Control and assembly of reusable medical devices takes place after cleaning and disinfection.
Cleaned/disinfected RMDs are assembled without delay. If this is not possible, they are temporarily stored in a clean cart for example.
Controls (i.e., visual checks, technical functional tests, or both) are done before and after assembly of multi-component RMD’s or RMD compositions (for example surgical sets).
Medical devices subject to control can be items which were used on a patient but also new devices or devices returned from repair.
The control and assembly workstation is adapted to needs (e.g. surface and light) (see facility air & water)
Reusable textile are controlled in a separate space.
Controls and assembly of multi-components RMD’s, and RMD composition consider RMD manufacturer instruction for use (IFU)
Assembly of surgical sets are prepared in partnership with medical or surgical users. Agreed instructions specify:
- The items belonging to the set and quantity of each item. Missing instruments are indicated on the label.
- The type of tray (mesh, perforated, thermoformed) and size (large enough to permit equal distribution of weight and metal mass)
- As needed, the arrangement and protection accessories to be used (e.g., protection of sharp and fragile items, wedges to avoid shift or shocks during transport tray liners, etc.)
- As needed, the position of an RMD, as required for safe extraction at point of use
The following general rules apply:
- Heavy instruments are placed in such a way that they will not damage more delicate items.
- Items with concave surfaces broad, flat surfaces, or both, which may retain water are placed on edge to allow runoff.
- For RMD’s with lumen,lumen ports are open.
- Ratcheted instruments are unlatched. A description of the accessories needed to hold the instruments in the unlatched position is included.
Instrument identifiers and visual guides assist the assembly of sets.
It is verified that:
- Certificate of compatibility of the arrangement and protection accessories with the intended sterilization cycle are available.
- Sterilizing agent has free access to all RMD surfaces. Tip protectors, if used, must be permeable to the sterilizing agent, fit loosely, and be used according to the manufacturer’s written IFU. Only approved accessories are used.
- The weight of the equipment must not exceed applicable occupational health and safety limits (maximum weight of an item, including packaging varies between 10 kg and 11 kg (25 lb) according to each country’s guidelines)
For basin sets, all basins are in the same direction and processed with lint-free, absorbent material between nested basins.
For textiles, the product manufacturer is consulted for recommendations on the pack size, dimensions, and density that have been validated for the intended steam sterilization cycles. Packs are prepared with freshly laundered textiles.