Advanced Medical Systems, Inc; Denial of Petition for Rulemaking

NUCLEAR REGULATORY COMMISSION

10 CFR Part 32

[Docket No. PRM-32-3]

Advanced Medical Systems, Inc; Denial of Petition for Rulemaking

AGENCY: Nuclear Regulatory Commission.

ACTION: Denial of petition for rulemaking.

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SUMMARY: The Nuclear Regulatory Commission (NRC) is denying a petition

for rulemaking (PRM-32-3) from Advanced Medical Systems, Inc. The

petitioner requested that the NRC amend its regulations because it

believed that the requirements of part 32, which are applicable to

original manufacturers and suppliers, were not equally applicable to

manufacturers and suppliers of replacement parts. The petition is being

denied because current regulations apply equally to manufacturers and

suppliers of both original and replacement parts, ensuring the

integrity of these parts; therefore, no additional requirements

addressing the regulation of manufacturers and suppliers of replacement

parts are necessary. Further, current regulations address service and

maintenance of sources and devices possessed and used under an NRC

license, including replacement parts, whether manufactured or supplied

by the original manufacturer or supplier or some other manufacturer or

supplier. Therefore the amendments suggested by the petitioner are not

necessary.

ADDRESSES: Copies of the petition for rulemaking, the public comments

received, and the NRC's letter to the petitioner are available for

public inspection or copying in the NRC Public Document Room, 2120 L

Street NW., (Lower Level), Washington, DC.

FOR FURTHER INFORMATION CONTACT:

Naiem S. Tanious, Office of Nuclear Regulatory Research, U.S. Nuclear

Regulatory Commission, Washington, DC 20555, telephone (301) 492-3878.

SUPPLEMENTARY INFORMATION:

The Petition

In a letter dated June 28, 1991, Advanced Medical Systems, Inc.

(AMS) filed a petition for rulemaking with the NRC. The petition was

docketed by the Commission on July 19, 1991, and was assigned Docket

No. PRM-32-3. The petitioner requested that the NRC amend its

regulations because it believed that the requirements of part 32, which

are applicable to original manufacturers and suppliers, were not

equally applicable to manufacturers and suppliers of replacement parts.

The petitioner has suggested two alternatives for accomplishing this

objective. The first alternative is to insert the necessary language

regarding manufacturers and suppliers of replacement parts into each

appropriate section of part 32. The second alternative would revise the

purpose and scope provisions of Sec. 32.1 to include manufacturers and

suppliers of replacement parts.

Basis for Petitioner's Request

The petitioner identified itself as an original teletherapy

equipment manufacturer. As such, it has a definite and direct interest

in the health and safety of the public who may use or be treated by

equipment it manufactures.

According to the petitioner, it appears that the requirements of

part 32 are being interpreted as applying only to manufacturers and

suppliers of original equipment and not to manufacturers and suppliers

of replacement parts, devices, products, or sources designated for

units originally manufactured or transferred by others. In the

petitioner's view, lack of specific requirements applicable to

manufacturers and suppliers of replacement parts, devices, products, or

sources, can lead to use of inferior quality replacement parts which in

turn can cause malfunction or failure of devices, in particular

teletherapy equipment, and thereby risk of overexposure. Advanced

Medical Systems cited two incidents as examples of this problem: Access

No. M49250, Anderson Memorial Hospital, Anderson, South Carolina; and

Access No. M49324, St. Mary's Medical Center, Saginaw, Michigan.

Public Comments on the Petition

A notice of receipt of the petition for rulemaking was published in

the Federal Register on October 10, 1991 (56 FR 51182). Interested

persons were invited to submit written comments concerning the

petition. The comment period closed December 9, 1991. The NRC received

comments from the State of Illinois, Department of Nuclear Safety, and

the Department of the Air Force, Headquarters Air Force Office of

Medical Support.

The State of Illinois, Department of Nuclear Safety, stated that

the Department fully supports development of the rule proposed in the

petition. The Department further stated that the integrity of NRC

evaluated devices (NRC or an Agreement State evaluate for safety any

devices containing radioactive materials) may be compromised

significantly if nonstandard replacement parts are used during the life

of the device. While the Department agreed that the issue of

replacement components needs to be addressed, it was concerned with the

use of the term ``replacement sources and devices'' in the wording of

Secs. 32.74, 32.110 and 32.210 as suggested by the petitioner. The

Department believed that all sources and devices must be evaluated by

the NRC or an Agreement State, whether or not they are considered

``original'' or ``replacement'' equipment. Therefore, the Department

did not believe it is necessary to distinguish between original or

replacement sources or devices. The Department was in favor of the

petitioner's suggested alternative to modify Sec. 32.1, Purpose and

Scope.

The Headquarters Air Force Office of Medical Support, Department of

the Air Force, opposed the rule language proposed by the petitioner, as

written, although it agreed with the petitioner's intent to ensure that

the safety and effectiveness of devices not be compromised because

original parts are replaced by inferior ones. They did not agree that

all replacement parts should be subject to the requirements of 10 CFR

part 32. They stated that NRC review and approval should apply to

replacements of parts or components that are essential to the proper

and safe operations of a device. The Air Force gave examples of parts

(such as panel screws and covers) that conform to industry standards.

These, the Air Force stated, should not be subject to the proposed

requirements. The Air Force voiced concern that the petition, as

written, may serve to restrict competition and would lead to greater

expense which would have to be recouped through higher medical costs

from patients, or, in the case of the Air Force, from taxpayers.

NRC Action on the Petition

The NRC reviewed the petition, the public comments, and the two

cases (incidents) cited by the petitioner as supporting evidence for

filing this petition. The NRC also reviewed its regulations pertinent

to the petition.

Shortly after the NRC received correspondence\1\ from AMS about the

two cases, the NRC advised\2\ AMS of its intention to investigate these

incidents, especially with regard to the quality of service and

replacement parts used in servicing the teletherapy units. From October

to December 1989, the NRC conducted a thorough investigation which

included three onsite inspections: Atom Mechanical Company, Cleveland,

Ohio (The servicing company that conducted the maintenance and

replacement of parts in the two cases), St. Mary's Medical Center,

Saginaw, Michigan, and Picker International, Highland Heights, Ohio

(The company that manufactured the teletherapy units at Anderson

Memorial Hospital and at St. Mary's Medical Center). The NRC also

referred the case of Anderson Memorial to the State of Maryland,

because the company that serviced the teletherapy unit there, Atom

Mechanical Company, is an authorized user on the Neutron Products, Inc.

license, and Neutron Products is located in the State of Maryland, an

Agreement State.

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\1\Three letters dated June 20, August 8, and August 25, 1989,

to Hugh L. Thompson, Jr., Deputy Executive for Nuclear Materials

Safety and Safeguards & Operations Support, NRC, from Sherry Stein,

Director, Regulatory Affairs, Advanced Medical Systems, Inc.

\2\By a letter dated September 15, 1989 from Robert M. Bernero,

Director, Office of Nuclear Material Safety and Safeguards, NRC, to

Sherry Stein, Director, Regulatory Affairs, Advanced Medical

Systems, Inc.

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The incident at Anderson Memorial Hospital was caused by a broken

spring in a teletherapy unit which failed to retract the source into

the OFF position following a cobalt-60 cancer treatment. The hospital

technologist promptly retracted the source manually. According to the

hospital report, the technologist received very little additional

exposure over expected monthly exposure, as evidenced by the

individual's radiation film badge reading. Moreover, according to the

same report the delivered daily dose to the patient was less than the

prescribed daily dose, i.e., no patient overexposure for that

treatment, because the technologist acted promptly. In its

communication with NRC (prior to filing the petition), AMS stated that

it was concerned about the quality of the replacement springs used in

the teletherapy machine.

The incident at St. Mary's Medical Center was caused by the failure

of a microswitch. The failure of the switch prevented a timing device

from operating properly, to automatically terminate the treatment. No

misadministration occurred because the subsequent treatment times were

adjusted and the total delivered dose did not differ from the total

prescribed dose. Neutron Products, Inc. was called to repair the

machine.

The NRC investigation and subsequent inspections revealed several

violations. Enforcement action was taken by the NRC against Atom

Mechanical for violation of part 21 requirements, and against St.

Mary's Hospital and Picker International for violations of part 35 and

part 30 requirements, respectively.3 Moreover, the State of

Maryland determined from its own investigation that the incident at

Anderson Memorial Hospital resulted from a failure of the part, i.e.,

breakage of the return spring. No enforcement action was taken by the

State of Maryland.

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\3\Specifically, Atom Mechanical Company was found to be in

violation of 10 CFR 21.21 (October 16, 1989), St. Mary Medical

Center was found to be in violation of 10 CFR 35.59(g), 10 CFR

35.605, 10 CFR 35.630(a), 10 CFR 35.615(d)(4), 10 CFR 35.632(a), and

10 CFR 35.634(a) (October 17 and 26, 1989), and Picker

International, Inc. was found to be in violation of 10 CFR 30.3

(subsequent to inspections that occurred on October 26 and November

9, 1989). Inspection reports are available for review in the NRC

Public document room.

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Under current NRC regulations, persons authorized under a specific

license to use devices containing byproduct material (e.g., use of

teletherapy equipment under a part 35 specific license) ultimately are

responsible for the safe use of these devices, and for assuring that

such devices are properly maintained. Suppliers of sources or devices

containing byproduct material, whether they are an original

manufacturer or a manufacturer of replacement sources or devices, must

be licensed under parts 30 or 32 or an appropriate Agreement State

license, and also have responsibility for the safety of the sources or

devices that they supply or replace. Service or repair, which would

include the replacement of parts or components of medical or industrial

sources or devices that present a risk of radiation exposure from the

failure of certain parts, such as the teletherapy devices discussed as

examples in this petition, may be performed only by qualified persons

authorized under an NRC or Agreement State license (cf. Secs. 35.605,

and 39.43(e)). Some generally licensed devices may be serviced by

general licensees who are authorized to perform limited service work if

sufficient information about the service work (e.g., procedures,

training, expected dose, etc.) is submitted by manufacturer or initial

distributor and accepted by the NRC. However, these devices typically

are not mechanically complex and do not present the same risk of

significant radiation exposure. Moreover, the NRC has no record of

failure of these devices leading to a radiation exposure attributable

to defective replacement parts or improper servicing. Finally, under

the provisions of part 21, the supplier of any basic component,4

whether or not a licensee of NRC or an Agreement State, is also

responsible for the quality of the component, whether it is original or

replacement.

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\4\A ``basic component'' is defined in part 21 as one, ``* * *

in which a defect could create a substantial safety hazard.''

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Reasons for Denial

The NRC has examined the petition (1) in light of its regulations

and policies for both general and specific licensees, and (2) in view

of the cases cited by the petitioner in support of the petition. The

NRC is denying the petition because current regulations apply equally

to manufacturers and suppliers of both original and replacement parts,

ensuring the integrity of these parts; therefore, no additional

requirements addressing the regulation of manufacturers and suppliers

of replacement parts are necessary. Further, current regulations

address service and maintenance of sources and devices possessed and

used under an NRC license, including replacement parts, whether

manufactured or supplied by the original manufacturer or supplier or

some other manufacturer or supplier.

Accordingly, the petition for rulemaking is denied.

Dated at Rockville, Maryland this 28th day of March, 1994.

For the Nuclear Regulatory Commission.

James M. Taylor,

Executive Director for Operations.

[FR Doc. 94-8697 Filed 4-11-94; 8:45 am]

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