Control & Assembly – WFHSS Guidelines

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)

Control and assembly, and quality

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

Process validation of control and assembly manages that:

SOP’s are up-to-date, follow RMD manufacturers IFU’s, and are in-line with medical or surgical users expectations.
Training is delivered and training certificates are available.
Occupational health and safety measures are in place.
Traceability is operational and effective.

WFHSS recommendations for control and assembly

Control and assembly standard operating procedures take into account RMD manufacturer IFU’s and are in-line with expectations of surgical or medical users.
Compatibility of protection accessories with the selected sterilization technology and cycle is verified.
Control and Assembly process is implemented according to quality management principles and undergoes process validation .