Information Notice 2005-27, Low-Dose-Rate Manual Brachytherapy Equipment-Related Medical Events

Low-Dose-Rate Manual Brachytherapy Equipment-Related Medical Events

ML052780358
Person / Time
Issue date:	10/07/2005
From:	Chris Miller NRC/NMSS/IMNS
To:
Zelac R
Shared Package
ML052780535	List: Information Notice 2005-27, Low-Dose-Rate Manual Brachytherapy Equipment-Related Medical Events
References
IN-05-027
Download: ML052780358 (9)

UNITED STATES

NUCLEAR REGULATORY COMMISSION

OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS

WASHINGTON, D.C. 20555-0001 October 7, 2005 NRC INFORMATION NOTICE 2005-27: LOW-DOSE-RATE MANUAL BRACHYTHERAPY--

EQUIPMENT-RELATED MEDICAL EVENTS

ADDRESSEES

All medical licensees.

PURPOSE

The U.S. Nuclear Regulatory Commission (NRC) is issuing this information notice (IN) to inform

addressees of recently reported medical events that occurred during an NRC licensees

implementation of low-dose-rate (LDR) manual brachytherapy procedures. It is expected that

recipients will review this information for applicability to their licensed operations and consider

actions, as appropriate, to avoid similar problems. However, the information contained in this

IN does not constitute new NRC requirements; therefore, no specific action nor written

response is required.

DESCRIPTION OF CIRCUMSTANCES

On March 28, 2005, an NRC licensee reported to NRC its identification of two medical events

involving radiation doses to unintended treatment sites of two patients. The licensee had

administered LDR manual brachytherapy treatments to the patients in February and March

2004 and, during a subsequent review, licensee staff determined that the treatments had

resulted in medical events, as defined in NRCs regulations. During a special NRC inspection

conducted on March 30, 2005, to review the circumstances of the two medical events reported

by the licensee, the inspector identified three additional patients who had treatments similar to

those that resulted in the reported medical events. One of those additional patients exhibited

observable side effects, as did the two patients involved in the medical events reported by the

licensee. As a result, NRC upgraded the special inspection to an Augmented Inspection Team

(AIT) on March 31, 2005. The purpose of the AIT was to examine the conditions and

circumstances surrounding the medical events to determine the probable causes and

contributing factors of the events.

The AIT concluded that five LDR manual brachytherapy treatments had resulted in medical

events, as defined in Title 10 of the Code of Federal Regulations (CFR) Part 35. Three of the

patients developed skin lesions on the upper thighs from radiation doses to the skin of the

upper thighs, an unintended treatment site. The nature of the lesions indicated that the doses

were greater than 1100 centigray (cGy) (1100 rads). The other two patients did not exhibit any

unintended radiation effects. Therefore, those two patients received unintended doses to the

thighs that were below the threshold for observable radiation effects. The AIT also determined

that the root cause of these medical events was the licensee staff use of radioactive sources

with smaller diameters than that specified in the instructions distributed with the brachytherapy

applicator employed in all five cases. This error allowed the sources to move from their

intended position within the applicator to a position that resulted in the unintended doses to the

skin of the five patients.

The applicator involved in the five medical events was a Mick Radio-Nuclear Instruments, Inc.

Wang Front-Loading Vaginal Applicator, Model 8524 (applicator), intended for use with

cesium-137 sources, to treat patients. See the attached diagram of the Wang applicator. The

instructions provided with the applicator specified the use of sources manufactured by the 3M

Company (3M), and the applicator was marked with the appropriate source dimensions.

The applicator design allowed the sources to be inserted into the applicator after the applicator

had been positioned in the patient for treatment (i.e., afterloaded), thereby reducing the

radiation dose to brachytherapy staff. After the applicator was positioned within the patient, one

of the sources was placed into a hinged insert, referred to as a bucket, and subsequently

positioned within the applicator, perpendicular to two sources to be positioned in the tandem

portion of the applicator. The tandem sources were loaded into a closable flexible carrier tube, and a coil spring was inserted into the tube, to hold the sources in position. Once the loaded

flexible carrier tube was closed, the tube was placed into the applicator.

During each of the first five brachytherapy treatments performed by the licensee with the Wang

applicator, that resulted in medical events, licensee staff selected G.E. Healthcare (formerly

known as Amersham; hereafter referred to as Amersham) sources for use in the tandem

portion of the applicator. The Amersham sources were different in a critical dimension from the

3M sources specified in the instructions - they were too small in diameter, being 2.6 millimeter

(mm) (0.10 inch) in diameter, when 3.1 mm (0.12 inch) diameter sources were specified. As a

result, the tandem sources slid down to the opposite end of the applicators flexible carrier tube

whenever the applicator was tilted more than 20 degrees off-level (i.e., the tandem sources

moved out of their intended position whenever a patient moved more than 20 degrees off-level

(e.g., sat up) during treatment), resulting in irradiation of the skin on the patients thighs. The

Amersham sources moved through the center of the applicators carrier tube spring because

the diameter of the sources was smaller than the inner diameter of the coil spring.

The licensee became aware of the error in April 2004, after the authorized user observed

effects during examinations of the three patients who exhibited skin injury. The authorized user

requested that licensee staff investigate the possible cause of the injuries. During this

investigation, licensee staff reviewed the instructions that came with the applicator, noticed

that the instructions specified the use of 3M sources, recognized that the sources that had been

used were Amersham sources, not 3M sources, and discovered the mobility of Amersham

sources when used in the applicators tandem source holder.

In April 2004, immediately after the licensee identified that the Amersham sources could

change position in the Wang applicators tandem source carrier tube during brachytherapy

treatments, the licensee initiated actions to prevent similar unintended patient exposures. The licensee modified the applicator by using different hardware to keep the radioactive sources in

proper position during brachytherapy treatments. The licensees modification of the applicator

was effective.1 However, the licensee misinterpreted the medical event reporting requirements

in 10 CFR 35.3045(a)(3) and failed to promptly identify, in April 2004, that multiple medical

events had occurred. Reporting of medical events (2) to NRC was delayed until March 2005, when, following patient reexaminations, the licensee determined that treatment side effects for

two patients were more severe than previously observed.

DISCUSSION

NRC staff reviewed the instructions associated with use of the Wang applicator and identified

several issues of generic concern that staff believes may result in improper use of the device.

For example:

• Instructions explaining the use of alternate sources were not clear. Portions of the

instructions provided with the applicator indicated that only 3M sources should be used

with the applicator. However, other portions of the instructions indicated that the

tandem portion of the applicator may be loaded with sources manufactured by other

suppliers, and it referenced an attachment with source comparisons. The attachment

was not clear regarding what other sources could be used (e.g., it did not indicate the

source manufacturers names or the technical limitations on source physical

dimensions).

• Instructions explaining the proper configuration of sources were not clear. The

instructions indicated that the applicator used three sources in a T configuration (e.g.,

one in the bucket and two in the tandem portion of the applicator). However, another

section stated that up to four sources could be used in the tandem portion of the

applicator.

• Instructions did not clearly alert the user to proper action that must be taken if the spring

in the tandem portion of the applicator required shortening. The distal end of the

applicator coil spring was designed with an inward bend, to prevent source movement

down the center of the spring. The instructions stated that the applicator spring could

be shortened. This would be necessary if more than two sources were used in the

tandem portion of the applicator. The instructions did not provide a warning to the user

not to cut the distal end of the spring with the inward bend, if shortening of the spring

was necessary. Such an action could result in source movement down the center of the

spring.

The licensee had not used more than two sources in the tandem portion of the applicator for

any of the five similar brachytherapy treatments completed. Therefore, the licensee did not cut

the applicator spring. However, the spring supplied with the licensees applicator did not

include the inward bend at the distal end, which increased the potential for source movement

under certain circumstances. The Amersham sources could, and did, for the five patients

involved in

__________

1 Such a user modification is not regulated by the Food and Drug Administration (FDA). medical events, move down the center of the spring to the opposite end of the tandem portion

of the applicator when the patients undergoing treatment raised up from horizontal positions.

NRC referred the generic-concern issues of the applicator instructions and this licensees

experience with the applicator spring to the FDA for its review and evaluation. Presently, FDAs

review and evaluation of these issues is in progress and has not been completed.

The medical events involved errors in selection of ancillary equipment--sealed radioactive

sources--required for use of the afterloader applicator employed in the treatments, resulting in

failure of the sealed sources to remain in their intended positions throughout the specified

treatment times. Licensees performing LDR manual brachytherapy procedures are expected to

review this IN and:

• Assure that radioactive sources and any other ancillary devices to be used with an LDR

manual brachytherapy applicator for a therapeutic procedure are designed for use with, or are known to be compatible with, the LDR applicator to be used during

the procedure;

• Assure that all LDR manual brachytherapy applicator users are familiar with the

operating procedures and applicable usage restrictions of all equipment to be employed

in a therapeutic procedure, before actual use of such devices, associated radioactive

sources, and any other ancillary equipment;

• Encourage device and equipment users to review all vendors pertinent documentation

and clarify any concerns with the vendors, regarding particular devices, sources, or

equipment, before the devices, sources, or equipment are used for patient treatments.

Licensees are expected to clarify any uncertainties, discrepancies, or potential errors in

usage directions provided in vendor-supplied documentation and/or through verbal

discussion with a vendor or on-site vendor representative before use of the device(s),

sources, or equipment; and

• Promptly report: 1) any and all medical events, to NRC; and 2) all equipment

malfunctions or problems, to the vendors and, if required, to the licensing authorities.

CONTACT

S

This information notice does not require any specific action or written response. Please direct

any questions about this matter to the technical contact below, or the appropriate

regional office.

/RA/ Patricia K. Holahan, for

Charles L. Miller, Director

Division of Industrial and

Medical Nuclear Safety

Office of Nuclear Material Safety

and Safeguards

Ronald E. Zelac, Ph.D., NMSS

(301) 415-7635 E-mail: rez@nrc.gov

Attachments: 1. Diagram of Wang Applicator

2. List of Recently Issued NMSS Generic Communications

CONTACT

S

This information notice does not require any specific action or written response. Please direct

any questions about this matter to the technical contact below, or the appropriate

regional office.

/RA/Patricia K. Holahan, for

Charles L. Miller, Director

Division of Industrial and

Medical Nuclear Safety

Office of Nuclear Material Safety

and Safeguards

Ronald E. Zelac, Ph.D., NMSS

(301) 415-7635 E-mail: rez@nrc.gov

Attachments: 1. Diagram of Wang Applicator

2. List of Recently Issued NMSS Generic Communications

ML052780535 OFFIC MSIB MSIB Tech. Ed. IMNS MSIB IMNS

E:

NAME: RZelac LChang EKraus ICabrera TEssig CMiller/PHolahan

DATE: 7/13 /05 7 /13 /05 7 /12 /05 7 /20 /05 8 /10/05 9/27/05/10/06/05 OFFICIAL RECORD COPY

Attachment 2 Recently Issued NMSS Generic Communications

Date GC No. Subject

Addressees

2/11/05 BL-05-01 Material Control and All holders of operating licenses

Accounting at Reactors and for nuclear power reactors, Wet Spent Fuel Storage decommissioning nuclear power

Facilities reactor sites storing spent fuel in

a pool, and wet spent fuel storage

sites.

8/25/05 RIS-05-18 Guidance for Establishing All licensees, applicants for

and Maintaining a Safety licenses, holders of certificates of

Conscious Work compliance, and their contractors

Environment subject to NRC authority

8/10/05 RIS-05-16 Issuance of NRC All licensees and certificate

Management Directive 8.17, holders.

Licensee Complaints

Against NRC Employees

8/3/05 RIS-05-15 Reporting Requirements for All material licensees possessing

Damaged Industrial industrial radiographic equipment, Radiographic Equipment regulated under 10 CFR Part 34.

7/13/05 RIS-05-13 NRC Incident Response and All licensees and certificate

the National Response Plan holders.

7/11/05 RIS-05-12 Transportation of Licensees authorized to possess

Radioactive Material radioactive material that equals or

Quantities of Concern NRC exceeds the threshold values in

Threat Advisory and the Additional Security Measures

Protective Measures System (ASM) for transportation of

Radioactive Material Quantities of

Concern (RAMQC) under their 10

CFR Part 30, 32, 50, 70, and 71 licenses and Agreement State

licensees similarly authorized to

possess such material in such

quantities under their Agreement

State licenses.

7/11/05 RIS-05-11 Requirements for Power All holders of operating licenses

Reactor Licensees in for nuclear power reactors and

Possession of Devices generally licensed device

Subject to the General vendors.

License Requirements of 10

CFR 31.5 Date GC No. Subject

Addressees

6/10/05 RIS-05-10 Performance-Based All industrial radiography

Approach for Associated licensees and manufacturers and

Equipment in 10 CFR 34.20 distributors of industrial

radiography equipment.

4/18/05 RIS-05-06 Reporting Requirements for All material licensees possessing

Gauges Damaged at portable gauges, regulated under

Temporary Job Sites 10 CFR Part 30.

4/14/05 RIS-05-04 Guidance on the Protection All holders of operating licenses

of Unattended Openings or construction permits for nuclear

that Intersect a Security power reactors, Boundary or Area research and test reactors, decommissioning reactors with

fuel on site, Category 1 fuel cycle

facilities, critical mass facilities, uranium conversion facility, independent spent fuel storage

installations, gaseous diffusion

plants, and certain other material

licensees.

2/28/05 RIS-05-03 10 CFR Part 40 Exemptions All persons possessing aircraft

for Uranium Contained in counterweights containing

Aircraft Counterweights - uranium under the exemption in

Storage and Repair 10 CFR 40.13(c)(5).

7/29/05 IN-05-22 Inadequate Criticality Safety All licensees authorized to

Analysis of Ventilation possess a critical mass of special

Systems at Fuel Cycle nuclear material.

Facilities

6/23/05 IN-05-17 Manual Brachytherapy All medical licensees authorized

Source Jamming to possess a Mick applicator.

5/17/05 IN-05-13 Potential Non-conservative All licensees using the Keno-V.a

Error in Modeling Geometric criticality code module in

Regions in the Standardized Computer Analyses

Keno-v.a Criticality Code for Licensing Evaluation (SCALE)

software developed by Oak Ridge

National Laboratory (ORNL)

5/17/05 IN-05-12 Excessively Large Criticality All licensees authorized to

Safety Limits Fail to Provide possess a critical mass of special

Double Contingency at Fuel nuclear material.

Cycle Facility Date GC No. Subject

Addressees

4/7/05 IN-05-10 Changes to 10 CFR Part 71 All 10 CFR Part 71 licensees and

Packages certificate holders.

4/1/05 IN-05-07 Results of HEMYC Electrical All holders of operating licenses

Raceway Fire Barrier for nuclear power reactors, except

System Full Scale Fire those who have

Testing permanently ceased operations

and have certified that fuel has

been permanently removed

from the reactor vessel, and fuel

facilities licensees.

3/10/05 IN-05-05 Improving Material Control All licensees authorized to

and Accountability Interface possess a critical mass of special

with Criticality Safety nuclear material.

Activities at Fuel

Cycle Facilities

Note: NRC generic communications may be found on the NRC public website at

http://www.nrc.gov, under Electronic Reading Room/Document Collections.