A Profile of the Radiation Source Sector Committee on Radiation Source Use and Replacement

1. A Profile of the Radiation Source Sector Committee on Radiation Source Use and Replacement The National Academies Washington, D.C. July 10, 2006 Grant Malkoske, P.Eng. Chairman, ISSPA and GIPA

2. Innovation in radioisotope applications • Radiation technology is used to improve global health • Radiation technology provides important industrial benefits • Radioisotopes are at the heart of industry safety systems and counter-terrorism • The radioisotope sector is broad, diverse with a culture of safety and security.

3. The radioisotope sector profile Why are radiation sources used? • Dose penetration ability provides for development of medical devices that cannot be sterilized by other means • Ability to perform in aggressive environments precludes known alternative technologies • Throughput performance characteristics provide a cost effective technology • Regulatory oversight provides for safe and secure application of technology

4. The radioisotope sector profile What are radiation sources used for? • Medical treatment and diagnostics • Sterilization of single-use medical devices • Research and development • Food safety and agricultural applications • Industrial and safety applications • Law enforcement & counterterrorism

5. Cancer Treatment • U.N. declares that cancer is a “silent crisis” in the developing world and the need to treat cancer is rising • Cancer takes more lives than HIV/AIDS, TB and malaria, combined • Cobalt-60 teletherapy delivers 15 million treatments annually worldwide in 50 countries • Over 1200 units installed globally • Brachytherapy techniques employ Iridium-192, Iodine-125, Palladium-103, Strontium-90 for novel treatment applications

6. Blood Irradiator • Treat blood to prevent TA-GVHD • Over 750 units installed in 50 countries • High throughput and dose delivery compared to x-ray technology • Reliant on availability of high activity Caesium-137 sources

7. Sterile Single-Use Medical Devices • Cobalt-60 radiation sources are depended upon to sterilize some 45% of all single-use medical supplies in the world • 40% in US • An estimated 80% of all surgeons’ gloves are sterilized with cobalt-60 • 50% of the world’s sterile single-use medical devices come from the US

8. Cobalt-60 Sterilization Capacity • Sterilization capacity is based on projected demand (growing 7-15% annually) and isotope decay (currently 19 MCi annually) • No excess cobalt-60 is maintained in irradiators • Irradiators operate on a 24/7 schedule to optimize utilization of cobalt-60 • There are approximately 152 MCI cobalt-60 installed in the US • Increase in sterilization demand for Health and Human Services would require additional cobalt-60 • Used to sterilize over 200MM cu. ft. of single-use medical devices annually

9. Medical Device Inventories • Most medical device companies practice “Just In Time (JIT)” manufacturing • Sterile device inventories in the order of 30 to 40 days are common • Low inventories help control healthcare costs • Disruption of the supply of cobalt-60 will result in backorders of sterile single-use devices

10. Impact on Healthcare • Only healthcare providers can define life threatening medical conditions • Backorders will result in shortages of critical medical devices • Healthcare facilities do not have substitutes for these medical devices • Shortages of medical devices can result in irreversible medical complications including death

11. Importance of cobalt-60 • Certain products can only be sterilized with cobalt-60: • Biological materials: tissue for transplant, plasma, serum • Alcohol swabs • Sealed medical devices: used for blood collection, endoscopic procedures, and for use with certain catheters • Many products are optimally sterilized with cobalt-60

12. Sampling of products sterilized with cobalt-60 Saline solution Scalpel blades Seafood Serum tubes Shampoo Specimen containers Spices Stopcocks Surgical gloves, gowns, kits and drapes Surgical needles Surgical scrub brushes, surgical sets Surgical marking pens Surgical staplers Suture removal tray and sutures Swabs and swab special kits Talc Tampons Test tubes Towels Tracheal suction kits Transfusion sets Transplant carrying containers Tubing and tube connectors Urine bags Urine sample collection kits Valves Vascular grafts Water And more Electrodes Enzymes Eye droppers and eye pads Filter clamps and filters First aid packs Fruits and vegetables Glove powder Hypodermic syringes Implants Infusion sets Intravenous sets Iron oxide pigment Juice containers Kidney transplant kits Laboratory animal bedding Laboratory animal feed Laboratory diagnostic kits Lab ware Lubricating jelly Mastitis test kit Needle counting systems Neonatal diapers Nutraceuticals Oxygenators Pet food Petri dishes Pharmaceuticals Pipettes Poultry Acupuncture and electrolysis needles Astronaut food Baby pacifiers, baby bottles Bandages Beakers Beef Bioassay dishes Bladder irrigation sets Blankets Blood agar (processed in frozen state) Blood collection tubes Bone joints Bottle and cups Brushes Burn ointments, burn pads Catheter collars Centrifuge tubes, clamps Coffee Contact lens, saline solution Culture flasks, tubes Cosmetics Diagnostic strips Dialysis units Dialyzers Disposable thermometers Dog chews Donor sets Drainage systems Dressings and dressing pads

13. Production Irradiator

14. Other Sterilization Methods • Devices are designed specifically for cobalt-60 sterilization • Other sterilization methods may require a design and/or material changes • Other sterilization methods would require evaluation and testing • Changes to products and/or sterilization methods require a new submission to FDA • Testing to determine appropriate changes, followed by submission review and approvals take months and years and add costs to health care system

15. Food Safety and Agricultural Applications • Food Safety • Relied upon to enhance food safety & preservation • Used by fruit-producing nations to control export of crop-destroying insects • Used by food producers to eliminate microbes from food packaging • Used to eliminate pathogens and extend shelf-life of many foods • Well over 80% of spices used in instant noodles in Asia are irradiated.

16. Food Safety and Agricultural Applications • Agriculture • Crop production (fertilizer efficiency, moisture content) • Crop improvement (disease resistant crops, improved yields) • Animal husbandry (feeding, reproduction, disease diagnosis) • Insect control

17. Industrial Applications • Radiography • Oil well logging • Gauges

18. Radiography • Well established NDT method • Welds, castings, engines, pipelines • Fixed, portable and self propelled equipment for various applications • Equipment is rugged and designed to use in remote and hostile environments

19. Radiography equipment

20. Oil well logging • Aggressive environments in drilling operation preclude use of known alternative technologies • Gauges • Tracer investigations (flow rates, by-pass streams, process mixing, leak detection, wear & corrosion) • Metal coating, ore processing • Thickness, density, height requirements • Statistical measurement precision from sources greatly exceeds other technologies enabling cost control and minimizing process waste

21. Law Enforcement & Counterterrorism • Explosives detection at airports and other monitoring points • Drug and gas detection • Crime analysis • Finger printing, counterfeiting

22. Safety and Security of Radiation Sources • Continuous design development to improve source safety in the case of fire or explosion (e.g. dispersion resistant designs) • Industry engages in life-cycle management activities to minimize the amount of unused material in circulation and avoid loss of control • Extensive monitoring and tracking is associated with movements of these materials to avoid the risk of them being diverted • Security measures meet IAEA guidelines and USNRC requirements

23. RecommendationIndustry recommends that the National Academies Committee consider the following perspectives in performing the study: • Radiation sources are generally selected as they provide the only or optimal technology for the intended benefit • Other technologies may be ineffective or add cost burden • Engage industry groups and users in a broad based consultation • To understand the technology pull, benefits and risks