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HeartMate 3™ Left Ventricular Assist System: Class I Recall - Due to Potential Malfunction that may Lead to Graft Occlusion

FDA MedWatch -

The class I recall is due to a malfunction in the device’s outflow graft assembly that may cause the outflow graft to twist and close up (occlusion) over time. Occlusion of the outflow graft can reduce or stop pump flow and set off a persistent low flow alarm in the system. A reduction in pump can lead to serious adverse events such as blood clots and death.

Juluca, Tivicay, Triumeq (dolutegravir): FDA to Evaluate - Potential Risk of Neural Tube Birth Defects

FDA MedWatch -

Preliminary results from an ongoing observational study in Botswana found that women who received dolutegravir at the time of becoming pregnant or early in the first trimester appear to be at higher risk for these defects. Neural tube defects are birth defects that can occur early in pregnancy when the spinal cord, brain, and related structures do not form properly. To date, in this observational study there are no reported cases of babies born with neural tube defects to women starting dolutegravir later in pregnancy. We are investigating this new safety issue and will update the public when we have more information.

MindFrame Capture LP Revascularization Device by Medtronic: Class I Recall - Due to Wire Material That May Break or Separate During Use

FDA MedWatch -

There is a risk of the delivery wire breaking or separating during use. The clot retriever could be left inside the patient's bloodstream, and this or the attempts made to retrieve the device, can lead to further complications including bleeding, additional blockage of blood vessels, more severe stroke symptoms, or death.

7K and Poseidon 4500 by Shoreside Enterprises: Voluntary Recall - Due to Presence of Undeclared Sildenafil and/or Tadalafil

FDA MedWatch -

Use of products with the undeclared active ingredients, sildenafil and tadalafil, may pose a threat to consumers because the active ingredient may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. Among the adult male population who are most likely to use these products, adult males who use nitrates for cardiac conditions are the most at risk from these products. These products are considered tainted. To date, Shoreside Enterprises, Inc. has not received any reports of adverse events related to this recall.

Using report cards and dashboards to drive quality improvement: lessons learnt and lessons still to learn

Quality and Safety in Health Care Journal -

More than 50 years of health services research has driven home a core lesson: unintended and inappropriate variations in care are common.1 2 Identification of such variation in obstetrics was the impetus for Archie Cochrane to start his work.3 In this issue of BMJ Quality & Safety, Weiss and colleagues report an intervention developed to address inappropriate variation in aspects of maternal newborn care across Ontario, Canada’s most populous province.4 The intervention involved systematic collection and analysis of administrative data to assess key quality indicators for all hospital births in the province and provision of this data in a ‘dashboard’ back to hospitals.

Measuring quality of care and comparing this against agreed-upon standards of practice or peer performance (ie, audit) and delivery of the results to healthcare professionals and/or administrators (ie, feedback) is a common quality improvement strategy.5 Whether referred...

Pathology of poverty: the need for quality improvement efforts to address social determinants of health

Quality and Safety in Health Care Journal -

A massive body of literature characterises the impact of poverty on health outcomes. In 1817, Rene Villermé, a young French surgeon (and later economist-cum-social commentator), demonstrated stark differences in life expectancy across Parisian neighbourhoods or arondissements.1 This demonstration of disparities in basic health outcomes across income levels helped configure our early understanding of the ‘social determinants of health’. These determinants refer to the conditions in which people are born, grow, live, work and age, including income, housing and education, among others. Even 200 years after Villermé, with so many technological advances both within and outside of healthcare, the unequal distribution of resources across society continues to exert tremendous influence on the health outcomes of individuals and their communities.2–5

Underappreciated impacts of poverty as a cognitive impediment

In this issue of BMJ Quality and Safety, two papers draw attention...

Effect of a population-level performance dashboard intervention on maternal-newborn outcomes: an interrupted time series study

Quality and Safety in Health Care Journal -

Objectives

To assess the effect of the Maternal Newborn Dashboard on six key clinical performance indicators in the province of Ontario, Canada.

Design

Interrupted time series using population-based data from the provincial birth registry covering a 3-year period before implementation of the Dashboard and 2.5 years after implementation (November 2009 through March 2015).

Setting

All hospitals in the province of Ontario providing maternal-newborn care (n=94).

Intervention

A hospital-based online audit and feedback programme.

Main outcome measures

Rates of the six performance indicators included in the Dashboard.

Results

2.5 years after implementation, the audit and feedback programme was associated with statistically significant absolute decreases in the rates of episiotomy (decrease of 1.5 per 100 women, 95% CI 0.64 to 2.39), induction for postdates in women who were less than 41 weeks at delivery (decrease of 11.7 per 100 women, 95% CI 7.4 to 16.0), repeat caesarean delivery in low-risk women performed before 39 weeks (decrease of 10.4 per 100 women, 95% CI 9.3 to 11.5) and an absolute increase in the rate of appropriately timed group B streptococcus screening (increase of 2.8 per 100, 95% CI 2.2 to 3.5). The audit and feedback programme did not significantly affect the rates of unsatisfactory newborn screening blood samples or formula supplementation at discharge. No statistically significant effects were observed for the two internal control outcomes or the four external control indicators—in fact, two external control indicators (episiotomy and postdates induction) worsened relative to before implementation.

Conclusion

An electronic audit and feedback programme implemented in maternal-newborn hospitals was associated with clinically relevant practice improvements at the provincial level in the majority of targeted indicators.

Transportation characteristics associated with non-arrivals to paediatric clinic appointments: a retrospective analysis of 51 580 scheduled visits

Quality and Safety in Health Care Journal -

Background

Prior work has not studied the effects of transportation accessibility and patient factors on clinic non-arrival.

Objectives

Our objectives were: (1) to evaluate transportation characteristics and patient factors associated with clinic non-arrival, (2) to evaluate the comparability of bus and car drive time estimates, and (3) to evaluate the combined effects of transportation accessibility and income on scheduled appointment non-arrival.

Methods

We queried electronic administrative records at an urban general pediatrics clinic. We compared patient and transportation characteristics between arrivals and non-arrivals for scheduled appointments using multivariable modeling.

Results

There were 15 346 (29.8%) clinic non-arrivals. In separate car and bus multivariable models that controlled for patient and transit characteristics, we identified significant interactions between income and drive time, and clinic non-arrival. Patients in the lowest quartile of income who were also in the longest quartile of travel time by bus had an increased OR of clinic non-arrival compared with patients in the lowest quartile of income and shortest quartile of travel time by bus (1.55; P<0.01). Similarly, patients in the lowest quartile of income who were also in the longest quartile of travel time by car had an increased OR of clinic non-arrival compared with patients in the lowest quartile of income and shortest quartile of travel time by car (1.21, respectively; P<0.01).

Conclusions

Clinic non-arrival is associated with the interaction of longer travel time and lower income.

Impact of out-of-hours admission on patient mortality: longitudinal analysis in a tertiary acute hospital

Quality and Safety in Health Care Journal -

Background

Emergency hospital admission on weekends is associated with an increased risk of mortality. Previous studies have been limited to examining single years and assessing day—not time—of admission. We used an enhanced longitudinal data set to estimate the ‘weekend effect’ over time and the effect of night-time admission on all-cause mortality rates.

Methods

We examined 246 350 emergency spells from a large teaching hospital in England between April 2004 and March 2014. Outcomes included 7-day, 30-day and in-hospital mortality rates. We conducted probit regressions to estimate the impact on the absolute difference in the risk of mortality of two key predictors: (1) admission on weekends (19:00 Friday to 06:59 Monday); and (2) night-time admission (19:00 to 06:59). Logistic regressions were used to estimate ORs for relative mortality risk differences.

Results

Crude 30-day mortality rate decreased from 6.6% in 2004/2005 to 5.2% in 2013/2014. Adjusted mortality risk was elevated for all out-of-hours periods. The highest risk was associated with admission on weekend night-times: 30-day mortality increased by 0.6 percentage points (adjusted OR: 1.17, 95% CI 1.10 to 1.25), 7-day mortality by 0.5 percentage points (adjusted OR: 1.23, 95% CI 1.12 to 1.34) and in-hospital mortality by 0.5 percentage points (adjusted OR: 1.14, 95% CI 1.08 to 1.21) compared with admission on weekday daytimes. Weekend night-time admission was associated with increased mortality risk in 9 out of 10 years, but this was only statistically significant (p<0.05) in 5 out of 10 years.

Conclusions

There is an increased risk of mortality for patients admitted as emergencies both on weekends and during the night-time. These effects are additive, so that the greatest risk of mortality occurs in patients admitted during the night on weekends. This increased risk appears to be consistent over time, but the effects are small and are not statistically significant in individual hospitals in every year.

Peoples experiences of hospital care on the weekend: secondary analysis of data from two national patient surveys

Quality and Safety in Health Care Journal -

Objective

To determine whether patients treated in hospital on the weekend report different experiences of care compared with those treated on weekdays.

Design

This is a secondary analysis of the 2014 National Health Service (NHS) adult inpatient survey and accident and emergency (A&E) department surveys. Differences were tested using independent samples t-tests and multiple regression, adjusting for patient age group, sex, ethnicity, proxy response, NHS trust, route of admission (for the inpatient survey) and destination on discharge (for the A&E survey).

Setting

The inpatient survey included 154 NHS hospital trusts providing overnight care; the A&E survey 142 trusts with major emergency departments.

Participants

Three cohorts were analysed: patients attending A&E, admitted to hospital and discharged from hospital. From the inpatient survey’s 59 083 responses, 10 382 were admitted and 11 542 discharged on weekends or public holidays. The A&E survey received 39 320 responses, including 11 542 (29.4%) who attended on the weekend or on public holidays. Weekday and weekend attendees’ response rates were similar once demographic characteristics were accounted for.

Main outcome measures

For the A&E survey, six composite dimensions covered waiting times, doctors and nurse, care and treatment, cleanliness, information on discharge, and overall experiences. For the inpatient survey, three questions covered admissions and two dimensions covered information about discharge and about medicines.

Results

People attending A&E on weekends were significantly more favourable about ‘doctors and nurses’ and ‘care and treatment’. Inpatients admitted via A&E on a weekend were more positive about the information given to them in A&E than others. Other dimensions showed no differences between people treated on weekdays or on weekends.

Conclusions

Patients attending emergency departments or admitted to or discharged from an inpatient episode on weekends and public holidays report similar or more positive experiences of care to other patients after adjusting for patient characteristics.

Evaluation of the association between Nursing Home Survey on Patient Safety culture (NHSOPS) measures and catheter-associated urinary tract infections: results of a national collaborative

Quality and Safety in Health Care Journal -

Background

Recent efforts to reduce patient infection rates emphasise the importance of safety culture. However, little evidence exists linking measures of safety culture and infection rates, in part because of the difficulty of collecting both safety culture and infection data from a large number of nursing homes.

Objective

To examine the association between nursing home safety culture, measured with the Nursing Home Survey on Patient Safety Culture (NHSOPS), and catheter-associated urinary tract infection rates (CAUTI) using data from a recent national collaborative for preventing healthcare-associated infections in nursing homes.

Methods

In this prospective cohort study of nursing homes, facility staff completed the NHSOPS at intervention start and 11 months later. National Healthcare Safety Network-defined CAUTI rates were collected monthly for 1 year. Negative binomial models examined CAUTI rates as a function of both initial and time-varying facility-aggregated NHSOPS components, adjusted for facility characteristics.

Results

Staff from 196 participating nursing homes completed the NHSOPS and reported CAUTI rates monthly. Nursing homes saw a 52% reduction in CAUTI rates over the intervention period. Seven of 13 NHSOPS measures saw improvements, with the largest improvements for ‘Management Support for Resident Safety’ (3.7 percentage point increase in facility-level per cent positive response, on average) and ‘Communication Openness’ (2.5 percentage points). However, these increases were statistically insignificant, and multivariate models did not find significant association between CAUTI rates and initial or over-time NHSOPS domains.

Conclusions

This large national collaborative of nursing homes saw declining CAUTI rates as well as improvements in several NHSOPS domains. However, no association was found between initial or over-time NHSOPS scores and CAUTI rates.

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