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Storage

key principles

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After sterilization or disinfection, Reusable Medical Device (RMD) may be immediately used or stored until use.

  • Critical sterile RMD’s are protected from environmental and handling contamination by packaging and may be stored under controlled conditions until use or expiry date (see below, storage of sterile items).
  • Semi-critical RMD’s may be temporarily stored under controlled conditions. Maximum time before use is defined by local regulation (commonly from 3 to 12 hours). If the time limit is exceeded, RMD’s must be reprocessed. See flexible endoscopes.
  • Storage of non-critical RMD is according to internal policies.

Storage of sterile items

Storage takes place in a room adjacent to the central sterilization department or at point of use.

Key design and maintenance considerations for the storage room and shelves are as follows:

  • The storage area is an enclosed space dedicated to sterile supplies. The access to the storage area is restricted to authorized personnel.
  • Surface of the storage area and shelves must allow for the maximum required volumes to be stored without stacking.
  • Adequate space is left around the stored equipment to allow air circulation and avoid contact of packaged items with interior surface of walls upon which condensation which may form..
  • Floor is smooth, waterproof, intact, and easy to clean. Sufficient space is left below storage units to facilitatecleaning (i.e., at least 8 to 10 inches, around 20 cm).
  • Distance from the ceiling and sprinkler heads is defined by local fired code.
  • Open evacuation, water supply, ducts are avoided.
  • Packaging is not exposed to direct sunlight. UV accelerates material aging.
  • Major temperature fluctuations are avoided to prevent the accumulation of moisture (condensate). Recommended temperature and relative humidity ranges vary according to local guidelines (from 15°C or 18°C and 25°C for temperature, around 60 % or between 40 and 75% for RH). For some sensitive supplies, manufacturer IFUs may require specific humidity ranges.
  • There are no standardized air quality or aero-contamination limits for storage areas. Local recommendations may apply.
  • Open shelves (wire or solid shelves) are permissible for confined storage areas, where traffic and ventilation are controlled. Closed or covered cabinets are needed for high-traffic areas where dust might accumulate. It is recommended that the bottom shelf of storage carts or shelving is solid.
  • Housekeeping is regularly performed and registered. Shelving, carts and bins used for sterile storage are kept organized, clean, and dry.

Storage is organized according to first in first out principle to allow rotation of RMD’s.

Expiration date is defined by risk analysis carried out during the validation of the packaging process.

The shelf life of sterile RMD is event-related and based on the quality of the packaging material, the storage conditions, the methods and conditions of transport, and the amount and conditions of handling. The probability of damages increases over time and with frequency of handling

Control of packaging integrity and expiration dates are periodically performed.

Pouches and reels are stored vertically or flat in baskets. Compression can force air and microorganisms onto the package content, cause the seal to burst, or puncture the packaging. Small pouches are stored in boxes and not directly on shelves. they are not held together by rubber bands, staples or paper clips.

Wraps are not stacked. Wrapped packages are not stored beneath rigid sterilization containers on the same shelf.

explanations

Transport trays with solid or perforated bottoms may be used to prevent tears in wraps or pouches during handling.

For safety and ease of handling, heavy instrument trays are stored on middle shelves

Items are never stored directly on the floor, even temporarily.

Storage and quality

Written storage standard operating procedures (SOP’s) are prepared in accordance with quality management principles.

Storage conditions contribute to the preservation of sterility and undergo process validation

  • Training of all operators allowed in storage space are executed and training certificates available.
  • Occupational healh & safety measures are in place for handling of heavy items.
  • Standard operating procedures (SOP’s) are up to date for storage rules and cleaning of storage space.
  • Risk analysis is performed for determination of expiration dates.
  • Audits are performed

WFHSS recommendations for storage

  1. The storage area is dedicated to the storage of sterile items. Access is restricted to authorized and trained personnel. Must not be overfilled. Storage conditions (lights, T°C, humidity) are under control. Storage precautions are adapted to items and packaging
  2. Storage process is implemented according to quality management principles and undergoes process validation
  3. Expiration date are defined by risk analysis of transport and storage conditions
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