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| number = ML23198A273 | | number = ML23198A273 | ||
| issue date = 07/19/2023 | | issue date = 07/19/2023 | ||
| title = Responses to the Advisory Committee on the Medical Uses of | | title = Responses to the Advisory Committee on the Medical Uses of Isotopes Recommendations on Draft Licensing Guidance for Superficial Manual Brachytherapy Civaderm Device | ||
| author name = Einberg C | | author name = Einberg C | ||
| author affiliation = NRC/NMSS/DMSST/MSEB | | author affiliation = NRC/NMSS/DMSST/MSEB | ||
| Line 16: | Line 16: | ||
=Text= | =Text= | ||
{{#Wiki_filter:UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 | {{#Wiki_filter:UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 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 Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards | ||
==SUBJECT:== | ==SUBJECT:== | ||
RESPONSES TO THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES RECOMMENDATIONS ON DRAFT LICENSING GUIDANCE FOR SUPERFICIAL MANUAL BRACHYTHERAPY CIVADERM DEVICE Below are the U.S. Nuclear Regulatory Commissions (NRC) staff responses to the recommendations and comments on the draft licensing guidance for the superficial manual brachytherapy CivaDerm device from the Advisory Committee on the Medical Uses of Isotopes (ACMUI). The ACMUI provided these recommendations and comments to the NRC staff on December 15, 2021, following review of the draft licensing guidance. The full report from the ACMUI can be found at Agencywide Documents Access and Management System Accession No. ML22021B299. | RESPONSES TO THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES RECOMMENDATIONS ON DRAFT LICENSING GUIDANCE FOR SUPERFICIAL MANUAL BRACHYTHERAPY CIVADERM DEVICE Below are the U.S. Nuclear Regulatory Commissions (NRC) staff responses to the recommendations and comments on the draft licensing guidance for the superficial manual brachytherapy CivaDerm device from the Advisory Committee on the Medical Uses of Isotopes (ACMUI). The ACMUI provided these recommendations and comments to the NRC staff on December 15, 2021, following review of the draft licensing guidance. The full report from the ACMUI can be found at Agencywide Documents Access and Management System Accession No. ML22021B299. | ||
1.ACMUI Comment: The Subcommittee agrees that CivaDerm should be licensed under 10 CFR 35.400 as it does not present any unique radiation safety issues not already covered by Part 35. | |||
Staff Response: No Action. | Staff Response: No Action. | ||
CONTACT: Katie Tapp, NMSS/MSST 301-415- | CONTACT: Katie Tapp, NMSS/MSST 301-415-0236July 19, 2023 Signed by Einberg, Christian on 07/19/23 | ||
D. Metter 2 | |||
2.ACMUI Recommendation: The ACMUI strongly disagreed with newly proposed Regulatory Guide (RG) 8.39, Section 6 Material Separated from the Patient, that stated the dose limits in 10 CFR Part 20 apply to exposure from radioactive material separated from a released patient, with the exception of temporary implants. While the CivaDerm device may have a higher potential for the source(s) to become dislodged from a patient due to its superficial application than with previous manual brachytherapy devices, the potential is not high enough to warrant specific consideration for patient release in Regulatory Guide 8.39. Other temporary implants such as eye plaques also have the potential for becoming dislodged or lost. Regulations and licensing guidance already exist that require licensees to develop, implement, and maintain written procedures to provide high confidence that each administration is in accordance with the written directive. | |||
Staff Response: Not Accepted. See staff response memo given to the ACMUI on comments specific to the Regulatory Guide 8.39 (ML23178A090). | Staff Response: Not Accepted. See staff response memo given to the ACMUI on comments specific to the Regulatory Guide 8.39 (ML23178A090). | ||
3.ACMUI Recommendation: Since NRC determined that CivaDerm may be licensed under 10 CFR 35, Subpart F, the Subcommittee recommends developing shorter guidance, more consistent with past examples. The guidance should focus on the specific radiation safety challenge, rather than providing comprehensive considerations for use. | |||
Staff Response: Not Accepted. The NRC reviewed the memo and shortened where possible. However, this memo provides guidance on several areas that are unique to this product which resulted in a longer memo than previously issued. In addition, as license reviewers and applicants have requested more guidance to support licensing new technologies even when they are not licensed under 10 CFR 35.1000, the memo remains longer than past examples. | Staff Response: Not Accepted. The NRC reviewed the memo and shortened where possible. However, this memo provides guidance on several areas that are unique to this product which resulted in a longer memo than previously issued. In addition, as license reviewers and applicants have requested more guidance to support licensing new technologies even when they are not licensed under 10 CFR 35.1000, the memo remains longer than past examples. | ||
4.ACMUI Comment: The Subcommittee notes that it would be highly unlikely for a member of the public to exceed the public dose limits in 10 CFR 20.1301 due to exposure from a palladium-103 source no longer affixed to a released patient. | |||
Staff Response: Not Accepted. It is possible that an unknowing person may pick up a source if it becomes loose and handle it incorrectly. The purpose of this memo is to inform licensees that it is their responsibility to ensure the public dose limit is not exceeded if a source does become detached from a patient and provides guidance to avoid noncompliance with regulations if this should happen. | Staff Response: Not Accepted. It is possible that an unknowing person may pick up a source if it becomes loose and handle it incorrectly. The purpose of this memo is to inform licensees that it is their responsibility to ensure the public dose limit is not exceeded if a source does become detached from a patient and provides guidance to avoid noncompliance with regulations if this should happen. | ||
5.ACMUI Recommendation: The guidance should acknowledge that CivaDerm may be used intraoperatively. | |||
Staff Response: Accepted. The staff added a statement to note that this guidance is for CivaDerm sources affixed superficially. | Staff Response: Accepted. The staff added a statement to note that this guidance is for CivaDerm sources affixed superficially. | ||
D. Metter | 6.ACMUI Recommendation: Remove sentence, In accordance with 10 CFR 35.400, the Pd-103 sources must be listed on a Sealed Source and Device Registry (SSDR) for manual brachytherapy and used in accordance with the radiation safety conditions and limitations described in that SSDR or in research under an active Investigational Device Exemption as described in 10 CFR 35.400(b). | ||
D. Metter 3 | |||
Staff Response: Accepted. Staff removed sentence. However, based on comments by license reviewer, staff added a similar sentence to the end of the memo as a reminder that the CivaDerm must follow radiation safety conditions and limitations in the SSDR, such as labeling. | |||
7.ACMUI Recommendation: Remove sentence, The manufacturer states the CivaDerm sources can be affixed to a patients skin by a variety of means, such as staples, glue, tape, sutures, or cast. | |||
Staff Response: Accepted. Staff removed sentence. | Staff Response: Accepted. Staff removed sentence. | ||
8.ACMUI Recommendation: Remove sentence, If a CivaDerm source becomes loose or dislodged, it is likely the administration would not go in accordance with the written directive and result in a medical event as defined in 10 CFR 35.3045, Reports and notification of a medical event. This is a negative, what if, worst case scenario that is not appropriate for an introductory sentence. | |||
Staff Response: Accepted. Sentence has been removed. | Staff Response: Accepted. Sentence has been removed. | ||
9.ACMUI Recommendation: Remove phrase, to ensure high confidence the procedure will be in accordance with the written directive. In addition, licensees must have procedures to determine if a medical event has occurred in accordance with 10 CFR 35.41. It is not necessary to describe the regulations. | |||
Staff Response: Not Accepted. These phrases provide the regulations which the staff is providing the stated guidance for. However, the phrase was modified. | Staff Response: Not Accepted. These phrases provide the regulations which the staff is providing the stated guidance for. However, the phrase was modified. | ||
10.ACMUI Recommendation: Remove sentence, If the NRC becomes aware of future developments related to the production, distribution, or medical use of the Civaderm (sic) that may negatively impact radiation safety, the NRC staff will revisit this licensing decision for any additional actions. | |||
Staff Response: Not Accepted: The NRC staff will revisit its licensing decisions for any modality if developments impact radiation safety. The term negatively was removed. | Staff Response: Not Accepted: The NRC staff will revisit its licensing decisions for any modality if developments impact radiation safety. The term negatively was removed. | ||
11.ACMUI Recommendation: First paragraph, remove unsealed byproduct material or. This phrase is not relevant for CivaDerm use. | |||
Staff Response: Accepted. Phrase has been removed. | Staff Response: Accepted. Phrase has been removed. | ||
12.ACMUI Recommendation: Remove sentences, As members of the public could be exposed to the hot side of the source, it is possible that public dose limits could be exceeded if the source becomes loose. Therefore, licensees must ensure that the CivaDerm (sic) sources are affixed to the patient so that they are highly unlikely to become loose or dislodged. | |||
Staff Response: Partially Accepted. Staff agrees that it is unlikely the total effective dose equivalent limit of 500 mrem described in 10 CFR 35.75 is going to be exceeded from a Pd-103 source due to self-shielding of the exposed individual. However, 10 CFR 35.2075 requires licensees to retain a record of the basis for release if the licensee considers shielding by the tissue. Therefore, the guidance was updated to reflect that regulation. | Staff Response: Partially Accepted. Staff agrees that it is unlikely the total effective dose equivalent limit of 500 mrem described in 10 CFR 35.75 is going to be exceeded from a Pd-103 source due to self-shielding of the exposed individual. However, 10 CFR 35.2075 requires licensees to retain a record of the basis for release if the licensee considers shielding by the tissue. Therefore, the guidance was updated to reflect that regulation. | ||
D. Metter 3 | |||
13.ACMUI Recommendation: Remove sentences, As described in 10 CFR 20.1003, public dose limits in 10 CFR Part 20 do not apply to exposure to individuals released under 10 CFR 35.75. However, public dose limits would apply if the source became dislodged or separated from the patient, as Part 20 does not exclude exposure from sources which are no longer affixed to a patient. | |||
Staff Response: Not Accepted. As described in the 10 CFR 20.1002, 10 CFR Part 20 limits only exclude exposure due to background radiation, to exposure of patients to radiation for the purpose of medical diagnosis or therapy, to exposure from individuals administered radioactive material and released under 10 CFR 35.75, or to exposure from voluntary participation in medical research programs. As sources separated from patients is not included in this list, all 10 CFR Part 20 limits would apply to exposure from them. As CivaDerm may have a higher potential to be dislodged from a patient and there is no guidance for situations of dislodged sources, the NRC staff believes there is a necessity to provide this guidance to regulators and licensees in case a source is dislodged. | Staff Response: Not Accepted. As described in the 10 CFR 20.1002, 10 CFR Part 20 limits only exclude exposure due to background radiation, to exposure of patients to radiation for the purpose of medical diagnosis or therapy, to exposure from individuals administered radioactive material and released under 10 CFR 35.75, or to exposure from voluntary participation in medical research programs. As sources separated from patients is not included in this list, all 10 CFR Part 20 limits would apply to exposure from them. As CivaDerm may have a higher potential to be dislodged from a patient and there is no guidance for situations of dislodged sources, the NRC staff believes there is a necessity to provide this guidance to regulators and licensees in case a source is dislodged. | ||
14.ACMUI Recommendation: First paragraph, remove last sentence. The Subcommittee believes that licensees should only be held accountable for locations of use prior to patient release. | |||
Staff Response: Not Accepted. Regulations in 10 CFR 35.2406 require records of source accountability for temporary implants to include the location of use for temporary implants. | Staff Response: Not Accepted. Regulations in 10 CFR 35.2406 require records of source accountability for temporary implants to include the location of use for temporary implants. | ||
Therefore, licensees must include the general locations of use. This information could also help the licensee locate a source if a source becomes dislodged and lost during treatment. | Therefore, licensees must include the general locations of use. This information could also help the licensee locate a source if a source becomes dislodged and lost during treatment. | ||
Note the guidance does provide some flexibility as it is not recommending licensees document all expected patient locations as that would not be feasible. | Note the guidance does provide some flexibility as it is not recommending licensees document all expected patient locations as that would not be feasible. | ||
15.ACMUI Recommendation: Change the second paragraph to read, in its entirety: If a licensee is unable to retrieve the source from the patient following treatment for whatever reason such as the source fell off or the patient does not return, the source would be considered lost or missing and would need to be reported in accordance with 10 CFR 20.2201 Reports of theft of loss of licensed material. It is highly unlikely that a Pd-103 brachytherapy implant would exceed the activity threshold (100 mCi) requiring immediate reporting; however, 30-day notification is required for aggregated activities exceeding 1 mCi which have not been found. | |||
Staff Response: Accepted. Staff updated the paragraph. | Staff Response: Accepted. Staff updated the paragraph. | ||
ML23052A197; Memo ML23198A273 OFFICE | ML23052A197; Memo ML23198A273 OFFICE NMSS/MSST/MSEB NMSS/MSST NMSS/MSST/MSEB NAME KTapp KT CValentin-Rodriguez CEinberg CE CV DATE Jul 19, 2023 Jul 19, 2023 Jul 19, 2023}} | ||
Latest revision as of 18:35, 13 November 2024
| ML23198A273 | |
| Person / Time | |
|---|---|
| Issue date: | 07/19/2023 |
| From: | Christian Einberg NRC/NMSS/DMSST/MSEB |
| To: | Metter D Advisory Committee on the Medical Uses of Isotopes |
| Shared Package | |
| ML23052A197 | List: |
| References | |
| Download: ML23198A273 (5) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 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 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 LICENSING GUIDANCE FOR SUPERFICIAL MANUAL BRACHYTHERAPY CIVADERM DEVICE Below are the U.S. Nuclear Regulatory Commissions (NRC) staff responses to the recommendations and comments on the draft licensing guidance for the superficial manual brachytherapy CivaDerm device from the Advisory Committee on the Medical Uses of Isotopes (ACMUI). The ACMUI provided these recommendations and comments to the NRC staff on December 15, 2021, following review of the draft licensing guidance. The full report from the ACMUI can be found at Agencywide Documents Access and Management System Accession No. ML22021B299.
1.ACMUI Comment: The Subcommittee agrees that CivaDerm should be licensed under 10 CFR 35.400 as it does not present any unique radiation safety issues not already covered by Part 35.
Staff Response: No Action.
CONTACT: Katie Tapp, NMSS/MSST 301-415-0236July 19, 2023 Signed by Einberg, Christian on 07/19/23
D. Metter 2
2.ACMUI Recommendation: The ACMUI strongly disagreed with newly proposed Regulatory Guide (RG) 8.39, Section 6 Material Separated from the Patient, that stated the dose limits in 10 CFR Part 20 apply to exposure from radioactive material separated from a released patient, with the exception of temporary implants. While the CivaDerm device may have a higher potential for the source(s) to become dislodged from a patient due to its superficial application than with previous manual brachytherapy devices, the potential is not high enough to warrant specific consideration for patient release in Regulatory Guide 8.39. Other temporary implants such as eye plaques also have the potential for becoming dislodged or lost. Regulations and licensing guidance already exist that require licensees to develop, implement, and maintain written procedures to provide high confidence that each administration is in accordance with the written directive.
Staff Response: Not Accepted. See staff response memo given to the ACMUI on comments specific to the Regulatory Guide 8.39 (ML23178A090).
3.ACMUI Recommendation: Since NRC determined that CivaDerm may be licensed under 10 CFR 35, Subpart F, the Subcommittee recommends developing shorter guidance, more consistent with past examples. The guidance should focus on the specific radiation safety challenge, rather than providing comprehensive considerations for use.
Staff Response: Not Accepted. The NRC reviewed the memo and shortened where possible. However, this memo provides guidance on several areas that are unique to this product which resulted in a longer memo than previously issued. In addition, as license reviewers and applicants have requested more guidance to support licensing new technologies even when they are not licensed under 10 CFR 35.1000, the memo remains longer than past examples.
4.ACMUI Comment: The Subcommittee notes that it would be highly unlikely for a member of the public to exceed the public dose limits in 10 CFR 20.1301 due to exposure from a palladium-103 source no longer affixed to a released patient.
Staff Response: Not Accepted. It is possible that an unknowing person may pick up a source if it becomes loose and handle it incorrectly. The purpose of this memo is to inform licensees that it is their responsibility to ensure the public dose limit is not exceeded if a source does become detached from a patient and provides guidance to avoid noncompliance with regulations if this should happen.
5.ACMUI Recommendation: The guidance should acknowledge that CivaDerm may be used intraoperatively.
Staff Response: Accepted. The staff added a statement to note that this guidance is for CivaDerm sources affixed superficially.
6.ACMUI Recommendation: Remove sentence, In accordance with 10 CFR 35.400, the Pd-103 sources must be listed on a Sealed Source and Device Registry (SSDR) for manual brachytherapy and used in accordance with the radiation safety conditions and limitations described in that SSDR or in research under an active Investigational Device Exemption as described in 10 CFR 35.400(b).
D. Metter 3
Staff Response: Accepted. Staff removed sentence. However, based on comments by license reviewer, staff added a similar sentence to the end of the memo as a reminder that the CivaDerm must follow radiation safety conditions and limitations in the SSDR, such as labeling.
7.ACMUI Recommendation: Remove sentence, The manufacturer states the CivaDerm sources can be affixed to a patients skin by a variety of means, such as staples, glue, tape, sutures, or cast.
Staff Response: Accepted. Staff removed sentence.
8.ACMUI Recommendation: Remove sentence, If a CivaDerm source becomes loose or dislodged, it is likely the administration would not go in accordance with the written directive and result in a medical event as defined in 10 CFR 35.3045, Reports and notification of a medical event. This is a negative, what if, worst case scenario that is not appropriate for an introductory sentence.
Staff Response: Accepted. Sentence has been removed.
9.ACMUI Recommendation: Remove phrase, to ensure high confidence the procedure will be in accordance with the written directive. In addition, licensees must have procedures to determine if a medical event has occurred in accordance with 10 CFR 35.41. It is not necessary to describe the regulations.
Staff Response: Not Accepted. These phrases provide the regulations which the staff is providing the stated guidance for. However, the phrase was modified.
10.ACMUI Recommendation: Remove sentence, If the NRC becomes aware of future developments related to the production, distribution, or medical use of the Civaderm (sic) that may negatively impact radiation safety, the NRC staff will revisit this licensing decision for any additional actions.
Staff Response: Not Accepted: The NRC staff will revisit its licensing decisions for any modality if developments impact radiation safety. The term negatively was removed.
11.ACMUI Recommendation: First paragraph, remove unsealed byproduct material or. This phrase is not relevant for CivaDerm use.
Staff Response: Accepted. Phrase has been removed.
12.ACMUI Recommendation: Remove sentences, As members of the public could be exposed to the hot side of the source, it is possible that public dose limits could be exceeded if the source becomes loose. Therefore, licensees must ensure that the CivaDerm (sic) sources are affixed to the patient so that they are highly unlikely to become loose or dislodged.
Staff Response: Partially Accepted. Staff agrees that it is unlikely the total effective dose equivalent limit of 500 mrem described in 10 CFR 35.75 is going to be exceeded from a Pd-103 source due to self-shielding of the exposed individual. However, 10 CFR 35.2075 requires licensees to retain a record of the basis for release if the licensee considers shielding by the tissue. Therefore, the guidance was updated to reflect that regulation.
D. Metter 3
13.ACMUI Recommendation: Remove sentences, As described in 10 CFR 20.1003, public dose limits in 10 CFR Part 20 do not apply to exposure to individuals released under 10 CFR 35.75. However, public dose limits would apply if the source became dislodged or separated from the patient, as Part 20 does not exclude exposure from sources which are no longer affixed to a patient.
Staff Response: Not Accepted. As described in the 10 CFR 20.1002, 10 CFR Part 20 limits only exclude exposure due to background radiation, to exposure of patients to radiation for the purpose of medical diagnosis or therapy, to exposure from individuals administered radioactive material and released under 10 CFR 35.75, or to exposure from voluntary participation in medical research programs. As sources separated from patients is not included in this list, all 10 CFR Part 20 limits would apply to exposure from them. As CivaDerm may have a higher potential to be dislodged from a patient and there is no guidance for situations of dislodged sources, the NRC staff believes there is a necessity to provide this guidance to regulators and licensees in case a source is dislodged.
14.ACMUI Recommendation: First paragraph, remove last sentence. The Subcommittee believes that licensees should only be held accountable for locations of use prior to patient release.
Staff Response: Not Accepted. Regulations in 10 CFR 35.2406 require records of source accountability for temporary implants to include the location of use for temporary implants.
Therefore, licensees must include the general locations of use. This information could also help the licensee locate a source if a source becomes dislodged and lost during treatment.
Note the guidance does provide some flexibility as it is not recommending licensees document all expected patient locations as that would not be feasible.
15.ACMUI Recommendation: Change the second paragraph to read, in its entirety: If a licensee is unable to retrieve the source from the patient following treatment for whatever reason such as the source fell off or the patient does not return, the source would be considered lost or missing and would need to be reported in accordance with 10 CFR 20.2201 Reports of theft of loss of licensed material. It is highly unlikely that a Pd-103 brachytherapy implant would exceed the activity threshold (100 mCi) requiring immediate reporting; however, 30-day notification is required for aggregated activities exceeding 1 mCi which have not been found.
Staff Response: Accepted. Staff updated the paragraph.
ML23052A197; Memo ML23198A273 OFFICE NMSS/MSST/MSEB NMSS/MSST NMSS/MSST/MSEB NAME KTapp KT CValentin-Rodriguez CEinberg CE CV DATE Jul 19, 2023 Jul 19, 2023 Jul 19, 2023