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Eugia US LLC (f/k/a AuroMedics Pharma LLC) Issues Voluntary Nationwide Recall of Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) (Single Dose Vial) Due to Presence of White Particles

FDA MedWatch -

East Windsor, New Jersey, Eugia US LLC (f/k/a AuroMedics Pharma LLC) has initiated a voluntary recall of lot number 3MC23011 of Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) (Single Dose Vial) - 10mL Vial to the consumer level due to a customer product complaint for the presence of white par

Amneal Pharmaceuticals, LLC. Issues a Nationwide Voluntary Recall of Vancomycin Hydrochloride for Oral Solution USP, 250mg/5mL, Due to the Potential for Some Bottles to be Super Potent Which May be Harmful

FDA MedWatch -

Amneal Pharmaceuticals, LLC. Bridgewater, New Jersey (Amneal), is voluntarily recalling 4 lots (see table below) of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL packaged in 80 mL, 150 mL, or 300 mL pack sizes, to the Consumer Level. Some bottles may have been overfilled which can res

Lost in translation: does measuring 'adherence to the Surgical Safety Checklist indicate true implementation fidelity?

Quality and Safety in Health Care Journal -

The use of checklists in surgery is a best practice.1 There is a plethora of evidence that suggests using the WHO Surgical Safety Checklist (SSC) reduces complications such as pneumonia,2 intraoperative blood loss,2 3 sepsis,2 unplanned intubation,2 urinary tract infections,2 wound infections,2–4 30-day readmissions and 30-day mortality.2–4 The SSC has three components, which need to be carried out for each phase of a surgical procedure, including sign-in, timeout and sign-out.5 The SSC serves as an aide memoir that includes vital information to prompt team discussions and actions that may otherwise be overlooked or forgotten, thereby promoting clear, consistent and timely communications among team members that prevents errors and enhances patient safety.6 Importantly, the SSC is more than merely a...

Elusive but hopefully not illusive: coordinating care for patients with heart failure with preserved ejection fraction

Quality and Safety in Health Care Journal -

Depending on your perspective, a unicorn could be either a magical horned creature or a billion-dollar start-up. Alternatively, it could represent coordinated care for patients with heart failure with preserved ejection fraction (HFpEF), as it does for Brooman-White et al.1 In their accompanying paper on coordination of care for patients with HFpEF, which included an analysis of 12 clinical guidelines and secondary analysis of qualitative interviews with patients and healthcare professionals in the UK’s National Health Service, the authors describe the apparent illusiveness of securing coordinated specialist and generalist care for this complex patient group. However, by explicating when and why problems arise, Brooman-White et al offer hope that the pursuit of coordinated care is not really as illusive as the unicorn they describe it as, but rather an elusive challenge which requires renewed focus and strategies designed around the needs of patients who use these services....

Effective use of interdisciplinary approaches in healthcare quality: drawing on operations and visual management

Quality and Safety in Health Care Journal -

Thinkers from the broad field of quality management, such as Edwards Deming, have influenced the more focused field of healthcare quality including international organisations such as the Institute for Healthcare Improvement and The Health Foundation. Quality management was initially established for industrial settings but has since been applied in many other sectors such as education, travel and, in this context, healthcare. Quality management encompasses quality assurance, control and improvement. Healthcare practitioners and researchers have applied aspects of these in examples such Benneyan et al1 who in their much-cited text apply statistical process control in healthcare quality improvement using standard techniques developed in quality management. Other industrial research fields such as change management and organisational culture have also been adopted by the healthcare quality field. The value of learning from these fields was summarised by Davies et al2 who noted that ‘there is a rich literature...

Intrapartum electronic fetal monitoring: imperfect technologies and clinical uncertainties--what can a human factors and social science approach add?

Quality and Safety in Health Care Journal -

For many women, fetal well-being in labour is assessed using continuous electronic fetal monitoring with cardiotocography (CTG), a technique used to monitor the fetal heartbeat and uterine contractions during pregnancy and labour.1 However, problems in the assessment of fetal well-being in labour and delays in escalation and response have been consistently highlighted in maternity care safety inquiries, both in the UK and internationally, causing untold distress to parents and families.2–6

Taking an interdisciplinary perspective, drawing on both human factors/ergonomics and social science, the study from Lamé and colleagues,7 published in this issue of BMJ Quality and Safety, aims to understand the everyday practice of electronic fetal monitoring with CTG and the organisational and work context within which this takes place. Findings are based on ethnographic observations and interviews with midwives and doctors at different levels...

CheckPOINT: a simple tool to measure Surgical Safety Checklist implementation fidelity

Quality and Safety in Health Care Journal -

Introduction

The WHO Surgical Safety Checklist (SSC) is a communication tool that improves teamwork and patient outcomes. SSC effectiveness is dependent on implementation fidelity. Administrative audits fail to capture most aspects of SSC implementation fidelity (ie, team communication and engagement). Existing research tools assess behaviours during checklist performance, but were not designed for routine quality assurance and improvement. We aimed to create a simple tool to assess SSC implementation fidelity, and to test its reliability using video simulations, and usability in clinical practice.

Methods

The Checklist Performance Observation for Improvement (CheckPOINT) tool underwent two rounds of face validity testing with surgical safety experts, clinicians and quality improvement specialists. Four categories were developed: checklist adherence, communication effectiveness, attitude and engagement. We created a 90 min training programme, and four trained raters independently scored 37 video simulations using the tool. We calculated intraclass correlation coefficients (ICC) to assess inter-rater reliability (ICC>0.75 indicating excellent reliability). We then trained two observers, who tested the tool in the operating room. We interviewed the observers to determine tool usability.

Results

The CheckPOINT tool had excellent inter-rater reliability across SSC phases. The ICC was 0.83 (95% CI 0.67 to 0.98) for the sign-in, 0.77 (95% CI 0.63 to 0.92) for the time-out and 0.79 (95% CI 0.59 to 0.99) for the sign-out. During field testing, observers reported CheckPOINT was easy to use. In 98 operating room observations, the total median (IQR) score was 25 (23–28), checklist adherence was 7 (6–7), communication effectiveness was 6 (6–7), attitude was 6 (6–7) and engagement was 6 (5–7).

Conclusions

CheckPOINT is a simple and reliable tool to assess SSC implementation fidelity and identify areas of focus for improvement efforts. Although CheckPOINT would benefit from further testing, it offers a low-resource alternative to existing research tools and captures elements of adherence and team behaviours.

Informing understanding of coordination of care for patients with heart failure with preserved ejection fraction: a secondary qualitative analysis

Quality and Safety in Health Care Journal -

Background

Patients with heart failure with preserved ejection fraction (HFpEF) are a complex and underserved group. They are commonly older patients with multiple comorbidities, who rely on multiple healthcare services. Regional variation in services and resourcing has been highlighted as a problem in heart failure care, with few teams bridging the interface between the community and secondary care. These reports conflict with policy goals to improve coordination of care and dissolve boundaries between specialist services and the community.

Aim

To explore how care is coordinated for patients with HFpEF, with a focus on the interface between primary care and specialist services in England.

Methods

We applied systems thinking methodology to examine the relationship between work-as-imagined and work-as-done for coordination of care for patients with HFpEF. We analysed clinical guidelines in conjunction with a secondary applied thematic analysis of semistructured interviews with healthcare professionals caring for patients with HFpEF including general practitioners, specialist nurses and cardiologists and patients with HFpEF themselves (n=41). Systems Thinking for Everyday Work principles provided a sensitising theoretical framework to facilitate a deeper understanding of how these data illustrate a complex health system and where opportunities for improvement interventions may lie.

Results

Three themes (working with complexity, information transfer and working relationships) were identified to explain variability between work-as-imagined and work-as-done. Participants raised educational needs, challenging work conditions, issues with information transfer systems and organisational structures poorly aligned with patient needs.

Conclusions

There are multiple challenges that affect coordination of care for patients with HFpEF. Findings from this study illuminate the complexity in coordination of care practices and have implications for future interventional work.

Why is safety in intrapartum electronic fetal monitoring so hard? A qualitative study combining human factors/ergonomics and social science analysis

Quality and Safety in Health Care Journal -

Background

Problems in intrapartum electronic fetal monitoring with cardiotocography (CTG) remain a major area of preventable harm. Poor understanding of the range of influences on safety may have hindered improvement. Taking an interdisciplinary perspective, we sought to characterise the everyday practice of CTG monitoring and the work systems within which it takes place, with the goal of identifying potential sources of risk.

Methods

Human factors/ergonomics (HF/E) experts and social scientists conducted 325 hours of observations and 23 interviews in three maternity units in the UK, focusing on how CTG tasks were undertaken, the influences on this work and the cultural and organisational features of work settings. HF/E analysis was based on the Systems Engineering Initiative for Patient Safety 2.0 model. Social science analysis was based on the constant comparative method.

Results

CTG monitoring can be understood as a complex sociotechnical activity, with tasks, people, tools and technology, and organisational and external factors all combining to affect safety. Fetal heart rate patterns need to be recorded and interpreted correctly. Systems are also required for seeking the opinions of others, determining whether the situation warrants concern, escalating concerns and mobilising response. These processes may be inadequately designed or function suboptimally, and may be further complicated by staffing issues, equipment and ergonomics issues, and competing and frequently changing clinical guidelines. Practice may also be affected by variable standards and workflows, variations in clinical competence, teamwork and situation awareness, and the ability to communicate concerns freely.

Conclusions

CTG monitoring is an inherently collective and sociotechnical practice. Improving it will require accounting for complex system interdependencies, rather than focusing solely on discrete factors such as individual technical proficiency in interpreting traces.

How to co-design a prototype of a clinical practice tool: a framework with practical guidance and a case study

Quality and Safety in Health Care Journal -

Clinical tools for use in practice—such as medicine reconciliation charts, diagnosis support tools and track-and-trigger charts—are endemic in healthcare, but relatively little attention is given to how to optimise their design. User-centred design approaches and co-design principles offer potential for improving usability and acceptability of clinical tools, but limited practical guidance is currently available. We propose a framework (FRamework for co-dESign of Clinical practice tOols or ‘FRESCO’) offering practical guidance based on user-centred methods and co-design principles, organised in five steps: (1) establish a multidisciplinary advisory group; (2) develop initial drafts of the prototype; (3) conduct think-aloud usability evaluations; (4) test in clinical simulations; (5) generate a final prototype informed by workshops. We applied the framework in a case study to support co-design of a prototype track-and-trigger chart for detecting and responding to possible fetal deterioration during labour. This started with establishing an advisory group of 22 members with varied expertise. Two initial draft prototypes were developed—one based on a version produced by national bodies, and the other with similar content but designed using human factors principles. Think-aloud usability evaluations of these prototypes were conducted with 15 professionals, and the findings used to inform co-design of an improved draft prototype. This was tested with 52 maternity professionals from five maternity units through clinical simulations. Analysis of these simulations and six workshops were used to co-design the final prototype to the point of readiness for large-scale testing. By codifying existing methods and principles into a single framework, FRESCO supported mobilisation of the expertise and ingenuity of diverse stakeholders to co-design a prototype track-and-trigger chart in an area of pressing service need. Subject to further evaluation, the framework has potential for application beyond the area of clinical practice in which it was applied.

Practice or perfect? Coaching for a growth mindset to improve the quality of healthcare

Quality and Safety in Health Care Journal -

Introduction

Perfection in this science, or rather art [i.e. medicine] takes longer to be mastered than human life [affords]—Maimonides, philosopher and physician, Middle Ages.1

A veritable quality improvement (QI) industry has emerged that centres around initiatives to improve patient outcomes or health system performance. These initiatives often target high-risk and high-cost disease states,2 with common foci of reducing waste,3 ‘hot-spotting’4 and readmissions.5 While these initiatives can help improve health system performance across the Quintuple Aim,6 they often fall short of achieving sustained improvements in outcomes at scale due to short attention spans, limited resources and shifting priorities or incentives.7–9 Furthermore, improvement initiatives can have unintended negative consequences that increase staff burnout and inadvertently exacerbate health human resource challenges,10 highlighting a need to clarify what we are trying...

Pyramid Wholesale Issues Recall of Various Brands of Products Sold as Dietary Supplements for Sexual Enhancement Because They Contain Undeclared Prescription Drugs Including Sildenafil (Viagra) and/or Tadalafil (Cialis)

FDA MedWatch -

Pyramid Wholesale is issuing a recall of various brands of products sold as dietary supplements for sexual enhancement because they contain undeclared prescription drugs including Sildenafil (Viagra) and/or Tadalafil (Cialis).

Sleepnet Corporation Issues Worldwide Recall of CPAP and BIPAP Masks with Magnets Due to Potential Interference with Certain Medical Implants

FDA MedWatch -

Hampton, NH – On March 1, 2024, Sleepnet Corporation initiated a worldwide recall for all CPAP and BIPAP masks with magnets due to potential interference with certain medical devices. When a magnet comes into close proximity to certain medical implants or metallic implants, it could interfere with t

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