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Biomedical subjects

T P Gross

Publications and source records attributed to T P Gross.

At least 19 recordsLinked to original sources
PubMed1998

Improving patient care by reporting problems with medical devices.

Healthcare practitioners are the primary users of medical devices for direct patient care. As such, they are in the best position to recognize problems that result from the use of medical devices. The outcome of a device-related adverse event or product problem, as with any other medical product, can be serious and result in illness injury, or even death. The sooner that FDA learns about a problem, the sooner the agency can take action to protect patient and user safety. Healthcare practitioners are major contributors to the knowledge base related to device use and safety through astute monitoring, rapid identification of device-related problems, and reporting these problems. An understanding of the voluntary and mandatory mechanism of reporting will ensure that device problems are reported appropriately and in a timely manner. As the primary users of medical equipment for direct patient care, health care professionals have the training and expertise to improve patient care by reporting actual and suspected problems with medical devices.

Adverse Drug Reaction Reporting Systems↗
PubMed1997

Use and effectiveness of condoms during anal intercourse. A review.

BACKGROUND AND OBJECTIVES: Anal intercourse has been associated with a high risk of human immunodeficiency virus transmission. Survey data suggest that unprotected anal intercourse is practiced by a substantial proportion of the sexually active population, regardless of sexual orientation. GOAL: To review the literature related to the use and effectiveness of condoms during anal intercourse, with emphasis on prevention of human immunodeficiency virus transmission. STUDY DESIGN: Literature review. RESULTS: Epidemiologic studies have shown that consistent, correct condom use reduces the overall risk of sexual transmission of human immunodeficiency virus. Evidence for the effectiveness of condoms used during anal intercourse is less definitive. Survey and clinical trials data indicate that condom breakage and slippage rates vary during anal intercourse and may be considerably higher than during vaginal intercourse. Although condoms designed for anal intercourse have been studied and marketed in Europe, data on their actual performance are scarce. In addition, no information exists on the effectiveness of polyurethane or other nonlatex condoms for use during anal intercourse. CONCLUSIONS: Development of newer and more effective condoms for use during anal intercourse requires consideration of the ethical issues involved in testing and marketing devices used during an activity that carries with it the potential for a substantial risk to health.

Condoms↗
PubMed1997

Home oxygen therapy in Medicare beneficiaries, 1991 and 1992.

STUDY OBJECTIVE: Obtain descriptive data on the use of home oxygen by Medicare beneficiaries and study the impact of certain demographic factors and diagnoses on oxygen use. METHODS: A home oxygen user was defined as any Medicare beneficiary with at least one claim for home oxygen in the Health Care Financing Administration National Claims History 5% Physician Supplier Files for 1991 and 1992. Railroad board beneficiaries, health maintenance organization members, and those without continuous part B coverage were excluded. RESULTS: In 1991, there were 21,489 beneficiaries in the sample who received oxygen therapy. In 1992, there were 8,418 new users. Twenty-six percent of new users died in 1992. Factors significantly associated with death included age 76 years or older (relative risk [RR], 1.3), pneumonia (RR, 1.3), lung cancer (RR, 3.8), male gender (RR, 1.2), heart failure (RR, 1.3), and diagnoses suggestive of COPD (RR, 0.45). Seven percent of new users discontinued therapy within 1 month, 28% within 6 months. Liquid oxygen was used by 19% of current and 14% of new users. Factors significantly associated with liquid oxygen use included portable oxygen claims (odds ratio [OR], 2.4), nonmetropolitan residence (OR, 0.73), and white race (OR, 1.2). CONCLUSIONS: Descriptive information on patterns of home oxygen use, including associated medical conditions, types and duration of therapy, and survival is useful for regulatory purposes. This information supports concerns that current payment policy may discourage suppliers from providing liquid oxygen in underserved areas.

Aged↗
PubMed1997

Injury and death associated with hospital bed side-rails: reports to the US Food and Drug Administration from 1985 to 1995.

OBJECTIVES: Hospital bed side-rails, while intended for patient protection, can contribute to injury and death. Reports to the Food and Drug Administration (FDA) of hospital bed side-rail entrapment have increased. In this paper entrapment cases are reviewed and the population potentially at risk identified. METHODS: FDA's database was searched for events involving hospital beds from January 1985 to August 1995 and entrapment cases were identified. RESULTS: Of 111 entrapments, 65% were associated with death and 23% with injury. CONCLUSIONS: Advanced age, female sex, low body weight, and cognitive impairment may be associated with increased risk. Preventive measures are detailed.

Adolescent↗
PubMed1996

Prevalence of latex-specific IgE antibodies in hospital personnel.

BACKGROUND: Rubber latex hypersensitivity is an important concern for health care workers. PURPOSE: The Center for Devices and Radiological Health, in collaboration with the Consumer Product Safety Commission, conducted a multicenter study of the prevalence of latex-specific IgE antibodies among United States hospital personnel. MATERIALS AND METHODS: Nine hospitals participated in the cross-sectional study. A total of 504 hospital personnel completed questionnaires that provided an array of demographic, occupational, and clinical information, including a history, if any, of allergies and the use of latex and nonlatex gloves. More than three-quarters (76.5%) of the participants were tested for total IgE and latex specific IgE. RESULTS: A total of 21 (5.5%, 95% CI = 3%-7%) of the tested participants were positive for the presence of latex specific IgE antibodies, defined as a latex IgE level of > or = 0.6 ng/mL. Latex specific IgE antibodies were more prevalent in participants who reported tachycardia, palpitations, flushing, or wheezing associated with latex gloves (Odds Ratio = 10.2, 95% CI = 3.7-28.6). CONCLUSION: The study's results suggest that the prevalence of latex-specific IgE antibodies among hospital personnel is appreciable and these personnel and their health care providers should be aware of this entity.

Adult↗
PubMed1996

Medical device vigilance at FDA.

This overview of medical device vigilance at the U.S. Food and Drug Administration (FDA) discusses the basic reporting regulation and program at FDA. The FDA program has grown to the point where we now receive over 100,000 reports per year. How FDA examines the data patterns in overall reporting, to identify signals in the database, and the potential actions FDA takes to respond to these problems are also presented. New initiatives include, for example, new methods to triage reports and the move developing an internationally harmonised nomenclature.

Databases, Factual↗
PubMed1995

The epidemiology of prosthetic heart valves in the United States.

The Center for Devices and Radiological Health of the Food and Drug Administration, in collaboration with the National Center for Health Statistics, conducted the Medical Device Implant Supplement to the 1988 National Health Interview Survey, generating the 1st available population-based estimates of the use of prosthetic heart valves in the United States. The 1988 National Health Interview Survey was a massive, nationally representative cross-sectional survey that encompassed 47,485 households and 122,310 individuals. Data from the Medical Device Implant Supplement indicate that an estimated 253,283 persons with 279,175 heart valves were present in the civilian, non-institutionalized US population (population prevalence of 1.1/1,000, 95% CI 0.8-1.3). Prevalence of valve prostheses ranged from 0.2 per 1,000 in those age 44 and under to 5.3 per 1,000 in those 75 years of age and older. Age-adjusted prevalence of valve prostheses did not differ significantly according to sex, race, region of residence, education, or income of recipients. Two thirds of aortic valve recipients identified by the survey were male, compared with only one third of mitral valve recipients. Approximately two thirds of both aortic and mitral valve implants were reported as mechanical. Reported use of anticoagulative agents was significantly more common in recipients of mechanical than of bioprosthetic valves. The single most common reported reason for prosthetic valve implantation was rheumatic heart disease. These data provide useful epidemiologic and public health planning information on prosthetic heart valve use.

Adult↗
PubMed1994

The estimated effect of oral contraceptive use on the cumulative risk of epithelial ovarian cancer.

OBJECTIVE: To determine the effect of oral contraceptive (OC) use on the cumulative incidence of epithelial ovarian cancer from ages 20-40, 20-50, and 20-55 years among four groups of women: positive family history, negative family history, parous, and nulliparous. METHODS: Cancer and Steroid Hormone Study data were combined with data from the Surveillance, Epidemiology, and End Results Network to provide estimates of the age-specific incidence rates of epithelial ovarian cancer among never-users of OCs in the four specified groups of women. These rates provided the basis for calculating cumulative incidences. The rates in women using OCs were estimated from meta-analyses of the epidemiologic literature, using regression equations expressing the log-relative rate of epithelial ovarian cancer as a function of duration of use and recency. RESULTS: In all four groups, the cumulative number of epithelial ovarian cancer cases estimated to occur per 100,000 OC users, compared to never-users, decreased with increasing duration of OC use. Our results suggest that 5 years of OC use by nulliparous women can reduce their ovarian cancer risk to the level seen in parous women who never use OCs, and that 10 years of OC use by women with a positive family history can reduce their risk to a level below that for women whose family history is negative and who never use OCs. CONCLUSION: These data represent the first published estimates of the effect of OC use on the cumulative incidence of epithelial ovarian cancer by family history and by parity. The demonstrated substantial noncontraceptive benefit from OCs justifies their judicious use as a potentially powerful resource for primary prevention in women at high risk of ovarian cancer.

Adult↗
PubMed1992

The risk of epithelial ovarian cancer in short-term users of oral contraceptives.

Short-term use (less than 1 year) or oral contraceptives has been associated with increased to slightly decreased risks of epithelial ovarian cancer in several studies. To determine what might account for a statistically significant 40% reduction in risk associated with as little as 3 to 6 months of use, a finding previously reported from the Cancer and Steroid Hormone Study, and to consider the implications for mechanisms of pathogenesis, the authors compared numerous characteristics of short-term users of oral contraceptives (41 cases, 412 controls) with those of never users (242 cases, 1,517 controls). The reduced risk among short-term users was consistently restricted to women who stopped using oral contraceptives for medical reasons, which were essentially side effects; there was little evidence of a protective effect among women who stopped for nonmedical reasons. Factors such as age, parity, family history of ovarian cancer, estrogen dose, history of sterilization, and latency (interval from first use) could not account for the finding. These analyses suggest that short-term use of oral contraceptives has little to no effect per se on reducing the risk of epithelial ovarian cancer and that side effects resulting in cessation of oral contraceptive use shortly after it was begun may be indicative of factors that are protective against the disease.

Adult↗
PubMed1992

Pain and cyanosis associated with alpha 1-proteinase inhibitor.

PURPOSE: The purpose of this study was to investigate adverse reaction reports of pain and/or cyanosis attributed to alpha 1-proteinase inhibitor (A1PI), a plasma alpha-globulin protein used to treat A1PI deficiency. PATIENTS AND METHODS: The Food and Drug Administration's (FDA) Spontaneous Reporting System for the collection and analysis of suspected adverse reactions to drugs and biologics was searched for all reports with dates from January 1, 1988, through October 31, 1989, in which A1PI was named as the suspect biologic. A case of pain and/or cyanosis was defined and characteristics of cases were compared with all other reactions. Information about the production of A1PI and results from animal studies conducted by the manufacturer were also gathered. RESULTS: Fourteen cases of acute chest pain, back pain, and/or cyanosis among patients receiving A1PI infusions were reported to the FDA. The clinical aspects of reported cases were consistent with a rapidly acting, nonallergic mechanism and were easily distinguished from other reactions associated with A1PI. The characteristics of reported cases, the epidemic curve, and lot-specific analyses suggested a point source and strongly implicated two A1PI lots. Information about the production of A1PI and results from animal studies further implicated high-molecular-weight polysaccharides associated with sucrose stabilization of the suspect lots. CONCLUSION: These cases resemble adverse reactions attributed to complexes of protamine and heparin (a mucopolysaccharide). Similar vasoactive mechanisms are suggested. Research is needed to further define the pathophysiology associated with polysaccharide moieties.

Adult↗
PubMed1991

Haemophilus b disease after vaccination with Haemophilus b polysaccharide or conjugate vaccine.

The reported frequency of invasive Haemophilus influenzae type b disease occurring within 1 year after immunization was compared in American children who received either Praxis Biologics' Haemophilus b polysaccharide vaccine or Connaught Laboratories' Haemophilus b conjugate vaccine during the first year of distribution. All domestic cases reported to the Food and Drug Administration or the Centers for Disease Control were included in the study. An estimated 4.5 million and 2.0 million doses of polysaccharide and conjugate vaccines were administered, respectively. Approximately three cases of early-onset disease (disease developing less than 15 days after vaccination) per million doses were reported for the polysaccharide compared with four cases per million doses for the conjugate vaccine. There were 30.7 reported vaccine failures per million doses of the polysaccharide vaccine compared with 9.0 per million doses of the conjugate vaccine, a 3.4-fold difference. The reporting rate ratios (cases of vaccine failure to cases of early-onset disease) for the polysaccharide and conjugate were 11.5 and 2.3, respectively, a fivefold difference. Thus, compared with recipients of the polysaccharide vaccine, vaccine failures reported among recipients of the conjugate vaccine were 80% fewer than expected.

Bacterial Capsules↗
PubMed1991

Thyroid hormone use: trends in the United States from 1960 through 1988.

Thyroid hormone preparations comprised over 1% of all prescriptions filled by retail pharmacies during 1988 in the conterminous United States, i.e., the 48 contiguous states. Their large market share gives the patterns of their use substantial public health importance. This article describes prescription thyroid hormone use in the United States from 1960 through 1988, using pharmaceutical marketing research data collected from panels of retail pharmacies and office-based physicians. Although the use of natural products has declined by over 50% since 1960, about one fourth of all thyroid hormone prescriptions were for natural preparations as recently as 1988. Per capita thyroid mentions (i.e., patient-physician contacts during which a thyroid agent of any kind was recommended, prescribed, dispensed, administered, ordered to be given by a hospital, or given as a sample) doubled during this period among those over 59 years old. Per capita mentions for synthetic thyroid products increased fourfold and tenfold among men and women in this age group, respectively. Use for weight loss, despite the label's boxed warning indicating it to be ineffective and potentially dangerous, has diminished but persists. Obesity was second only to hypothyroidism among the diagnoses underlying thyroid product mentions.

Adolescent↗
PubMed1991

Trends in the content and use of oral contraceptives in the United States, 1964-88.

Drug marketing and physician survey data were used to examine trends in the use and hormonal content of oral contraceptives in the United States between 1964 and 1988. Retail prescriptions for oral contraceptives peaked at approximately 68 million in 1973 and have remained between 50 million and 60 million since 1981. Despite this relative consistency in the number of prescriptions, physician "mentions" of oral contraceptives have increased by approximately 75 percent. This increase may reflect closer monitoring of women on oral contraceptives. Use of multiphasic formulations has steadily risen, accounting for 37 percent of the oral contraceptive prescriptions in 1988. Mean estrogen and progestin doses in all types of formulations have steadily declined. A change in the type of estrogen and progestin used in preparations has coincided with this decline in dose. The association between age and use of high-dose formulations seen in the past was no longer evident in 1988. The data demonstrate that oral contraceptive formulations in wide use today differ in hormone content from those of the past, when most of the major studies addressing the risks associated with oral contraceptive use were completed. There is therefore a need to determine the risks and long-term effects associated with these newer formulations.

Adolescent↗