The purpose of this procedure is to establish guidelines for the decontamination of Loan Set packs to ensure safety, compliance, and quality standards.
(Version at end of page)
Signed V20 ML 18.11.2025
This procedure applies to all personnel involved in the handling, decontamination, and storage of medical products within Werkomed.
Approval: Author of the document, Monica Lucas
Changes: Logistics Manager
Decontamination - Removal of all debris both physical (dirt ) and biological (organisms & protein)
hot water is 49° C or above. Warm water is between 48° to 29° C. Cold water is generally between 28° to 15° C
Mixing “part of” e.g 1 cup of Solution to 7 cups of water or 1 litre of solution to 7 litres of water.
MSDS- Material Safety Data Sheet
NCR – Non conformance Record
SOP - Standard Operating Procedure
ISO13485 Clause 7.2, 8.2.1
MSDS - ORTHOZIME.pdf, SURGISTAIN.pdf, SURGISLIP.pdf - refer to Decontamination Drive Folder (MSDS)
Components arriving from the manufacturers are clean and need not be decontaminated.
All instruments and products are sterilized on site at hospitals and clinics.
Sets returning from use in theater are cleaned by the representative at the hospital, upon arrival at the Werkomed premises sets are then decontaminated and washed in the "Decontamination Area " before storage in demarcated store facility.
Safety eye wear, leather apron and protective gloves to be used during component cleaning
Protective gloves, thick leather apron and eye-ware is used during this process.
Take apart instruments to ensure thorough cleaning.
Scrub instruments with brushes to remove remaining debris.
Use tube brush made of nylon bristles imbedded in twisted stainless steel wire to clean cannulated instruments.
Fill up basin with warm water (anything over 30° C) and add Orthozime solution, 15ml of Orthozime per 5 litres of warm water as instructed by the local distributor.
Submerge sets in basin for 2 – 5 min.
Drain washing fluid (water and cleaning agent) after each use.
Move instruments to the rinsing basin and rinse with running tap water
Instruments/Sets are drip dried after rinsing.
Sets are then moved to the drying rack for Air drying.
Orthozime is a cleaning solvent designed for cleaning Orthopedic and Arthoscopic surgical instruments.
Directions for use:
Add 15ml of Orthozime® to 5 litres of warm water
Submerge instruments to be cleaned as soon as possible after use.
Soak for 2-10 minutes to remove fat, protein and all organic material
RINSE thoroughly in warm water, distilled or sterile water. Works in all temperatures.
Should any instruments show signs of rust, then these instruments are submerged in a solution of Surgistain.
Directions for use:
Add Mix one (1) part Surgi-stain® with seven (7) parts HOT water (49° or above).
Place solution in a non-porous container (preferably stainless steel).
Place thoroughly cleaned and opened instruments in Surgistain® solution for 10 minutes (gross or heavily stained instruments – soak for 30 minutes).
Remove instruments from Surgistain® solution and rinse thoroughly
Discard solution after use
Once the rust has been removed, they are then submerged for a short period in Surgislip®, a concentrate instrument lubricant and oxidation prohibitor designed for the purpose of protecting the instruments from rust.
Directions for use:
Mix one (1) part Surgislip® with ten (10) parts water.
Place diluted solution in container.
Immerse thoroughly cleansed instruments into the Surgislip® solution.
Remove instruments and let drain until dry.
Do not rinse or wipe.
For exceptionally stiff instruments, actively open and shut clamps or scissors in solution for 30 seconds.
Dried instruments are ready for preparation
Discard solution after 1 week
VERY IMPORTANT: Implants may not be immersed in either Surgistain, or Surgislip. Surgistain and Surgislip are kept in a plastic container that is seal-able.
Component Cleaning Instruction
Record the cleaning of the sets in the Component Cleaning Logbook. This record is filed away when the page is full.
Each instrument or implant is to be inspected carefully to make sure that all visible dirt has been removed. If any ingrained dirt is found, the cleaning cycles should be repeated.
Any instruments with an attached movable mechanism should be treated with a commercially available lubricant authorized for surgical instruments that can be sterilized
The mobility of movable parts should be checked to ensure that the planned sequence of motion can be completely carried out
In the case of instruments which can be reassembled into larger units, check whether the single parts can be put together easily.
The delivery packaging is purely for transport purposes and is not suitable for sterilization. The hospital is responsible for in-house procedures regarding assembly, inspection and packaging of instruments
Packaging is carried out in accordance with the general standard packaging guidelines of relevant standards and guidelines of specialist organisations using sterile barrier systems that conform with standards.
A "COMPONENT CLEANING" logbook contains information on the components, operator and the cleaning date as a record of the cleaning.
Prior to dispatch the Loan sets are configured and dispatched according to SOP. The loan sets are wrapped in a plastic sealed with a red sticker and placed into a rough tote storage bin marked CLEAN, to preserve the cleanliness for delivery to the hospital.
On return the loan sets are placed into a rough tote storage bin marked DIRTY, to ensure the safety of the goods and the staff.
In the event of non compliance follow SOP NON CONFORMANCE CORRECTIVE ACTION
The Risk Assessment to is found in SOP PREVENTIVE ACTION RISK ASSESSMENT refer Document
The analytical reviews of internal audits, and any other quality related matters, are reported to management and as part of the input to management review
The Trend analysis may identify any potential and recurring incidents, where corrective action must be reported at the management review to facilitate continual improvement.
Revision 20, 18.11.2025 - ML - Digitally Signed by ML
Revision 19, 13/11/2025 - CR - Component cleaning instruction link updated to the latest version
Revision 18; 19/11/2024 - HJM - Relinked the hyperlink for Component Cleaning Logbook & for Component Cleaning Instruction
Revision 17; 02/04/2024 - ML - Digitally signed by ML; Confirmed and Checked
Revision 16; 28.03.2024 - CR - updated Purpose; updated Scope; updated Definitions; updated Abbreviations; updated Procedure, added hyperlink; updated 8.1.1; updated 8.1.2; updated hyperlink on 8.1.3; removed 8.1.4, 8.1.5, 8.2 & 8.2.1; removed 'disinfection' under "Checking, maintenance and Inspection"; updated hyperlink on "cleaning of Device" under Packaging and paraphrased statement; updated Packaging .
Revision 15; 20.11.2023 - ML - Spelling corrected. Confirmed and checked.
Revision 14; 14.08.2023 - PM - Updated the hyperlink at 8.1.3 for the Component Log Book
Revision 13; 17.10.2022 - ML - Digitally signed by ML; Confirmed and Checked
Revision 12; 07.10.2021 - ML - Digitally signed by ML; boil replaced with warm water (defined) as per instructions
Revision 11; 10.05.2021 - ML - Digitally signed new Site by ML
Revision 10, 05.05.2021 - TNA - Updating the SOP to the new format. Approval / Scope / Responsibilities / Risk Based Approach / Records and Revision History. Amending links and forms
Revision 9, Digitally signed on 12.11.2018 by ML
Revision 1-8, unknown due to googlesite change to new googlesite
Name Retained by/ in Retention period Hard copies Destroyed by
Change Request Form Google Site Indefinite n/a
Change Register Google Site Indefinite n/a