ML24108A126
| ML24108A126 | |
| Person / Time | |
|---|---|
| Issue date: | 04/08/2024 |
| From: | Harvey R Advisory Committee on the Medical Uses of Isotopes |
| To: | |
| D DiMarco | |
| References | |
| Download: ML24108A126 (24) | |
Text
1 ACMUIs Review and Analysis of Reported Medical Events from Fiscal Years 2021-2023 Richard P. Harvey, DrPH Advisory Committee on the Medical Uses of Isotopes April 8, 2024
Subcommittee Members
- Richard Harvey, DrPH (Chair)
- Michael Folkert, M.D.
- Richard Green, B.S.
- Darlene Metter, M.D.
- Zoubir Ouhib, M.S.
- Harvey Wolkov, M.D.
- Consultant: John Angle, M.D.
- NRC Staff Resource: Daniel DiMarco, M.S.
2
Subcommittee Charge
- Review Medical Events (MEs) to advise the Advisory Committee on the Medical Use of Isotopes (ACMUI) and United States Nuclear Regulatory Commission (NRC) about emerging trends that may need regulatory attention.
3
=
Background===
- The NRC and ACMUI review MEs that occur throughout the country.
- MEs occur when radioactive material use in healthcare results in unexpected radiation dose to patients. (Please refer to 10 CFR 35 Subpart M - Reports and more specifically 10 CFR 35.3045 - Report and Notification of a Medical Event for more information.)
- The Medical Events Subcommittee of the ACMUI reviews the data to analyze the nature of medical events, identify emerging trends and provide recommendations to the ACMUI and NRC.
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Medical Event Review
- FY21 - October 1, 2020 to September 30, 2021
- FY22 - October 1, 2021 to September 30, 2022
- FY23 - October 1, 2022 to September 30, 2023 5
Summary
- Two overarching themes remain
- Human Error
- Communication/feedback
- Failure to work in teams
- Inexperience
- Rapidly evolving use of radiopharmaceuticals
- Dissemination of use to smaller institutions with lower frequency of procedures performed 6
Specific Issues
- Increasing MEs: new and increasing use of current therapeutic radiopharmaceuticals 90Y microsphere procedures remain the most common MEs.
- ACMUI Action: Added 2 specialty-specific subcommittee members
- ACMUI recommendation: AU adhere to manufacturer recommendations (i.e. avoid aggregation: use recommended catheter size and needle gauge) 7
35.200 Use of Unsealed Byproduct Material for Imaging and Localization 8
5/5 (100%) possibly preventable by time out in 2021 & 2023 (Wrong Drug, Wrong Dosage & Wrong Patient)
Medical Events Summary 2017 2018 2019 2020 2021 2022 2023 Total Cause Wrong Drug 0
0 0
0 1
0 1
2 Wrong Dosage 2
0 0
0 1
0 0
3 Wrong Patient 1
0 0
0 2
0 0
3 Extravasation*
1 0
0 0
0 0
0 1
Human Error 0
0 1 (8 patients) 0 0
0 0
1 (8 patients)
Total 4
0 1
0 4
0 1
10
- NRC does not have reporting requirement for extravasations
9 35.300 Use of Unsealed Byproduct Material, Written Directive Required Medical Event Summary 2017 2018 2019 2020 2021 2022 2023 Total WD not done or incorrectly 2
1 2
0 0
1 1
7 Error in delivery
(# capsules) 1 0
1 0
0 1
0 3
Wrong Dose 0
0 0
0 4
3 8
15 Equipment 0
1 4
0 2
1 0
8 Human Error 0
0 1
2 3
4 0
10 Wrong Patient 1
0 1
0 0
0 0
2 Wrong Drug 0
0 0
0 1
0 2
3 Total 4
2 9
2 10 10 11 48 Time out: 2021-5/10 (50%), 2022-3/10 (30%), 2023-10/11 (91%)
(Wrong Drug, Wrong Dosage & Wrong Patient)
35.400 Manual Brachytherapy Medical Event Summary
- Still using dose-based criteria 2017 2018 2019 2020 2021 2022 2023 Total Applicator issue (e.g.
jam, eye plaque dislodged) 0 0
0 2
0 1
1 4
Wrong site implanted (e.g. penile bulb, bladder) 1 1
1 2
2 0
0 7
Activity/prescription error (e.g. air kerma vs mCi, enter wrong activity in planning software) 1 0
1 0
1 0
0 3
Wrong Dose 5
11 3
0 0
0 2
21 New Device 0
1 0
0 0
0 0
1 10
11 35.400 Manual Brachytherapy Medical Event Summary 2017 2018 2019 2020 2021 2022 2023 Total Wrong Source 0
0 0
1 0
0 0
1 Patient Health
(?patient intervention) 0 0
0 1
0 0
0 1
Wrong Patient 0
0 0
0 1
0 0
1 Total 7
13 5
6 4
1 3
39 "Time Out" may have prevented 1
0 5
1 2
0 0
9
Potentially ~23% (9/39) of ME from 2017 to 2023 may have been prevented with the use of a Time Out (wrong site, wrong source and wrong patient):
- Time Out or checklist for 2021 may have prevented: 3/4 (75%)
- No benefit in 2022 or 2023 12 35.400 Manual Brachytherapy
13 35.600 Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic unit Medical Event Summary 2017 2018 2019 2020 2021 2022 2023 Total Wrong position 2
3 4
7 0
1 3
20 Wrong reference length 2
1 4
2 2
2 0
13 Wrong plan 0
2 0
0 0
0 0
4 Wrong dose/source strength 0
1 0
0 0
0 2
1 Machine/applicator malfunction 2
3 1
1 1
2 2
12 Software/hardware failure 2 (9 patients) 0 1
1 0
0 0
4 Treatment planning 0
0 0
2 1
2 0
5 Human Error 0
0 0
0 1
4 1
6 Total 8
10 10 13 5
11 8
65
14 GYN tumors most common site of ME 35.600 Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic unit Medical Event Summary 2017 2018 2019 2020 2021 2022 2023 Total Location Breast 0
1 0
1 0
0 0
2 Gynecological 7
7 8
10 4
2 5
43 Skin/neck 0
1 0
2 1
5 1
10 Bronchus 0
0 0
0 0
0 0
0 Prostate 0
0 0
0 0
0 1
1 Brain 1
1 2
0 0
0 0
4 Unknown 0
0 0
0 0
4 1
5 Total 8
10 10 13 5
11 8
65
MEs that may have been prevented by timeout (wrong plan or dose)
- 2017 0/8 events
- 2018 3/10 events
- 2019 0/10 events
- 2020 0/13 events
- 2021 0/5 events
- 2022 0/11 events
- 2023 2/8 events Total 5/65 (8%)
15 35.600 Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic unit
MEs caused by infrequent user/inattention This is difficult to determine based on information in NMED. For this assessment, assumed wrong position is a surrogate for infrequent user/inattention - improved training may be beneficial 2017 2/8 events 2018 3/10 events 2019 4/10 events 2020 7/13 events 2021 0/5 events 2022 1/11 events 2023 3/8 events 16 35.600 Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic unit Total 20/65 (31%)
35.1000 Radioactive Seed Localization Medical Events Summary 2018 2019 2020 2021 2022 2023 Total Medical Events 0
1 0
1 0
1 Cause:
Delayed seed removal (patient intervention) 0 1
0 0
0 1
Lost seed 0
0 0
0 0
0 Wrong implant site 0
0 0
0 0
0 Seed migration 0
0 0
1 0
0 17
35.1000 Intravenous Cardiac Brachytherapy Medical Events Summary 2017 2018 2019 2020 2021 2022 2023 Total Did not follow proper procedure 0
0 1
0 0
0 0
1 Tortuous vessel anatomy 0
1 1*
0 0
0 0
2 Catheter issue 0
1 0
1 0
0 0
2 Wrong Site 0
0 0
0 0
0 1
1 Total 0
2 2
1 0
0 1
6 18
- AU felt this is patient intervention No time out issues
35.1000 Gamma Knife Perfexion',
Icon' and Esprit' Medical Events Summary 2017 2018 2019 2020 2021 2022 2023 Total Total Medical Events 0
1 2
2 0
2 1
8 Cause:
Back-up battery power source failure 0
1 0
0 0
0 0
1 Patient set-up error 0
0 0
1 0
0 0
1 Patient movement 0
0 2
0 0
0 0
2 Wrong site (treatment plan) 0 0
0 0
0 0
0 0
Wrong site (human error-shifting of co-registration images) 0 0
0 1
0 1
0 2
Patient motion management system failure 0
0 0
0 0
1 0
1 Device Malfunction 0
0 0
0 0
0 1
1 19
35.1000 90Y Theraspheres Medical Events Summary For 2021 - 2023: Time out 4/23 (17%), 2/23 (9%), 1/22 (5%) - Wrong Dose*
Infrequent/inattention 10/23 (43%), 2/23 (9%), 11/22 (50%) - > 20% Residual 2017 2018 2019 2020 2021 2022 2023 Total Total Medical Events 15 14 15 15 23 23 22 127 Cause:
> 20% residual activity remaining in delivery device/leakage 7
11 9
12 10 2
11 62 Delivery device set-up error 2
2 1
1 1
0 2
9 Wrong dose (treatment plan calculation error) 4 0
1 0
0 3
1 9
Wrong site (catheter placement error & size) 2 0
0 2
1 7
3 15 Wrong dose vial selected*
0 1
4 0
1 1
1 8
Wrong dose (calibration error)*
0 0
0 0
3 1
0 4
Aggregation of microspheres 0
0 0
0 7
9 4
20 20
35.1000 90Y SirSpheres Medical Events Summary 2021 - 2023: Time out: 1/18(6%), 1/9(11%), 2/9(22%) - Wrong Site (WD)
Infrequent/inattention: 2/18(11%), 1/9(11%), 6/9(67%) - >20% Residual 2017 2018 2019 2020 2021 2022 2023 Total Total Medical Events 8
7 11 8
18 9
9 70 Cause:
> 20% residual activity remaining in delivery device/leakage 7
2 8
8 2
1 6
34 Wrong dose (treatment plan calculation error) 0 2
0 0
2 1
0 5
Wrong site (catheter placement error & defective catheter) 1 2
2 0
4 0
1 10 Wrong site (WD error) 0 1
1 0
1 1
2 6
Aggregation of microspheres 0
0 0
0 9
6 0
15 21
Actions to Prevent 35.1000 90Y Microsphere Medical Events
- Ensure familiarity with the mechanics of 90Y microsphere delivery device and setup procedures
- Confirm all data and calculations in treatment plan
- Perform Time Out to assure all elements of treatment are in accordance with Written Directive 22
Identity of patient via two identifiers (e.g. name and DOB)
Procedure to be performed Radiopharmaceutical Activity Dosage -second check of dosage calculation and that the WD and dosage to be delivered are identical Others as applicable
- units of activity (LDR prostate)
- anatomic location
- patient name on treatment plan
- treatment plan independent second check has been performed
- reference length (HDR)
- Implant site location (RSL) 23 Possible Elements of a Time Out
Acronyms 10 CFR - Title 10 of the Code of Federal Regulations AUs - authorized users FY - fiscal year GYN - gynecological HDR - high dose-rate LDR - low dose rate mCi - milliCurie ME - medical event RSL - radioactive seed localization WD - written directive Y - Yttrium 24