ML19038A495

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ACMUI Medical Event Subcommittee Slides, September 20, 2018, Review of FY14-17 Events
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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Subcommittee Members

  • Ronald D. Ennis, M.D. (Chair)
  • Richard Green Medical Events Subcommittee
  • Darlene Metter, M.D.

Report

  • Michael OHara, Ph.D.
  • John Suh, M.D.

Ronald D. Ennis, M.D.

  • Michael Sheetz Advisory Committee for the Medical Uses of Isotopes September 20, 2018 1 2 Process Summary
  • This year, rather than review the details of specific
  • Two overarching themes emerged cases, we are reporting on our overview of events

- Performance of a time out immediately prior to over last 3.5 years to discern common themes administration of radioactive byproduct material, as within each section of 10 CFR Part 35 and across is done in surgery and other settings, could have the sections, to inform a discussion of possible prevented some MEs ways to decrease medical events (MEs). - Lack of recent or frequent performance of the specific administration appears to be a contributing factor in a number of cases

  • 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 4 1

35.200 Use of Unsealed Byproduct 35.200 Use of Unsealed Byproduct Material for Imaging and Localization Material for Imaging and Localization Medical Events Summary How Can These Events Be Prevented?

2014 2015 2016 2017 Total Cause

  • Wrong drug: Time out - confirm the order, compare to Wrong drug* 0 3 3 0 6 the prescription Wrong dosage 5 0 3 3 11
  • Wrong dosage: If a dose calibrator is available -

Wrong patient 1 1 2 0 4 measure the activity Total 6 4 8 3 21

  • Wrong patient: Time out - Verify patients by two means of identification
  • In most cases wrong drug was also wrong dosage
  • 10/21 preventable if time out had been used 21 events over 4 years 5

35.300 Use of Unsealed Byproduct 35.400 Manual Brachytherapy Material, Written Directive Required Medical Event Summary Medical Event Summary 2014 2015 2016 2017 Total 2014 2015 2016 2017 Total WD not done or 0 1 0 2 3 incorrectly Applicator issue (e.g. movement 1 1 1 0 3 during implant Error in delivery 2 3 1 1 7

(#capsules) Wrong site implanted (e.g. penile 3 1 1 1 6 bulb)

Wrong dose 0 2 3 0 5 Activity/prescription error (e.g. air 1 2 0 1 4 Equipment 1 1 0 0 2 kerma vs mCi)

Unauthorized clinic 0 0 1 0 1 Prostate Dose 0 4 18 5 27 Wrong patient 1 0 0 1 2 Total 4 7 5 4 20 Time out could prevent 10-17/20 7

2

35.400 Manual Brachytherapy 35.400 Manual Brachytherapy Medical Event Summary Many MEs in this category are no longer categorized 2014 2015 2016 2018 Total as MEs due to change from dose- to activity-based Total ME 5 8 20 7 40 definition.

Time out 1 2 0 1 4 (10%)

may have prevented Lack of experience possibly plays a role in the true Lack of 3 1 1 1 6 (15%) MEs of this type, but hard to assess to what degree experience in each case.

may have played a role In approximately 25% of cases, a time out or enhanced retraining prior to performance of an uncommon procedure might have prevented the ME.

9 10 35.600 Use of a sealed source in a 35.600 Use of a sealed source in a remote afterloader unit, teletherapy remote afterloader unit, teletherapy unit, or gamma stereotactic unit unit, or gamma stereotactic unit Medical Event Summary Medical Event Summary 2014 2015 2016 2017 2014 2015 2016 2017 Cause Location Wrong position 3 6 1 2 Breast 1 1 0 0 Wrong reference length 2 3 0 2 Gynecological 5 9 2 7 (14 pts)

Wrong plan 1 3 1 0 Skin 2 1 1 0 Wrong dose/source 2 0 0 0 Bronchus 1 2 0 0 strength Prostate 0 0 2 0 Machine malfunction 2 2 3 2 Brain 1 1 0 1 Software failure 0 0 0 2 (9 pts)

Total 10 14 5 8 (14 pts)

Total 10 14 5 8 (14 pts)

GYN tumors most common site of ME 37 events over 4 years 11 12 3

35.600 Use of a sealed source in a 35.600 Use of a sealed source in a remote afterloader unit, teletherapy remote afterloader unit, teletherapy unit, or gamma stereotactic unit unit, or gamma stereotactic unit MEs that may have been prevented by MEs caused by infrequent user timeout (wrong plans or dose) This is difficult to determine based on information on

  • 2014 3/10 events NMED. If assumption is made about wrong position as surrogate for infrequent user
  • 2015 3/14 events
  • 2016 1/5 events
  • 2014 3/10 events
  • 2017 0/8 events
  • 2015 6/14 events Total 12/37 (32.4%)
  • 2016 1/5 events Total 6/37 (16.2%)
  • 2017 2/8 events 13 14 35.1000 Radioactive Seed 35.1000 Gamma Knife Perfexion' Localization and Icon' Medical Events Summary Medical Events Summary 2014 2015 2016 2017 2014 2015 2016 2017 Total Medical Events 1 8 3 0 Total Medical Events 1 1 0 2 Cause:

Cause:

Patient positioning system misalignment 8 Delayed seed removal (patient 1 1 by vendor (same site) intervention)

Patient setup error 2 Lost seed 1 Patient movement 1 Wrong implant site 1 Wrong site (treatment plan) 1 4

35.1000 Y-90 Theraspheres 35.1000 Y-90 SirSpheres Medical Events Summary Medical Events Summary 2014 2015 2016 2017 2014 2015 2016 2017 Total Medical Events 9 8 13 15 Total Medical Events 15 10 13 8 Cause: Cause:

> 20% residual activity remaining in 6 7 9 7 > 20% residual activity remaining in 10 2 9 7 delivery device delivery device not due to stasis Delivery device setup error 1 2 Wrong site (shunting) 2 4 Wrong dose (treatment plan 1 1 4 Delivery device setup error 1 3 calculation error) Wrong dose (treatment plan 1 1 2 Wrong site (catheter placement error) 1 1 2 2 calculation error)

Wrong site (shunting) 1 Wrong site (catheter placement error) 1 2 1 Overview Y-90 Microsphere Actions to Prevent 35.1000 Y-90 ME Microsphere Medical Events 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 5

35.1000 Medical Events That May 35.1000 Medical Events That May Have Been Prevented by Time Out Have Been Attributed to Lack of Experience or Infrequent User RSL Perfexion/Icon Y-90 Microspheres RSL Perfexion/Icon Y-90 Microspheres 2014 1/2 1/1 3/24 2015 0/1 0/8 2/18 2014 0/2 0/1 1/24 2015 0/1 0/8 3/18 2016 0/1 2/3 3/26 2016 0/1 2/3 1/26 2017 0 0 3/23 2017 0 0 2/23 Total 1/4 (25%) 3/12 (25%) 11/91 (12%)

Total 0/4 (0%) 2/12 (17%) 7/91 (8%)

Possible Elements of a Possible Elements of Refresher Time Out for Infrequent Procedure

  • Identity of patient via two identifiers (e.g. name and DOB)
  • Take review course from professional society
  • Procedure to be performed
  • Isotope
  • Read review articles
  • Activity
  • Speak to colleague with experience
  • Dosage
  • Do dry run of procedure with the team
  • Others as applicable

- units of activity (LDR prostate)

  • Review mechanics of device set up and

- anatomic location procedure

- patient name on treatment plan

- treatment plan independent second check has been performed

- reference length (HDR)

- Implant site location (RSL) 23 24 6

Recommendation for Action Acronyms

  • 10 CFR - Title 10 of the Code of Federal Regulations
  • AUs - authorized users The subcommittee recommends the NRC
  • DOB - date of birth issue an Information Notice alerting AUs to
  • FY - Fiscal Year the themes identified herein
  • Gy - Gray
  • gyn - gynecological
  • LDR - low dose rate
  • mCi - milliCurie
  • ME - Medical Event
  • RSL - radioactive seed localization
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