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{{#Wiki_filter:Medical Events Subcommittee Report Ronald D. Ennis, M.D.
{{#Wiki_filter:1 1
Advisory Committee on the Medical Uses of Isotopes September 21, 2020 1
Medical Events Subcommittee Report Ronald D. Ennis, M.D.
1 Subcommittee Members
Advisory Committee on the Medical Uses of Isotopes September 21, 2020
* Ronald D. Ennis, M.D. (Chair)
* Ronald D. Ennis, M.D. (Chair)
* Richard Green
* Richard Green
Line 25: Line 25:
* Harvey Wolkov, M.D.
* Harvey Wolkov, M.D.
NRC Staff Resource: Donna-Beth Howe, Ph.D.
NRC Staff Resource: Donna-Beth Howe, Ph.D.
2 2
2 Subcommittee Members 1
1
2


Process
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).
* 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.
* The Subcommittee reviewed the medical events for FYs 2016-2019.
3 3
3 Process Summary
Summary
* Two overarching themes remained
* 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
- 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
- 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
* One new issue identified
    - Increase complexity of unsealed source administrations of newer agents may be leading to more equipment related MEs 4
- 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
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


35.200 Use of Unsealed Byproduct Material for Imaging and Localization 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        1 (8 patients)  patients)
4 2016 2017 2018 2019 Total Applicator issue (e.g. movement during implant 1
Total                   0        4      0          1          5 3/5 possibly preventable by time out 5
0 0
5 35.300 Use of Unsealed Byproduct Material, Written Directive Required Medical Events Summary 2016     2017     2018     2019       Total WD not done or            1        2      1        2            6 incorrectly Error in delivery        1        1      0        1            3
0 1
(# capsules)
Wrong site implanted (e.g. penile bulb) 1 1
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 Time out could prevent 13/19 = 68%
1 1
Emerging increase in equipment issues 5/19 = 26% compared to 10% in last review 6
4 Activity/prescription error (e.g. air kerma vs mCi, enter wrong activity in planning software) 0 1
6 3
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


35.400 Manual Brachytherapy Medical Events Summary 2016    2017  2018 2019    Total Applicator issue (e.g. movement        1      0      0  0        1 during implant Wrong site implanted (e.g. penile      1      1      1  1        4 bulb)
5
Activity/prescription error (e.g. air  0      1      0  1        2 kerma vs mCi, enter wrong activity in planning software)
Prostate Dose                          18      5     11  3*      37 New device                            0      0      1  0        1 Total                                  20      7    13  5      45
  *Still using dose-based criteria 7
35.400 Manual Brachytherapy Medical Events Summary 2016        2017    2018    2019    Total Total MEs          20            7      13        5      45 Time out may have 0            1        0        1        2 prevented ME Lack of experience may have 1            1        1        1        4 played a role 8
8 4
 
35.400 Manual Brachytherapy
* 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.
* 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.
* 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.
* 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 9
9 35.400 Manual Brachytherapy 2016 2017 2018 2019 Total Cause Wrong position 1
35.600 Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic unit Medical Events Summary 2016     2017   2018   2019     Total Cause Wrong position       1         2       3     4       10 Wrong reference       0         2       1     4         7 length Wrong plan           1         0       2     0         3 Wrong dose/source     0         0       1     0         1 strength 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 10 5
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


35.600 Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic unit Medical Events Summary 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 GYN tumors were most common site of ME.
6 2016 2017 2018 2019 Location Breast 0
11 11 35.600 Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic unit MEs that may have been prevented by timeout (wrong plans or dose)
0 1
* 2016       1/5 events
0 Gynecological 2
* 2017       0/8 events
7 (14 pts) 7 8
* 2018       3/10 events
Skin 1
* 2019       3/10 events Total: 7/33 (21.2%) compared to 16% on last review 12 12 6
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


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 in NMED. If assumption is made about wrong position as surrogate for infrequent user.
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
* 2016 1/5 events
* 2017           2/8 events
* 2017 2/8 events
* 2018           1/10 events
* 2018 1/10 events
* 2019           1/10 events Total: 5/33 (15.2%) compared to 32% on last review 13 13 35.1000 Radioactive Seed Localization Medical Events Summary 2016 2017 2018 2019 Total Medical Events                       1     0   1   0 Cause:
* 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
Delayed seed removal                 1        1 (patient intervention)
0 1
Lost seed                                           0 Wrong implant site                                 0 14 14 7
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


35.1000 Intravenous Cardiac Brachytherapy Medical Events Summary 2016       2017       2018         2019       Total Did not follow         0           0           0           1           1 proper procedure Tortuous               0           0           1           1*           2 vessel anatomy Catheter issue         0           0           1           0           1 Total                   0           0           2           1           4
8 35.1000 Intravenous Cardiac Brachytherapy Medical Events Summary 2016 2017 2018 2019 Total Did not follow proper procedure 0
    *AU felt this is patient intervention No time out issues Difficult to assess the unfamiliarity issue, but possibly played a role in some 15 15 35.1000 Gamma Knife Perfexion' and Icon' Medical Events Summary 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 16 16 8
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


35.1000 Y-90 Theraspheres Medical Events Summary 2016 2017 2018 2019 Total Total Medical Events                       13   15   14   15   57 Cause:
9 2016 2017 2018 2019 Total Total Medical Events 13 15 14 15 57 Cause:
            > 20% residual activity remaining   9   7   11   9   36 in delivery device Delivery device setup error         1   2   2   1   6 Wrong dose (treatment plan           1   4   0   1   6 calculation error)
> 20% residual activity remaining in delivery device 9
Wrong site (catheter placement       2   2   0   0   4 error)
7 11 9
Wrong dose vial selected                       1   4   5 17 17 35.1000 Y-90 SirSpheres Medical Events Summary 2016 2017 2018 2019 Total Total Medical Events                       13   8   7   11   39 Cause:
36 Delivery device setup error 1
          > 20% residual activity remaining     9    7    2    8  26 in delivery device not due to stasis Wrong dose (treatment plan           2   0   2   0   4 calculation error)
2 2
Wrong site (catheter placement       2   1   2   2   7 error)
1 6
Wrong site (WD error)               0   0   1   1   2 18 9
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


Overview Y-90 Microsphere MEs FY2014 - 2017 N=91       FY2016 - 2019    N=96 Cause
10 Overview Y-90 Microsphere MEs FY2014 - 2017 N=91 62, 65%
                                                > 20% residual not due to stasis Wrong dose 7%          (treatment plan 6%
10%
error) 12%              Wrong site (catheter placement error) 10%      62, 65%
12%
Device setup error Wrong dose vial/WD error 19 Actions to Prevent 35.1000 Y-90 Microsphere Medical Events
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
* Review mechanics of Y-90 microsphere delivery device and setup procedures
* Confirm all data and calculations in treatment plan
* Confirm all data and calculations in treatment plan
* Perform Time Out to assure all elements of treatment are in accordance with Written Directive 20 10
* 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


35.1000 Medical Events That May Have Been Prevented by Time Out Y-90 RSL       Perfexion/Icon 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%)
11 RSL Perfexion/Icon Y-90 Microspheres 2016 0/1 2/3 3/26 2017 0
21 35.1000 Medical Events That May Have Been Attributed to Lack of Experience or Infrequent User Y-90 RSL       Perfexion/Icon 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%)
0 3/23 2018 0/1 0/1 4/21 2019 0
22 11
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


Possible Elements of a Time Out
12
* Identity of patient via two identifiers (e.g., name and DOB)
* Identity of patient via two identifiers (e.g., name and DOB)
* Procedure to be performed
* Procedure to be performed
* Isotope
* Isotope
* Activity
* Activity
* Dosage - second check of dosage calculation and that the WD and dosage to be delivered are identical 23 23 Possible Elements of a Time Out contd.
* 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
* Others, as applicable
      - units of activity (LDR prostate)
- units of activity (LDR prostate)
      - anatomic location
- anatomic location
      - patient name on treatment plan
- patient name on treatment plan
      - treatment plan independent second check has been performed
- treatment plan independent second check has been performed
      - reference length (HDR)
- reference length (HDR)
      - implant site location (RSL) 24 24 12
- implant site location (RSL) 24 Possible Elements of a Time Out contd.
23 24


Subcommittee Response to Findings
13
* The subcommittee recommended that the NRC staff issue an Information Notice alerting Authorized Users to the themes identified herein.
* 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.
* IN-19-07, Methods to Prevent Medical Events, was published on August 26, 2019.
(ADAMS Accession No. ML19240A450) 25 25 Acronyms
(ADAMS Accession No. ML19240A450) 25 Subcommittee Response to Findings
* 10 CFR - Title 10 of the Code of Federal Regulations
* 10 CFR - Title 10 of the Code of Federal Regulations
* AUs - authorized users
* AUs - authorized users
Line 127: Line 268:
* ME - Medical Event
* ME - Medical Event
* RSL - radioactive seed localization
* RSL - radioactive seed localization
* Y yttrium-90 26 26 13}}
* Y yttrium-90 26 Acronyms 25 26}}

Latest revision as of 17:53, 29 November 2024

ACMUI Medical Event Subcommittee Slides, September 21, 2020, Review of FY16-19 Events
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)
v • d • e


Text

1 1

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

5

  • 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

12

  • 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

13

  • 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
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