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Biomedical subjects

Thomas P Gross

Publications and source records attributed to Thomas P Gross.

7 recordsLinked to original sources
PubMed2006

Pacemaker and ICD generator malfunctions: analysis of Food and Drug Administration annual reports.

CONTEXT: Pacemakers and implantable cardioverter-defibrillators (ICDs) are complex medical devices proven to reduce mortality in specific high-risk patient populations. It is not known if increasing device complexity is associated with decreased reliability. OBJECTIVES: To analyze postapproval annual reports submitted to the US Food and Drug Administration (FDA) by manufacturers of pacemakers and ICDs to determine the reported number and rate of pacemaker and ICD malfunctions and to assess trends in device performance. DESIGN AND SETTING: Pacemaker and ICD annual reports submitted to the FDA for the years 1990-2002 were reviewed. A pacemaker or ICD generator was defined as having malfunctioned if it was explanted due to an observed malfunction, returned to the manufacturer, and confirmed by the manufacturer to be functioning inappropriately. Leads and biventricular devices were not included in the study. Deaths were attributed to device malfunction only if they were witnessed, the malfunction immediately led to the death, and the malfunction was confirmed by the manufacturer. MAIN OUTCOME MEASURES: Number of implanted pacemaker and ICD generators; number of reported malfunctions; and annual malfunction replacement rates. Generator malfunction replacement rates were defined as the annual number of replacements due to confirmed malfunction divided by the annual number of implants. RESULTS: During the study period, 2.25 million pacemakers and 415,780 ICDs were implanted in the United States. Overall, 17,323 devices (8834 pacemakers and 8489 ICDs) were explanted due to confirmed malfunction. Battery/capacitor abnormalities (4085 malfunctions [23.6%]) and electrical issues (4708 malfunctions [27.1%]) accounted for half of the total device failures. The annual pacemaker malfunction replacement rate per 1000 implants decreased significantly during the study, from a peak of 9.0 in 1993 to a low of 1.4 in 2002 (P = .006 for trend). In contrast, the ICD malfunction replacement rate per 1000 implants, after decreasing from 38.6 in 1993 to 7.9 in 1996, increased markedly during the latter half of the study, peaking in 2001 at 36.4 (P = .04 for trend). More than half of the reported ICD malfunctions occurred in the last 3 years of the study. Overall, the annual ICD malfunction replacement rate was significantly higher than the pacemaker malfunction replacement rate (mean [SD], 20.7 [11.6] vs 4.6 [2.2] replacements per 1000 implants; P<.001; rate ratio, 5.9 [95% confidence interval, 2.7-9.1]). Sixty-one deaths (30 pacemaker patients, 31 ICD patients) were attributable to device malfunction. CONCLUSIONS: This study demonstrates that thousands of patients have been affected by pacemaker and ICD malfunctions, the pacemaker malfunction replacement rate has decreased, the ICD malfunction replacement rate increased during the latter half of the study, and the ICD malfunction replacement rate is significantly higher than that for pacemakers. Although pacemakers and ICDs are important life-sustaining devices that have saved many lives, careful monitoring of device performance is still required.

Defibrillators, Implantable↗
PubMed2004

Estimates of medical device--associated adverse events from emergency departments.

BACKGROUND: The true public health burden of adverse events associated with medical devices is unknown. The purpose of this study, therefore, was to produce the first-ever national estimates of medical device-associated adverse events resulting in emergency department (ED) visits. METHODS: From July 1999 through June 2000, reports of 10,395 medical device-associated adverse events were accumulated using the National Electronic Injury Surveillance System (NEISS), which collects information on product-related injuries from the ED records of a national stratified probability sample of hospitals. The reports were used to estimate annual total number of medical device-associated adverse events as well as number of adverse events associated with specific devices, injury diagnoses, demographic characteristics, and patient disposition status. RESULTS: The total estimated number of adverse events was 454,383 (95% confidence interval [CI]=371,156-537,610), involving a broad range of devices from 15 medical specialty groups. Unintentional traumatic events associated with a particular device appeared to be the most common mechanism of injury. The most prevalent types of injuries included contusions/abrasions, punctures, and lacerations; 13% of total estimated cases resulted in patient hospitalization. Adverse events occurred within healthcare facilities, and some were occupationally related, although they occurred at home more frequently than any other location (about 42%). CONCLUSIONS: The magnitude of the total estimate, which is over four times greater than the annual number of adverse event reports received by medical device-regulating surveillance systems, emphasizes medical device-associated adverse events as an under-recognized public health problem. Planned collection of more detailed NEISS data will allow for appropriate public health interventions.

Contusions↗
PubMed2003

Medical device surveillance: gender differences in pulmonary artery rupture after pulmonary artery catheterization.

BACKGROUND: Pulmonary artery (PA) rupture is a rare but often fatal complication of PA catheterization. METHODS: An analysis was performed of all the case reports of PA rupture after PA catheterization that were submitted to the Food and Drug Administration's Medical Device Reporting (MDR) system between the years 1991 and 2001. The MDR system is a national passive surveillance system that includes adverse event reports from such sources as manufacturers and healthcare professionals. The Nationwide Inpatient Sample (NIS), a massive, nationally representative database maintained by the Agency for Healthcare Research and Quality, was examined to study patterns of PA catheter use. RESULTS: A total of 71 PA rupture cases were identified from the MDR data. The most likely outcome following PA rupture was death. These PA ruptures were associated with 47 deaths and 24 injuries. The range of reported ages of the cases was between 40 and 91 years, with a mean age of 74 years. Of the 71 PA rupture cases, 52 were in women and 10 were in men, with gender not reported in 9 of the cases. There were significantly more cases in women than expected (Mantel-Haenszel common odds ratio estimate = 5.84, 95% confidence interval = 2.97 - 11.46, p < 0.001). CONCLUSIONS: These data suggest that women may be at significantly greater risk of PA rupture after PA catheterization than men. Clinicians must be aware of the potential for this complication of PA catheterization.

Adult↗
PubMed2002

Health effects associated with medical glove use.

Adverse reactions to medical gloves represent an important public health issue. Accordingly, there is increasing interest in understanding the information reported to the US Food and Drug Administration (FDA) describing health effects associated with the use of medical gloves. This article provides a retrospective analysis and summary of health effects associated with medical glove use reported to the FDA. The FDA's medical device adverse event databases were searched via computer using keywords to identify reports of reactions associated with any type of medical glove. Demographic and clinical information abstracted from these reports was used to perform frequency and trend analyses. The reported medical glove-related events, including the noted trends in reporting, suggest the need for further study and continued monitoring of such reports.

Adult↗