ML20279A812
| ML20279A812 | |
| Person / Time | |
|---|---|
| Issue date: | 09/21/2020 |
| From: | Richard Ennis Advisory Committee on the Medical Uses of Isotopes |
| To: | |
| Jamerson K | |
| References | |
| Download: ML20279A812 (13) | |
Text
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Medical Events Subcommittee Report Ronald D. Ennis, M.D.
Advisory Committee on the Medical Uses of Isotopes September 21, 2020
- Ronald D. Ennis, M.D. (Chair)
- Richard Green
- Darlene Metter, M.D.
- Michael OHara, Ph.D.
- Michael Sheetz
- Harvey Wolkov, M.D.
NRC Staff Resource: Donna-Beth Howe, Ph.D.
2 Subcommittee Members 1
2
2
- As begun in 2018, every two years the Medical Events Subcommittee will report on our review of events over the last 4 years to discern common themes within each section of 10 CFR Part 35 and across the sections, to inform a discussion of possible ways to decrease medical events (MEs).
- The Subcommittee reviewed the medical events for FYs 2016-2019.
3 Process Summary
- Two overarching themes remained
- Performance of a time out 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 appears to be a contributing factor in a number of cases
- One new issue identified
- Increase complexity of unsealed source administrations of newer agents may be leading to more equipment related MEs 4
3 4
3 35.200 Use of Unsealed Byproduct Material for Imaging and Localization 5
3/5 possibly preventable by time out Medical Events Summary 2016 2017 2018 2019 Total Cause Wrong drug 0
0 0
0 0
Wrong dosage 0
2 0
0 2
Wrong patient 0
1 0
0 1
Extravasation 0
1 0
0 1
Human error 0
0 0
1 (8 patients) 1 (8 patients)
Total 0
4 0
1 5
2016 2017 2018 2019 Total WD not done or incorrectly 1
2 1
2 6
Error in delivery
(# capsules) 1 1
0 1
3 Wrong dose 1
0 0
0 1
Equipment 0
0 1
4 5
Human Error 1
0 0
1 2
Wrong patient 1
1 0
1 3
Total 4
4 2
9 19 6
Time out could prevent 13/19 = 68%
Emerging increase in equipment issues 5/19 = 26% compared to 10% in last review 35.300 Use of Unsealed Byproduct Material, Written Directive Required Medical Events Summary 5
6
4 2016 2017 2018 2019 Total Applicator issue (e.g. movement during implant 1
0 0
0 1
Wrong site implanted (e.g. penile bulb) 1 1
1 1
4 Activity/prescription error (e.g. air kerma vs mCi, enter wrong activity in planning software) 0 1
0 1
2 Prostate Dose 18 5
11 3*
37 New device 0
0 1
0 1
Total 20 7
13 5
45 35.400 Manual Brachytherapy Medical Events Summary
- Still using dose-based criteria 2016 2017 2018 2019 Total Total MEs 20 7
13 5
45 Time out may have prevented ME 0
1 0
1 2
Lack of experience may have played a role 1
1 1
1 4
8 35.400 Manual Brachytherapy Medical Events Summary 7
8
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- 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 possibly plays a role in the true MEs of this type, but hard to assess to what degree in each case.
- In approximately 13% (down from 25% in last review) of cases, a time-out or enhanced retraining prior to performance of an uncommon procedure might have prevented the ME.
9 35.400 Manual Brachytherapy 2016 2017 2018 2019 Total Cause Wrong position 1
2 3
4 10 Wrong reference length 0
2 1
4 7
Wrong plan 1
0 2
0 3
Wrong dose/source strength 0
0 1
0 1
Machine malfunction 3
2 3
1 9
Software failure 0
2 (9 pts) 0 1
3 Total 5
8 (14 pts) 10 10 33 10 35.600 Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic unit Medical Events Summary 9
10
6 2016 2017 2018 2019 Location Breast 0
0 1
0 Gynecological 2
7 (14 pts) 7 8
Skin 1
0 1
0 Bronchus 0
0 0
0 Prostate 2
0 0
0 Brain 0
1 1
2 Total 5
8 (14 pts) 10 10 11 GYN tumors were most common site of ME.
35.600 Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic unit Medical Events Summary MEs that may have been prevented by timeout (wrong plans or dose)
- 2016 1/5 events
- 2017 0/8 events
- 2018 3/10 events
- 2019 3/10 events Total: 7/33 (21.2%) compared to 16% on last review 12 35.600 Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic unit 11 12
7 MEs caused by infrequent user This is difficult to determine based on information in NMED. If assumption is made about wrong position as surrogate for infrequent user.
- 2016 1/5 events
- 2017 2/8 events
- 2018 1/10 events
- 2019 1/10 events Total: 5/33 (15.2%) compared to 32% on last review 13 35.600 Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic unit 2016 2017 2018 2019 Total Medical Events 1
0 1
0 Cause:
Delayed seed removal (patient intervention) 1 1
Lost seed 0
Wrong implant site 0
35.1000 Radioactive Seed Localization Medical Events Summary 14 13 14
8 35.1000 Intravenous Cardiac Brachytherapy Medical Events Summary 2016 2017 2018 2019 Total Did not follow proper procedure 0
0 0
1 1
Tortuous vessel anatomy 0
0 1
1*
2 Catheter issue 0
0 1
0 1
Total 0
0 2
1 4
15
- AU felt this is patient intervention No time out issues Difficult to assess the unfamiliarity issue, but possibly played a role in some 2016 2017 2018 2019 Total Medical Events 3
0 1
0 Cause:
0 0
0 0
Back-up battery power source failure 0
0 1
0 Patient setup error 2
0 0
0 Patient movement 1
0 0
2 Wrong site (treatment plan) 0 0
0 0
35.1000 Gamma Knife Perfexion' and Icon' Medical Events Summary 16 15 16
9 2016 2017 2018 2019 Total Total Medical Events 13 15 14 15 57 Cause:
> 20% residual activity remaining in delivery device 9
7 11 9
36 Delivery device setup error 1
2 2
1 6
Wrong dose (treatment plan calculation error) 1 4
0 1
6 Wrong site (catheter placement error) 2 2
0 0
4 Wrong dose vial selected 1
4 5
35.1000 Y-90 Theraspheres Medical Events Summary 17 2016 2017 2018 2019 Total Total Medical Events 13 8
7 11 39 Cause:
> 20% residual activity remaining in delivery device not due to stasis 9
7 2
8 26 Wrong dose (treatment plan calculation error) 2 0
2 0
4 Wrong site (catheter placement error) 2 1
2 2
7 Wrong site (WD error) 0 0
1 1
2 35.1000 Y-90 SirSpheres Medical Events Summary 17 18
10 Overview Y-90 Microsphere MEs FY2014 - 2017 N=91 62, 65%
10%
12%
6%7%
Cause
> 20% residual not due to stasis Wrong dose (treatment plan error)
Wrong site (catheter placement error)
Device setup error Wrong dose vial/WD error FY2016 - 2019 N=96
- 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 19 20
11 RSL Perfexion/Icon Y-90 Microspheres 2016 0/1 2/3 3/26 2017 0
0 3/23 2018 0/1 0/1 4/21 2019 0
0/2 7/26 Total 0/2 2/6 (33%)
17/96 (18%)
35.1000 Medical Events That May Have Been Prevented by Time Out RSL Perfexion/Icon Y-90 Microspheres 2016 0/1 2/3 1/26 2017 0
0 2/23 2018 0/1 0/1 2/21 2019 0
0/2 1/26 Total 0/2 (0%)
2/6 (33%)
6/96 (6%)
35.1000 Medical Events That May Have Been Attributed to Lack of Experience or Infrequent User 21 22
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- 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 23 Possible Elements of a Time Out
- 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) 24 Possible Elements of a Time Out contd.
23 24
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- The subcommittee recommended that the NRC staff issue an Information Notice alerting Authorized Users to the themes identified herein.
- IN-19-07, Methods to Prevent Medical Events, was published on August 26, 2019.
(ADAMS Accession No. ML19240A450) 25 Subcommittee Response to Findings
- 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
- Y yttrium-90 26 Acronyms 25 26