216 R.I. Code R. 216-RICR-40-20-5.13

Current through December 26, 2024

Section 216-RICR-40-20-5.13 - Emerging and Future Technologies

A. Each registrant must develop, implement, and maintain a dedicated quality management program to control the processes used to administer therapeutic radiation with newly acquired, FDA-cleared emerging technologies or previously unused features of a future technology system.

B. Implementation and on-going clinical use of the emerging technology or new features must include:

1. An explicit strategy to ensure quality of processes and patient safety.

2. Approval from facility management and the radiation oncology safety team before the technology arrives and/or new features are used.

C. The quality management program must be developed by the radiation oncology safety team.

D. The quality management program must address, at a minimum:

1. Education and training about the new technology and/or features;

2. A system and timeline for on-going competency assessment of all registrant staff involved with the planning or administration of therapeutic radiation to patients or human research subjects;

3. A system for real-time recording of on-going issues related to the technology and clinical use of the new technology and/or features;

4. A strategy for timely investigation and adjudication of accidents and process deviations that may be captured in the system developed in § 5.13(B)(1) of this Part;

5. A strategy for routine review at intervals not to exceed thirteen (13) months of the clinical use of the new technology and/or features which includes an assessment of the current use compared to § 5.13(B) of this Part and plan to either update the clinical use plan or steps to bring the clinical use back into alignment with § 5.13(B) of this Part;

6. A strategy to ensure quality of equipment functions;

7. An explicit strategy for ensuring quality after hardware and software updates and after equipment repair.

E. The quality management program must be in accordance with current published recommendations from a recognized national professional association with expertise in the use of therapeutic radiation technologies. In the absence of a protocol published by a recognized national professional association, the manufacturer's protocol or equivalent quality, safety, and security protocol must be followed.

F. New technology issues should be reported through the vendor/manufacturer, applicable regulatory agency alerts, and/or customer service bulletins and be reviewed and addressed via a documented reporting system.

216 R.I. Code R. 216-RICR-40-20-5.13

Adopted effective 1/1/2019
Amended effective 5/25/2022
Amended effective 11/27/2023