Medical Device Daily Washington Editor

Those who handle regulatory affairs in most of the industries under the FDA's purview would celebrate a decrease in the agency's oversight of their operations, and the operators of mammography clinics have picked up a late Christmas present in the form of just such a break.

Thanks in part to a recommendation by the Institute of Medicine (IOM), mammography clinics will soon be able to wait for three years to reapply for accreditation instead of reapplying annually. However, clinics that are using computed radiography (CR) equipment with their film systems may find their accreditation efforts stuck in a peculiar wedge as the agency tries to get accrediting bodies up to speed on standards for this marriage of technologies.

The FDA guidance reminds the reader that up to now, regulations required that mammography clinics submit the results of their equipment check-ups to their accreditation bodies annually. These check-up, known as physics surveys, include a wide range of operational aspects of mammography equipment, and the recent surge in new technology in this area has forced the agency to review its approach to Mammography Quality Standards Act (MQSA) standards.

Some of the standards are specific to film systems, including the so-called phantom quality control review. This approach to image quality control examines whether any distortion of film images, called phantoms, occurs at any point in the image capture and development process. Film systems are also subject to quality control standards for darkrooms.

In the late 1990s and in the early part of this decade, the agency handed out warning letters fairly routinely to mammography clinics over violations of this and other parts of the regulatory apparatus. Those warning letters also included citations for personnel qualifications and other issues not directly related to equipment quality control. However, the volume of warning letters for deviations from MQSA standards has dropped in parallel with warning letters to other industries over the past three years. How much of this is due to the FDA's reduction in the overall volume of warning letters and how much is due to general improvements in compliance is difficult to assess, but the guidance document indicates that IOM backs the idea of requiring physics surveys every three years rather than annually. However, routine inspections of clinics will still take place each year.

The agency's announcement states that it will enforce the annual survey requirement until July 1 and that a clinic must conduct the survey any time it makes "significant changes" to its equipment base regardless of when it last applied for accreditation.

The addition of full-field digital mammography (FFDM) systems to the picture pushed a lot of changes to MQSA requirements. The FDA document states that FFDM systems were initially approved only for final interpretations of hardcopy of images, but that on-screen image review, known as softcopy, crept into the picture. The agency believes that "the majority of facilities now use only softcopy for final interpretation," thus forcing a tweak of regulations.

As matters currently stand, regulations require that clinics "be able to produce final-interpretation quality hard copy images" when a patient's records are shipped to another provider and that provider requests hardcopy. The national mammography quality assurance advisory committee decided in a meeting on Sept. 29 that facilities should perform quality control testing on laser printers to ensure that hardcopies are of final interpretation quality. Failure to perform such a quality control check could earn the violating clinic a citation on the inspection form and, potentially, a warning letter. However, it should be noted that the FDA has very rarely issued a warning letter for an inspection that disclosed only one regulatory violation.

Another area of interest in the new guidance is for accreditation and certification of FFDM equipment and operators. Up to now, the agency has allowed clinics to use unaccredited FFDMs if the clinic has no access to an accreditation body (such as a state's accreditation department) that is up to speed on this new technology. The introduction of CR systems has blurred the line between digital and analogue systems because the cassette that captures the images in a CR system can be used in a film system.

However, the guidance indicates that "CR systems are considered part of the mammographic modality known as FFDM" and that the standards applicable to the latter apply to film equipment, including personnel requirements. "All personnel using a CR system must have completed at least eight hours of training specific to digital mammography prior to using the CR system," even if this involves only the use of a CR cassette in a film system, according to the guidance.

Clinics that operate multiple film systems and plan to use CR with more than one will have to obtain accreditation for each of those systems and may have to purchase a separate CR cassette for each because "FDA grants accreditation and certification extension for the use of a CR system only with a specific mammography unit." This holds even if the clinic's film systems are identical. The agency also intends to impose inspection fees on the film system and the CR equipment as separate units until such time as the agency approves an accreditation body and the clinic obtains accreditation by that body. Because the agency is of the position that annual inspections, whether by FDA or a local government, will continue to take place annually, clinics that add CR attachments to their film systems without notifying the agency will have effectively notified the FDA upon the next inspection.

Priscilla Butler, senior director of breast imaging accreditation programs at the American College of Radiology (Reston, Virginia), told Medical Device Daily that the three-year re-accreditation period was reasonable and that "MQSA inspectors already inspect each mammography facility's physicist survey every year."

She said that the annual accreditation "is an unnecessary duplication of effort for the facility. This will save them some time." However, Butler took the position that the requirement of certifying each film systems that will be used with a CR cassette separately is appropriate because "the FDA regulations are different for FFDM vs. screen-film. The quality control is different and the image quality may [also] be different."