ML12146A390
| ML12146A390 | |
| Person / Time | |
|---|---|
| Issue date: | 05/25/2012 |
| From: | NRC/OI, NRC/OIG |
| To: | |
| References | |
| Download: ML12146A390 (53) | |
Text
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 0 H R T D Human Resources Training & Development H R T D Human Resources Training & Development MEDICAL APPLICATIONS
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 1 Medical Uses of Radiation Diagnostic Radiology (X-rays)
Nuclear Medicine (Liquids and Gases Inside the Body)
Radiation Therapy (Sealed Sources of Radiation Either Inside or Outside the Body)
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 2 NUCLEAR MEDICINE
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 3 Nuclear Medicine THERAPEUTIC (beta)
Uptake
Imaging
Function DIAGNOSTIC (gamma)
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 4 Nuclear Medicine Concepts Forms Liquid (injected or swallowed) (e.g., 131I)
Gas (inhaled) (e.g., 133Xenon)
Drug = Chemical Compound Radiopharmaceutical = Radioactive Drug Labeled Radiopharmaceutical = Organ Specific Drug (chemically tagged to force the RAM to travel to a specific organ)
Uses Diagnostic (gamma) - obtain information (uptake/imaging/function)
Therapeutic (beta) - destroy tissue
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 5 Isotope Generators vs Unit Doses Generators (99Mo 99mTc)
(aka cow) unit dose
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 6 Thyroid Ablation
~ 200 mCi of Iodine-131 (mostly use capsules now)
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 7 Positron Emission Tomography (PET)
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 8 PET Scanning Units PET PET/CT
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 9 Radiopharmacy Extremity Dosimeter Tongs for Distance Syringe Shield Shields
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 10 Some Nuclear Medicine Issues
Pregnancy
Breastfeeding
Patient Release
Wrong Patient
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 11 Pregnancy (LER 34998 - 11/98)
During thyroid ablation therapy, a woman received a dose of 150 millicuries of I-131 in accordance with approved hospital procedures.
The woman insisted multiple times that she was not pregnant. Later, it was determined that she was 12-14 weeks pregnant with twins.
Each fetus received an estimated dose of:
38 rem to the whole body and 200,000 rad to the thyroid
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 12 Breastfeeding (LER 34618 - 8/98)
A 43 year old female patient was to undergo thyroid ablation therapy.
The patient denied breast feeding her 4 year old son. She was given 3 mCi of I-131 for a whole body pre-scan.
During the scan (3 days later), she was advised of the precautions surrounding the impending ablation therapy. The patient admitted breast feeding her son during the previous three days. She was told to immediately discontinue breast feeding.
She returned the following week with her son to have his uptake assessed. His estimated doses were thyroid - 184 rads, TEDE - 5.5 rads. She revealed that she had continued to breast feed her son.
The hospital canceled the thyroid ablation procedure
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 13 Patient Release Criteria 10 CFR 35.75 (medical)
Patients administered radiopharmaceuticals or permanent implants may be released if dose to any other individual is not likely to exceed 500 mrem 10 CFR 20.1301 (public)
(a) Each licensee shall conduct operations so that--
(1) The dose to a member of the public does not exceed 100 mrem, excluding the dose from individuals administered radioactive material and released IAW
§35.75
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 14 Patient Release Criteria RIS 2006-18 (August 31, 2006)
For hospitalized patients, caregivers allowed up to 2 rem maximum May be increased on a case-by-case basis.
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 15 A patient received 10 millicuries of Technetium-99m Time for a Quiz WOULD YOU CONSIDER THIS A REPORTABLE MEDICAL EVENT?
A "Medical Event" may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.
It was later discovered that the patient was only there for a routine stress test involving NO radioactive material.
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 16 After discussion with NRC and calculations from the physicist, the licensee determined that there was no medical event.
Licensee Event Report 11/98
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 17 Medical Event (10 CFR 35.3045)
Dose exceeds 5 rem when:
wrong radioactive drug wrong route wrong individual wrong mode
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 18 According to the DuPont Merck website, a 10 mCi dose of Cardiolite will produce the following approximate doses:
Large Intestine 1.5 rem Bladder 1.5 rem Small Intestine 1.0 rem Kidneys 0.6 rem Ovaries*
0.4 rem Testes**
- if patient was female
- if patient was male Typical 99mTechnetium Doses
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 19 OK, so its not a Medical Event, but could it be an overexposure of a member of the public since hes not a radiation worker and he wasnt scheduled to receive the radiation dose as a patient ?
Licensee Event Report 11/98
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 20 Annual Dose Limits Minor & Embryo/Fetus of DPW 0.5 rem Member of Public 0.1 rem*
Patient
? (% of physicians Rx)
Natural Background 0.62 rem**
(** average annual dose, not a limit)
Adult (aka Rad Worker) 5.0 rem
[Occupationally Exposed Individual]
- from each licensee
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 21 Public Doses - 10 CFR 20.1301 (a) Each licensee shall conduct operations so that--
(1) The dose to a member of the public does not exceed 100 mrem, excluding the dose from any medical administration the individual has received Does this really qualify as a medical administration given that he wasnt supposed to get it at all (it wasnt prescribed by any physician)
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 22 NRC Policy It is a medical administration. Although he wasnt supposed to get it and it wasnt prescribed, the injection of radioactive material in a hospital is considered a medical administration and all medical administrations of byproduct material are subject to 10 CFR Part 35 (medical regulations) not 10 CFR Part 20 (radiation safety regulations) so the public limit specified in 10CFR20.1301 doesnt apply to him.
The bottom line is there was no violation of NRC regulations.
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 23 Hospital visitor:
exposed by source transported down hall (< 100 mrem)
exposed by source inside a nearby patient (< 500 mrem)
caregiver (2,000 mrem +)
inadvertently given radioactive material (< 5,000 mrem)
Some Limits on Exposures to a Member of the Public Releases to environment (15-50 mrem)
Nuclear Power Plant and Most Licensees (< 100 mrem)
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 24 Nuclear Medicine Accidents Phoenix AZ (89)
Therapeutic Dose Instead of Diagnostic
[article from Redbook]
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 25 Linear Accelerators (X-rays or Electrons)
Teletherapy (Sealed Source Outside the Body)
Brachytherapy (Sealed Source Inside the Body)
Radiation Therapy
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 26 TELETHERAPY
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 27 Teletherapy Unit Source Head (see source drawer display) 5,000 Ci 130 R/min @ 1 m
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 28 18 mm 19 mm Capsule
( 5,000 Ci)
Cobalt-60 Pellets Teletherapy Source
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 29 After 5 treatments, the prescribing physician realized the tumor was actually located to the RIGHT side of the brain rather than the left!
A patient received cobalt-60 treatment for a brain tumor LEFT of midline. 10 treatments were prescribed at 180 rad per day. The written directive prescribed 2 fields.
73% to the LEFT 27% of the dose was to be delivered to the RIGHT side R
L Time for Another Quiz WOULD YOU CONSIDER THIS A REPORTABLE MEDICAL EVENT?
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 30 OGC Interpretation The doc incorrectly identified the location of the tumor volume and thus prepared a written directive based on this error.
However, the prescribed dose was administered in accordance with the written directive, therefore this incident does not constitute a medical event.
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 31 Stereotactic Radiosurgery (SRS)
Gamma Knife 201 Co-60 sources about 33 Curies each
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 32 Gamma Knife 8
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 33 Cyber Knife
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 34 BRACHYTHERAPY
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 35 Sealed Source Inside Body Terminology Temporary vs Permanent Implant Intracavitary vs Interstitial Applicators Seeds-Needles-Wire-Rods-Ribbons Low Dose Rate Afterloading (LDR)
High Dose Rate Remote Afterloading (HDR)
Emerging Technologies Brachytherapy
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 36 Tubes - Seeds - Needles Wires - Applicators
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 37 LDR Accidents CAUSES miscommunication lack of visual distinction lack of assay requirement inadequate training management control BACKUS HOSPITAL CT (94) 112 Iodine-125 seeds implanted in prostate Incorrect source activity (10 times too high)
Two surgeries removed 84 seeds, 28 remained
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 38 High Dose Remote Afterloading (HDR)
Source travels from unit, through catheter (plastic guide tube) into patient
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 39 HDR Source (0.3 mm)
(0.1 mm)
(0.5 mm) 0.08 R/min @ 1 m 13 R/sec @ 1 cm
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 40 HDR Accident CAUSES Inadequate Training Failure to Follow Procedures Equipment Design & Testing Weak Regulations INDIANA PA (92) [NUREG 1480]
4.3 Curie Iridium-192 Source Left Inside Patient Patient Died Source Discovered at Commercial Waste Facility Prescribed Dose 1.8 Krad - Delivered 1.6 Mrad Doses to 94 people other than patient
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 43 Patient Intervention What happens if the patient pulls the source out or shifts position so that an unintended part of the body is exposed?
§ 35.3045 Report and notification of a medical event.
(a) A licensee shall report any event, except for an event that results from patient intervention, in which the administration of byproduct material or radiation from byproduct material results in
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 44 Patient Intervention
§ 35.3045 Report and notification of a medical event.
(b) A licensee shall report any event resulting from intervention of a patient or human research subject in which the administration of byproduct material or radiation from byproduct material results or will result in unintended permanent functional damage to an organ or a physiological system, as determined by a physician.
Information Notice 2006-11 addresses GSR Intervention
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 45 Brachytherapy (Stent & Microspheres) 20-40 micrometers diameter (about 1,000th of an inch)
Beads with beta source
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 46 Stented artery of the leg with area of in-stent restenosis Balloon angioplasty catheter inside stented artery Radiation source train placed at treatment site for <5 min Peripheral artery post balloon angioplasty and vascular brachytherapy treatment IVB - Best Vascular Beta Cath System
GliaSite catheter is implanted into a brain resection cavity - the GliaSite is inflated with Iotrex (liquid 125I) -
3-6 days later, the Iotrex is retrieved
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 48 GliaSite
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 49 Mammosite (1 minute video)
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 50 NeoVista Epi-Rad90
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 51 Sr-90 eye applicator in storage box
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 52 Strontium-90 Beta Eye Applicator plastic shield for physician source attached here and placed on eye sources
G-112 OIG/OI Reactor & Materials Overview 03/22/10 - slide 53 END OF RADIATION THERAPY