products to x-ray people for security presented to the : technical electronic product radiation...
TRANSCRIPT
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Products to X-ray People for Security
Presented to the:
Technical Electronic Product Radiation Safety Standards
CommitteeMay 22, 2002
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ANSI N43.17 Radiation Safety for Personnel
Security Screening Systems Using X-rays
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Secure 1000
Manufactured by Rapiscan Products Inc.
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Bodysearch
Manufactured by American Science and Engineering, Inc.
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• Sep. 1998: TEPRSSC Recommends a Mandatory Standard
• Apr. 1999: FDA Proposes New Project toANSI/HPS N43
• Nov. 1999: N43.17 TG Convenes• June 2001: Draft Standard Submitted to
N43 Committee• Apr. 2002: Final ANSI Approval
Chronology
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Summary of Main Requirements
• Subject dose limits: 0.1Sv (10 µrem) Effective Dose per Scan250 Sv (25 mrem) per Year
• Benefit vs. Risk & Negligible IndividualDose (< 10 µSv/y)
• Subject Informed of the X-Ray Exposureand Associated Risk
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Summary of Main Requirements
• Radiation Leakage:2.5 Sv/h (0.25 mrem/h) @ 30 cm from Surface
• Bystander Protection:Inspection Zone — 20 Sv/h (2 mrem/h)
• Safety Interlocks• Labeling & Indicators
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Summary of Main Requirements
• Operator Training• Manufacturer Records• User Facility Records
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Informative Annexes
• Risks and Rationale• Measurement Protocol and Estimation
of Effective Dose
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Transmission X-Ray Products
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Transmission X-Ray(Conpass Body Scanner)
Manufactured by MMC International
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Transmission X-Ray
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Specifications(Conpass Body Scanner)
• Scanning Time: 10 Seconds• Anode Voltage: 70 - 200 KvP with 10 kV Step• Tube Current: 1- 3 mA with 0.5 mA Step• Dose to a Subject: 0.5 mrem per Inspection• Dose to Operator < 0.5 mrem per hour• Note: Other Systems Exist
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Mfr’s Proposed Uses
• Passenger Control
• Diamond Mines
• Prisons
• Public Offices
• Banks
• Etc.
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Issue
• Non-medical Exposure to Ionizing Radiation
Linear no threshold model
Societal benefit from increased security
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Principles
• 1 mrem Negligible Individual Dose
• 100 mrem Annual Public Effective Dose Limit
• Individual or Society Receives a Clear and Compelling Benefit that Outweighs Risk
• Dose as Low as Reasonably Achievable
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Negligible Individual Dose
• NCRP Recommends: An Annual Effective Dose Of 1000 µRem Be Considered A Negligible Individual Dose Per Source Or Practice
Magnitude of the dose
Difficulty in detection and measurement of dose and health effects
Estimated risk for the mean and variance of natural background radiation exposure levels
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Transmission vs. Backscatter
• X-Ray Transmitted Through the Subject• Image Interpretation Significantly More Complex• Adjustable Technique Factors (More Complex)• 100x More Dose to Subject
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Regulatory Status
• They are Not Medical Devices
• They are Electronic Products that Emit Radiation
• Currently No Federal Performance Standard Applies to these Products (21 CFR 1010 through 1050)
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FDA’s Proposed Response
• Guidance Document
• Radiation Safety Recommendation
• Mandatory Performance Standard
• New Instruments
• Suggested State Regulations
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Proposed Mandatory Standard
• Based on ANSI N43.17• Dose Limit• Interlocks• Labeling & Indicators• Controls• Product Performance Only
Use Covered in a Radiation Safety Recommendation
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Discussion
• Societal Benefit vs. Risk
• Appropriate Use?
• Scope of StandardWhat Products?
Alternatives Based on Intended Use?
Controls – Fixed or Automatic?