Care and Handling of Instruments – Verification of Cleanliness

14.4.1.1 Visual inspection and testing

Cleanliness and functionality of all medical devices shall be verified by visual inspection

(see Clause 12.4.10).

Testing for cleanliness and functionality shall be performed when indicated by the MIFUs to check the hidden parts of medical devices for invisible organic soils. See Clause 14.4.2.

14.4.1.2 Inspection criteria

Inspection shall occur under appropriate visual conditions, such as good task lighting and, where necessary, magnification.

The type of lighting and magnification shall be appropriate for the medical device being examined.

Lighting and magnification requirements shall also take into consideration the

1. a) visual acuity of the area staff;
2. b) degree of surface reflection in the inspection area; and
3. c) complexity of the medical device(s) being examined.

14.4.2 Verification of cleanliness

14.4.2.1 General

The cleanliness of decontaminated medical devices shall be verified visually or with verification tools as per MIFUs, regulatory body, or institutional policy before terminal sterilization, disinfection, or subsequent use.

Soiled medical devices shall be returned to the decontamination area to be reprocessed.

Note: Soil on a medical device can harbour pathogens and impede disinfection and sterilization.

14.4.2.2 Disassembly

Medical devices shall be disassembled to their simplest component parts for inspection for cleanliness.

If MIFUs require the medical device to be disassembled for sterilization, then the medical device shallbe

1. a) assembled during inspection;
2. b) checked for functionality; and
3. c) disassembled for sterilization.

14.4.2.3 Inspection and testing

Inspection and testing shall be used to check parts of medical devices that are hidden, or to check for invisible organic soils.