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

On April 7, 2025, the U.S. Food and Drug Administration (“FDA” or “the agency”), classified Q’Apel Medical, Inc.’s (“Q’Apel” or “the company”) voluntary recall of 1,617 units of its 072 Aspiration System (also known under the product name “Hippo”, which includes “Cheetah”; collectively, the “product

Bridgewater, NJ, Amneal Pharmaceutical LLC, is recalling two lots of Ropivacaine Hydrochloride Injection, USP, 500mg/100mL, Infusion bags to the hospital/user level as the products may contain an inert fiber identified as polypropylene fibers from the IV bag.

Diagnostic delay, a type of diagnostic error, is the failure to establish an accurate and timely diagnosis; diagnostic delay remains a significant source of error in healthcare.1 As in other areas of medicine, there are racial and ethnic disparities in the risk of diagnostic delay; increased risk has been found among marginalised populations in a wide range of conditions, including breast cancer, acute coronary syndrome and even appendicitis in children.2–4 In issue 34:3 of BMJQS, Elena et al present the results of their systematic review of the perspectives of minoritised patients on the causes of diagnostic delay.5 They further map their findings onto an adapted Model of Pathways to Treatment, a conceptual model widely used to describe the diagnostic process.6 Through their work, the authors add voices from marginalised groups to a field of study where patient...

Antimicrobial resistance (AMR) has quietly become a global health crisis, claiming 1.1 million lives annually as of 2021. If left unchecked, the death toll is forecasted to climb to 1.9 million per year by 2050.1Despite the mounting volume of data on the burden of AMR, the global response has been sluggish with limited progress.

Global leaders agree that multi-sectorial and multi-faceted approaches are needed to limit the emergence and spread of AMR. Antimicrobial use is a key driver of AMR, where as much as 50% of use is unnecessary.2 3 In humans, the vast majority of antimicrobial use occurs outside of hospitals, making this setting crucial for antimicrobial stewardship efforts. With the estimated number of global outpatient treatment courses of antimicrobials in the billions,4 curtailing inappropriate prescribing is a daunting task. However, audit and feedback has a robust evidence base and...

Structural and social barriers to healthcare contribute significantly to the poorer health outcomes observed among minoritised ethnic people around the world.1 2 Globally, women who are members of an ethnic group that is a minority in their country of residence have been reported to receive suboptimal maternity care. This can include access challenges, poorer quality of care and support, as well as discrimination.3 4 This global pattern is mirrored in UK maternity services, where black, Asian and minoritised ethnic groups are at greater risk of severe morbidity and death during pregnancy, childbirth and postnatally than their white counterparts.5 Poor maternal outcomes have been attributed to intersecting factors, including social circumstances, cross-cultural communication barriers and organisational factors, which combine to delay help-seeking, reduce access and negatively impact experiences of care.6 7 Poor communication is a persistent...

‘Knowing what you are doing’ is a simple, but elemental value for any (care) professional. Acknowledging that treatments in healthcare can be inherently harmful, and the practice of medicine often involves weighing one harm (the disease) against the other (the treatment), it is obviously vital to know and understand the effects of medical interventions on humans. However, healthcare is becoming increasingly complex, not in the least due to the abundant body of in-depth knowledge that professionals need to weigh into their decisions for patients. Data science is rapidly changing healthcare as we speak, creating tools such as scores,1 2 benchmarks provided by clinical audits3 and guidelines that alter our clinical strategies. Artificial intelligence and machine learning solutions may be less comprehensible than the information provided by, for example, guidelines, but are revolutionising the world and healthcare at an unstoppable speed.4 The...

Vaccination has led to the control of many infectious diseases, reducing morbidity and mortality, and is estimated by the WHO to save between two and three million lives a year globally.1 Many vaccinations are given in infancy to offer protection against diseases such as measles, polio and meningitis. However, low vaccine uptake is a growing concern and has been linked to outbreaks.2 The COVID-19 pandemic appears to have exacerbated vaccine hesitancy, through a growing mistrust of vaccines.3 During the pandemic, many people could also have been reluctant to access healthcare settings due to fear of infection. Relevant to health inequalities, vaccine uptake is often lower in groups considered underserved, such as those from minority ethnic groups, or higher deprivation.3 4 Interventions are needed to increase vaccination rates to avoid preventable disease.

The study by Rosen et al5...

Objective

To evaluate the impact of a personalised audit and feedback prescribing report (AF) and brief educational summary (ES) on empiric treatment of uncomplicated lower urinary tract infections (UTIs) by family physicians (FPs).

Design

Cluster randomised control trial.

Setting

The intervention was conducted in British Columbia, Canada between 23 September 2021 and 28 March 2022.

Participants

We randomised 5073 FPs into a standard AF and ES intervention arm (n=1691), an ES-only arm (n=1691) and a control arm (n=1691).

Interventions

The AF contained personalised and peer-comparison data on first-line antibiotic prescriptions for women with uncomplicated lower UTI and key therapeutic recommendations. The ES contained detailed, evidence-based UTI management recommendations, incorporated regional antibiotic resistance data and recommended nitrofurantoin as a first-line treatment.

Main outcome measures

Nitrofurantoin as first-line pharmacological treatment for uncomplicated lower UTI, analysed using an intention-to-treat approach.

Results

We identified 21 307 cases of uncomplicated lower UTI among the three trial arms during the study period. The impact of receiving both the AF and ES increased the relative probability of prescribing nitrofurantoin as first-line treatment for uncomplicated lower UTI by 28% (OR 1.28; 95% CI 1.07 to 1.52), relative to the delay arm. This translates to additional prescribing of nitrofurantoin as first-line treatment, instead of alternates, in an additional 8.7 cases of uncomplicated UTI per 100 FPs during the 6-month study period.

Conclusion

AF prescribing data with educational materials can improve primary care prescribing of antibiotics for uncomplicated lower UTI.

Trial registration number

NCT05817253.

Background

Ethnic inequities in maternity care persist in England for Black, African, Caribbean and mixed-Black heritage families, resulting in poorer care experiences and health outcomes than other minoritised ethnic groups. Co-production using an integrated care approach is crucial for reducing these disparities and improving care quality and safety. Therefore, this study aimed to understand the alignment of health and local authority professional perspectives with community needs on how to improve maternity experiences for this ethnic group within a London integrated care system (ICS).

Methods

Between March and June 2024, five workshops were conducted with health professionals, local authorities, voluntary, community and social enterprise (VCSE) sector and the public from Black, African, Caribbean and mixed-Black heritage backgrounds across the North West London ICS. Using the nominal group technique (NGT), attendees prioritised ideas to improve the experience of maternity care for families from Black, African, Caribbean and mixed-Black heritage backgrounds, which were thematically synthesised using framework analysis.

Results

Fifty-four attendees, covering primary, secondary, regional and national health professionals, public health teams from three local authorities, VCSE sector and the public, generated 89 potential interventions across 11 themes. All attendees prioritised improving staff knowledge and capacity in culturally competent care and communication. Community-identified needs for advocacy mechanisms and mental health support throughout the maternity pathway were not reflected in professional priorities.

Conclusion

The study highlights the need for an integrated, community-centred approach beyond hospital settings when addressing ethnic inequities in maternity care, recognising key differences between community and professional priorities within an ICS. Leveraging lived experience expertise to lead the NGT community workshops was essential in building trust and buy-in of the overall prioritisation process.

Background

Healthcare staff adapt to challenges faced when delivering healthcare by using workarounds. Sometimes, safety standards, the very things used to routinely mitigate risk in healthcare, are the obstacles that staff work around. While workarounds have negative connotations, there is an argument that, in some circumstances, they contribute to the delivery of safe care.

Objectives

In this scoping review, we explore the circumstances and perceived implications of safety standard workarounds (SSWAs) conducted in the delivery of frontline care.

Method

We searched MEDLINE, CINAHL, PsycINFO and Web of Science for articles reporting on the circumstances and perceived implications of SSWAs in healthcare. Data charting was undertaken by two researchers. A narrative synthesis was developed to produce a summary of findings.

Results

We included 27 papers in the review, which reported on workarounds of 21 safety standards. Over half of the papers (59%) described working around standards related to medicine safety. As medication standards featured frequently in papers, SSWAs were reported to be performed by registered nurses in 67% of papers, doctors in 41% of papers and pharmacists in 19% of papers. Organisational causes were the most prominent reason for workarounds.

Papers reported on the perceived impact of SSWAs for care quality. At times SSWAs were being used to support the delivery of person-centred, timely, efficient and effective care. Implications of SSWAs for safety were diverse. Some papers reported SSWAs had both positive and negative implications for safety simultaneously. SSWAs were reported to be beneficial for patients more often than they were detrimental.

Conclusion

SSWAs are used frequently during the delivery of everyday care, particularly during medication-related processes. These workarounds are often used to balance different risks and, in some circumstances, to achieve safe care.

To improve patient safety, surgeons can continually monitor the surgical outcomes of their patients. To this end, they can use statistical process control tools, which primarily originated in the manufacturing industry and are now widely used in healthcare. These tools belong to a broad family, making it challenging to identify the most suitable methodology to monitor surgical outcomes. The selected tools must balance statistical rigour with surgeon usability, enabling both statistical interpretation of trends over time and comprehensibility for the surgeons, their primary users. On one hand, the observed minus expected (O-E) chart is a simple and intuitive tool that allows surgeons without statistical expertise to view and interpret their activity; however, it may not possess the sophisticated algorithms required to accurately identify important changes in surgical performance. On the other hand, a statistically robust tool like the cumulative sum (CUSUM) method can be helpful but may be too complex for surgeons to interpret and apply in practice without proper statistical training. To address this issue, we developed a new risk-adjusted (RA) O-E CUSUM chart that aims to provide a balanced solution, integrating the visualisation strengths of a user-friendly O-E chart with the statistical interpretation capabilities of a CUSUM chart. With the RA O-E CUSUM chart, surgeons can effectively monitor patients’ outcomes and identify sequences of statistically abnormal changes, indicating either deterioration or improvement in surgical outcomes. They can also quantify potentially preventable or avoidable adverse events during these sequences. Subsequently, surgical teams can try implementing changes to potentially improve their performance and enhance patient safety over time. This paper outlines the methodology for building the tool and provides a concrete example using real surgical data to demonstrate its application.

Previous studies have demonstrated that text message reminders can improve pediatric vaccination rates, including low income & diverse settings such as those served by federally qualified health centers. In this study, we aimed to improve compliance with routine childhood immunizations via a text message intervention in a network of urban, federally qualified health centers at a large academic medical center. We targeted parents or guardians of children aged 0-2 years who were overdue or due within 14 days for at least one routine childhood immunization without a scheduled appointment. In Round 1, two versions of a text were compared to a control (no text). In subsequent Rounds, a new text was compared to a control (no text). In each round the content, wording, and frequency of texts changed. Subjects were randomized to receive a text (treatment group(s)) or to not receive a text (control group) in each round between 2020 and 2022. The primary outcome was whether overdue vaccines had been given by 12 week follow up. The secondary outcome was appointment scheduling within the 72 hours after text messages were sent. In Round 1 (n=1203) no significant differences were found between groups in overdue vaccine administration per group or per patient at follow up, or in appointment scheduling. In Round 2 (n=251) there was no significant difference in vaccine administration per group or per patient. However, significantly more patients in the intervention group scheduled an appointment (9.1% vs. 1.7%, p=0.01). In Round 3 (n=1034), vaccine administration was significantly higher in the intervention group compared to the control overall (7.0% vs. 5.5%, 0.016) and per subject (p=0.02). Significantly more patients in the intervention group scheduled an appointment compared to the control (3.3% vs. 1.2%, p=0.02). We found that text messaging can be an effective intervention to promote health service utilization such as pediatric vaccination rates, which although improved in this study, remain low.

The Oxford Professional Practice Handbook of Quality Improvement in Healthcare1 is the latest in a series of books that will be very familiar to readers in the UK and other parts of the world. Many medical students, practicing doctors and other healthcare professionals will have used the various Oxford Handbooks—including books on Clinical Medicine, General Practice, Emergency Medicine and many more. This new book, focusing on quality improvement in healthcare, is both a welcome addition to the series and evidence of the growing recognition of the importance of understanding quality improvement methods alongside our clinical skills.

As with other books in the series, the book is well signposted, with summary tables, diagrams and examples throughout that make it a very practical resource. Each chapter starts with a summary of the key points, which is useful in signposting the reader to what is to follow. Brief examples and...

Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, today announced a voluntary recall of intraocular lenses (IOLs) on its enVista platform.

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.