Safety Considerations for Hand-Held X-Ray Equipment: Radiation Protection and Testing Requirements
This guidance addresses safety considerations for hand-held X-ray equipment, focusing on protecting operators from two main radiation exposure sources: leakage radiation through equipment housing and backscatter radiation from patients and nearby structures. It provides recommendations for manufacturers and FDA staff regarding safety procedures and information that should be provided to end users.
What You Need to Know? 👇
What are the main radiation exposure risks for operators using hand-held X-ray equipment?
Hand-held X-ray systems pose two primary exposure risks: leakage radiation from the equipment housing and backscatter radiation from patients and nearby structures. The operator’s proximity to the source assembly increases these exposure concerns compared to traditional fixed X-ray systems.
What federal regulations govern hand-held X-ray equipment performance standards?
Hand-held X-ray equipment must comply with 21 CFR 1020.30-1020.33, which sets performance requirements including radiation leakage limits of 0.88 mGy (100 mR) per hour at one meter distance. Manufacturers must also provide adequate safety instructions for unique equipment features.
How can manufacturers reduce operator radiation exposure in hand-held X-ray devices?
Manufacturers should incorporate sufficient shielding around the source assembly, provide external shields or remote operation capabilities, measure exposures at operator contact points, and include comprehensive safety precautions in user instructions to minimize radiation exposure risks.
Are there state-level restrictions on hand-held X-ray equipment use?
Yes, many states regulate X-ray equipment use under their own regulations based on CRCPD guidelines. Some state programs completely prohibit hand-held X-ray equipment use. Users must check with their state radiation control program for specific requirements and restrictions.
What safety precautions should be included in hand-held X-ray equipment user instructions?
Instructions must include exposure measurements near the unit, designation of occupancy zones, recommendations for personnel monitoring devices, protective equipment like lead-lined gloves, procedural controls limiting exposures, and guidance for protecting patients and bystanders during examinations.
What international standards apply to hand-held X-ray equipment radiation safety?
The International Electrotechnical Commission (IEC) standard 60601-1-3 provides radiation safety requirements for diagnostic X-ray equipment. Additionally, NCRP Report 145 offers voluntary guidelines particularly relevant to handheld equipment used in dental applications.
What You Need to Do 👇
Recommended Actions
- Conduct comprehensive radiation exposure measurements at various distances and positions
- Design and implement adequate shielding in the device housing
- Develop external shielding solutions or remote operation capabilities
- Create detailed safety documentation including exposure data and safety procedures
- Prepare comprehensive labeling addressing all safety aspects
- Verify compliance with state-specific regulations where the device will be marketed
- Establish recommended exposure limits and safety protocols for operators
- Develop training materials for proper use of safety features
- Consider implementing monitoring systems for tracking exposure levels
- Create guidelines for protective equipment use
Key Considerations
Non-clinical testing
- Measure exposure levels at distances closer than 1m from the unit
- Perform exposure measurements at locations representative of operator positioning
- Report exposure measurements at handgrips and control devices locations
Labelling
- Provide adequate instructions for radiological safety procedures
- Include exposure information near and around the unit in operator instructions
- Describe safety procedures and precautions necessary to reduce operator exposure
- Include information about exposure hazards and safety precautions for patients and assisting personnel
Safety
- Limit radiation leakage from x-ray source assembly to air kerma of 0.88 mGy in one hour at one meter distance
- Incorporate physical means to protect operator from leakage radiation
- Include sufficient shielding surrounding the source assembly
- Provide external shielding or means to increase distance between operator and unit
- Consider implementing an equipment stand and remote switch option
Other considerations
- Consider state-specific regulations as some states may not allow hand-held x-ray equipment
- Recommend appropriate personnel monitoring and protective equipment
- Consider implementing procedural controls to limit exposure numbers per operator
Relevant Guidances 🔗
- Marketing Clearance Requirements for Diagnostic Ultrasound Systems and Transducers
- X-Ray Equipment Performance Standards and Radiation Safety Requirements
- Safety and Performance Requirements for Cabinet X-ray Security Screening and Industrial Quality Control Systems
- Radiation Control Requirements and Interpretations for Diagnostic X-ray Equipment
Related references and norms 📂
- IEC 60601-1-3: Medical electrical equipment – Part 1-3: General requirements for basic safety and essential performance – Collateral Standard: Radiation protection in diagnostic X-ray equipment