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INTRODUCTION

In clinical practice there are many situations, where an assistant or the surgeon himself opens a sterilized packet to find that the size is wrong. Alternatively it may also happen that during or after opening the sterilie packet, the prosthesis / medical products falls to the ground inside the operating room or gets contaminated. In Thailand and in many developing countries, this a real time problem. In this event the cost of the opened prosthesis has to be born by the patient or the surgeons/assistant. The Bangkok Biomaterial Center with the advantage of an in-house Gamma Ray Cobalt60 source, has come out with a new service for the medical community and i.e. to resterilize this medical product. In addition to that, this service is open for other medical professionals, who desire to have their research or clinical work / items to be sterilized by Gamma Rays. This idea of resterilizing or sterilizing on request came after the Center in co-ordination with International Atomic Energy Agency, Vienna has done irradiation of 4 batches of Amniotic Membranes for the Myanmar Tissue Bank. However sterilization is done, keeping in mind nature of the product and effect of irradiation on the chemical structure of the product.

OBJECTIVE

1. To help the medical community in Thailand as well in the neighbouring countries with sterilizing and resterilizing of medical products on request.

2. To add up to the quest of innovations.

3. To effectively utilize Gamma Ray Irradiation source facility at the Center.

EQUIPMENT DETAILS Gamma Chamber - 5000

                             Initial Strength of the source. 12000 Ci

                             Year of installation: 1997

 

SUPPLIER        BRIT, INDIA.

 

RESPONSIBLE PERSON : BBC Technical Assistant (TA)

 

PART - A: Pre-irradiation

I . Examine the product received for irradiation, type of product and number of packets.

2. Modify the packets with vacuum packaging (double) with polyethylene packet (each).

Keep 5-6.0 cm free space at the top of the packets.

3. Place the LABEL on the packets (2nd layer).

4. Paste the RADIATION INDICATOR on the packet (each).

5. Fill up Form IFL- I (Irradiation form) as well as in a register book with irradiation Batch No.

6. Place packets into the irradiation container in vertical position.

7. Place Perspex dosimeters at D. position (middle of the left wall of the container) and Dma

Position (middle of the bottom) in vertical position (2 dosimeters per location).

8. Send to the irradiation /gamma chamber room.

PART - B: Irradiation.

I . Wear film badge, bring along the survey meter, irradiation container and main door Key (* 2 keys. I with TA, I with admin.-combines both keys to open the main door and fill up protocol log book).

2. Unlock gamma room.

3. Measure the radiation level (pre irradiation) of the gamma source room by survey meter.

4. Fill up the gamma room log book (check in entry) indicating date, time, purpose, accomplices, radiation level of the room and signature of the responsible person.

5. Remove the chamber lid by turning the lever.

6. Place the container in the chamber.

7. Close the chamber lid followed by closing the lever.

8. Insert the machine key into the key hole on the control panel.

9. Switch ON electrical circuit breaker.

10. Manual control.

10.1. Turn ON the key manual.

10.2. Press DOWN button (Red) for loading.

10.3. Record - starting time (in IRI form).

10.4. Let the material expose to radiation (pre determined time).

10.5. After complete the irradiation cycle according to “time of exposure” {as on table prepared by Office of Atomic Energy for Peace (OAEP)} press UP button (Green).

10.6. Record the finish time (11FL 1).

10.7. Turn OFF the manual key.

10.8. Switch OFF the electrical circuit breaker.

10.9. Open the chamber lid by turning the lever.

10.10. Remove the product container.

10.11. Close the chamber lid by closing the lever.

10.12. Measure the radiation level (post irradiation) of the gamma source room.

11. Fill up the log book & IR- I form indicating check out entry, radiation level of the room

(post irradiation) and signature (TA). The form counter signed by responsible authority.

12. Lock the gamma room.

 

PART - C : Post Irradiation.

I . Bring the irradiated product/sample (with container) to BBC.

2. Remove product/sample and check - packaging material, sealing status and product status.

3. Check radiation indicator color.

4. Keep the irradiated product at room temperature safely & arrange to dispatch as early as possible.

5. Dosimeters send to OAEP for analysist measurement.

6. Results collect and keep for documentation.

 

 

BANGKOK BIOMATERIAL CENTER

UNDER THE PATRONAGE OF PRINCESS GALYANIVADHANA

                                                           FORM: IR-1

IRRADIATION SERVICE FORM

 

Type of product                  :                                    Irradiation batch no    :

Date                              :                                             Technical assistant        :

Type of packaging              :                                       Packaging condition      :

IRRADIATION

Date/time start               :                                                 Date/time finish          :

Irradiation dose applied    :                                           Exposure time              :

 

POST IRRADIATION EXAMINATION

Sample/product condition (overall)     :

Product status (specific)              :

Packaging material                  :

Sealing status                      :

indicator (color)              :

Storage condition and temperature :

 

DOSIMETRY

Type of Dosimeter ...............................:

Date (sending to OAEP) ............................:

Date (received from OAEP) .......................:

Absorbed dose Dmax kGy) .........................:                                                Dmin (kGy) :

Calculation of DUR (Dose uniformity Ratio)       :

Comments                                              :

 

AUTHORIZATION

Fill up by     :

Checked by  :

Authorized by  :

Date             :

                                                                                                                            BBC irradiation service form@2000

 

resteri-1.jpg (9987 bytes)                        resteri-2.jpg (8216 bytes)

Hip Prosthesis Vacuum packed with label and cover box                  Protocol for resterilization of medical products

 

resteri-3.jpg (11088 bytes)                  resteri-4.jpg (8889 bytes)

Two components of hip prosthesis packed and                                 Resterilized medical product ready for use

kept ready for irradiation        

                                    

 

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