Products to X-ray People for Security

Presented to the:

Technical Electronic Product Radiation Safety Standards

CommitteeMay 22, 2002

ANSI N43.17 Radiation Safety for Personnel

Security Screening Systems Using X-rays

Secure 1000

Manufactured by Rapiscan Products Inc.

Bodysearch

Manufactured by American Science and Engineering, Inc.

• 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

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

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

Summary of Main Requirements

• Operator Training• Manufacturer Records• User Facility Records

Informative Annexes

• Risks and Rationale• Measurement Protocol and Estimation

of Effective Dose

Transmission X-Ray Products

Transmission X-Ray(Conpass Body Scanner)

Manufactured by MMC International

Transmission X-Ray

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

Mfr’s Proposed Uses

• Passenger Control

• Diamond Mines

• Prisons

• Public Offices

• Banks

• Etc.

Issue

• Non-medical Exposure to Ionizing Radiation

Linear no threshold model

Societal benefit from increased security

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

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

Transmission vs. Backscatter

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

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)

FDA’s Proposed Response

• Guidance Document

• Radiation Safety Recommendation

• Mandatory Performance Standard

• New Instruments

• Suggested State Regulations

Proposed Mandatory Standard

• Based on ANSI N43.17• Dose Limit• Interlocks• Labeling & Indicators• Controls• Product Performance Only

Use Covered in a Radiation Safety Recommendation

Discussion

• Societal Benefit vs. Risk

• Appropriate Use?

• Scope of StandardWhat Products?

Alternatives Based on Intended Use?

Controls – Fixed or Automatic?