Transcript Roles and Responsibilities of Manufacturers and Suppliers

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 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 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 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 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, Palladium103, Strontium-90 for novel treatment
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applications
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 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 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 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 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-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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Sampling of products sterilized with cobalt-60
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
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
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
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Production Irradiator
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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
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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 shelflife of many foods
– Well over 80% of spices used in instant
noodles in Asia are irradiated.
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Food Safety and Agricultural Applications
 Agriculture
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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 Applications
 Radiography
 Oil well logging
 Gauges
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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
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Radiography 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 & 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 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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Recommendation
Industry 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
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