14.4.3 Verification of function
Decontaminated medical devices shall be reassembled before inspection for functionality unless the MIFUs specify otherwise. See Clause 7.
Note: Decontamination definition includes cleaning and disinfection.
Reassembly shall take place in a clean and dry area.
Inspection for damage, integrity, and functionality shall include, but is not limited to, the examination of:
a) hinge and joint action;
b) jaw and teeth alignment;
c) ratchet alignment and function;
d) cutting edge sharpness;
e) lens clarity; and
f) materials integrity, including:
- surface damage such as wear, corrosion, chips, burrs, dents, loss of finish, or other damage;
- insulation integrity; and
- bends or kinks.
Notes:
1) Visual inspection is particularly important for plastic and rubber medical device components, given their susceptibility to cracking, crazing, or deformation, and the possibility that adhesives will fail.
2) Chips on the surface can harbour soil. Burrs and chips can damage tissue and gloves. Worn medical devices can corrode.
3) Consult the MIFUs for inspection and test information.
Medical devices that are damaged or in poor working condition shall be removed from service, labelled, and segregated from usable medical devices.
The label shall indicate that the medical device is out of order and it shall state the problem and the action to be taken.
Damaged medical devices shall either be repaired or disposed of in accordance with the documented policies and SOPs.
