability: At each flush and washer disinfector, there must be a logbook containing instructions for use, daily control routines, product information and maintenance protocols. Signing lists for controls are kept for at least one year.
• Management responsibility: The operations manager has overall responsibility for ensuring that the staff have the right competence and that daily checks are carried out and documented.
• Education: Infection control in many regions offers training for hygiene representatives, hygiene-responsible nurses, and operations managers.

Reflection questions for sterile management
Care staff
1. How do you ensure in your daily work that material once taken out of local storage or a home care box is never returned to the clean storage?
2. What do you do if you discover that a product package for a sterile instrument is damp, damaged or has passed its expiration date?

Manager, Nurse, Occupational Therapist and Physiotherapist
1. How do we systematically follow up that self-inspection, temperature logging in sterile storage and monthly disinfection of storage bags are actually performed and documented at our unit?
2. How do we ensure that new and existing staff have completed Infection Control’s training materials and have the right conditions to apply the three-layer principle in their daily routines?

Residents and Relatives
1. Do you feel that the storage of care and hygiene materials at home or in the room feels clean, safe and well-structured?
2. Have you received sufficient information about why staff use protective equipment and disinfect their hands when handling products and performing care procedures?

Erland Olsson
Specialist Nurse
Sofrosyne – Better care every day.