ML19259A112
| ML19259A112 | |
| Person / Time | |
|---|---|
| Issue date: | 12/16/2019 |
| From: | Christian Einberg NRC/NMSS/DMSST |
| To: | Metter D Advisory Committee on the Medical Uses of Isotopes |
| KATIE Tapp MSST | |
| References | |
| Download: ML19259A112 (4) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 December 16, 2019 MEMORANDUM TO: Darlene Metter, M.D., Chairman Advisory Committee on the Medical Uses of Isotopes FROM: Christian Einberg, Branch Chief Medical Safety and Events Assessments Branch /RA/
Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
SUBJECT:
RESPONSES TO THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES RECOMMENDATIONS ON DRAFT YTTRIUM-90 MICROSPHERE BRACHYTHERAPY SOURCE AND DEVICE LICENSING GUIDANCE, REVISION 10 Below are the U.S. Nuclear Regulatory Commissions (NRC) staff responses to the recommendations on the draft Yttrium-90 Microsphere Brachytherapy Sources and Devices TheraSphere and Sir-Spheres Licensing Guidance, Revision 10 from the Advisory Committee on the Medical Uses of Isotopes (ACMUI). The ACMUI provided two sets of recommendations to the NRC staff on this licensing guidance, one on October 7, 2017, following review of the draft licensing guidance for public comment (Agencywide Documents Access and Management System [ADAMS] Accession No. ML17138A352) and one on May 9, 2019, following review of the final draft licensing guidance (ADAMS Accession No. ML19130A103).
- 1. ACMUI Recommendation: ACMUI recommends defining what manufacturers representative means to ensure the manufacturers trainer has the proper experience in providing training for items listed in the training and experience criterion A.3.iii.
Staff Response: Not Accepted. Revision 10 requires an authorized user to supervise training in all clinical topics necessary to ensure radiation safety. The staff determined that the other radiation safety topics could be provided by a manufacturers representative. To ensure licensing guidance consistency with vendor training requirements specified in Title 10 of the Code of Federal Regulations (10 CFR) 35.690, the staff did not define the training requirements of the manufacturer trainer. In addition, Revision 10 requires a written attestation similar to 10 CFR, Part 35 which requires an Authorized User (AU) or residency CONTACT: Katie Tapp, NMSS/MSST 301-415-0236
D. Metter 2 program director to attest that the individual has satisfactorily completed the requirements in criteria A and B in Section 5.1, AUs, and is able to independently fulfill the radiation safety-related duties as an AU for the type of Yttrium-90 (Y-90) microsphere requested.
- 2. ACMUI Recommendation: ACMUI suggest keeping three hands on cases for each type of microsphere delivery device. The Y-90 spheres are slightly different (glass or polymeric) and the delivery systems of the two devices have different characteristics. This will ensure that the user has documented experience with both device types.
Staff Response: Accepted. The licensing guidance states that the training should include at least three hands-on patient cases for each type of Y-90 microsphere requested.
- 3. ACMUI Recommendation: ACMUI recommends adding a phrase that a Radiation Safety Officer should be familiar with all devices used at the facility.
Staff Response: Accepted. The staff added the recommended phrase.
- 4. ACMUI Recommendation: ACMUI recommends adding a phrase to indicate unexpected dose or activity to an organ or tissue other than the treatment site that is caused by catheter placement during delivery of the y-90 microspheres is not considered shunting should be evaluated as a possible medical event to the end of the sentence.
Staff Response: Accepted. The staff added the recommended phrase.
- 5. ACMUI Recommendation: ACMUI suggests describing the site to be treated more specifically (left lobe, right lobe) in the written directive section.
Staff Response: Accepted. The guidance was updated to say that treatment site may be described as the lobe or segment that is intended to receive the Y-90 microspheres and the tissue that is expected to receive Y-90 microspheres due to shunting.
- 6. ACMUI Recommendation: ACMUI suggests changing tissue to tissues in the following phrase, anatomical description of the tissue intended to receive a radiation dose.
Staff Response: Not Accepted. Tissue is phrasing directly from 10 CFR 35.2.
- 7. ACMUI Recommendation: ACMUI recommends we define the term patient intervention in the guidance document.
Staff Response: Accepted. The guidance was updated to add the definition of patient intervention from 10 CFR 35.2.
- 8. ACMUI Recommendation: ACMUI recommends the addition of the term intended before treatment site in the phrase, organ or tissue other than the treatment site.
Staff Response: Not accepted. The current phrasing is consistent with 10 CFR 35.3045 (a)(1)(iii). Where possible, the staff stays as consistent as possible with the regulations when developing guidance for 10 CFR 35.1000 uses.
D. Metter 3
- 9. ACMUI Recommendation: ACMUI recommends that the syringes and syringe radiation shields labels should be explicit and include patient name, device type, dose and date, and treatment site, if feasible. The term radioactive drug should be changed to device type since these products are licensed as medical devices and not drugs.
Staff Response: Partially Accepted. Radioactive drug was changed to device throughout the guidance. However, the staff did not add the requirement that syringes and syringe radiation shield labels include the information requested by the ACMUI. Staff understands that physicians need to have clear visibility of the syringes and vials to ensure the Y-90 microspheres are being administered correctly and the administration needs to occur in a sterile field. Therefore, instead of directing a specific labeling requirement which could limit this visibility or cause a sterility issue, the staff updated the guidance to include a requirement for procedures to ensure licensees have high confidence that each administration is in accordance with the written directive, including verification of patient name prior to administration. This allows licensees the flexibility to develop the appropriate site-specific procedures to ensure the correct dose is given to the correct patient. This is consistent with manual brachytherapy regulations in 10 CFR 35.400.
ML19259A112 OFFICE MSST MSST MSST NAME KTapp LDimmick CEinberg DATE 10-4-19 10-7-19 12/16/19