ML19038A495
| ML19038A495 | |
| Person / Time | |
|---|---|
| Issue date: | 09/20/2018 |
| From: | Advisory Committee on the Medical Uses of Isotopes |
| To: | |
| Holiday, Sophie | |
| References | |
| Download: ML19038A495 (7) | |
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Medical Events Subcommittee Report Ronald D. Ennis, M.D.
Advisory Committee for the Medical Uses of Isotopes September 20, 2018
- Ronald D. Ennis, M.D. (Chair)
- Richard Green
- Darlene Metter, M.D.
- Michael OHara, Ph.D.
- John Suh, M.D.
- Michael Sheetz 2
Subcommittee Members
- This year, rather than review the details of specific cases, we are reporting on our overview of events over last 3.5 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).
- We reviewed the last three reports of this subcommittee (FYs 2014-16) as well as the spring report of Dr. Howe for FY 2017 3
Process Summary
- Two overarching themes emerged
- 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 4
2 35.200 Use of Unsealed Byproduct Material for Imaging and Localization 2014 2015 2016 2017 Total Cause Wrong drug*
0 3
3 0
6 Wrong dosage 5
0 3
3 11 Wrong patient 1
1 2
0 4
Total 6
4 8
3 21 5
21 events over 4 years
- In most cases wrong drug was also wrong dosage Medical Events Summary How Can These Events Be Prevented?
- Wrong drug: Time out - confirm the order, compare to the prescription
- Wrong dosage: If a dose calibrator is available -
measure the activity
- Wrong patient: Time out - Verify patients by two means of identification
- 10/21 preventable if time out had been used 35.200 Use of Unsealed Byproduct Material for Imaging and Localization 2014 2015 2016 2017 Total WD not done or incorrectly 0
1 0
2 3
Error in delivery
(#capsules) 2 3
1 1
7 Wrong dose 0
2 3
0 5
Equipment 1
1 0
0 2
Unauthorized clinic 0
0 1
0 1
Wrong patient 1
0 0
1 2
Total 4
7 5
4 20 7
Time out could prevent 10-17/20 35.300 Use of Unsealed Byproduct Material, Written Directive Required Medical Event Summary 2014 2015 2016 2017 Total Applicator issue (e.g. movement during implant 1
1 1
0 3
Wrong site implanted (e.g. penile bulb) 3 1
1 1
6 Activity/prescription error (e.g. air kerma vs mCi) 1 2
0 1
4 Prostate Dose 0
4 18 5
27 35.400 Manual Brachytherapy Medical Event Summary
3 2014 2015 2016 2018 Total Total ME 5
8 20 7
40 Time out may have prevented 1
2 0
1 4 (10%)
Lack of experience may have played a role 3
1 1
1 6 (15%)
9 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.
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 25% of cases, a time out or enhanced retraining prior to performance of an uncommon procedure might have prevented the ME.
10 35.400 Manual Brachytherapy 2014 2015 2016 2017 Cause Wrong position 3
6 1
2 Wrong reference length 2
3 0
2 Wrong plan 1
3 1
0 Wrong dose/source strength 2
0 0
0 Machine malfunction 2
2 3
2 Software failure 0
0 0
2 (9 pts)
Total 10 14 5
8 (14 pts) 11 37 events over 4 years 35.600 Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic unit Medical Event Summary 2014 2015 2016 2017 Location Breast 1
1 0
0 Gynecological 5
9 2
7 (14 pts)
Skin 2
1 1
0 Bronchus 1
2 0
0 Prostate 0
0 2
0 Brain 1
1 0
1 Total 10 14 5
8 (14 pts) 12 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
4 MEs that may have been prevented by timeout (wrong plans or dose)
- 2014 3/10 events
- 2015 3/14 events
- 2016 1/5 events
- 2017 0/8 events Total 6/37 (16.2%)
13 35.600 Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic unit MEs caused by infrequent user This is difficult to determine based on information on NMED. If assumption is made about wrong position as surrogate for infrequent user
- 2014 3/10 events
- 2015 6/14 events
- 2016 1/5 events
- 2017 2/8 events 14 35.600 Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic unit Total 12/37 (32.4%)
2014 2015 2016 2017 Total Medical Events 1
1 0
2 Cause:
Delayed seed removal (patient intervention) 1 1
Lost seed 1
Wrong implant site 1
35.1000 Radioactive Seed Localization Medical Events Summary 2014 2015 2016 2017 Total Medical Events 1
8 3
0 Cause:
Patient positioning system misalignment by vendor (same site) 8 Patient setup error 2
Patient movement 1
Wrong site (treatment plan) 1 35.1000 Gamma Knife Perfexion' and Icon' Medical Events Summary
5 2014 2015 2016 2017 Total Medical Events 9
8 13 15 Cause:
> 20% residual activity remaining in delivery device 6
7 9
7 Delivery device setup error 1
2 Wrong dose (treatment plan calculation error) 1 1
4 Wrong site (catheter placement error) 1 1
2 2
Wrong site (shunting) 1 35.1000 Y-90 Theraspheres Medical Events Summary 2014 2015 2016 2017 Total Medical Events 15 10 13 8
Cause:
> 20% residual activity remaining in delivery device not due to stasis 10 2
9 7
Wrong site (shunting) 2 4
Delivery device setup error 1
3 Wrong dose (treatment plan calculation error) 1 1
2 Wrong site (catheter placement error) 1 2
1 35.1000 Y-90 SirSpheres Medical Events Summary Overview Y-90 Microsphere ME 2014 - 2017
- 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
6 RSL Perfexion/Icon Y-90 Microspheres 2014 1/2 1/1 3/24 2015 0/1 0/8 2/18 2016 0/1 2/3 3/26 2017 0
0 3/23 Total 1/4 (25%)
3/12 (25%)
11/91 (12%)
35.1000 Medical Events That May Have Been Prevented by Time Out RSL Perfexion/Icon Y-90 Microspheres 2014 0/2 0/1 1/24 2015 0/1 0/8 3/18 2016 0/1 2/3 1/26 2017 0
0 2/23 Total 0/4 (0%)
2/12 (17%)
7/91 (8%)
35.1000 Medical Events That May Have Been Attributed to Lack of Experience or Infrequent User Identity of patient via two identifiers (e.g. name and DOB)
Procedure to be performed Isotope Activity Dosage 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
- Take review course from professional society
- Read review articles
- Speak to colleague with experience
- Do dry run of procedure with the team
- Review mechanics of device set up and procedure 24 Possible Elements of Refresher for Infrequent Procedure
7 The subcommittee recommends the NRC issue an Information Notice alerting AUs to the themes identified herein 25 Recommendation for Action
- 10 CFR - Title 10 of the Code of Federal Regulations
- AUs - authorized users
- DOB - date of birth
- FY - Fiscal Year
- Gy - Gray
- gyn - gynecological
- LDR - low dose rate
- mCi - milliCurie
- ME - Medical Event
- RSL - radioactive seed localization