Institut für Kern- und Hadronenphysik Radiation Source ELBE.
A Profile of the Radiation Source Sector Committee on Radiation Source Use and Replacement
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Transcript of A Profile of the Radiation Source Sector Committee on Radiation Source Use and Replacement
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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
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Innovation in radioisotope applicationsInnovation 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.
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The radioisotope sector profileThe 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
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The radioisotope sector profileThe 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
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Cancer TreatmentCancer 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
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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
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Sterile Single-Use Medical DevicesSterile 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
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Cobalt-60 Sterilization CapacityCobalt-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
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Medical Device InventoriesMedical 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
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Impact on HealthcareImpact 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
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Importance of cobalt-60Importance 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
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Acupuncture and electrolysis needlesAstronaut foodBaby pacifiers, baby bottlesBandagesBeakersBeefBioassay dishesBladder irrigation setsBlanketsBlood agar (processed in frozen state)Blood collection tubesBone jointsBottle and cupsBrushesBurn ointments, burn padsCatheter collarsCentrifuge tubes, clampsCoffeeContact lens, saline solutionCulture flasks, tubesCosmeticsDiagnostic stripsDialysis unitsDialyzersDisposable thermometersDog chewsDonor setsDrainage systemsDressings and dressing pads
ElectrodesEnzymesEye droppers and eye padsFilter clamps and filtersFirst aid packsFruits and vegetablesGlove powderHypodermic syringesImplantsInfusion setsIntravenous setsIron oxide pigmentJuice containersKidney transplant kitsLaboratory animal beddingLaboratory animal feedLaboratory diagnostic kitsLab wareLubricating jellyMastitis test kitNeedle counting systemsNeonatal diapersNutraceuticalsOxygenatorsPet foodPetri dishesPharmaceuticalsPipettesPoultry
Saline solution Scalpel bladesSeafoodSerum tubesShampooSpecimen containersSpicesStopcocksSurgical gloves, gowns, kits and drapesSurgical needlesSurgical scrub brushes, surgical setsSurgical marking pensSurgical staplersSuture removal tray and suturesSwabs and swab special kitsTalcTamponsTest tubesTowelsTracheal suction kitsTransfusion setsTransplant carrying containersTubing and tube connectorsUrine bagsUrine sample collection kitsValvesVascular graftsWaterAnd more
Sampling of products sterilized with cobalt-60
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Production Irradiator
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Other Sterilization MethodsOther 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
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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.
Food Safety and Agricultural Applications
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Food Safety and Agricultural ApplicationsFood 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
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Industrial ApplicationsIndustrial Applications
Radiography Oil well logging Gauges
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RadiographyRadiography 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
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Radiography equipmentRadiography equipment
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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
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Law Enforcement & CounterterrorismLaw Enforcement & Counterterrorism
Explosives detection at airports and other monitoring points
Drug and gas detection Crime analysis Finger printing, counterfeiting
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Safety and Security of Radiation SourcesSafety 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
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RecommendationIndustry recommends that the National Academies Committee consider the following perspectives in performing the study:
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