Max Mobility/Permobil has expanded the recall of the Speed Control Dial, a wired control option for the SmartDrive MX2+ Power Assist Device due to safety and performance concerns. The recall was originally initiated on December 20, 2024, and has been expanded to address recalled product that may hav

Use of Baxter MiniCap Extended Life PD Transfer Sets during peritoneal dialysis may expose patients to higher than allowable NDL-PCBAs.

The FDA expanded its evaluation of the potential risk of exposure to toxic compounds when using hemodialysis and peritoneal dialysis systems

Aortic Root Cannulas are used during heart surgery. There is a risk of extra material in the device due to a manufacturing error.

Megadyne is updating the instructions and product labeling to reflect that the Mega Soft Universal pads should not be used in patients under 12 years old.

Read the FDA’s recommendations related to four recalls of Megadyne Mega 2000 and Mega Soft patient return electrodes for patient burn injuries.

ORAL/NASAL Endotracheal Tubes keep air flowing through a patient’s airway, but some tubes may be smaller in diameter than expected.

Software from Alaris System Manager and CCE Infusion Adapter needs updates so outdated infusion information does not load to the Alaris infusion pump system.

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

Healthcare is at a crossroads. On one hand, health systems are increasingly committed to promote evidence-based practices and reduce wasteful spending. On the other hand, there is a persistent reality of low-value care as demonstrated by procedures, tests and treatments that provide little to no benefit and sometimes even cause harm. Compounding the problem is the increasing availability, complexity and volume of information patients have to grasp when making decisions. While health-seeking behaviours are associated with better patient engagement and better overall outcomes, online health-related information can be a frequent source of misinformation. In the pursuit to decrease low-value care, one critical factor remains consistently underestimated: health literacy (HL).

HL role in low-value care

HL represents the extent to which patients are able to understand and act on health information.1 With rates ranging from 12% in the USA to 53% in European countries over the last...

This edition of BMJ Quality & Safety includes a systematic review on practices to reduce transmission of infections with resistant organisms led by the Agency for Healthcare Research and Quality (AHRQ) as part of the ‘Making Healthcare Safer IV’ initiative.1 The AHRQ team has done a great service to healthcare providers and infection preventionists by summarising the evidence succinctly and in one document. This systematic review focuses on literature on these five safety practices published from 2011 to 2023: universal gloving, contact precautions, cohorting patients, environmental decontamination and patient decolonisation. Included studies took place in inpatient or nursing home settings. The starting place for the review was previously published systematic reviews (n=9), augmented by original research studies not included in these reviews (n=17). Unfortunately, the main finding of this review is that the certainty of evidence that these practices may reduce transmission of infections with multidrug-resistant organisms...

Objective

To (a) examine whether the effect of the Choosing Wisely consumer questions on question-asking and shared decision-making (SDM) outcomes differs based on individuals’ health literacy and (b) explore the relationship between health literacy, question-asking and other decision-making outcomes in the context of low value care.

Methods

Preplanned analysis of randomised trial data comparing: the Choosing Wisely questions, a SDM video, both interventions or control (no intervention). Randomisation was stratified by participant health literacy (‘adequate’ vs ‘limited’), as assessed by the Newest Vital Sign.

Main outcome measures

Self-efficacy to ask questions and be involved in decision-making, and intention to engage in SDM.

Participants

1439 Australian adults, recruited online.

Results

The effects of the Choosing Wisely questions and SDM video did not differ based on participants’ health literacy for most primary or secondary outcomes (all two-way and three-way interactions p>0.05). Compared with individuals with ‘adequate’ health literacy, those with ‘limited’ health literacy had lower knowledge of SDM rights (82.1% vs 89.0%; 95% CI: 3.9% to 9.8%, p<0.001) and less positive attitudes towards SDM (48.3% vs 58.1%; 95% CI: 4.7% to 15.0%, p=0.0002). They were also more likely to indicate they would follow low-value treatment plans without further questioning (7.46/10 vs 6.94/10; 95% CI: 0.33 to 0.72, p<0.001) and generated fewer questions to ask a healthcare provider which aligned with the Choosing Wisely questions (2 (1)=73.79, p<.001). On average, 67.7% of participants with ‘limited’ health literacy indicated that they would use video interventions again compared with 55.7% of individuals with ‘adequate’ health literacy.

Conclusion

Adults with limited health literacy continue to have lower scores on decision-making outcomes in the context of low value care. Ongoing work is needed to develop and test different intervention formats that support people with lower health literacy to engage in question asking and SDM.

Background

Current adverse effects of medical treatment (AEMT) incidence estimates rely on limited record reviews and underreporting surveillance systems. This study evaluated global and national longitudinal patterns in AEMT incidence from 1990 to 2019 using the Global Burden of Disease (GBD) framework.

Methods

AEMT was defined as harm resulting from a procedure, treatment or other contact with the healthcare system. The overall crude incidence rate, age-standardised incidence rate and their changes over time were analysed to evaluate temporal trends. Data were stratified by sociodemographic index (SDI) quintiles, age groups and sex to address heterogeneity across and within nations. An age–period–cohort model framework was used to differentiate the contributions of age, period and cohort effects on AEMT incidence changes. The model estimated overall and age-specific annual percentage changes in incidence rates.

Findings

Although the global population increased 44.6% from 1990 to 2019, AEMT incidents rose faster by 59.3%. The net drift in the global incidence rate was 0.631% per year. The proportion of all cases accounted for by older adults and the incidence rate among older adults increased globally. The high SDI region had much higher and increasing incidence rates versus declining rates in lower SDI regions. The age effects showed that in the high SDI region, the incidence rate is higher among older adults. Globally, the period effect showed a rising incidence of risk after 2002. Lower SDI regions exhibited a significant increase in incidence risk after 2012. Globally, the cohort effect showed a continually increasing incidence risk across sequential birth cohorts from 1900 to 1950.

Conclusion

As the global population ageing intensifies alongside the increasing quantity of healthcare services provided, measures need to be taken to address the continuously rising burden of AEMT among the older population.

Background

Proximal femoral fractures in older adults affect prognosis, quality of life and medical expenses. Therefore, identifying patients with an elevated risk for proximal femoral fractures and implementing preventive measures to mitigate their occurrence are crucial.

Objective

This study aimed to develop an accurate in-hospital fracture prediction model that considers patients’ daily conditions and medical procedure status. Additionally, it investigated the changes in their conditions associated with fractures during hospital stays.

Design

A retrospective observational study.

Setting(s)

Acute care hospitals in Japan.

Participants

Participants were 8 514 551 patients from 1321 medical facilities who had been discharged between April 2018 and March 2021 with hip and proximal femoral fractures.

Methods

Logistic regression analysis determined the association between patients’ changes in their ability to transfer at admission and the day before fracture, and proximal femoral fracture during hospital stays.

Results

Patients were classified into fracture and non-fracture groups. The mean ages were 77.4 (SD: 7.7) and 82.6 (SD: 7.8), and the percentages of women were 42.7% and 65.3% in the non-fracture and fracture groups (p<0.01), respectively. Model 4 showed that even if a patient required partial assistance with transfer on the day before the fracture, the fracture risk increased in each category of change in ability to transfer in the following order: ‘declined’, ‘improved’ and ‘no change’.

Conclusions

Patients showing improved ability to transfer during their hospitalisation are at a higher risk for fractures. Monitoring patients’ daily conditions and tracking changes can help prevent fractures during their hospital stays.

Background

Healthcare-associated infections due to multidrug-resistant organisms (MDROs) remain a high priority patient safety topic, despite broad acceptance as standard-of-care safety practices to prevent central line-associated bloodstream infection, catheter-associated urinary tract infection and ventilator-associated pneumonia. Prior editions of Making Healthcare Safer have mixed certainty evidence for various other patient safety practices.

Objectives

As part of Making Healthcare Safer IV, we performed an updated systematic review on the certainty of evidence for the following safety practices at reducing in-facility MDRO infections in adult patients: universal gloving, contact precautions, cohorting, environmental decontamination, patient decolonisation and the adverse effects of isolation.

Methods

We searched PubMed and the Cochrane Library 2011–May 2023 for systematic reviews and original research studies, both randomised and observational. Settings were limited to high-income countries. Screening and eligibility were done in duplicate, while data extraction was done by one reviewer and checked by a second reviewer. The synthesis of results is narrative. Certainty of evidence was based on the GRADE (Grading of Recommendations Assessment, Development and Evaluation) framework.

Results

Three systematic reviews and three original research studies provided moderate certainty evidence that patient decolonisation reduced MDRO infections, although restricted to certain populations and organisms. One systematic review provided low certainty evidence that universal gloving was beneficial, again limited to certain populations. One systematic review and two original research studies provided low certainty evidence of benefit for environmental decontamination. One systematic review and one new original study provided low certainty evidence of benefit for cohorting in outbreak settings, and very low certainty evidence of benefit in endemic settings. Six original research studies provide mixed evidence for benefit of contact precautions. There is very low certainty evidence of a signal of increased non-infectious adverse events under patients in contact isolation.

Conclusion

In general, the reviewed patient safety practices reduced MDRO infections, but certainty of evidence was low.

PROSPERO registration number

CRD42023444973.

Introduction

Many patient safety practices are only partly established in routine clinical care, despite extensive quality improvement efforts. Implementation science can offer insights into how patient safety practices can be successfully adopted.

Objective

The objective was to examine the literature on implementation of three internationally used safety practices: medication reconciliation, antibiotic stewardship programmes and rapid response systems. We sought to identify the implementation activities, factors and outcomes reported; the combinations of factors and activities supporting successful implementation; and the implications of the current evidence base for future implementation and research.

Methods

We searched Medline, Embase, Web of Science, Cumulative Index to Nursing and Allied Health Literature, PsycINFO and Education Resources Information Center from January 2011 to March 2023. We included original peer-reviewed research studies or quality improvement reports. We used an iterative, inductive approach to thematically categorise data. Descriptive statistics and hierarchical cluster analyses were performed.

Results

From the 159 included studies, eight categories of implementation activities were identified: education; planning and preparation; method-based approach; audit and feedback; motivate and remind; resource allocation; simulation and training; and patient involvement. Most studies reported activities from multiple categories. Implementation factors included: clinical competence and collaboration; resources; readiness and engagement; external influence; organisational involvement; QI competence; and feasibility of innovation. Factors were often suggested post hoc and seldom used to guide the selection of implementation strategies. Implementation outcomes were reported as: fidelity or compliance; proxy indicator for fidelity; sustainability; acceptability; and spread. Most studies reported implementation improvement, hindering discrimination between more or less important factors and activities.

Conclusions

The multiple activities employed to implement patient safety practices reflect mainly method-based improvement science, and to a lesser degree determinant frameworks from implementation science. There seems to be an unexploited potential for continuous adaptation of implementation activities to address changing contexts. Research-informed guidance on how to make such adaptations could advance implementation in practice.

Introduction

Quality measurement that focuses on important processes and outcomes within healthcare is typically seen as an essential feature of well-functioning healthcare systems.1 While outcome measures are concerned with assessing the impact of healthcare interventions (eg, the number of adverse drug events or the average length of stay for inpatients), process measures focus instead on assessing whether elements or steps within healthcare systems are happening as planned (eg, the number of patients seen in a clinic or the proportion of patients receiving a particular intervention). The relationship between processes and outcomes is acknowledged to be complex.2

Many population-based screening programmes, both in the UK and internationally, have as a key performance indicator (KPI) some sort of measure that assesses how many of the population eligible for that screening intervention participate in it (typically referred to as either ‘uptake’ or ‘coverage’). For example, for the...

The Enhancing the Quality and Transparency of Health Research (EQUATOR) Network indexes over 600 reporting guidelines designed to improve the reproducibility of manuscripts across medical fields and study designs. Although several such reporting guidelines touch on adverse events that may occur in the context of a study, there is a large body of research whose primary focus is on adverse events, near-misses and medical errors that do not currently have a dedicated reporting guideline to help set reporting standards and facilitate comparisons across studies. As part of the process prescribed by EQUATOR for developing such a reporting guideline, we performed a needs assessment, evaluating whether existing standards address key features of a proposed reporting guideline in development, entitled Standard Elements in Studies of Adverse Events and Medical Error (SESAME). We evaluated 12 EQUATOR reporting guidelines for the presence of eight key features of SESAME. Five of the 12 failed to include any of these key features. None of the remaining seven incorporated more than four of the eight SESAME key components, confirming the need for a dedicated reporting guideline for studies of adverse events and medical errors.