PRODUCT DECONTAMINATION

1. Purpose 

This documents provides the process for Product Decontamination and it defines the practices/processes that must be followed in compliance with ISO 13485.

2. Approval

(Version at end of page)

Signed V16 12.09.2025 -SZ  

3. Scope

The process covers all documents and process and products as defined in the SOP.

This Policy must be read-with and comply with the Protection of Personal Information Act 04 of 2013, ("POPI"), the Company POPI Policy, PAIA Manual and processing of personal information envisaged under this Policy must be done in accordance with the aforementioned. 

4. Responsibilities

 Approval: Author of the document, Henry Manyike, Managing Director

Changes: Author of the document, Bonang Ntuli, Business Administrator

5. Definitions

Decontamination - removal of all debris both physical (dirt) and biological (organisms & protein).

Warm water is filling the trough from a hot water tap by running the tap until hot, then plug and start filling when the water presents. 

[Please Note: In general, Hot water is 130 F (54.4 C) or above. Warm water is between 110 and 90 F (43.3 to 32.2 C). Cold water is generally between 80 and 60 F (26.7 to 15 C)]

VAH - The VAH List of Disinfectant is the standard reference for disinfection in medical and non-medical institutions.  The VAH List contains products for chemical disinfection for hand, skin, instruments, surfaces, textiles.  These were tested by accredited laboratories and approved by independent experts.   https://vah-online.de/en/vah-list

6. Abbreviations

IFU- Instructions for use

MSDS- Material Safety Data Sheet

NCR – Non-conformance Record

SOP - Standard Operating Procedure

NS - Non sterile

VAH - Verbund fur Angewandte (Association for Applied Hygiene)

7. References

ISO13485 Clause 7.2, 8.2.1

MSDS - ORTHOZIME.pdf, 

SURGISTAIN.pdf  

SURGISLIP.pdf 

- refer to file at end of SOP below - These cleaning products are supplied by an approved external Supplier, see Supplier SOP

8. Procedure

8.1 OHSA: Health and Safety

• Safety eye wear and gloves to be used during component cleaning

8.2 Process for the cleaning of components - INSTRUMENTATION

• Components arriving from the manufacturers are clean and need not be boiled or 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 and are boiled and sanitized in the wash bay at Implantcast upon return before storage in demarcated store facility

a) Cleaning Instruction - correlate to IC Instruments Instructions

1. Protective gloves, eye-ware and thick PVC apron is used during this process 

2. The returned instruments are disassembled. The instruments are soaked for 2-5 minutes in a solution of 15ml of concentrate of ORTHOZIME per 5L of warm water from HOT tap and the instruments are washed with a cloth. 

3.  The full trays are then removed from the wash basin and submerged in the boiler with 110C temperature boiling water for 10 minutes.

4. On completion of the 10min boiling process the sets are removed from the boiler, and put on the drying rack to drip dry

5. Orthozime is a cleaning solvent designed for cleaning Orthopedic and Arthoscopic surgical instruments.

6. To learn more about the Cleaning instructions, please refer to the Google Drive.

b) Recording

1. Record the cleaning of the sets in the Component Cleaning Logbook. This record is filed away when the page is full. 

Product Decontamination - Component Cleaning Instruction Link

If a cleaning agent without a disinfectant effect is used, separate disinfection must be carried out after manual cleaning. (Order: Decontamination for staff protection cleaning, disinfection). Equipment: Commercially available disinfectant authorized for use with medical products from the VAH list. Manufacturer’s information, e.g. concerning concentration, temperature and exposure time should be followed. The steps described in the table above also apply. 

8.3 Drying

See table above

8.4 Checking, maintenance and inspection

1. 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/disinfection cycles should be repeated.

2. Any instruments with an attached movable mechanism should be treated with a commercially available lubricant authorized for surgical instruments that can be sterilized.

3. The mobility of movable parts should be checked to ensure that the planned sequence of motion can be completely carried out.

4. In the case of instruments which can be reassembled into larger units, check whether the single parts can be put together easily.

8.5 Packaging

1. 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

2. 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 to the standards.

A record of the cleaning is with the details of the components and the date of cleaning a “Cleaning of Device” logbook,

Prior to dispatch the Loan sets are configured and dispatched according to SOP. The loan sets are placed into a black bin marked CLEAN, to preserve the cleanliness for delivery to the hospital.

On return the loan sets are placed into a black bin marked DIRTY, to ensure the safety of the goods and the staff.

9. Risk Based Approach

In the event of non compliance follow SOP  NON CONFORMANCE CORRECTIVE ACTION

Risk Based Approach Report

[Risk Assessment to is found in SOP PREVENTIVE ACTION RISK ASSESSMENT   refer Document]

9.1 Trend Analysis and Continual Improvement

The analytical reviews of internal audits, and any other quality related matters, are reported to management and as part of the input from Data Analysis 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.

10. Revision History

Revision 16, 12.09.2025 -SZ - updating the cleaning instruction 8.2. 

Revision 15  removal of automatic washing 

Revision 14, 04.06.2024 - BN - approved by HM

Revision 13, 18.05.2022 - NT - approved by HM

Revision 12, 10.12.2021 - NT  - adding information of point 5: Definition

Revision 11, 17.11.2021 - NT - signed off from TNA

Revision 10, 03.03.2021 (TNA) New format with Responsibilities, Risk based approach, Approval and Records added and new googlesite format.   Amending links and forms

Revision 9, Digitally signed on 21.10.2019 by NT

Revision 1-8, unknown due to googlesite change to new googlesite

11. Records

Name                           Retained by/ in Retention period Hard copies Destroyed by

Component Cleaning Logbook             google site indefinite                   n/a

Product Decontamination Work Instruction   google site indefinite   n/a

Quarantine List google site indefinite n/a