The Principles of Medical Device Decontamination

Trouble shooting - Surgical Instrument Staining

The following focuses on three areas, the manufacturing; logistics challenges; processing challenges. These notes do not encompass all information relating to the root cause of instruments staining but they do provide a starter for ten in a local investigation. 1. The Manufactuer a. Stainless steel for instruments should be as per ISO 7153 Surgical Instruments materials, Part 1: Metals 11 b. A validated passivation process should be used (see definition of passivation) c. An up-to-date validated decontamination process MUST be followed d. Instruments should be finished appropriately to reduce/mitigate wettability (see definition of wettability 2. Logistics challenges - post surgery a. Has there been a recent change in reprocessing? E.g. move to off site processing? Instruments sitting in a vehicle wet/dirty for prolonged periods? b. Is there saline used in the surgery and then left on the instruments? Saline is also a challenge regardless of logistics. c. Is a pre-cleaner used? Trial these and get the correct solution; do they have rust inhibitors? Leaving instruments in humid environment may help. (recommended that all instruments are kept moist after use and prior to the start of the decontamination process) Results will vary according to instrument finish. 3. Processing Challenges a. Are the chemistries used, compatible with the devices? Too high a pH can damage b. Is the water quality of acceptable levels? Too much chloride/minerals will cause staining and silicates too. Regularly check the quality of the water used for washer c. Are instruments suitably dry when they come out of the WD? d. Ensure instruments are not closed (recommended to leave ratcheted instruments on the first rachet only) a combination of lack of oxygen and water will cause staining.

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