ML22105A578
| ML22105A578 | |
| Person / Time | |
|---|---|
| Issue date: | 10/04/2021 |
| From: | Richard Ennis Advisory Committee on the Medical Uses of Isotopes |
| To: | |
| Don Lomwan, NMSS/MSST/MSEB | |
| References | |
| Download: ML22105A578 (21) | |
Text
1 Medical Events Subcommittee Report Ronald D. Ennis, M.D.
Advisory Committee on the Medical Uses of Isotopes October 4, 2021
- Ronald D. Ennis, M.D. (Chair)
- Richard Green
- Darlene Metter, M.D.
- Zoubir Ouhib, M.S.
- Michael OHara, Ph.D.
- Michael Sheetz
- Harvey Wolkov, M.D.
2 Subcommittee Members
Summary Two overarching themes remain
- Performance of a time out/use of a checklist immediately prior to administration of radioactive byproduct material, as is done in surgery and other settings, could have prevented some MEs
- Lack of recent or frequent performance of the specific administration or inattention during performance of the procedure/treatment appear to be contributing factor(s) in a number of cases
- NRC issued an Information Notice alerting the users to this issue in 2019.
https://www.nrc.gov/docs/ML1924/ML19240A450.pdf 3
Summary Specific issues
- Increase complexity of unsealed source administrations of newer agents may lead to more equipment related MEs in future
- MEs involving Y90 administration continue to be the most common MEs. We propose the creation of a subcommittee to evaluate this issue in more depth and, in conjunction with the vendors, propose solutions to decrease the frequency of MEs 4
35.200 Use of Unsealed Byproduct Material for Imaging and Localization 5
3/5 possibly preventable by time out Medical Events Summary 2017 2018 2019 2020 Total Cause Wrong drug 0
0 0
0 0
Wrong dosage 2
0 0
0 2
Wrong patient 1
0 0
0 1
Extravasation 1
0 0
0 1
Human error 0
0 1 (8 patients) 0 1 (8 patients)
Total 4
0 1
0 5
2017 2018 2019 2020 Total WD not done or incorrectly 2
1 2
0 5
Error in delivery
(#capsules) 1 0
1 0
2 Wrong dose 0
0 0
0 0
Equipment 0
1 4
0 5
Human Error 0
0 1
2 3
Wrong patient 1
0 1
0 2
Total 4
2 9
2 17 6
35.300 Use of Unsealed Byproduct Material, Written Directive Required Medical Event Summary
35.400 Manual Brachytherapy Medical Event Summary
- Still using dose-based criteria 2017 2018 2019 2020 Total Applicator issue (e.g.
jam, eye plaque dislodged) 0 0
0 2
2 Wrong site implanted (e.g. penile bulb, bladder) 1 1
1 2
5 Activity/prescription error (e.g. air kerma vs mCi, enter wrong activity in planning software) 1 0
1 0
2 Prostate Dose 5
11 3
0 19 New device 0
1 0
0 1
Wrong source 0
0 0
1 1
Patient health
(?patient intervention) 0 0
0 1
1
2017 2018 2019 2020 Total Total ME 7
13 5
6 45 Time out may have prevented 1
0 1
1 3
Lack of experience/i nattention may have played a role 1
1 1
1 4
8 35.400 Manual Brachytherapy Medical Event Summary
Many MEs in this category are no longer categorized as MEs due to change from dose to activity-based definition, although even in 2019 this definition continued to be used for some MEs.
Lack of experience or inattention possibly plays a role in the true MEs of this type, but hard to assess to what degree in each case.
In approximately 15% of cases, a time out/checklist, enhanced retraining prior to performance of an uncommon procedure or increase attention during the procedure might have prevented the ME.
9 35.400 Manual Brachytherapy
10 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 Total Wrong position 2
3 4
7 16 Wrong reference length 2
1 4
2 9
Wrong plan 0
2 0
0 2
Wrong dose/source strength 0
1 0
0 1
Machin/applic ator malfunction 2
3 1
1 7
Software/har dware failure 2 (9 pts) 0 1
1 4
Treatment planning 0
0 0
2 2
Total 8 (14 pts) 10 10 13 41
2017 2018 2019 2020 Location Breast 0
1 0
1 Gynecological 7 (14 pts) 7 8
10 Skin/neck 0
1 0
2 Bronchus 0
0 0
0 Prostate 0
0 0
0 Brain 1
1 2
0 Total 8 (14 pts) 10 10 13 11 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
MEs that may have been prevented by timeout (wrong plan or dose)
- 2017 0/8 events
- 2018 3/10 events
- 2019 3/10 events
- 2020 10/13 events Total 16/41 (39%)
12 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 2017 2/8 events
- 2018 1/10 events
- 2019 1/10 events
- 2020 9/13 events 13 35.600 Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic unit Total 13/41 (32%)
35.1000 Radioactive Seed Localization Medical Events Summary 2018 2019 2020 2021 Total Medical Events 0
1 0
1 Cause:
Delayed seed removal (patient intervention) 0 1
0 0
Lost seed 0
0 0
0 Wrong implant site 0
0 0
0 Seed migration 0
0 0
1
35.1000 Intravenous Cardiac Brachytherapy
- Medical Events Summary 2017 2018 2019 2020 Total Did not follow proper procedure 0
0 1
0 1
Tortuous vessel anatomy 0
1 1*
0 2
Catheter issue 0
1 0
1 2
Total 0
2 2
1 5
15
- AU felt this is patient intervention No time out issues Difficult to assess the unfamiliarity issue, but possibly played a role in some
35.1000 Gamma Knife Perfexion' and Icon' Medical Events Summary 2017 2018 2019 2020 Total Medical Events 0
1 2
2 Cause:
0 0
0 0
Back-up battery power source failure 0
1 0
0 Patient setup error 0
0 0
1 Patient movement 0
0 2
0 Wrong site (treatment plan) 0 0
0 0
Pt motion management system failure 0
0 0
1
2017 2018 2019 2020 Total Total Medical Events 15 14 15 15 59 Cause:
> 20% residual activity remaining in delivery device 7
11 9
12 39 Delivery device setup error 2
2 1
1 6
Wrong dose (treatment plan calculation error) 4 0
1 0
5 Wrong site (catheter placement error) 2 0
0 2
4 Wrong dose vial selected 0
1 4
0 5
35.1000 Y-90 Theraspheres Medical Events Summary For 2020: Time out 3/15 (20%),
Infrequent/inattention 12/15 (80%)
2017 2018 2019 2020 Total Total Medical Events 8
7 11 8
34 Cause:
> 20% residual activity remaining in delivery device not due to stasis 7
2 8
8 25 Wrong dose (treatment plan calculation error) 0 2
0 0
2 Wrong site (catheter placement error) 1 2
2 0
5 Wrong site (WD error) 0 1
1 0
2 35.1000 Y-90 SirSpheres Medical Events Summary 2020: Time out: 0 Infrequent/inattention: 8/8 (100%)
- Review mechanics of Y-90 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 Actions to Prevent 35.1000 Y-90 Microsphere Medical Events
Identity of patient via two identifiers (e.g. name and DOB)
Procedure to be performed Isotope 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) 20 Possible Elements of a Time Out
- 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