Studies on the absorptive defect for triglyceride in abetalipoproteinemia.

The nature of the gastrointestinal absorptive defect for triglyceride in three subjects with abetalipoproteinemia has been investigated by studying peroral biopsies of the gastrointestinal mucosa. The following conclusions were reached.1) In confirmation of other studies, the abnormal vacuoles within the duodenal absorptive cells of these individuals were lipophilic.2) On chemical analysis there was significantly more mucosal lipid than found in normal fasting specimens, and almost the entire increase was due to triglyceride.3) This excess mucosal lipid was reduced by a low fat diet, but even after 34 days on such a diet there was still an excess of lipophilic material near the villus tip and increased quantities of total lipid and triglyceride when compared with material from normal subjects similarly treated.4) Although there are demonstrable qualitative changes in mucosal and plasma lipids after an acute fat load, they are not quantitatively as great as in normal individuals. Fat balance studies and the qualitative changes in plasma and tissue lipids that do occur after more extended periods on different types of dietary fat do indicate that a considerable percentage of the dietary fat is assimilated. The route by which it is absorbed remains to be clarified.

Silicone gel breast implant adverse event reports to the Food and Drug Administration, 1984-1995.

OBJECTIVES: To characterize the adverse event reports on silicone gel breast implants (SGBIs), including death reports, submitted to the Food and Drug Administration (FDA) from 1984 through 1995 and to analyze changes in the type and complexity of reports following extensive media coverage of breast implants. METHODS: The authors analyzed mandatory and voluntary reports from the adverse events reporting system for medical devices at the FDA. RESULTS: In 1988, adverse event reports related to SGBIs accounted for 2.4% of the 14,473 mandatory reports entered into the FDA database on medical devices. In 1992, SGBI-related reports accounted for 30.3% of the total 66,476 mandatory reports of adverse events. The most frequently reported adverse event in 1988, before the widespread publicity on breast implants, was implant burst or rupture. In contrast, in 1992 the most frequently reported event was reaction, a term used to describe a range of adverse effects. CONCLUSIONS: The numbers of mandatory and voluntary reports of SGBI-related adverse events increased exponentially, as did the complexity of the reports, following publicity over the lack of safety data on breast implants and a short voluntary moratorium on their sale. A significant proportion of reports lacked information on specific medical symptoms or diagnoses.

Infections related to breast implants reported to the Food and Drug Administration, 1977-1997.

The FDA has a surveillance system for monitoring adverse events related to medical devices. Infection reports submitted to the FDA by breast implant manufacturers between 1977 and 1997 are characterized. Two cases of death caused by toxic shock syndrome after mammoplasty reported to the FDA are presented. Overall, 1,971 reports with a principal adverse event of infection were reported in this time frame. There was a large increase in the number of reports on infections related to breast implants between 1992 and 1995 due to the publicity and litigation surrounding breast implants. When an organism was identified in the report, the most common organism reported was Staphylococcus sp. Information on the time between the implantation and the onset of the infection or the explantation of the implant was not always reported. However, in reports that did contain this information, there were differences between the length of time to infection onset reported for saline breast implants (earlier) compared to silicone gel breast implants (later). More than half of the reports (56.6%) asserted only that there was an infection and that breast implants were explanted as a result; the remaining reports asserted that infection and other signs, symptoms, or diagnoses had afflicted the patient.

Human error and patient-controlled analgesia pumps.

Contrary to the prevailing attitude that error is a source of blame and punishment, errors can be an opportunity to discover a problem and institute activities to correct the problem to reduce the likelihood of recurrence. Often the source of error may be the system in which it occurred, not the person associated with it. Error in any domain, including healthcare, is difficult to identify and address because persons are reluctant to report errors for fear of self-incrimination. The discipline of human factors addresses issues related to human performance including use error. Human factors analysis provides insight into the etiology of use errors and how they can be reduced. Patient-controlled analgesia (PCA) pumps were developed to allow the patient or care-giver more control over pain relief. The PCA pumps can be programmed to deliver pain medication on a continuous basis, intermittently, or as a bolus. Selected adverse incidents involving PCA pumps that were due to use error and reported to the U.S. Food and Drug Administration are described. Finally, implications of those findings and the potential for reducing use error by applying considerations of the discipline of human factors are discussed.

Infusion pump adverse events: experience from medical device reports.

Infusion pumps are used in the hospital setting, nursing home, and increasingly, in the home. Medical Device Reports to the Food and Drug Administration of adverse events during the use of infusion pumps for a 10-year period are described. Examples of cases reported to the Food and Drug Administration are provided. The problems reported by medical facilities (hospitals, medical centers, hospital pharmacies, or nursing homes) are compared with those that occur in the home or reported by home health care agencies. Overall, there were no differences in the types of adverse events reported by medical facilities when compared with reports from home health care agencies. However, there were differences in the location of use of some of the infusion pumps studied, which could reflect the trend toward home care over the past decade.