Proposed Quality Standards for Mammography Equipment and Quality Assurance

DEPARTMENT OF HEALTH AND HUMAN SERVICES

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 900

[Docket No. 95N-0195]

RIN 0910-AA24

Proposed Quality Standards for Mammography Equipment and Quality

Assurance

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend

the regulations for facility standards established in the interim

regulations implementing the Mammography Quality Standards Act of 1992

(the MQSA). This proposed rule will establish additional performance

standards for mammography equipment and equipment-related quality

assurance practices currently required of mammography facilities. FDA

is proposing these amendments based on advice from the National

Mammography Quality Assurance Advisory Committee (NMQAAC), mammography

equipment manufacturers, and public comments received in response to

the interim regulations. This proposed rule is intended to assure safe,

accurate, and reliable mammography on a nationwide basis. This document

is the fifth of five related proposed rules that FDA is publishing

concurrently in this issue of the Federal Register.

DATES: Written comments by July 2, 1996. The agency is proposing that

any final rule based on this proposed rule become effective 1 year

after its date of publication in the Federal Register, except where

otherwise indicated.

ADDRESSES: Submit written comments to the Dockets Management Branch

(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,

Rockville, MD 20857. The Regulatory Impact Study (RIS) is available at

the Dockets Management Branch for review between 9 a.m. and 4 p.m.,

Monday through Friday. Requests for copies of the RIS should be

submitted to the Freedom of Information Staff (HFI-35), Food and Drug

Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Charles K. Showalter, Center for

Devices and Radiological Health (HFZ-240), Food and Drug

Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-594-3332.

SUPPLEMENTARY INFORMATION:

I. Background

This proposal is the fifth of five related proposed rules published

in this issue of the Federal Register to amend interim regulations

published on December 21, 1993 (58 FR 67558 and 58 FR 67565),

implementing the MQSA (Pub. L. 102-539). The first proposed rule,

``Quality Mammography Standards; General Preamble and Proposed

Alternative Approaches'' contains background information and a summary

of the preliminary analysis of the costs and benefits of the proposed

rules, a description of the information collection requirements,

proposed revisions to Sec. 900.1 Scope and Sec. 900.2 Definitions (21

CFR 900.1 and 900.2), and proposed alternative approaches to

mammography quality standards and a request for comments on the

proposed alternatives.

II. Provisions of the Proposed Rule

A. Development of the Proposed Regulation

As with the interim regulations, FDA was guided in the development

of this proposed rule by the intent of the legislation to guarantee

access to safe and effective mammography services for all women in the

United States (Ref. 1). FDA also relied upon three major sources of

information, in addition to the expertise and research of FDA

personnel.

First, the agency considered public comments received on the

interim regulations. The agency received 103 comments from individuals

and organizations, including: Professional organizations, medical

facilities, State agencies, consumer groups, manufacturers, and

individual physicians, medical physicists, and radiologic

technologists. The proposed regulations were also discussed in a series

of quarterly meetings with the NMQAAC. Members of the NMQAAC include

interpreting physicians, medical physicists, radiologic technologists,

representatives of State agencies, and consumer representatives.

Consultants to the NMQAAC and guests invited to attend the committee

meetings in recognition of their expertise in mammography also

participated in these discussions of the proposed regulations. Finally,

the agency obtained input through discussions with various professional

and trade organizations and individuals with expertise related to

mammography equipment, quality assurance, and infection control.

Preliminary drafts of the proposed regulations were made generally

available at the NMQAAC meetings and through notices of availability

published in the Federal Register on December 30, 1994 (59 FR 67710)

and January 26, 1995 (60 FR 5152).

Organizations participating in discussions of the regulations

included the National Electrical Manufacturers Association (NEMA), the

Conference of Radiation Control Program Directors (CRCPD), and four

national medical physicist organizations: The American Association of

Physicists in Medicine, the American Academy of Health Physics, the

American College of Medical Physicists, and the Health Physics Society.

A discussion of the proposed amendments and a summary and analysis

of NMQAAC input and public comments regarding the regulations is

provided below.

B. Equipment Regulations

In Sec. 900.12(b) of the interim regulations, performance standards

were established for equipment used in the production of mammograms.

These standards were substantially harmonized with existing standards,

such as those established by the Health Care Financing Administration

(HCFA), the American College of Radiology (ACR), and some States. This

interim approach was consistent with the legislative intent of the MQSA

(Ref. 1) and enabled FDA to certify the thousands of facilities that

already met voluntary accreditation standards prior to publication of

the interim regulations. This approach also allowed the agency to

concentrate its initial resources on facilities with no such prior

accreditation. Now that additional input regarding the equipment

standards has been obtained from the NMQAAC, equipment manufacturers,

and the public, FDA is proposing additional requirements in

Sec. 900.12(b) for radiographic, processing, and ancillary equipment

used in mammography.

In developing the proposed equipment standards, FDA recognized the

need to balance the economic impact of new standards against the

associated gains to the public health. It was also necessary for FDA to

consider the availability (initially, and over time) of mammography

equipment meeting the new requirements. This was necessary because, for

some requirements, considerable time might be needed to allow for

redesign, production, purchase, and installation of new equipment, or

for retrofitting of the installed equipment base. The amount of time

needed would depend on the nature of the requirement, the capacity of

manufacturers, and the number of facilities already meeting the

requirement. In consideration of these factors, the agency is proposing

to phase in the equipment standards in proposed Sec. 900.12(b) over the

next 1 to 10 years.

In accordance with guidance from the NMQAAC, three effective dates

are being proposed for different phases of implementation. Requirements

to be implemented during the first phase would have an effective date

of 1 year after the date of publication of the final rule. Such

requirements would cover aspects of equipment performance that the

NMQAAC considered fundamental to the delivery of quality mammography.

Requirements to be

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implemented during the second and third phases would have effective

dates of 5 and 10 years after the date of publication of the final

rule, which FDA estimates would correspond to approximately October 1,

2000, and October 1, 2005, respectively. Although these dates have been

used for the purpose of this proposal, the final effective dates will

be modified to correspond to the dates 5 and 10 years after the

publication date of the final rule. The agency believes that this

advance guidance to the industry regarding upcoming changes in

requirements and the phasing in of such requirements will minimize the

economic impact of implementing improvements in mammography.

Several comments received on the interim regulations indicated a

lack of awareness of agency plans for notice-and-comment rulemaking in

promulgating final regulations, or listed specific recommendations for

changes or additions. Most of the recommendations for specific

equipment requirements have been incorporated into the proposed

standards. A summary of these comments and the FDA responses follow:

1. General

One comment disagreed with the prohibition in the interim

regulations against performance of mammography using a conventional x-

ray system with device modifications or options specifically designed

to enable use of the system for mammography. The comment stated that

allowing use of such systems for mammography would represent an

economical source of equipment that should not be problematic as long

as the systems can produce quality images without compromising examinee

safety or dosage considerations.

In response to this comment, FDA notes that the MQSA expressly

states that equipment standards must ``require use of radiological

equipment specifically designed for mammography'' (42 U.S.C.

263b(f)(1)(B)). Therefore, FDA is continuing the prohibition against

use of nonmammography x-ray equipment for the production of mammograms.

One comment supported the interim requirements in Sec. 900.12

(b)(2)(i) to (b)(2)(iii) but requested the addition of two subsections

requiring: (1) Cassettes of appropriate size, to allow the technologist

to obtain a complete breast image on a single film, and (2) grids

specifically designed for mammography for each size of cassette.

FDA agrees with these comments and has included such requirements

in proposed Sec. 900.12(b)(4).

Three comments suggested that the provision in

Sec. 900.12(b)(2)(iii), requiring mammography equipment to have a

removable grid, be expanded to require a reciprocating removable grid.

A reciprocating (moving) grid would avoid grid lines often seen with a

stationary grid. One comment did not understand the requirement in

Sec. 900.12(b)(2)(iv), and in particular the phrase ``removable grid.''

The comment stated that, if the intent is not to reduce radiation dose,

the appropriate word would be ``moving,'' rather than ``removable,''

because moving the grid improves image quality. Also, the comment

questioned whether this standard refers to regular view or

magnification mode.

FDA believes that all equipment should be provided with

reciprocating (moving) grids and that these grids should be removable

for all systems providing magnification capability. These grid

requirements have been proposed in Sec. 900.12 (b)(4)(ii) and

(b)(4)(iii). The intent is that the grid be removable so that

magnification procedures can be completed properly without increasing

the radiation dose to the examinee.

Discussions with the NMQAAC indicated considerable concern that

radiographic equipment be equipped to enable a number of routine views

for all examinees. Of specific concern were the mediolateral oblique,

caudo-cranial, and cranio-caudal views, and the need to ensure that

each facility has equipment that allows for variation in individual

body habitus.

Under Sec. 900.12(b)(3) (ii) and (iii), FDA has proposed specific

requirements related to the motion capability of the gantry assembly

that the NMQAAC believes will achieve this goal.

The NMQAAC also strongly recommended that all mammography systems

be required to have a light field that approximates the x-ray field and

passes through the collimation system. This configuration would assist

in positioning and allow visual verification that the radiographic view

of the breast remains unobstructed. In response to this NMQAAC

recommendation, FDA received comments from a major trade association

representing manufacturers of mammography x-ray equipment indicating

that a significant portion of the installed equipment base would not

meet these requirements. This association further indicated that there

may be significant costs associated with retrofitting existing

equipment to comply with this recommendation.

FDA is proposing to require in Sec. 900.12(b)(5) that all

mammography systems have the light field recommended by the NMQAAC,

effective October 1, 2000. FDA is requesting public comment on this

proposed requirement and its likely impact on the cost and availability

of mammography services.

Proposed Sec. 900.12(b)(11)(i) references the requirements in

Sec. 1020.30(m)(l) (21 CFR 1020.30(m)(1)) for minimum beam quality

(half-value layer (HVL)) for mammography x-ray systems. FDA realizes

that this reference is redundant with proposed Sec. 900.12(b)(2), but

believes that it is necessary to clarify the requirements stated in

proposed Sec. 900.12(b)(11)(i).

One comment stated that, in addition to requiring the incorporation

of a breast compression device, the regulation should mandate use of

this device (at least for screening mammography), because compression

enables better visualization of the breast and permits lower radiation

dose to be used.

FDA recognizes that use of a breast compression device is

considered by professionals to be essential for proper imaging of the

breast. By requiring that each system be equipped with a breast

compression device, FDA has attempted to ensure that this feature is

always available to the technologist. However, because the requirement

that the compression device always be used would be extremely difficult

to enforce, such a requirement has not been proposed.

In Sec. 900.12(b)(12), FDA is proposing that all mammography

systems be equipped with both foot-controlled power driven and fine

adjustment controls (either manual or power driven). The intent of this

requirement is to allow the technologist to use both hands to position

the examinee under foot regulated power control, and to make final

adjustments to the compression under the increased control provided by

the fine adjustment mechanism. FDA is specifically requesting

additional comments on this proposed requirement. For example, would a

power-only system that provided a slower, more controlled, final

application of power driven compression be as useful as a combination

of power and manual compression?

One comment suggested requiring that all compression equipment

allow for automatic release of compression in case of power or

mechanical failure.

FDA recognizes that some facilities consider an automatic

compression release desirable, and the proposed regulations permit

this. However, under

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some conditions, an automatic release may represent a physical hazard

to the examinee. Therefore, under Sec. 900.12(b)(12)(ii), FDA is

proposing certain restrictions on systems that provide an automatic

decompression feature.

Two comments noted that the interim regulations do not require that

the breast compression device be parallel to the imaging plane, thus

potentially allowing unequal compression to occur.

FDA agrees and the proposed regulations contain a requirement under

Sec. 900.12(b)(12)(iii)(B) to address this concern. FDA notes, however,

that there is one manufacturer that does not meet this proposed

requirement because it claims that the nonparallel design of its device

provides uniform compression. FDA requests comments (and supporting

data) regarding whether the agency should: (1) Modify the proposed

regulations to accommodate this alternative design, or (2) retain the

requirement as proposed and allow manufacturers to obtain variances to

market alternative devices, in accordance with the alternative

equipment provision in proposed Sec. 900.18 (published elsewhere in

this issue of the Federal Register).

Seven comments recommended that FDA require automatic exposure

control (AEC) capability on all systems. One comment suggested that the

equipment requirements should be more specific to address phototimers,

acceptable operating energies, radiation output, and milliampere (mA)

requirements.

FDA agrees and has included requirements for each of these areas in

proposed Sec. 900.12 (b)(13), (b)(14), and (b)(15). These requirements

were supported by the NMQAAC.

One comment suggested that all mammography systems installed or

transferred following implementation of the interim regulations should

provide for milliampere second (mAs) readout following each exposure.

FDA agrees that mAs readout is important and under proposed

Sec. 900.12(b)(13)(iv), all equipment that automatically selects the

mAs will be required to indicate the mAs value used following the

exposure.

Two comments suggested a number of technical requirements that all

mammography equipment should be required to meet.

The recommended requirements are supported by FDA and the NMQAAC

and have been included in proposed Sec. 900.12 (b)(4), (b)(5), (b)(8),

(b)(11), (b)(14), and (b)(15), or were already covered under the

diagnostic x-ray system performance standard in Secs. 1020.30 and

1020.31 (21 CFR 1020.31), with the exception of the following:

(1) One comment suggested that a tungsten target tube should never

be used for screen-film mammography.

FDA disagrees with this comment. The agency believes there is no

evidence to support prohibiting the use of tungsten target tubes and

has not included this limitation in the proposed regulations.

(2) One comment stated that the nominal focal spot size should be

regulated in conjunction with the system source-image receptor distance

(SID).

FDA is proposing to address the issue of focal spot size through

the proposed requirement for system resolution in Sec. 900.12(b)(8).

The intent of this requirement (which has been adopted by the ACR), is

to provide a test for system resolution that is easier to perform than

a focal spot size determination.

(3) One comment stated that the SID should not be less than 50

centimeters (cm).

FDA is proposing to adopt the ACR's minimum requirement for SID,

which is 55 cm.

2. Xeromammography

Three comments requested FDA to prohibit use of xeromammography,

which the comments believed produces lower quality mammograms at a

higher dose of radiation than screen-film modalities.

FDA is aware of the controversy regarding use of xeromammography,

but the agency believes that, with respect to certain diagnostic

applications, the modality may still be equal to screen-film systems.

At the same time, the virtual disappearance of xeromammography units

from the marketplace indicates that the mammography community itself is

discontinuing the general use of this modality. Both the interim and

proposed regulations place a maximum limit on the dose that can be

delivered to an examinee using xeromammography. In proposed

Sec. 900.12(c), published elsewhere in this issue of the Federal

Register, the dose that may be delivered by xeromammography has been

reduced from the interim requirement of 4.0 milliGray (mGy) to 3.0 mGy.

This decision was based on communication from the manufacturer of

xeromammography systems informing FDA that properly adjusted and

maintained xeromammography systems could meet such a requirement. Under

the proposed regulations, therefore, the dose limits for screen-film

and xeromammography would be the same.

One comment questioned whether xeromammography will continue to be

considered inadequate for screening purposes, in accordance with HCFA

regulations.

FDA regulations replace those issued by HCFA concerning mammography

facilities and FDA regulations do not prohibit the use of

xeromammography for screening.

3. Operator Protection

Two comments expressed concern that no regulations addressed the

protection of the operator by requiring radiation protective barriers

or anchored exposure switches.

FDA believes that specific operator safety requirements remain the

responsibility of State and local authorities regulating the use of

diagnostic x-ray equipment. Therefore, FDA has not proposed any

requirements relating to this aspect of the facility operation.

4. Examinees With Disabilities

In addition to meeting the specific requirements listed in this

regulation, it was the opinion of the NMQAAC that each facility has the

responsibility to accommodate examinees with physical disabilities and

to provide such examinees with access to the same quality mammography

provided to other examinees. The NMQAAC further believed that

facilities that could not provide such special services should be

required to screen prospective examinees during the appointment

scheduling process and refrain from scheduling disabled examinees who

cannot be accommodated.

FDA has included a requirement in proposed Sec. 900.12(b)(16)

reflecting this recommendation. The agency also encourages facilities

that cannot accommodate disabled individuals to refer these individuals

to a facility that is equipped to provide mammography services for

them. FDA encourages comments regarding the necessity and

appropriateness of this section in light of the requirements currently

imposed by the Americans with Disabilities Act of 1990.

5. Interventional Mammography

Five comments indicated that standards and test methods are needed

for stereotactic units and dedicated biopsy-type machines.

FDA agrees with these comments. However, the agency believes that

no consensus exists in the mammography community regarding appropriate

standards for such equipment and

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procedures. Various public and private organizations are working to

develop such standards and FDA will propose requirements some time in

the future.

6. International Harmonization

In the Federal Register of November 28, 1994 (59 FR 60870), FDA

published an agency policy on international harmonization of regulatory

requirements. In accordance with that policy, the agency requests

comments regarding the implications of the proposed equipment standards

on any related international harmonization efforts for mammography

equipment.

C. Quality Assurance (QA)--Equipment

The primary purpose of the equipment aspects of the quality

assurance program is to prevent problems with equipment or detect and

correct problems before they can have a significant effect on clinical

image quality. To achieve this, the performance parameters of the

equipment must be tested at appropriate frequencies, the test results

must be promptly analyzed to determine if the performance of the

equipment is satisfactory, and any identified problems must be

corrected as soon as possible. In addition, followup tests must be

conducted to determine whether the corrective actions were effective.

Requirements for these types of tests are proposed in Sec. 900.12(e).

1. Testing of Screen-Film Systems

Proposed Sec. 900.12 (e)(1) through (e)(5) establish the minimum

performance tests to be conducted on screen-film systems. The agency

has decided not to propose extensive detailed requirements in order to

provide facilities with the flexibility to use alternative methods that

might be equally satisfactory or to add other tests. Under the interim

regulations, FDA adopted the ACR's relatively detailed QA requirements

(Ref. 2). However, the NMQAAC has advised FDA that these ACR

requirements were intended to be used as guidelines, not in a

prescriptive manner.

Therefore, the agency is proposing to limit the quality assurance

requirements for equipment to a more general listing of the required

tests, establishment of the required test frequencies, definition of

action limits, and, in some cases, specification of critical test

conditions.

At the July 1994 NMQAAC meeting, an additional daily total system

test was discussed, which read as follows:

Total System Test:

(A) The optical density (OD) of the film at the center of an image

of a uniform phantom when exposed in AEC mode shall not change by more

than 0.20 from the established operating level. The OD of

the established operating level shall be above 1.20. The mAs shall not

change by more than 10 percent from the established value corresponding

to the operating level OD.

(B) The film shall be examined for system artifacts.

The agency believes that this total system test, in conjunction

with the processor performance test set forth in proposed

Sec. 900.12(e)(1), should be performed daily before the first examinee

is examined. The performance of these two tests will assure the overall

quality of the x-ray machine, processor, and films. The records of the

tests will also enable a medical physicist to quickly detect the source

of a problem when it occurs. The above described system test takes only

a few minutes to perform and can be performed by a quality control

technologist.

The NMQAAC suggested that more data about the usefulness of the

total system test should be gathered before this test is introduced as

a required daily test. The NMQAAC also agreed that the image quality

evaluations described in proposed Sec. 900.12(e)(2) should be performed

weekly if the total system test is not required.

The agency is proposing system testing requirements in accordance

with the NMQAAC's advice. Although FDA is not proposing to require the

daily total system test at this time, the agency requests comments

regarding the utility of this test. If the total system test were

introduced, FDA would revise the regulations to require monthly, rather

than weekly, performance of the image quality evaluations in proposed

Sec. 900.12(e)(2).

Several comments on the interim regulations raised concern about

basing the quality control requirements on a single manual, such as the

ACR manual (Refs. 2 and 3).

In the proposed regulations, no manual has been referenced. A

facility may consult any appropriate manual or rely on agency guidance

to meet the requirements in proposed Sec. 900.12(e)(1) through (e)(5).

One comment requested that any standard that is developed be

achievable with current technology. As an example of a test that the

comment believed could not be achieved using current technology, the

comment cited ACR's criteria for passing the screen-film contact test,

as described in the 1992 ACR manual (Ref. 2).

The agency is convinced, based on the expertise of its staff and

experience with the interim regulations, that the requirements and

action limits proposed in this regulation can be met with current

technology.

One comment suggested that a minimum allowable dose should be

specified for a 4.5-cm compressed breast composed of 50 percent

glandular tissue and 50 percent adipose tissue. Also, one comment

suggested that the mean glandular dose should not exceed 1.0 mGy for

screen-film systems without grids.

FDA believes that placing a lower limit on dose may hamper further

technological advancement of systems that may reduce the dose without

compromising image quality. In addition, the agency has decided to use

only one upper dose limit for all systems.

Several comments stated that FDA's data indicate that an accepted

phantom simulates a 4.2-cm thick compressed breast, not 4.5 cm.

Therefore, the regulations should use a 4.2-cm thickness. One comment

stated that the dose should be determined using clinically employed

technique factors for a 4.5-cm thick compressed breast composed of 50

percent glandular tissue and 50 percent adipose tissue, instead of

using the phantom technique factors promulgated in the interim

regulations. Two comments noted that, in many cases, the technique

factors used by a facility to produce phantom images do not reflect the

technique factors actually used on examinees. This could result in

examinees receiving doses exceeding the limits specified in the

regulations, even though the facility technically passed the compliance

test by using their phantom image technique factors. One comment stated

that the dose should be determined under the facility's proposed

technique factors for a 4.2-cm thick compressed 50 percent glandular/50

percent adipose breast.

After review of these comments, FDA is proposing to require

clinical technique factors and a phantom simulating a 4.2-cm thick

compressed 50 per cent glandular/50 per cent adipose tissue breast to

be used during dose measurements. Although FDA has data to show that an

accepted phantom simulates the attenuation properties of 4.2 cm of 50/

50 compressed breast tissue, the agency recently has developed

additional data indicating that the phantom may be equivalent in

attenuation properties to approximately 4.0-cm of 50/50 compressed

breast tissue, as per the dose model used to convert skin exposure to

dose. The agency, therefore, is soliciting more information and

comments on the appropriate equivalent thickness of the phantom for

dose calculation.

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One comment requested an explanation of the methods for obtaining

FDA certification of QA phantoms. Another comment suggested that the

regulations should specify one, and only one phantom, and should

specify the minimum acceptable performance, rather than leaving this to

the discretion of accreditation bodies.

The agency continues to believe that accreditation bodies should

establish phantom specifications and related performance criteria.

However, as part of it responsibilities for accreditation body approval

and oversight, FDA will examine each body's phantom specifications and

performance requirements, which will have to be substantially the same

among different accreditation bodies.

One comment recommended that FDA publish some type of voluntary

form(s) for maintaining appropriate records.

FDA believes it is inadvisable for the agency to generate sample

forms because such forms may be unnecessarily restrictive. Facilities

that do not want to generate their own forms may adopt forms that are

provided in various manuals, as appropriate.

2. Systems With Other Modalities

Proposed Sec. 900.12(e)(6) would require that the facility quality

assurance program for systems with image receptor modalities other than

screen-film (e.g., xeromammography) be substantially the same as that

recommended by the image receptor manufacturer. This section would also

require that such systems meet the same dose limits as screen-film

systems.

3. Mobile Units

Proposed Sec. 900.12(e)(7) would establish additional quality

assurance requirements for mobile mammography units. These mobile units

are operated in a variety of environments and undergo the stress of

frequent movements, often over rough surfaces. In view of this, a

number of comments on the interim regulations urged FDA to require that

a phantom image quality test be performed after every move, before any

additional examinations are conducted at the new site. These comments

stated that if a problem occurs after a move which could compromise the

quality of clinical images, this problem should be detected and

corrected before any further clinical use of the equipment. These

comments believe this additional testing is necessary for mobile units

in order to minimize the need for repeat examinations, which would

result in additional radiation exposure and expense and might result in

some cancers going undetected if it is not possible to get examinees to

return to the facility.

In contrast, other comments noted that a requirement for a post-

move, pre-examination image quality test would pose great difficulties

to mobile services that are some distance from their home base and do

not have access to adequate processing at the test site. These comments

expressed concern that such a requirement would cause some mobile

services to cease operation and would significantly reduce access to

mammography in rural and inner city areas. Several comments cited their

own experience in stating that image quality tests conducted after

moves rarely or never show that a problem has occurred because of the

move. The preliminary results of a survey of mobile facilities

conducted by the ACR found that nearly 90 percent of the facilities

rarely found problems after a move. However, the remaining facilities

found problems as often as daily or weekly.

The 1992 edition of the ACR QA manual (Ref. 2) recommended that an

image quality test be conducted after every move, but was somewhat

ambiguous regarding when the processing and analysis of the images

should occur. However, the agency has been informed by members of the

ACR committee who were responsible for the manual that they did not

intend to require processing before further examinations were

conducted. The 1994 edition of the ACR QA manual (Ref. 3) completely

dropped the requirement for conducting image quality testing after

every move. Under this revised ACR requirement, therefore, mobile units

are required to undergo image quality testing at the same frequency as

fixed units, which ordinarily is monthly.

At its September 1994 meeting, the NMQAAC discussed this issue and

recommended that post-move, pre-examination testing of mobile units be

required in the final regulations. FDA agreed with this recommendation

and has incorporated it in proposed Sec. 900.12(e)(7).

The NMQAAC further recommended allowing use of a method of testing

based on post-exposure mAs readout values in place of phantom image

testing. FDA has decided not to require a particular method of testing

at this time. Instead, the agency is proposing to require each facility

to adopt a test method that will verify the adequacy of image quality

following a move, but to leave the choice of test method to the

facility. The agency believes that this approach will give individual

facilities maximum flexibility. FDA will issue guidance documents that

reflect the agency's current thinking about test methods that are

appropriate. At this time, FDA expects those methods to include the

method recommended by the NMQAAC as well as the traditional phantom

image quality test.

Including these methods of testing in guidance rather than in

regulations has the advantage of increased speed and flexibility. As

the agency becomes aware of new test methods of proven value, the

agency's evaluation of such methods can be publicized through

modification of guidance materials much more rapidly than through

amendment of regulations. In addition, mobile units will have the

option of using post-move pre- examination image quality test methods

that are different from those described in guidance. Testing methods

described in these materials will guide inspectors as they evaluate the

adequacy of an individual facility's testing methods. Although the

methods described in guidance will represent the agency's most current

thinking about appropriate testing for this purpose, such guidance will

not bind the facility or the agency. If a facility chooses alternative

procedures, FDA encourages the facility to discuss the choice in

advance in order to prevent expenditure of efforts and resources on

testing that may later be determined to be unacceptable because it does

not establish the adequacy of image quality following a move.

4. Use of Test Results

Proposed Sec. 900.12(e)(8) describes how results from the tests

specified in paragraphs (e)(1) through (e)(7) would be used to ensure

that problems are detected and corrected before they adversely affect

the quality of examinations.

5. Survey

Proposed Sec. 900.12(e)(9) describes the activities that would have

to be carried out by the medical physicist as part of the annual

evaluation of facility equipment performance and quality assurance

programs. A concern raised at the February 1994 NMQAAC meeting and

elsewhere was that qualified medical physicists might delegate the

onsite survey work to less qualified personnel and merely review and

sign the survey report.

Because FDA is also concerned about such delegation occurring, the

agency is proposing in Sec. 900.12(e)(9)(i) that only qualified medical

physicists be authorized to conduct the surveys. The agency is further

proposing to require in Sec. 900.12(e)(9)(V) that the report be signed

and dated by the individual who

[[Page 14914]]

performs the survey. As is the case with the signature of the

interpreting physician on the mammography report (see discussion of

Sec. 900.12(c)(1) published elsewhere in this issue of the Federal

Register), the purpose of the signature requirement is to identify the

individual who performed or provided direct supervision of the work.

Therefore, in addition to handwritten signatures, FDA will accept

``signatures'' that are generated from computer systems, typewritten,

name stamped, and possibly provided in other ways. These requirements

would not prohibit physicists-in-training from performing surveys to

gain experience, but would require that such surveys be done under the

direct supervision of a fully qualified medical physicist, who would

have to sign the report as the responsible physicist. If another

individual performs any part or all of the survey under the direct

supervision of a medical physicist, that person and the part of the

survey that person performed must also be identified on the survey

report.

6. Mammography Equipment Evaluation

Proposed Sec. 900.12(e)(10) would require a mammography equipment

evaluation to be performed whenever a mammography unit or image

processor is installed or major components of that unit or processor

are changed. This requirement was added to ensure that the performance

of new or significantly changed equipment is evaluated, and problems

corrected, before such equipment is used during examinations. FDA

believes mammography equipment evaluation, rather than a complete

survey of the facility as described in Sec. 900.12(e)(9), is adequate

for this purpose because not all aspects of the facility operation

which are checked during a survey would be affected by the installation

of new equipment or the modification of old equipment.

The agency will describe its current thinking about appropriate

procedures for carrying out these evaluations in guidance documents and

will update that guidance, when warranted, to reflect scientific and

professional developments. Similarly, the agency will describe in

guidance its current thinking about appropriate qualifications for

persons doing this work. As discussed previously with respect to agency

guidance for testing mobile units, facilities will have the option of

using procedures other than those described in guidance or employing

individuals with qualifications different than those listed in

guidance, assuming such alternative procedures or qualifications are

adequate to examine equipment for such purposes. The guidance issued by

FDA will not be binding on either the facility or the agency. Once

again, however, FDA encourages facilities that choose alternative

personnel or procedures, to discuss the choice in advance in order to

prevent expenditure of efforts and resources on evaluations that may

later be determined to be inadequate.

FDA realizes that Sec. 900.12(e)(10), as presently proposed, raises

the question as to what constitutes a ``major component'' of the

equipment, i.e., what components would have a significant impact on the

performance of the equipment if their repair or replacement were done

improperly. The agency specifically requests comments on this issue.

7. Housekeeping and Maintenance Tasks

At its July 1994 meeting, the NMQAAC stressed the importance of

carrying out regular maintenance and housekeeping activities as well as

properly storing film and processing chemicals. However, the agency

decided, for two reasons, not to propose detailed and comprehensive

requirements for such activities.

First, failure to follow proper maintenance and housekeeping

activities at a facility will be revealed through failure of the tests

outlined in Sec. 900.12(e)(1) through (e)(6) and through adverse

findings in the physicist's survey. Additional detailed requirements

would be redundant.

Second, there are a wide variety of effective maintenance and

housekeeping activities. The agency believes that it would be overly

prescriptive to limit facilities to one set of activities in this area

by regulation.

At its January 1995 meeting, the NMQAAC agreed that the details of

these activities could be incorporated into guidance materials rather

than regulatory requirements. However, the members believed that

general requirements should be established for certain especially

important activities. Therefore, FDA is proposing to require in

Sec. 900.12(e)(11) that facilities establish and follow protocols for

the maintenance of darkroom, screen, and view box cleanliness.

8. Calibration of Exposure Measuring Instruments

In order to have reliable uniform dose measurements in facilities

all across the United States, it is important to have proper

traceability of the instruments used to measure x-ray exposure. The

agency is proposing to add in Sec. 900.12(e)(12) a requirement for

annual calibration of such instruments, which must be traceable to a

national standard.

9. Infection Control

Concern was expressed during the open public portion of several

NMQAAC meetings and by one comment on the interim regulations that,

because of the possibility of nipple discharge during mammography, FDA

should mandate the use of universal precautions during all mammography

examinations to protect examinees and health care workers from possible

transmission of bloodborne pathogens. The comment also expressed

concern that present procedures used to disinfect mammography equipment

between examinations are inadequate to prevent disease transmission.

FDA notes that the concept of ``universal precautions'' is an

approach to infection control stipulating that all human blood and

certain human body fluids should be treated as if known to be

infectious for human immunodeficiency virus (HIV), hepatitis B and C

viruses (HBV, HCV), and other bloodborne pathogens. The Occupational

Safety and Health Administration (OSHA) already mandates the use of

universal precautions for all situations where occupational exposure

can reasonably be anticipated (29 CFR 1910.1030). Although staff at the

Centers for Disease Control (CDC) have advised FDA that there have been

no reported cases of transmission of HIV, HBV, or HCV to examinees or

health care workers during mammography, such transmission is

theoretically possible (if no infection control precautions are taken).

Therefore, the OSHA regulations are applicable to the practice of

mammography, and it would be redundant for FDA to issue a universal

precautions requirement under the MQSA authority.

With respect to appropriate decontamination practices, members of

the NMQAAC noted during an advisory committee meeting that guidelines

and regulations addressing infection control practices relevant to

mammography are available from CDC (Ref. 4) and OSHA (29 CFR

1910.1030(d)(4)). These guidelines and regulations specifically address

the decontamination of medical equipment and working surfaces after

contact with blood or other potentially infectious materials. Local

infection control policies are also in effect in many locations.

In addition, the Association for the Advancement of Medical

Instrumentation (AAMI) recently published a technical information

report on reprocessing of reusable medical

[[Page 14915]]

devices (Ref. 5). Several other national and international standards

setting organizations are developing guidance in this area as well.

However, these guidelines, regulations, reports, and standards do not

completely cover all aspects of reprocessing mammography equipment,

because they may not address the special concerns of disinfecting

electrical equipment, and may not consider the effect of the

disinfecting agent upon the equipment. For these reasons, FDA is

developing a guidance document regarding labeling of reusable medical

devices for reprocessing in health care facilities (Ref. 6). A notice

of availability requesting comments on this guidance document was

published in the Federal Register on June 15, 1995 (60 FR 31484). FDA

and industry will utilize this document to ensure appropriate labeling

for new devices as well as for improving labeling for currently

marketed devices.

FDA believes that the concern raised by the comment transcends the

issue of reuse of mammography devices and addresses the broader general

issue of safe reuse of any reusable medical device. Therefore, it is an

issue to be resolved under the agency's general medical device

authority, rather than under the authority of the MQSA. In light of the

concerns raised, however, FDA is reviewing current guidance and

regulations, as well as additional guidance under development by the

agency, to determine whether new labeling information or accessories

are necessary with respect to reuse of mammography devices. FDA

encourages interested parties to communicate to the agency any concerns

and proposed solutions in this area.

To ensure that the practice of mammography benefits from infection

control guidance already available, FDA is proposing to require that

facilities establish, adhere to, and document their compliance with a

system of infection control. In addition to requiring compliance with

any applicable infection control regulations, each facility's system

would have to require adherence to infection control recommendations

provided by the manufacturer(s) of the mammography equipment used in

the facility, or, if adequate manufacturer's recommendations are not

available, adherence to generally accepted guidance on infection

control (e.g., Refs. 4 and 5), until such recommendations become

available.

III. Environmental Impact

The agency has determined under 21 CFR 25.24(e)(3) that this action

is of a type that does not individually or cumulatively have a

significant effect on the human environment. Therefore, neither an

environmental assessment nor an environmental impact statement is

required.

IV. Analysis of Impacts

FDA has examined together the impacts of this proposed rule and the

proposed rules on accreditation bodies, general facility requirements,

and personnel, published elsewhere in this issue of the Federal

Register, under Executive Order 12866, the Regulatory Flexibility Act

(Pub. L. 96-354), and under the Unfunded Mandates Reform Act. The

analysis has addressed the proposed requirements of these four rules as

one unit for purposes of determining their economic impact. The

preamble to the proposed rule ``Quality Mammography Standards; General

Preamble and Proposed Alternative Approaches,'' published elsewhere in

this issue of the Federal Register, contains a brief summary of the

cost and benefit determination and the Regulatory Impact Study that

details the agency's calculation of these economic impacts and is

available at the Dockets Management Branch (address above) for review.

FDA recognized that these proposed regulations may have a

disproportionate effect on small volume mammography facilities and is

currently collecting additional information on the potential impact on

this industry sector. The agency requests comments that will assist it

in accounting for this impact.

V. Paperwork Reduction Act of 1995

This proposed rule contains no information collection or

recordkeeping requirements under the Paperwork Reduction Act of 1995.

VI. Comments

Interested persons may, on or before July 2, 1996, submit to the

Dockets Management Branch (address above) written comments regarding

this proposal. Two copies of any comments are to be submitted, except

that individuals may submit one copy. Comments are to be identified

with the docket number found in brackets at the heading of this

document. Information submitted in response to this notice may be seen

in the office above between 9 a.m. and 4 p.m., Monday through Friday.

VII. References

The following information has been placed on display in the Dockets

Management Branch (address above) and may be seen by interested persons

between 9 a.m. and 4 p.m., Monday through Friday:

1. ``Report on the Mammography Quality Standards Act of 1992,''

U.S. Senate, Report 102-448, October 1, 1992.

2. American College of Radiology, ``Mammography Quality Control:

Radiologist's Manual, Radiologic Technologist's Manual, and Medical

Physicist's Manual,'' February, 1992.

3. American College of Radiology, ``Mammography Quality Control:

Radiologist's Manual, Radiologic Technologist's Manual, and Medical

Physicist's Manual,'' 1994.

4. Centers for Disease Control, ``Recommendations for Prevention

of HIV Transmission in Health-Care Settings,'' Morbidity and

Mortality Weekly Report, 36(2S):3S-18S, 1987.

5. AAMI TIR No. 12-1994, ``Designing, Testing, and Labeling

Reusable Medical Devices for Reprocessing in Health Care Facilities:

A Guide for Device Manufacturers,'' Association for the Advancement

of Medical Instrumentation, 3330 Washington Blvd., suite 400,

Arlington, VA 22201-4598, 1995.

6. Food and Drug Administration, ``Labeling Reusable Medical

Devices for Reprocessing in Health Care Facilities: FDA Reviewer

Guidance,'' Rockville, MD, March, 1995.

List of Subjects in 21 CFR Part 900

Electronic products, Health facilities, Mammography, Medical

devices, Radiation protection, Reporting and recordkeeping

requirements, X-rays.

Therefore, under the Federal Food, Drug, and Cosmetic Act, the

Public Health Service Act, and under authority delegated to the

Commissioner of Food and Drugs, it is proposed that 21 CFR part 900 be

amended to follows:

PART 900--MAMMOGRAPHY

1. The authority citation for 21 CFR part 900 continues to read as

follows:

Authority: Secs. 519, 537, and 704(e) of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 360i, 360nn, and 374(e)); sec. 354 of

the Public Health Service Act (42 U.S.C. 263b).

2. Section 900.12 is amended by revising paragraphs (b) and (e) to

read as follows:

Sec. 900.12 Quality standards.

* * * * *

(b) Equipment--(1) Prohibited equipment. Radiographic equipment

designed for general purpose or special nonmammography procedures shall

not be used for mammography. This includes systems that have been

modified or equipped with special attachments for mammography. This

requirement supersedes the implied acceptance of such systems in

Sec. 1020.31(f)(3) of this chapter.

(2) General. All radiographic equipment used for mammography shall

[[Page 14916]]

be specifically designed for mammography and shall be certified

pursuant to Sec. 1010.2 of this chapter as meeting the applicable

requirements of Secs. 1020.30 and 1020.31 of this chapter in effect at

the date of manufacture.

(3) Motion of Tube-Image receptor assembly. (i) Gantry assembly

motion.

(A) The gantry assembly shall be capable of being rigidly fixed in

any position where it is designed to operate. Once fixed in any such

position, the gantry shall not move without operator intervention.

(B) The mechanism assuring compliance with paragraph (b)(2)(A) of

this section shall not fail in the event of power interruption.

(ii) Effective October 1, 2000, the gantry assembly shall allow

continuous rotation of at least 180 deg. from vertical (cranio-caudal

position) in one direction and of at least 105 deg. from vertical in

the other direction.

(iii) Effective October 1, 2005, the gantry assembly shall allow

continuous rotation of at least 180 deg. from vertical (cranio-caudal

position) in one direction and of at least 135 deg. from vertical in

the other direction.

(iv) Effective October 1, 2005, the system shall provide visual

indication of the gantry angle to within 5 deg..

(4) Image receptor sizes. (i) Systems using screen-film image

receptors shall provide, at a minimum, for operation with image

receptors of 18 x 24 centimeters (cm) and 24 x 30 cm.

(ii) Systems using screen-film image receptors shall be equipped

with moving grids matched to all image receptor sizes provided.

(iii) Systems used for magnification procedures shall be capable of

operation with the grid removed.

(iv) Grid motion shall not be impeded when a breast is subjected to

compression during mammography. For each size of breast support device

provided with the system, compliance shall be determined by applying

compression to, and exposing, a 12-cm diameter acrylic disk, 1.5 cm-

thick, placed with its center located 4 cm in from the center of the

chest wall edge of the breast support surface. A 4-cm thick homogeneous

acrylic attenuator with rounded edges shall be located in the beam

between the source and the compression paddle during the exposure. A

film exposed at 28 kilovoltage peak (kVp) to obtain an optical density

as close to 1.3 as possible shall be examined for grid-related

artifacts. For equipment provided with automatic exposure control

(AEC), the test shall be performed in the AEC mode. The compression to

be applied during these tests shall be determined as follows:

(A) Before October 1, 2000, for systems meeting the requirements in

paragraph (b)(12)(i)(C) of this section, the maximum attainable power

driven compression shall be used; and for systems not meeting the

requirements in paragraph (b)(12)(i)(C) of this section, the

compression applied shall be as close to 200 newtons (45 pounds) as

possible, using manual compression or a combination of manual and power

driven compression.

(B) Effective October 1, 2000, the maximum attainable power-drive

compression shall be used to determine compliance.

(5) Beam limitation and light fields. (i) All systems shall have

beam limitation devices that provide means to restrict the useful beam

so that the x-ray field can be adjusted to extend beyond the chest wall

edge of the image receptor.

(ii) Any mammography system with a light field that passes through

the beam-limiting device shall meet the following requirements:

(A) The light field shall be aligned with the x-ray field so that

the total misalignment of the edges of the light field and the x-ray

field along either the length or the width of the visually defined

field at the plane of the breast support shall not exceed 2 percent of

the distance from the source to the midpoint of the chest wall edge of

the image receptor support device.

(B) The light field shall provide an average illumination of not

less than 160 lux (15 footcandles) at 100 cm or the maximum source-

image receptor distance (SID), whichever is less.

(iii) Effective October 1, 2000, all mammography systems shall be

equipped with light fields that pass through the beam-limiting device

and approximate the x-ray field.

(iv) Effective October 1, 2005, all systems shall be interlocked to

prevent exposure unless appropriate combinations of beam limitation and

image receptor size are selected.

(v) Effective October 1, 2005, all systems shall be interlocked to

prevent exposure with an x-ray field that extends beyond the nonchest

wall edges of the image receptor support device.

(6) Source-image receptor distance (SID). Effective October 1,

2000:

(i) Systems designed solely for contact mammography shall have a

minimum SID of at least 55 cm.

(ii) All systems shall provide visual indication of the selected

SID to within 2 percent of its actual value.

(7) Magnification. (i) Systems used for diagnostic procedures shall

have magnification capability available for use by the operator at any

time.

(ii) Systems designed for magnification procedures shall provide at

least one magnification setting within the range of 1.4 to 2.0.

(8) System resolution. (i) The focal spot shall be such that, with

the mammography screen-film combination used in the facility, the

system will provide a minimum resolution of 11 line-pairs/mm when the

high contrast resolution bar pattern is oriented with the bars

perpendicular to the anode-cathode axis, and 13 line-pairs/mm when the

bars are parallel to that axis.

(ii) Effective October 1, 2005, for those systems providing

magnification capability, a focal spot that meets the following

requirements shall be provided:

(A) The resolution provided by the magnification focal spot shall

meet, at a minimum, the requirements of paragraph (b)(8)(i) of this

section. Compliance shall be determined with the test pattern placed

4.5 cm above the magnification breast support, under the conditions of

system magnification providing a magnification factor as close to 1.5

as can be achieved with the system.

(B) When more than one target material is provided, the measurement

in paragraph (b)(8)(ii)(A) of this section shall be made using the

appropriate focal spot for each target material.

(C) The grid shall be removed from the imaging chain during these

measurements.

(9) Focal spot selection. (i) When more than one focal spot is

provided, the system shall indicate, prior to exposure, which focal

spot is selected.

(ii) When more than one target material is provided, the system

shall indicate, prior to exposure, the preselected target material.

(iii) When the target material is selected by the system algorithm,

based on the exposure or a test exposure, the system shall display the

target material selected after the exposure.

(iv) When the selected target is related to the kVp, the system

shall prevent exposure unless the correct combination of target and kVp

is selected.

(10) Focal spot location. (i) The focal spot shall be located so

that the ray falling on the mid-point of the chest wall edge of the

image receptor is within 5 deg. of perpendicular to the

image receptor.

(ii) Compliance shall be determined for each focal spot provided.

(11) Filtration. (i) General. Each system shall comply with the

beam quality requirements of Sec. 1020.30(m)(1)

[[Page 14917]]

of this chapter for the minimum half-value layer (HVL).

(ii) Variable filtration. (A) Effective October 1, 2000, systems

with variable filtration type or thickness shall be interlocked to

prevent exposure if the selected filtration material is inappropriate

for the target chosen or is outside the allowable range specified in

paragraph (b)(11)(i) of this section.

(B) If different types of filtration materials are available, the

system shall display the type of filtration in use prior to exposure.

(C) Effective October 1, 2000, if the filtration is automatically

selected based on a test exposure, the system shall visually indicate

the filtration that was actually used after the exposure is completed.

(12) Compression. All mammography systems shall incorporate a

compression device.

(i) Application of compression. Effective October 1, 2000:

(A) Power driven compression activated by foot controls operable

from both sides of the examinee shall be provided.

(B) Fine adjustment compression controls operable from both sides

of the examinee shall be provided.

(C) The compression device shall provide a maximum compression for

the power drive between 111 newtons (25 pounds) and 200 newtons (45

pounds).

(ii) Decompression. (A) If the system is equipped with a provision

for automatic decompression after completion of an exposure or

interruption of power to the system, the system shall also provide an

override capability to allow maintenance of compression and shall

continuously display the override status.

(B) Each system shall provide a manual emergency compression

release that can be activated in the event of power or automatic

release failure.

(C) If a system is equipped with a remote compression release

control for the operator, the release control shall be located in a

position that allows the operator to observe the examinee during

activation of the release control.

(iii) Compression paddle. (A) Systems shall be equipped with

different sized compression paddles that match the sizes of all full-

sized image receptors provided. Compression paddles for special

purposes, including those smaller than the full size of the image

receptor (for ``spot compression'') may be provided. Such compression

paddles for special purposes are not subject to the requirements of

paragraphs (b)(12)(iii)(B) and (b)(12)(iv)(A) of this section.

(B) When compression is applied, the compression paddle shall be

flat and parallel to the breast support table and shall not deflect

from parallel by more than 1.0 cm at any point on the surface of the

compression paddle. Compliance shall be determined by applying maximum

system power compression to a 12-cm diameter acrylic disk 1.5-cm thick

placed with its center located 4 cm in from the center of the chest

wall edge of the breast support surface for each full size compression

paddle provided. For systems without power driven compression, or for

systems which, before October 1, 2000, do not meet the requirements in

paragraph (b)(12)(i)(C), compliance shall be determined by applying

compression at as close to 200 newtons (45 pounds) as achievable using

manual or a combination of manual and power driven compression.

Vertical measurements shall be made between the breast support surface

and the compression paddle at each of the four corners of the image

receptor and shall be compared to each other and to the 1.5-cm

thickness of the test device. The maximum difference between any two

values shall not exceed 1.0 cm.

(C) The chest wall edge of the compression paddle shall be straight

and parallel to the edge of the image receptor.

(D) The chest wall edge should be bent upward, forming a lip to

allow for examinee comfort, but shall not interfere with the image at

the chest wall.

(iv) Compression paddle alignment. (A) Effective October 1, 2000,

when compression is applied, a line constructed perpendicular to the

flat surface of the compression paddle through the vertex of the angle

formed by the flat surface and the lip of the compression paddle and

extending to the plane of the image receptor, shall intercept that plan

within a distance no greater than 1 percent of the SID

from the useful edge of the image receptor at the chest wall side (see

Figure 1).

BILLING CODE 4160-01-P

[GRAPHIC] [TIFF OMITTED] TP03AP96.000

(B) Effective October 1, 2005, when compression is applied, a line

constructed perpendicular to the flat surface of the compression paddle

through the vertex of the angle formed by the flat surface and the lip

of the compression paddle and extending to the plane of the image

receptor, shall pass within 2 millimeters of the useful

[[Page 14918]]

edge of the image receptor at the chest wall side.

(C) When the system is configured without magnification capability,

compliance shall be determined with the bottom surface of the

compression paddle placed at a distance within the range of 2.0 to 6.0

cm above the breast support.

(D) When the system is configured for magnification procedures,

compliance shall be determined with the bottom surface of the

compression paddle placed at a distance within the range of 2.0 to 6.0

cm above the breast support of the magnification device.

(v) Display of compressed breast thickness. Effective October 1,

2005, the compressed breast thickness shall be displayed and visible to

the operator during positioning.

(A) The compressed breast thickness shall be displayed to within

0.5 cm.

(B) Compliance shall be determined at the maximum attainable power

compression using a flat sheet of rigid material with known thickness

placed between the examinee support and the compression device. This

sheet shall be placed in flat contact with the top surface of the

breast support. If the support is uneven or has projections around the

edges, the sheet shall be in contact with that part of the surface that

actually supports the breast. This test shall be performed using sheets

of the following thicknesses: 3 cm, 4.5 cm, and 6 cm.

(13) Technique factor selection and display. (i) Manual selection

of milliampere seconds (mAs) shall be available.

(ii) All technique factors shall be clearly displayed at the

control panel prior to exposure.

(iii) When operating in AEC mode, the system shall indicate initial

technique factors prior to exposure.

(iv) Following AEC mode use, the system shall indicate the actual

kVp and mAs used during the exposure.

(v) All indications of kVp shall be within 5 percent of

the actual kVp.

(vi) Effective October 1, 2005:

(A) Each system shall provide, at a minimum, for the selection of

tube potentials of between 22 and 34 kVp.

(B) Selection of kVp shall be available in increments no greater

than 1 kilovolt each over the entire range provided.

(C) Adjacent mAs settings shall differ by no more than 26 percent

of the lower of the adjacent settings.

(D) Combinations of exposure time and tube current (mAs) shall be

available over the range of at least 5 mAs to 300 mAs.

(14) Radiation output. (i) The system shall be capable of producing

a minimum output of 1.29 x 10-4 coulomb/kilogram (C/kg) per second

(500 milliroentgen (mR) per second) when operating at 28 kVp in the

standard mammography mode at any SID where the system is designed to

operate. Effective October 1, 2000, the system shall be capable of

producing a minimum output of 2.06 x 10-4 C/kg per second (800 mR

per second) when operating at 28 kVp in the standard mammography mode

at any SID where the system is designed to operate.

(ii) The system shall be capable of maintaining the required

minimum radiation output for at least 3.0 seconds.

(iii) Compliance shall be determined with the center of the

detector located 4.5 cm above the breast support device used for

contact mammography and centered on the breast support 4 cm in from the

chest wall edge of the support with the compression paddle in place

between the source and the detector.

(15) Automatic exposure control. (i) Each system shall provide an

AEC mode which is operable in all combinations of equipment

configuration provided, i.e. grid, nongrid; magnification,

nonmagnification; and various target-filter combinations.

(ii) The AEC shall be capable of providing automatic mAs selection.

(iii) The AEC shall provide reproducible radiation exposures with a

coefficient of variation not to exceed 0.05.

(iv) The positioning or selection of the active detector shall

permit flexibility in the placement of the detector under the target

tissue.

(A) The size and available positions of the detector shall be

clearly indicated at the input surface of the breast compression

paddle.

(B) The selected position of the detector shall be clearly

indicated and visible from both sides of the examinee.

(v) The system shall provide means for the operator to vary the

selected optical density from the normal (zero) setting.

(vi) Effective October 1, 2005, the system shall provide means for

the operator to vary the optical density a minimum of 4 steps above and

4 steps below the normal (zero) setting of optical density. These steps

shall vary in optical density increments of between 10 to 20 percent of

the difference between adjacent mAs settings;

(vii) The system shall meet, at a minimum, the following

requirements at all detector positions and for thicknesses of 2, 4, and

6 cm of homogeneous breast tissue-equivalent material. Compliance shall

be determined using the screen-film and processing combination used at

the facility when the mean optical density is at least 1.20.

(A) Effective October 1, 2000, equipment shall produce images with

optical densities that vary from the mean optical density by no more

than 0.30.

(B) Effective October 1, 2005, equipment shall produce images with

optical density that varies from the mean optical density by no more

than 0.15.

(16) Disabled examinees. Each facility scheduling disabled

individuals shall have equipment and established protocols to ensure

the facility's capability to perform mammography adequately on such

individuals.

(17) X-ray film. The facility shall use x-ray film for mammography

that has been designated by the film manufacturer as appropriate for

mammography.

(18) Intensifying screens. The facility shall use intensifying

screens for mammography that have been designated by the screen

manufacturer as appropriate for mammography and shall match them to the

spectral sensitivity specified by the manufacturer of the film used.

(19) Film processing solutions. For processing mammography films,

the facility shall use chemical solutions that are capable of

developing the films used in a manner equivalent to the minimum

requirements specified by the film manufacturer.

(20) Lighting. The facility shall provide a special light with

variable luminance capable of producing light levels greater than that

provided by the view box.

(21) Film Masking Devices. (i) All facilities shall have film

masking devices that can limit the illuminated area to a region equal

to or smaller than the exposed portion of the film.

(ii) Facilities using x-ray collimation that provides

nonrectangular exposed areas on the film shall provide masking devices

appropriate to these fields.

(iii) Facilities shall make devices meeting the requirements of

paragraphs (b)(21)(i) and (b)(21)(ii) of this section available to the

interpreting physician.

(22) Film processors. Film processors used to develop mammograms

shall meet the following requirements:

(i) The processor shall be adjusted and maintained to meet the

technical development specifications for the mammography film in use.

(ii) Effective October 1, 2000, the processor shall indicate the

selected time cycle reflecting the time from leading edge entry into

the developer to leading edge entry into the fixer.

[[Page 14919]]

(iii) Effective October 1, 2000, the processor shall be capable of

maintaining the developer temperature to within 0.3 deg.

Celsius (0.5 deg.F). Compliance measurements for immersion

tank type processors shall be taken at the center of the surface of the

developer solution and 7.5 cm (3 inches) below the surface when the

developer is at the proper operating level.

(iv) Effective October 1, 2005, the processor shall clearly display

the actual developer temperature to within 0.1 deg.C

(0.2 deg.F) of the actual temperature.

(v) Effective October 1, 2005, for processors with variable cycles,

the selectable parameters shall be interlocked to prevent any

initiation of changes in the parameters until any film in process is

completed, and to prevent any new film from entering the process cycle

until the variables are properly stabilized at the new cycle

parameters. If the unit is equipped with an override of this interlock

for maintenance procedures, the override status shall be clearly

indicated to the operator.

* * * * *

(e) Quality assurance--equipment--(1) Daily quality control tests.

Facilities with screen-film systems shall perform a processor

performance test on each day that examinations are performed before any

examinations are performed that day. The test shall include an

assessment of base plus fog density, mid-density, and density

difference, using the mammography film used clinically at the facility.

(i) The base plus fog density shall be within + 0.03 of the

established operating level.

(ii) The mid-density shall be within 0.15 of the

established operating level of no less than 1.20 optical density (OD).

(iii) The density difference shall be within 0.15 of

the established operating level.

(2) Weekly quality control tests. Facilities with screen-film

systems shall perform an image quality evaluation test at least weekly.

(i) The optical density of the film at the center of an image of a

standard FDA-accepted phantom shall be at least 1.20 when exposed under

a typical clinical condition.

(ii) The optical density of the film at the center of the phantom

image shall not change by more than 0.20 from the

established operating level.

(iii) The phantom image shall achieve at least the minimum score

acceptable to FDA in accordance with Sec. 900.3(d) or Sec. 900.4(a)(9).

(iv) The image contrast between the background of the phantom and

an added test object, used to assess density difference, shall be

measured and shall not vary by more than 0.05 from the

established operating level.

(3) Quarterly quality control tests. Facilities with screen-film

systems shall perform the following quality control tests at least

quarterly:

(i) Fixer retention in film. The residual fixer shall be no more

than 5 micrograms per square cm.

(ii) Repeat analysis. If the total repeat or reject rate changes

from the previously determined rate by more than 2.0 percent of the

total films included in the analysis, the reason(s) for the change

shall be determined and any corrective actions and their results shall

be recorded.

(4) Semiannual quality control tests. Facilities with screen-film

systems shall perform the following quality control tests at least

semiannually:

(i) Darkroom fog. The optical density attributable to darkroom fog

shall not exceed 0.05 when a mammography film of the type used in the

facility, which has a mid-density of no less than 1.2 OD, is exposed to

typical darkroom conditions for 2 minutes while such film is placed on

the counter top. If the darkroom has a safelight, it shall be on during

this test.

(ii) Screen-film contact. Testing for screen-film contact shall be

conducted using 40 mesh screen.

(iii) Compression. The compression device shall meet the

specifications described in Sec. 900.12(b)(12).

(5) Annual quality control tests. Facilities with screen-film

systems shall perform the following quality control tests at least

annually:

(i) Automatic exposure control performance. (A) The AEC shall be

capable of maintaining film optical density within 0.30 of

the mean optical density when phantom thickness is varied over a range

of 2 to 6 cm and the kVp is varied over the kVp range used in the

facility for such thicknesses.

(B) The operating optical density of the film in the center of the

phantom image shall not be less than 1.20.

(C) If the requirement of paragraph (e)(5)(i)(A) of this section

cannot be met, a technique chart shall be developed showing appropriate

techniques (kVp and density control settings) for different breast

thicknesses and compositions that must be used so that optical

densities within 0.30 of the average under phototimed

conditions can be produced.

(ii) Kilovoltage peak (kVp) accuracy and reproducibility.

(A) At the lowest and highest clinical values and at any other

commonly used clinical settings of kVp, the kVp shall be accurate to

within 10 percent, and

(B) At the most commonly used clinical settings of kVp, the

coefficient of variation of reproducibility of the kVp shall be equal

to or less than 0.02.

(iii) System Resolution. The limiting spatial resolution shall not

be less than 13 line-pairs/mm parallel to the anode-cathode axis of the

x-ray tube and 11 line-pairs/mm perpendicular to the anode-cathode

axis.

(iv) Beam quality and half-value layer (HVL). The HVL shall meet

the specifications in paragraph (b)(11) of this section.

(v) Breast entrance exposure and AEC reproducibility. The

coefficient of variation for both exposure and mAs shall not exceed

0.05.

(vi) Dosimetry. The average glandular dose delivered during a

single cranio-caudal view of an FDA-accepted phantom simulating a 4.2-

cm thick, compressed breast consisting of 50 percent glandular and 50

percent adipose tissue, shall not exceed 3.0 milliGray (0.3 rad) per

exposure. The dose shall be determined with technique factors and

conditions used clinically for a 4.2-cm, 50 percent glandular/50

percent adipose tissue compressed breast.

(vii) X-ray field/light field/image receptor/compression paddle

alignment. The x-ray field/light field/image receptor alignment shall

meet the specifications of paragraph (b)(5) of this section and

Sec. 1020.31(f)(3) of this chapter. In addition, the chest wall edge of

the compression paddle shall not extend beyond the chest wall edge of

the image receptor by more than one per cent of the SID.

(viii) Screen speed uniformity. Screen speed uniformity of all the

cassettes in the facility shall be tested and the difference between

the maximum and minimum optical densities shall not exceed 0.30. Screen

artifacts shall also be evaluated during this test.

(ix) System artifacts. System artifacts shall be evaluated with a

high-grade, defect-free phantom large enough to cover the mammography

cassette.

(6) Quality control tests--other modalities. For systems with

image receptor modalities other than screen-film, the quality assurance

program shall be substantially the same as the quality assurance

program recommended by the image receptor manufacturer, except that the

maximum allowable dose shall not exceed the maximum allowable dose for

screen-film systems in paragraph (e)(5)(vi) of this section.

[[Page 14920]]

(7) Mobile Units. The facility shall verify that mammography units

used to produce mammograms at more than one location meet the

requirements in paragraphs (e)(1) through (e)(6) of this section. In

addition, at each examination location, before any additional

examinations are conducted, the facility shall verify satisfactory

performance of such units using a test method that establishes the

adequacy of the image quality produced by the unit.

(8) Use of test results. (i) After completion of the tests

specified in paragraphs (e)(1) through (e)(7) of this section, the

facility shall compare the test results to the corresponding specified

action limits; or, for non screen-film modalities, to the

manufacturer's recommended action limits; or, for post-move, pre-

examination testing of mobile units, to the limits established in the

test method used by the facility. The applicable tests shall be

repeated immediately for any parameters found to be beyond the

specified acceptable ranges.

(ii) If the repeated tests continue to produce unacceptable

results, the source of the problem shall be identified and corrective

actions shall be taken before any further examinations are performed.

(9) Surveys. (i) At a frequency of no less than once a year, each

facility shall undergo a survey by a medical physicist or by an

individual under the direct supervision of a medical physicist. At a

minimum, this survey shall include the performance of tests to ensure

that the facility meets the quality assurance requirements of the

annual tests in paragraphs (e)(5) and (e)(6) of this section and the

weekly phantom image quality test in paragraph (e)(2) of this section.

(ii) The results of all tests conducted by the facility in

accordance with paragraphs (e)(1) through (e)(7) of this section, as

well as written documentation of any corrective actions taken and their

results, shall be evaluated for adequacy by the medical physicist

performing the survey.

(iii) The medical physicist shall prepare a survey report that

includes a summary of this review and recommendations for necessary

improvements.

(iv) The survey report shall be sent to the facility within 30 days

of the date of the survey.

(v) The survey report shall be dated and signed by the medical

physicist performing or supervising the survey. If the survey was

performed entirely or in part by another individual under the direct

supervision of the medical physicist, that individual and the part of

the survey that individual performed shall also be identified in the

survey report.

(10) Mammography equipment evaluations. Additional evaluations of

mammography units or image processors shall be conducted whenever a new

unit or processor is installed, or major components of a mammography

unit or processor equipment are changed. These evaluations shall be

used to determine whether the new or changed equipment meets the

requirements of applicable standards in paragraphs (b) and (e) of this

section. All problems shall be corrected before the new or changed

equipment is put into service for examinations. The mammography

equipment evaluation shall be performed by an individual whose

qualifications are adequate to examine equipment for this purpose and

in accordance with procedures that are adequate to ensure that the

examination is complete and accurate.

(11) Facility cleanliness. (i) The facility shall establish and

implement adequate protocols for maintaining darkroom, screen, and view

box cleanliness.

(ii) The facility shall document that all cleaning procedures are

performed at the frequencies specified in the protocols.

(12) Calibration of exposure measuring instruments. (i) Instruments

used to measure the exposure or exposure rate from a mammography unit

shall be traceable to a national standard.

(ii) Effective October 1, 2005, the manufacturers calibrating

instruments to measure exposure or exposure rate from mammography units

shall meet the requirements of a recognized quality assurance program.

A calibration laboratory calibrating instruments to measure exposure or

exposure rate from mammography units must be accredited by a recognized

national program or an equivalent international program which requires

continuing participation with NIST in measurements and testing for

maintaining quality assurance appropriate for mammography.

(13) Infection control. Facilities shall establish and comply with

a system specifying procedures to be followed by the facility for

cleaning and disinfecting mammography equipment after contact with

blood or other potentially infectious materials. This system shall

specify the methods for documenting facility compliance with the

infection control procedures established and shall:

(i) Comply with all applicable Federal, State, and local

regulations pertaining to infection control; and

(ii) Comply with the manufacturer's recommended procedures for the

cleaning and disinfection of the mammography equipment used in the

facility; or

(iii) If adequate manufacturer's recommendations are not available,

comply with generally accepted guidance on infection control, until

such recommendations become available.

Dated: March 22, 1996.

David A. Kessler,

Commissioner of Food and Drugs.

Donna E. Shalala,

Secretary of Health and Human Services.

[FR Doc. 96-7833 Filed 3-29-96; 8:45 am]

BILLING CODE 4160-01-P