ML20279A812

ACMUI Medical Event Subcommittee Slides, September 21, 2020, Review of FY16-19 Events

ML20279A812
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Issue date:	09/21/2020
From:	Richard Ennis Advisory Committee on the Medical Uses of Isotopes
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Jamerson K
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Medical Events Subcommittee Report Ronald D. Ennis, M.D.

Advisory Committee on the Medical Uses of Isotopes September 21, 2020 1

1 Subcommittee Members

• 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 2

1

Process

• 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 3

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

4 2

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)

Total 0 4 0 1 5 3/5 possibly preventable by time out 5

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

(# capsules)

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%

Emerging increase in equipment issues 5/19 = 26% compared to 10% in last review 6

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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)

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

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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.

• 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 9

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

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.

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)

• 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 12 6

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.

• 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 13 35.1000 Radioactive Seed Localization Medical Events Summary 2016 2017 2018 2019 Total Medical Events 1 0 1 0 Cause:

Delayed seed removal 1 1 (patient intervention)

Lost seed 0 Wrong implant site 0 14 14 7

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

• 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

35.1000 Y-90 Theraspheres Medical Events Summary 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)

Wrong site (catheter placement 2 2 0 0 4 error)

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:

> 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)

Wrong site (catheter placement 2 1 2 2 7 error)

Wrong site (WD error) 0 0 1 1 2 18 9

Overview Y-90 Microsphere MEs FY2014 - 2017 N=91 FY2016 - 2019 N=96 Cause

> 20% residual not due to stasis Wrong dose 7% (treatment plan 6%

error) 12% Wrong site (catheter placement error) 10% 62, 65%

Device setup error Wrong dose vial/WD error 19 Actions to Prevent 35.1000 Y-90 Microsphere Medical Events

• 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 20 10

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%)

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%)

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Possible Elements of a Time Out

• 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 23 Possible Elements of a Time Out contd.

• 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 24 12

Subcommittee Response to Findings

• 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 25 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

• Y yttrium-90 26 26 13