Breast Imaging: Mammography in the 1990's: The United States and Canada

This study was undertaken to evaluate trends in mammography quality before and after the implementation of the Mammography Quality Standards Act (MQSA) of 1992 and to compare technical data collected in the US with corresponding data obtained from the first survey of mammography facilities conducted in 1994-1995 in Canada. Data from MQSA inspections conducted in 1995-1997 were analyzed and compared with survey data on U.S. mammography facilities acquired before the MQSA. Technical indicators of mammography quality such as radiation dose, phantom image score, film processing, and darkroom fog were analyzed. The results indicate continuous improvement since 1985 in the US in areas such as phantom image scores, darkroom fog, and x-ray beam quality. The US mean glandular dose has increased to 1.6 mGy compared with the Canadian dose of 1.1 mGy. The mean total phantom image score with artifact subtraction was 11.1 in Canada in 1994-1995 and 11.8 in the US in 1997. The conclusions are that mammography quality is better today than it has been at any other time in the US and with the exception of radiation dose, Canadian technical measures of performance are comparable to measures before MQSA in the United States.

AGENCY SPONSOR: Office of Planning, Policy & Legislation

FEDERAL CONTACT: Tucker, Steve
301-827-5339

PIC ID: 6080.3

PERFORMER: Food and Drug Administration
Rockville MD

FDA Public Health Advisory: Need for Caution When Using Vacuum Assisted Delivery Devices

The Center for Devices and Radiological Health surveyed a random sample of 308 recipients of the Public Health Advisory on vacuum assisted delivery devices. The purpose of the survey was to help the Center evaluate the format and content of the Advisory, as well as its effectiveness as a means of communication. The survey was conducted during March, 1998, and has a sampling error of plus or minus 10 percentage points. Some highlights of the survey are as follows: ninety-nine percent of the respondents said the problem addressed in the advisory was clearly identified and easily understood. The respondents agreed that the actions for reducing risk in the Alert were clearly explained (86%), and that the Alert information was useful (81%) and timely (76%). Sixty-two percent would like to continue to receive future alerts, as they are currently sent, in printed form.

AGENCY SPONSOR: Center for Devices and Radiological Health

FEDERAL CONTACT: Blanken, Gary
301-594-1284

PIC ID: 6733.1

PERFORMER: Food and Drug Administration
Rockville MD

Final Report of a Study to Eval. the Feas. and Effectiv. of a Sentinel Reporting Syst. for Adverse Event Reporting of Med. Devices in User Facilities

This report outlines the first phase of the program to evaluate the feasibility and effectiveness of a new sentinel reporting system for documenting adverse events (those ending in serious injury or death) for medical devices in user facilities (See also PIC ID# 7108). It describes the schedule of events, the exploratory research performed before the study was launched, how the participating facilities were recruited and trained, the process of data collection, how the channels of communication were established among the participating facilities and the government and the results of qualitative and quantitative analyses. Such topics as overcoming reticence to participation and enhancing communication through use of newsletters and other devices are also discussed.

AGENCY SPONSOR: Center for Devices and Radiological Health

FEDERAL CONTACT: Gardner, Susan
301-594-2812

PIC ID: 7108.1

PERFORMER: Food and Drug Administration
Rockville MD

Mammography Quality Standards Act: Third Annual Government Entity Declaration Program Audit 1998

This report details the results of the third audit of the Mammography Quality Standards Act (MQSA) Government Entity (GE) Declaration Program. The goal of the audit was to 1) notify facilities that they would be held accountable for their self- certification of fee exemption, and 2) to determine the rate of compliance with the program. Ninety out of 793 claiming GE status were randomly selected for review. A second sample of 51 facilities was reviewed out of 138 that had recently claimed fee exemption status while having paid a fee in the past. The 1993 GE audit yielded the same results as the 1997 GE audit-- a 97% compliance rate. Three of the facilities were not confirmed as government entities. The second sample yielded a 100% compliance rate. The appendices to the report contain the names of the facilities, numbers, and audit results. Recommendations for the GE Declaration Program include: 1) publish the results in "Mammography Matters" as in previous years; 2) calculate future audit samples from three groups: facilities claiming CDC funding; facilities claiming GE status, and facilities claiming GE status that previously paid. The sample would come from three groups rather than 2 groups, using the same statistical calculation to achieve a high confidence level.

AGENCY SPONSOR: Office of Planning, Policy & Legislation

FEDERAL CONTACT: Tucker, Steve
301-827-5339

PIC ID: 6080.2

PERFORMER: Food and Drug Administration
Rockville MD