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Products to X-ray People for Security

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Technical Electronic Product Radiation Safety Standards Committee. May 22, 2002. ANSI N43.17. Radiation Safety for Personnel Security Screening Systems Using X-rays ... – PowerPoint PPT presentation

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Title: Products to X-ray People for Security


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 (lt 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) _at_ 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
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15
Transmission X-Ray Products
16
Transmission X-Ray(Conpass Body Scanner)
Manufactured by MMC International
17
Transmission X-Ray
18
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 lt 0.5 mrem per hour
  • Note Other Systems Exist

19
Mfrs Proposed Uses
  • Passenger Control
  • Diamond Mines
  • Prisons
  • Public Offices
  • Banks
  • Etc.

20
Issue
  • Non-medical Exposure to Ionizing Radiation
  • Linear no threshold model
  • Societal benefit from increased security

21
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

22
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

23
Transmission vs. Backscatter
  • X-Ray Transmitted Through the Subject
  • Image Interpretation Significantly More Complex
  • Adjustable Technique Factors (More Complex)
  • 100x More Dose to Subject

24
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)

25
FDAs Proposed Response
  • Guidance Document
  • Radiation Safety Recommendation
  • Mandatory Performance Standard
  • New Instruments
  • Suggested State Regulations

26
Proposed Mandatory Standard
  • Based on ANSI N43.17
  • Dose Limit
  • Interlocks
  • Labeling Indicators
  • Controls
  • Product Performance Only
  • Use Covered in a Radiation Safety Recommendation

27
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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