The new article focuses on fluoroscopic X-ray systems and the regulatory requirements established, particularly changes effective on June 10, 2006, providing guidance on compliance, system modifications, and operational features.
Table of content
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to radiation control regulations. The document is intended to provide additional clarification and recommendations to be taken into consideration by manufacturers of diagnostic X-ray equipment and other parties involved in order to ensure compliance with the regulatory requirements set forth under the existing legal framework.
At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the relevant legislation and has been agreed with the authority in advance.
In particular, the document provides answers to the most important questions associated with fluoroscopic x-ray systems and the regulatory requirements they are subject to.
Applicability of New Requirements
Question: Are new requirements applicable when post-2006 components are added to pre-2006 systems?
Answer: No. The updated requirements apply only if:
- The entire system is certified with a post-June 10, 2006 manufacturing date.
- All certified components in the system were manufactured on or after June 10, 2006.
For additional details, the interested parties are advised to refer to the relevant FDA guidance on fluoroscopic equipment requirements.
Display and Indication Standards
Last Image Hold (LIH) Display:
Question: How should systems indicate whether the displayed image is the LIH or live fluoroscopy?
Answer: A clear and distinguishable indication (e.g., wording, icons, or images) prominently displayed on the image or display area satisfies the requirement. Explanations in user manuals must complement this display (21 CFR 1020.32(j)(3)).
Air Kerma Rate (AKR) and Dose Area Product (DAP):
Question: Does displaying DAP and cumulative DAP meet the requirement for AKR display?
Answer: No. DAP and cumulative DAP do not provide equivalent information and do not fulfill the requirement for displaying AKR and cumulative air kerma (21 CFR 1020.32(k)).
Tube Classification and Indicators
Question: Is an under-table tube used for spot-film exposures considered a radiographic tube?
Answer: Yes. However, 21 CFR 1020.31(k), requiring an indicator for tube selection, does not apply since this tube is not operated with a shared exposure switch.
Air Kerma Rate Compliance
Question: Can a system momentarily exceed 88 mGy per minute during operator adjustments?
Answer: No. Exceeding 88 mGy per minute is allowed only during:
– High-Level Control (HLC) mode.
– Fluoroscopic image recording.
HLC mode requires activation through a special manual switch, an audible signal, and compliance with 21 CFR 1020.32(d)(2)(ii)(C).
High-Level Control (HLC) Mode Activation
Question: Can the HLC mode operate without continuous manual activation?
Answer: No. Continuous manual activation (e.g., hand or foot switch) is required to avoid indefinite activation of HLC, ensuring compliance with 21 CFR 1020.32(d)(2)(ii)(C).
Continuous Indication of Tube Parameters
Question: Is a label indicating tube current compliant with 21 CFR 1020.32(f)?
Answer: No. Continuous real-time indication of tube potential and current during fluoroscopic exposure is mandatory. A label is insufficient and does not meet regulatory requirements.
Modifications to Older Equipment
Question: Can manufacturers remove the 5-minute preset timer from older equipment upon request?
Answer: Yes, but only if the system is modified to meet new requirements under 21 CFR 1020.32(h)(2). The modification must include:
- Compliance with updated regulations.
- A label stating, “Modified to comply with 21 CFR 1020.32(h)(2)”.
Conclusion
In summary, the present FDA guidance covers the following key points:
- Applicability: New fluoroscopy requirements apply only to post-2006 certified systems or those with all components manufactured after June 10, 2006.
- Display Requirements: Clear indication of LIH or live fluoroscopy images and continuous AKR displays are mandatory.
- Compliance and Modification: Systems must not exceed AKR limits except in HLC mode, and older systems can be modified only if they meet updated standards.
- Operational Standards: Continuous manual activation for HLC and real-time tube parameter indication are essential for compliance.
The relevant regulations described in the guidance are intended to ensure safety, clarity, and effectiveness in fluoroscopic X-ray systems.
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