Barriers and facilitators to nurses' acceptance of and implications for injury rates of an IV catheter safety device

This study has the purpose of determining the barriers and facilitators to nurses' acceptance of the Johnson and Johnson Protectiv®* Plus IV catheter safety needle device and implications for needlestick injuries at St. Luke's Episcopal Hospital, Houston, Texas. A one-time cross-sectional survey of 620 responding nurses was conducted by this researcher during December, 2000. The study objectives were to: (1) describe the perceived (a) organizational and individual barriers and facilitators and (b) acceptance of implementation of the IV catheter device; (2) examine the relative importance of these predictors; (3) describe (a) perceived changes in needlestick injuries after implementation of the device; (b) the reported incidence of injuries; and (c) the extent of underreporting by nurses; and (4) examine the relative importance of (a) the preceding predictors and (b) acceptance of the device in predicting perceived changes in needlestick injuries. Safety climate and training were evaluated as organizational factors. Individual factors evaluated were experience with the device, including time using it and frequency of use, and background information, including nursing unit, and length of time as a nurse in this hospital and in total nursing career. The conceptual framework was based upon the safety climate model. Descriptive statistics and multiple and logistic regression were utilized to address the study objectives. ^ The findings showed widespread acceptance of the device and a strong perception that it reduced the number of needlesticks. Acceptance was notably predicted by adequate training, appropriate time between training and device use, solid safety climate, and short length of service, in that order. A barrier to acceptance was nurses' longtime of use of previous needle technologies. Over four-fifths of nurses were compliant in always using the device. Compliance had two facilitators: length of time using device and, to a lesser extent, safety climate. Rates of compliance tended to be lower among nurses in units in which the device was frequently used. ^ High quality training and an atmosphere of caring about nurse safety stand out as primary facilitators that other institutions would need to adopt in order to achieve maximum success in implementing safety programs involving utilization of new safety devices. ^

Middle managers' attitudes toward employee assistance programs in the corporate setting

Several studies have shown that successful Employee Assistance Programs (EAPs) have strong management endorsement. Strong management endorsement is defined as positive support in utilizing EAP services for themselves and their employees. This study focuses solely on middle management as opposed to upper or general management support. The study further examines success or lack of success of an EAP by the utilization rate defined as the number of employees over a year period who access EAP services.^ A analytical cross-sectional design was used to compare and observe differences between two groups of middle managers (utilizers and nonutilizers). Middle manager data was collected through a mail questionnaire. The study focused on identifying predictors that influence middle managers' utilization rate specifically: attitude toward EAPs, EAP knowledge level, attitude toward mental health professionals, age, gender, years worked as a middle manager, education level, training, and other possible predictors of utilization. The overall hypothesis states middle manager utilizers of EAP services have more positive attitudes and a better understanding of their EAP than middle management nonutilizers.^ As predicted, nonparametric bivariate results showed significant differences between the two groups. Middle managers in the utilization group (n = 473) tended to show more positive attitudes toward their EAP and mental health professionals and demonstrated greater EAP knowledge compared to the nonutilization group (n = 154). These findings support past studies on variables that influence EAP utilization rates.^ Further variables found to influence middle management utilization were identified by multivariate logistic regression results. These variable were gender (female supervisors), educational levels of employees supervised (employees with lower levels of education), number of employees supervised (greater the number supervised, more likely to utilize), managerial EAP training (trained supervisors) and awareness that problems do influence an employee's productivity.^ These findings strengthen the assertion that middle management's attitudes, as well as other variables may influence utilization. Study findings add new information about important variables specifically influencing middle management who utilize EAPs. An understanding of these variables is essential in developing competent EAP program training and orientation programs for middle managers. ^

Managing the risks of medical technology: Do hazard surveillance systems provide an early warning of medical device problems?

The Food and Drug Administration (FDA) is responsible for risk assessment and risk management in the post-market surveillance of the U.S. medical device industry. One of the FDA regulatory mechanisms, the Medical Device Reporting System (MDR) is an adverse event reporting system intended to provide the FDA with advance warning of device problems. It includes voluntary reporting for individuals, and mandatory reporting for device manufacturers. ^ In a study of alleged breast implant safety problems, this research examines the organizational processes by which the FDA gathers data on adverse events and uses adverse event reporting systems to assess and manage risk. The research reviews the literature on problem recognition, risk perception, and organizational learning to understand the influence highly publicized events may have on adverse event reporting. Understanding the influence of an environmental factor, such as publicity, on adverse event reporting can provide insight into the question of whether the FDA's adverse event reporting system operates as an early warning system for medical device problems. ^ The research focuses on two main questions. The first question addresses the relationship between publicity and the voluntary and mandatory reporting of adverse events. The second question examines whether government agencies make use of these adverse event reports. ^ Using quantitative and qualitative methods, a longitudinal study was conducted of the number and content of adverse event reports regarding breast implants filed with the FDA's medical device reporting system during 1985–1991. To assess variation in publicity over time, the print media were analyzed to identify articles related to breast implant failures. ^ The exploratory findings suggest that an increase in media activity is related to an increase in voluntary reporting, especially following periods of intense media coverage of the FDA. However, a similar relationship was not found between media activity and manufacturers' mandatory adverse event reporting. A review of government committee and agency reports on the FDA published during 1976–1996 produced little evidence to suggest that publicity or MDR information contributed to problem recognition, agenda setting, or the formulation of policy recommendations. ^ The research findings suggest that the reporting of breast implant problems to FDA may reflect the perceptions and concerns of the reporting groups, a barometer of the volume and content of media attention. ^

Unintended pregnancy: Attitudes toward contraception of women obtaining abortions

Forty-nine percent of pregnancies in the United States are unintended and significant numbers of pregnancies are unintended for women of all ages. One possible reason for the high rate is that while 85% of women at risk for an unintended pregnancy use contraception, negative attitudes about the method used make them poor contraceptors. Negative attitudes may prevent the remaining 15% of women from using any method of birth control. This study examined adult women's attitudes toward contraception and its use to see if attitudes correlate with unintended pregnancy. ^ To obtain a sample of women experiencing unintended pregnancies, women obtaining therapeutic abortions were surveyed since almost all women obtaining therapeutic abortions are experiencing an unintended pregnancy. The study used a cross-sectional survey design and included 312 women obtaining abortions at the Planned Parenthood Surgical Services Clinic in Houston in the latter half of 1999. ^ The responses revealed a lack of knowledge about the safety and effectiveness of contraception, particularly for methods other than oral contraceptives and condoms. Thirty-four percent of the participants were uncomfortable buying contraception. While 71% of the participants said their physician recommended their use of contraception, 17% were unsure and 35% did not talk to their physician about contraception on a regular basis. ^ The attitudes of women using contraception were compared with those not using contraception and many differences were seen. Women not using contraception responded with more ‘unsure’ answers and believed contraception was more difficult to use. They felt planning ahead for the use of contraception interfered with the enjoyment of sex (p-value = 0.06). They were less likely to use contraception if their partner disapproved (p-value = 0.01) and more of them believed their church disapproved of contraception (p-value = 0.02). In comparison, women using contraception had negative attitudes about the safety of the pill (p-values = 0.01–0.08) and the effectiveness of the condom (p-value = 0.04). Therefore, the negative attitudes women using contraception had about contraception may interfere with their effective use of birth control. Those not using contraception were found to hold attitudes that may contribute to their non-use of contraception. ^

Effects of congressional modernization laws on public access to innovative medical device technologies

The Federal Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid (CMS) play key roles in making Class III, medical devices available to the public, and they are required by law to meet statutory deadlines for applications under review. Historically, both agencies have failed to meet their respective statutory requirements. Since these failures affect patient access and may adversely impact public health, Congress has enacted several “modernization” laws. However, the effectiveness of these modernization laws has not been adequately studied or established for Class III medical devices. ^ The aim of this research study was, therefore, to analyze how these modernization laws may have affected public access to medical devices. Two questions were addressed: (1) How have the FDA modernization laws affected the time to approval for medical device premarket approval applications (PMAs)? (2) How has the CMS modernization law affected the time to approval for national coverage decisions (NCDs)? The data for this research study were collected from publicly available databases for the period January 1, 1995, through December 31, 2008. These dates were selected to ensure that a sufficient period of time was captured to measure pre- and post-modernization effects on time to approval. All records containing original PMAs were obtained from the FDA database, and all records containing NCDs were obtained from the CMS database. Source documents, including FDA premarket approval letters and CMS national coverage decision memoranda, were reviewed to obtain additional data not found in the search results. Analyses were conducted to determine the effects of the pre- and post-modernization laws on time to approval. Secondary analyses of FDA subcategories were conducted to uncover any causal factors that might explain differences in time to approval and to compare with the primary trends. The primary analysis showed that the FDA modernization laws of 1997 and 2002 initially reduced PMA time to approval; after the 2002 modernization law, the time to approval began increasing and continued to increase through December 2008. The non-combined, subcategory approval trends were similar to the primary analysis trends. The combined, subcategory analysis showed no clear trends with the exception of non-implantable devices, for which time to approval trended down after 1997. The CMS modernization law of 2003 reduced NCD time to approval, a trend that continued through December 2008. This study also showed that approximately 86% of PMA devices do not receive NCDs. ^ As a result of this research study, recommendations are offered to help resolve statutory non-compliance and access issues, as follows: (1) Authorities should examine underlying causal factors for the observed trends; (2) Process improvements should be made to better coordinate FDA and CMS activities to include sharing data, reducing duplication, and establishing clear criteria for “safe and effective” and “reasonable and necessary”; (3) A common identifier should be established to allow tracking and trending of applications between FDA and CMS databases; (4) Statutory requirements may need to be revised; and (5) An investigation should be undertaken to determine why NCDs are not issued for the majority of PMAs. Any process improvements should be made without creating additional safety risks and adversely impacting public health. Finally, additional studies are needed to fully characterize and better understand the trends identified in this research study.^

Survey analysis on dental infection control & occupational safety from India---1999 & 2010

The objective was to study knowledge, attitudes, practice (KAP) and needs regarding infection control measures using two cross-sectional surveys from 1999 and 2010 conducted in India. Both data collection instruments had only about 35 comparable variables in common. In 1999, there were 456 respondents (dentists) who completed a self-administered survey instrument compared to 272 respondents in 2010. Both the 1999 and 2010 samples were mutually independent with no overlap, had regional differences, and therefore, were not completely comparable for changes in KAP over time. While almost all respondents from both surveys felt that education in dental safety was needed and wanted mandatory dental safety curriculum in dental schools, severe inadequacies in dental safety knowledge, protection against immunizable diseases, and practice of universal precaution were noted. Data from the study demonstrated that there is a substantial opportunity to improve the knowledge, attitude and practice of dental infection control and occupational safety in India. Few respondents (27%) reported that the infectious disease status of a patient is always known and a significant number reported that they had the right to refuse care for patients of known infectious disease status. This indicates that Stigma in treating HIV/AIDS patients remains a concern, which in turn suggests that a stronger focus on educating dentists about dental safety and on stigma and infectious disease is needed. Information obtained from this study could be utilized for developing policies oriented towards increasing dental safety educational efforts, in both dental schools as curriculum, and for practicing dentists through professional updates or continuing dental education.^

Teaching safety at a summer camp: Evaluation of a children's fire safety curriculum in an urban community setting

Objectives: The purpose of this study was to evaluate the effectiveness of the Danger Rangers Fire Safety Curriculum in increasing the fire safety knowledge of low-income, minority children in pre-kindergarten to third grade in Austin, TX during a summer day camp in 2007.^ Methods: Data was collected from child participants via teacher and researcher administered tests at pretest, posttest (immediately after the completion of the fire safety module), and at a 3 week follow-up to asses retention. In addition, a self-administered questionnaire was collected from parents pre- and post-intervention to assess home-related fire/burn risk factors. Paired t-tests were conducted using STATA 12.0 to evaluate pretest, posttest, and retention test mean scores as well as mean fire safety rules listed by grade group. McNemar's test was used to determine if there was a difference in fire-related risk factors as reported by the parents of the participants before and after the intervention. Only those who had paired data for the tests/surveys being compared were included in the analysis.^ Results: The first/second grade group and the third grade group scored significantly higher on fire safety knowledge on the posttest compared to the pretest (p<0.0001 for both groups). However, there was no significant change in knowledge scores for the pre-kindergarten to kindergarten group (p=0.14). Among the first/second grade group, knowledge levels did not significantly decline between the posttest and retention test (p=0.25). However, the third grade group had significantly lower fire safety knowledge scores on the retention test compared to the posttest (p<0.001). A similar increase was seen in the amount of fire safety rules listed after the intervention (p<0.0001 between pre and posttest for both the first/second grade and third grade groups), with no decline from the posttest to the retention test (p=0.50) for the first/second grade group, but a significant decline in the third grade group (p=0.001). McNemar's chi-square test showed a significant increase in the percentage of participants' parents reporting smoke detector testing on a regular basis and having a fire escape plan for their family after the intervention (p=0.01 and p<0.0001, respectively). However, there was no significant change in the frequency of reports of the child playing in the kitchen while the parent cooks or the house/apartment having a working smoke detector.^ Conclusion: We found that general fire safety knowledge improved and the number of specific fire safety rules increased among the first to third grade children who participated in the Danger Rangers fire safety program. However, it did not significantly increase general fire safety knowledge among the pre-k/k group. This study also showed that a program targeted towards children has the potential to influence familial risk factors by proxy. The Danger Rangers Fire Safety Curriculum should be further evaluated by conducting a randomized controlled trial, using valid measures that assess fire safety attitudes, beliefs, behaviors, as well as fire/burn related outcomes.^