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PubMed1997

Quality mammography standards--FDA. Final rule.

The Food and Drug Administration (FDA) is amending its regulations governing mammography. Amendments are being made to the requirements for accreditation bodies; procedures for facility certification; and quality standards for mammography personnel, equipment and practices, including quality assurance. This action is being taken to provide increased assurance of adequate and consistent evaluation of mammography facilities on a nationwide level and compliance of the facilities with quality standards. It also carries out the intent of Congress that FDA replace the existing interim rules with more comprehensive final regulations.

Accreditation↗
PubMed1998

Medical devices; Mammography Quality Standards Act of 1992; inspection fees--FDA. Notice.

The Food and Drug Administration (FDA) is announcing the new fees the agency will assess for inspections of mammography facilities starting on February 13, 1998. The Mammography Quality Standards Act of 1992 (the MQSA) requires FDA to assess and collect fees from mammography facilities to cover the costs of annual inspections required by the MQSA. Because these costs have increased since inspections began in 1995, FDA is raising the fees accordingly. This notice explains which facilities are subject to payment of inspection fees, provides information on the costs included in developing inspection fees, and provides information on the inspection, billing, and collection processes. This is the first increase in inspection fees under the MQSA since the initial fee was established in 1995.

Accreditation↗
PubMedDate not supplied

1998 MQSA (Mammography Quality Standards Act) final rule released. American College of Radiology.

In October 1997, the Food and Drug Administration (FDA) released the final regulations for implementing the Mammography Quality Standards Act (MQSA). Briefly, the final rule establishes experience requirements for medical physicists and radiologic technologists and clarifies equipment standards. The Interim Rules, issued in late 1993 and amended in 1994, now apply. Final regulations become effective April 1999, with certain equipment regulations becoming effective in October 2002. Changes in experience and continuing education requirements for medical physicists and radiologic technologists parallel requirements in the interim rule. The FDA shifted the majority of quality assurance requirements for equipment to the quality assurance section of the regulations, and will treat them as performance standards. Under the final rule, each facility is required to have a system to ensure that mammogram exam results are communicated to patients in a timely manner. Under the interim regulations, mammography facility personnel must continue to participate in medical education programs in mammography to acquire five CME/CEU per year.

Accreditation↗
PubMed1998

Quality mammography standards; correcting amendment--FDA. Final rule; correcting amendment.

The Food and Drug Administration (FDA) is correcting its regulations governing mammography, published in a document entitled "Quality Mammography Standards" that appeared in the Federal Register of October 28, 1997. The regulations are effective April 28, 1999; except section 900.12(b)(8)(i), (e)(4)(iii)(B), and (e)(5)(i)(B), which become effective October 28, 2002. The October 28, 1997, document was published with some inadvertent typographical errors. Some of those errors were corrected in a document entitled "Quality Mammography Standards; Correction" that appeared in the Federal Register of November 10, 1997, but additional typographical errors occurred in the publication of this document. In addition, since November 10, 1997, certain other problems with the text of the regulations have been identified that, if uncorrected, would lead to unforeseen and undesirable consequences. This document corrects those errors.

Accreditation↗
PubMed1988

Affordable screening mammography: current status.

Societal pressure from physicians and patients for low-cost screening mammography is increasing. The American Cancer Society's guidelines for use of mammography in asymptomatic women older than 40 years of age are not being fully implemented, largely because of the high cost of mammography--more than $100 in many practices. This issue is discussed with a review of the recommendations to lower cost through high-volume programs and separation of screening examinations from consultation examinations.

Age Factors↗
PubMed1999

[Positive predictive value of radiologic features in mammography and contribution of assessment procedures].

PURPOSE: To investigate the positive predictive value for cancer of abnormal mammographic findings and the role of assessment procedures. MATERIALS AND METHODS: We reviewed a series of 962 patients recalled and examined in the 1st Breast Screening Center of Turin, out of 18; 996 women aged 50-59 screened for the first time from 1991 to 1995, within a population-based mammography program. The diagnostic assessment procedures included one or more of the following: physical examination, additional mammographic views (detail or magnification), ultrasonography, and ultrasonography/X-ray-guided fine needle aspiration cytology. Surgical biopsies detected 152 cancers. RESULTS: The positive predictive value for screening mammography with abnormal findings steadily grew from 10.9% in 1991-92 to 15.6% in 1993, topping 21.1% in 1994 and 20.1% in 1995. The highest positive predictive value for cancers was observed among cases referred for opacities with irregular margins (88.2%) and isolated calcifications (23.8%). The benign/malignant biopsy ratio was .54 in 1991-92, .31 in 1993, .27 in 1994 and .25 in 1995. The accuracy of assessment procedures was different for each abnormal radiologic sign: the accuracy of cytology was high for opacities, intermediate for calcifications, low for architectural distortions; ultrasonography and physical examination had low sensitivity among cases referred for calcifications or opacities with regular margins. The positive predictive value of surgical indications was high for opacities, intermediate for calcifications, low for architectural distortions. The role of assessment procedures in excluding surgery was different for each abnormal radiologic sign. DISCUSSION AND CONCLUSIONS: The results of this study confirm the accuracy of mammography in the early detection of breast cancer and the different role of assessment procedures in the various abnormal mammographic findings. The improvement in positive predictive value for screening recalls from about 10% (close to recommended European standards) up to about 20% (well above European standards) demonstrates the importance of the "learning curve" within the screening team. Most of this improvement could be referred to refined diagnostic criteria for calcifications, as shown by an increase in positive predictive value for calcifications from 13.7% in 1991-92 to 40.5% in 1995.

Breast Neoplasms↗
PubMed1999

[Morphological parameters of breast cancers detected by mammography with and without organized screening; a comparative study].

Some pathological findings and prognostic indices recorded in breast cancer cases, detected, on one hand, by a provider-initiated mammography screening program (Group 1), and, opportunistically, in self-referred symptomatic women (Group 2) on the other, are compared. In 8877 symptom-free women, aged 50-65 years, individually invited to attend the screening offered for the residents of the III., XII. and XIII. districts of Budapest, 67 cancer cases were detected (7.5 in 1000 screenees), in accordance with the cancer detection rate of the first, "prevalence" round of organised screening programmes. In the other group of 1593 symptomatic, self-referred women of the same age, 113 cancer cases were diagnosed by mammography. As far as the pathological parameters are concerned, the number of cases with invasive cancer less than 15 mm in diameter, and those with axillary nodes present was found to be significantly higher in the screened group as compared to the self-referred one (p < 0.01). In "small" cancers (i.e. less than 15 mm in diameter), no significant difference was found in the proportion of histologic grade III tumours among the two groups. In screen-detected cancers both the morphometric prognostic index (as calculated by Baak et al.) and the Nottingham Prognostic Index (NPI) proved to be more favourable, as compared to those in the self-referred group. The p-value as determined by Mann-Whithey test was 0.000003 in the screened group, and 0.000015 in the other one. These findings provide convincing evidence in support of the public health importance of provider-initiated, organised mammography screening for breast cancer, therefore, the introduction on service basis of organised breast screening into the health care system in Hungary is strongly recommended by the authors.

Breast Neoplasms↗
PubMed1999

Effectiveness of interventions designed to increase mammography use: a meta-analysis of provider-targeted strategies.

The objective of this study was to determine the effectiveness of interventions targeted at providers to enhance the use of mammography. We performed a meta-analysis and included United States studies that used a randomized or nonrandomized concurrent control design, had defined outcomes, and presented data that could be abstracted for reanalysis. Interventions were classified as behavioral, cognitive, or sociological and further categorized by the type of control group (active versus usual care). Data were combined using DerSimonian and Laird random effects models to yield summary effect sizes. Thirty-five studies met the inclusion criteria. All types of interventions targeted at providers were effective in increasing mammography rates. Behavioral interventions increased screening by 13.2% [95% confidence interval (CI), 7.8-18.4] as compared with usual care and by 6.8% (95% CI, 4.8-8.7) as compared with active controls. Cognitive intervention strategies improved mammography rates by 18.6% (95% CI, 12.8-24.4). Sociological interventions also had a similar magnitude of effect on screening rates (13.1% increase; 95% CI, 6.8-19.3). Interventions targeting both patients and providers were not significantly better at increasing screening than those targeting providers alone, and multiple approaches (e.g., behavioral and cognitive) were generally not more effective than a single approach. All interventions targeted at physicians were effective in increasing screening rates. Decisions to use a particular approach will depend on resources, expertise, feasibility, and cost effectiveness.

Adult↗
PubMed1999

Compliance Guidance: The Mammography Quality Standards Act Final Regulations Document #1; availability. Food and Drug Administration, HHS. Notice.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Compliance Guidance: The Mammography Quality Standards Act Final Regulations Document #1." The final regulations implementing the Mammography Quality Standards Act of 1992 (the MQSA) will become effective April 28, 1999, and will replace the interim regulations which, under the MQSA, currently regulate mammography facilities. The guidance is intended to assist facilities and their personnel to meet the MQSA final regulations.

Guidelines as Topic↗
PubMed1999

Managed care, consolidation among health care providers, and health care: evidence from mammography.

We discuss the effects of managed care on the structure of the health care delivery system, focusing on managed-care-induced consolidation among health care providers. We empirically investigate the relationship between HMO market share and mammography providers. We find evidence of consolidation: increases in HMO activity are associated with reductions in the number of mammography providers and with increases in the number of services produced by remaining providers. We also find that increases in HMO market share are associated with reductions in costs for mammography and with increases in waiting times for appointments, but not with worse health outcomes.

Adult↗
PubMedDate not supplied

Locally advanced breast carcinoma: evaluation of mammography in the prediction of residual disease after induction chemotherapy.

BACKGROUND: We aimed to assess the mammographic features of locally advanced breast carcinoma treated with neoadjuvant chemotherapy and to evaluate morphological criteria that determine the value of mammography in therapy monitoring. MATERIALS AND METHODS: We reviewed the pre- and post-therapeutic mammograms of 44 patients with stage III-breast carcinoma with regard to tumor characteristics and malignant calcifications and compared to histopathological results. RESULTS: Delineation of the tumor proved to be the most significant criterion. In 34 tumors more than 50% of the lesion was defined; these showed a high correlation between the mammographically determined tumor diameter and that determined on histopathological examination (r = 0.77). Less than 50% of the mass was definable in 14 tumors; here the correlation between mammographically and histopathologically determined tumor diameter was low (r = -0.19). CONCLUSIONS: The diagnostic value of mammography in the evaluation of tumor response to induction chemotherapy depends primarily on the extent to which the tumor can be delineated from the adjacent breast tissue. For tumors whose margins can be defined by more than 50% on the baseline mammogram, the diagnostic reliability of mammography is high. Ill-defined masses should preferably be assessed with other imaging procedures such as ultrasonography or magnetic resonance imaging.

Antineoplastic Combined Chemotherapy Protocols↗
PubMedDate not supplied

The role of Tc-99m methoxyisobutylisonitrile scintimammography as compared to mammography in evaluating palpable breast masses of Taiwanese women.

Eighty-one Taiwanese women (age range 31 to 79 years old) with palpable breast masses detected by mammography and or physical examination underwent technetium-99m methoxyisobutylisonitrile (Tc-99m-MIBI) scintimammography to assess its value in the detection of breast carcinomas and their differentiation from benign breast masses. The results showed that 58 of the 66 cases of breast carcinoma were detected by Tc-99m-MIBI scintimammography. Only 2 our of 15 patients with benign breast lesions had an abnormal scintimammographic finding. The mammography diagnosed 55 of the 66 cases of breast carcinoma, whilst 8 out of 15 patients with benign breast lesions had positive mammographic findings. The diagnostic sensitivity specificity and accuracy of Tc-99m-MIBI scintimammography were 88% 87% and 88%, respectively, whilst these parameters for mammography were 83%, 47% and 77%, respectively, regarding the differentiation of malignant from benign breast masses. We concluded that Tc-99m-MIBI scintimammography significantly improves the sensitivity and specificity for the detection of breast cancer in Taiwanese women with dense and small breasts.

Adult↗
PubMedDate not supplied

Seated mammography for older patients.

Standing for a mammography exam is difficult for some elderly patients due to dizziness, loss of strength or other age-related changes. This article reports on a pilot study that examined seated mammography as an alternative for older women. Results indicate that seated and standing mammography produced images of comparable quality and patients were equally satisfied with the procedures. The author advocates further investigation with a larger cohort of patients.

Aged↗
PubMed2000

[A pilot project with mammography--results from the first screening round].

BACKGROUND: Organised mammography screening can reduce mortality from breast cancer. A pilot project for organised mammography screening was started in four Norwegian counties in 1995/1996. This paper evaluates the results from the first screening round with focus on early indicators predicting future mortality reduction. MATERIALS AND METHODS: All women aged 50-69 were offered two-view mammography biennially. The screening examinations were performed in dedicated screening units, and the mammograms were read at breast diagnostic centres located in university hospitals. All test results and information about diagnostic procedures and treatment were reported to The Cancer Registry of Norway and registered in a central screening database. This database was essential in order to monitor and evaluate the pilot project. RESULTS: 79.5% of the invited women accepted and about 127,000 women were examined. The detection rate was 6.7 cancers per 1,000 women screened. 53.1% of the invasive tumours were less than 15 mm; about one fifth of the patients had axillary lymph node metastasis. INTERPRETATION: The obtained results met the predefined aims. Thus a future mortality reduction of at least 30% is expected. The parliamentary decision on expanding the pilot project to a nationwide programme seems well founded.

Aged↗
PubMed1975

[Procedure to be followed in cases of suspected changes diagnosed by means of mammography].

As a rule the diagnosis of larger focal lesions of the breast can be easily confirmed by biopsy. Intraoperative localization is more difficult, however, in lesions of below 5 mm diameter as measured by mammography or malignant alterations only indirectly indicated by mammography. Experience to date in 64 patients shows that specimen radiography provides immediate confirmation of large lesions detected by mammography and localizes the area for histologic examination. So far it has been found that precisely those biopsies that are performed as a result of indirect signs of malignancy or of small lesions are the most valuable contributing factor in the early diagnosis of breast cancer.

Biopsy, Needle↗
PubMedDate not supplied

Mammography technology overview.

As you can see, there are many options in mammography units. This article is not meant to recommend one unit or manufacturer over another, but rather to inform consumers that all units have assets to help technologists acquire the perfect mammogram. This article is meant to make you think about the pros and cons as you consider purchasing new mammography equipment. Though it may seem wise and certainly easier to equip your multiple-unit site(s) with one manufacturer's equipment or even one model, it might truly be wise to have a little variety; this addresses shortcomings of a particular unit. If you provide technologists with a mammography system with which they are comfortable and feel they can address any issues-accommodating disabled patients, patients with breast implants or patients with dense breast tissue-you will see the perfect mammograms you desire.

Data Collection↗
PubMed2001

Breast imaging: mammography and ultrasonography.

Mammography is the primary imaging for breast cancer screening and diagnosis. Recent improvements in mammography are related to programs established by professional societies and government agencies to bring standardization and quality assurance in the technical improvements that have extended its contributions to breast imaging. This article addresses the current roles and limitations of mammography and ultrasonography in the detection and diagnosis of breast cancer.

Adult↗
PubMed1975

Experience with contrast mammography in the diagnosis of various breast diseases.

Contrast mammography, with oxygen or positive contrast material, was performed on 88 women with various diseases of the breast. The examination was done after simple mammography had failed to establish a clear diagnosis. In each case, the roentgenologic diagnosis was confirmed by histological examination. In some cases, bicontrast studies of the duct system or of cysts were performed. With contrast mammography, a correct diagnosis was established in 98.7% of malignant tumors and in 97.8% of benign tumors. Bicontrast studies demonstrated intraductal and intracystic malignancies.

Adenofibroma↗