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Products to X-ray People for Security

Products to X-ray People for Security. Presented to the : Technical Electronic Product Radiation Safety Standards Committee May 22, 2002. ANSI N43.17 Radiation Safety for Personnel Security Screening Systems Using X-rays. Secure 1000. Manufactured by Rapiscan Products Inc. Bodysearch.

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Products to X-ray People for Security

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  1. Products to X-ray People for Security Presented to the: Technical Electronic Product Radiation Safety Standards Committee May 22, 2002

  2. ANSI N43.17 Radiation Safety for Personnel Security Screening Systems Using X-rays

  3. Secure 1000 Manufactured by Rapiscan Products Inc.

  4. Bodysearch Manufactured by American Science and Engineering, Inc.

  5. Chronology • Sep. 1998: TEPRSSC Recommends a • Mandatory Standard • Apr. 1999: FDA Proposes New Project to • ANSI/HPS N43 • Nov. 1999: N43.17 TG Convenes • June 2001: Draft Standard Submitted to • N43 Committee • Apr. 2002: Final ANSI Approval

  6. Summary of Main Requirements • Subject dose limits: • 0.1Sv (10 µrem) Effective Dose per Scan • 250 Sv (25 mrem) per Year • Benefit vs. Risk & Negligible Individual • Dose (< 10 µSv/y) • Subject Informed of the X-Ray Exposure • and Associated Risk

  7. 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

  8. Summary of Main Requirements • Operator Training • Manufacturer Records • User Facility Records

  9. Informative Annexes • Risks and Rationale • Measurement Protocol and Estimation • of Effective Dose

  10. Transmission X-Ray Products

  11. Transmission X-Ray(Conpass Body Scanner) Manufactured by MMC International

  12. Transmission X-Ray

  13. 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

  14. Mfr’s Proposed Uses • Passenger Control • Diamond Mines • Prisons • Public Offices • Banks • Etc.

  15. Issue • Non-medical Exposure to Ionizing Radiation • Linear no threshold model • Societal benefit from increased security

  16. 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

  17. 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

  18. Transmission vs. Backscatter • X-Ray Transmitted Through the Subject • Image Interpretation Significantly More Complex • Adjustable Technique Factors (More Complex) • 100x More Dose to Subject

  19. 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)

  20. FDA’s Proposed Response • Guidance Document • Radiation Safety Recommendation • Mandatory Performance Standard • New Instruments • Suggested State Regulations

  21. Proposed Mandatory Standard • Based on ANSI N43.17 • Dose Limit • Interlocks • Labeling & Indicators • Controls • Product Performance Only • Use Covered in a Radiation Safety Recommendation

  22. Discussion • Societal Benefit vs. Risk • Appropriate Use? • Scope of Standard • What Products? • Alternatives Based on Intended Use? • Controls – Fixed or Automatic?

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