ML22105A578

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ACMUI Medical Events Subcommittee Report - October 4, 2021
ML22105A578
Person / Time
Issue date: 10/04/2021
From: Richard Ennis
Advisory Committee on the Medical Uses of Isotopes
To:
Don Lomwan, NMSS/MSST/MSEB
References
Download: ML22105A578 (21)
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Text

Medical Events Subcommittee Report Ronald D. Ennis, M.D.

Advisory Committee on the Medical Uses of Isotopes October 4, 2021 1

Subcommittee Members

  • Ronald D. Ennis, M.D. (Chair)
  • Richard Green
  • Darlene Metter, M.D.
  • Zoubir Ouhib, M.S.
  • Michael OHara, Ph.D.
  • Michael Sheetz
  • Harvey Wolkov, M.D.

2

Summary

  • Two overarching themes remain

- Performance of a time out/use of a checklist 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 or inattention during performance of the procedure/treatment appear to be contributing factor(s) in a number of cases

- NRC issued an Information Notice alerting the users to this issue in 2019.

https://www.nrc.gov/docs/ML1924/ML19240A450.pdf 3

Summary

  • Specific issues

- Increase complexity of unsealed source administrations of newer agents may lead to more equipment related MEs in future

- MEs involving Y90 administration continue to be the most common MEs. We propose the creation of a subcommittee to evaluate this issue in more depth and, in conjunction with the vendors, propose solutions to decrease the frequency of MEs 4

35.200 Use of Unsealed Byproduct Material for Imaging and Localization Medical Events Summary 2017 2018 2019 2020 Total Cause Wrong drug 0 0 0 0 0 Wrong dosage 2 0 0 0 2 Wrong patient 1 0 0 0 1 Extravasation 1 0 0 0 1 Human error 0 0 1 (8 0 1 (8 patients) patients)

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

35.300 Use of Unsealed Byproduct Material, Written Directive Required Medical Event Summary 2017 2018 2019 2020 Total WD not done or 2 1 2 0 5 incorrectly Error in delivery 1 0 1 0 2

(#capsules)

Wrong dose 0 0 0 0 0 Equipment 0 1 4 0 5 Human Error 0 0 1 2 3 Wrong patient 1 0 1 0 2 Total 4 2 9 2 17 6

35.400 Manual Brachytherapy Medical Event Summary 2017 2018 2019 2020 Total Applicator issue (e.g. 0 0 0 2 2 jam, eye plaque dislodged)

Wrong site implanted 1 1 1 2 5 (e.g. penile bulb, bladder)

Activity/prescription 1 0 1 0 2 error (e.g. air kerma vs mCi, enter wrong activity in planning software)

Prostate Dose 5 11 3 0 19 New device 0 1 0 0 1 dose-

  • Still using based criteria Wrong source 0 0 0 1 1 Patient health 0 0 0 1 1

(?patient intervention)

35.400 Manual Brachytherapy Medical Event Summary 2017 2018 2019 2020 Total Total ME 7 13 5 6 45 Time out 1 0 1 1 3 may have prevented Lack of 1 1 1 1 4 experience/i nattention may have played a role 8

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 or inattention possibly plays a role in the true MEs of this type, but hard to assess to what degree in each case.

In approximately 15% of cases, a time out/checklist, enhanced retraining prior to performance of an uncommon procedure or increase attention during the procedure might have prevented the ME. 9

35.600 Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic unit 2017 2018 2019 2020 Total Wrong 2 3 4 7 16 position Wrong 2 1 4 2 9 reference length Wrong plan 0 2 0 0 2 Wrong Medical dose/source 0 Event 1Summary 0 0 1 strength Machin/applic 2 3 1 1 7 ator malfunction Software/har 2 (9 pts) 0 1 1 4 dware failure Treatment 0 0 0 2 2 planning Total 8 (14 pts) 10 10 13 41 10

35.600 Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic unit Medical Event Summary 2017 2018 2019 2020 Location Breast 0 1 0 1 Gynecological 7 (14 7 8 10 pts)

Skin/neck 0 1 0 2 Bronchus 0 0 0 0 Prostate 0 0 0 0 Brain 1 1 2 0 Total 8 (14 10 10 13 pts)

GYN tumors most common site of ME 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 plan or dose)

  • 2017 0/8 events
  • 2018 3/10 events
  • 2019 3/10 events
  • 2020 10/13 events Total 16/41 (39%)

12

35.600 Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic unit MEs caused by infrequent user/inattention This is difficult to determine based on information in NMED. For this assessment, assumed wrong position is a surrogate for infrequent user/inattention 2017 2/8 events

  • 2018 1/10 events
  • 2019 1/10 events
  • 2020 9/13 events Total 13/41 (32%)

13

35.1000 Radioactive Seed Localization Medical Events Summary 2018 2019 2020 2021 Total Medical 0 1 0 1 Events Cause:

Delayed seed 0 1 0 0 removal (patient intervention)

Lost seed 0 0 0 0 Wrong implant site 0 0 0 0 Seed migration 0 0 0 1

35.1000 Intravenous Cardiac Brachytherapy

  • Medical Events Summary 2017 2018 2019 2020 Total Did not follow 0 0 1 0 1 proper procedure Tortuous 0 1 1* 0 2 vessel anatomy Catheter issue 0 1 0 1 2 Total 0 2 2 1 5
  • AU felt this is patient intervention No time out issues Difficult to assess the unfamiliarity issue, but possibly played a role in some 15

35.1000 Gamma Knife Perfexion' and Icon' Medical Events Summary 2017 2018 2019 2020 Total Medical Events 0 1 2 2 Cause: 0 0 0 0 Back-up battery power source 0 1 0 0 failure Patient setup error 0 0 0 1 Patient movement 0 0 2 0 Wrong site (treatment plan) 0 0 0 0 Pt motion management system 0 0 0 1 failure

35.1000 Y-90 Theraspheres Medical Events Summary 2017 2018 2019 2020 Total Total Medical Events 15 14 15 15 59 Cause:

> 20% residual activity remaining 7 11 9 12 39 in delivery device Delivery device setup error 2 2 1 1 6 Wrong dose (treatment plan 4 0 1 0 5 calculation error)

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

Wrong dose vial selected 0 1 4 0 5 For 2020: Time out 3/15 (20%),

Infrequent/inattention 12/15 (80%)

35.1000 Y-90 SirSpheres Medical Events Summary 2017 2018 2019 2020 Total Total Medical Events 8 7 11 8 34 Cause:

> 20% residual activity remaining 7 2 8 8 25 in delivery device not due to stasis Wrong dose (treatment plan 0 2 0 0 2 calculation error)

Wrong site (catheter placement 1 2 2 0 5 error)

Wrong site (WD error) 0 1 1 0 2 2020: Time out: 0 Infrequent/inattention: 8/8 (100%)

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

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
  • 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) 20

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
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