FDA is alerting health care providers and lab staff of reports of false positives when using certain Micro Capillary Blood Collection tubes with the LeadCare Testing Systems.

The FDA is warning that patients stopping the oral allergy medicines cetirizine (Zyrtec) or levocetirizine (Xyzal) after long-term use may experience rare but severe itching. These medicines are available in prescription and over-the-counter (OTC) forms. The itching, also called pruritus, has been r

Esophagogastric Tube Recall: BD Issues Correction for Esophagogastric Balloon Tamponade Tubes due to Challenges Removing Plastic Plugs from Rubber Lumen

FOR IMMEDIATE RELEASE – Date: May 21 2025, Nogales, AZ, UMARY USA is voluntarily recalling all lots of Unavy Ácido HIALURÓNICO (30 caplets/850 mg) and Umovy Ácido HIALURÓNICO (30 caplets/850 mg), to the consumer level. FDA laboratory analysis confirmed that these products are tainted with the drug i

Healthcare systems worldwide have for decades sought to prioritise prompt diagnosis of cancer as a means to improve outcomes. The gatekeeping role of general practitioners (GPs) that restricts access to testing and referral,1 along with their relatively lower propensity to use diagnostic tests,2 has been offered as partial explanations for the UK’s consistently poor performance in cancer compared with other high-income countries.3

In this issue of BMJ Quality & Safety, Akter and colleagues examined primary care investigations prior to a cancer diagnosis using data on 53 252 patients and 1868 general practices from the 2018 English National Cancer Diagnostic Audit.4 Grouping tests into four categories (any investigation, blood tests, imaging and endoscopy), the study demonstrated large variation in use of tests in general practice prior to diagnosis with cancer. Recorded characteristics of practices accounted for only a small proportion of this variation,...

The significant adverse consequences of diagnostic errors are well established.1 2 Across clinical settings and study methods, diagnostic adverse events often lead to serious permanent disability or death and are frequently deemed preventable.3–5 In malpractice claims, diagnostic adverse events consistently account for more total serious harms than any other individual type of medical error,5 6 a finding supported by large, population-based estimates of total serious misdiagnosis-related harms.2 Despite this, they generally go unrecognised, unmeasured and unmonitored, causing the US National Academy of Medicine to label diagnostic errors as ‘a blind spot’ for healthcare delivery systems.1

Diagnostic errors have been described as ‘the bottom of the iceberg’ of patient safety. This analogy is intended to connote both their enormous impact and their unmeasured, hidden nature relative to more visible errors such as...

In this issue of the journal, the article ‘Developing the Allied Health Professionals workforce within mental health, learning disability, and autism inpatient services: Rapid review of learning from quality and safety incidents’ by Wilson and colleagues1 reviews materials on safety incidents in England published between 2014 and 2024, with a focus on the contribution of allied health professionals. In the context of this study, NHS England’s definition of ‘allied health professionals’ (AHPs) was used, namely the 14 registerable professions of art therapists (art/music/drama), chiropodists/podiatrists, dietitians, occupational therapists, operating department practitioners, orthoptists, osteopaths, paramedics, physiotherapists, prosthetists/orthotists, radiographers and speech and language therapists.1 The review largely considers more extreme forms of harm, such as death (including homicide and suicide), abuse by staff and self-harm.

In this editorial, we take a reflective stance informed by critical discourse analysis. Critical discourse analysis concerns itself with the use of language...

Quality improvement (QI) in the context of extremely limited healthcare access presents unique challenges, as the primary focus is often on increasing service quantity to meet needs. Access and quality in such situations can be at odds, as is the case with surgical care in resource-limited healthcare systems around the world. However, volumes and quality must advance in tandem to prevent inadvertent harm. In many healthcare systems, patients abandon treatment due to poor quality care despite reaching the hospital.1 These challenges are further magnified in very low-resource settings, where public hospitals serve populations in the lowest economic strata. Such realities underscore the vital importance of QI in such settings to build trust of communities in their healthcare system and providers.

An important contribution to the sparse body of literature in this space is the study by Barker et al in this issue of BMJ Quality & Safety.

Introduction

Use of investigations can help support the diagnostic process of patients with cancer in primary care, but the size of variation between patient group and between practices is unclear.

Methods

We analysed data on 53 252 patients from 1868 general practices included in the National Cancer Diagnosis Audit 2018 using a sequence of logistic regression models to quantify and explain practice-level variation in investigation use, accounting for patient-level case-mix and practice characteristics. Four types of investigations were considered: any investigation, blood tests, imaging and endoscopy.

Results

Large variation in practice use was observed (OR for 97.5th to 2.5th centile being 4.02, 4.33 and 3.12, respectively for any investigation, blood test and imaging). After accounting for patient case-mix, the spread of practice variation increased further to 5.61, 6.30 and 3.60 denoting that patients with characteristics associated with higher use (ie, certain cancer sites) are over-represented among practices with lower than the national average use of such investigation. Practice characteristics explained very little of observed variation, except for rurality (rural practices having lower use of any investigation) and concentration of older age patients (practices with older patients being more likely to use all types of investigations).

Conclusion

There is very large variation between practices in use of investigation in patients with cancer as part of the diagnostic process. It is conceivable that the diagnostic process can be improved if investigation use was to be increased in lower use practices, although it is also possible that there is overtesting in practices with very high use of investigations, and in fact both undertesting and overtesting may co-exist.

Background

Adverse event surveillance approaches underestimate the prevalence of harmful diagnostic errors (DEs) related to hospital care.

Methods

We conducted a single-centre, retrospective cohort study of a stratified sample of patients hospitalised on general medicine using four criteria: transfer to intensive care unit (ICU), death within 90 days, complex clinical events, and none of the aforementioned high-risk criteria. Cases in higher-risk subgroups were over-sampled in predefined percentages. Each case was reviewed by two adjudicators trained to judge the likelihood of DE using the Safer Dx instrument; characterise harm, preventability and severity; and identify associated process failures using the Diagnostic Error Evaluation and Research Taxonomy modified for acute care. Cases with discrepancies or uncertainty about DE or impact were reviewed by an expert panel. We used descriptive statistics to report population estimates of harmful, preventable and severely harmful DEs by demographic variables based on the weighted sample, and characteristics of harmful DEs. Multivariable models were used to adjust association of process failures with harmful DEs.

Results

Of 9147 eligible cases, 675 were randomly sampled within each subgroup: 100% of ICU transfers, 38.5% of deaths within 90 days, 7% of cases with complex clinical events and 2.4% of cases without high-risk criteria. Based on the weighted sample, the population estimates of harmful, preventable and severely harmful DEs were 7.2% (95% CI 4.66 to 9.80), 6.1% (95% CI 3.79 to 8.50) and 1.1% (95% CI 0.55 to 1.68), respectively. Harmful DEs were frequently characterised as delays (61.9%). Severely harmful DEs were frequent in high-risk cases (55.1%). In multivariable models, process failures in assessment, diagnostic testing, subspecialty consultation, patient experience, and history were significantly associated with harmful DEs.

Conclusions

We estimate that a harmful DE occurred in 1 of every 14 patients hospitalised on general medicine, the majority of which were preventable. Our findings underscore the need for novel approaches for adverse DE surveillance.

Background

Allied health professionals (AHPs) in inpatient mental health, learning disability and autism services work in cultures dominated by other professions who often poorly understand their roles. Furthermore, identified learning from safety incidents often lacks focus on AHPs and research is needed to understand how AHPs contribute to safe care in these services.

Methods

A rapid literature review was conducted on material published from February 2014 to February 2024, reporting safety incidents within adult inpatient mental health, learning disability and autism services in England, with identifiable learning for AHPs. 115 reports/publications were included, predominantly consisting of independent investigations by NHS England, prevent future deaths reports and Care Quality Commission reports.

Findings

Misunderstanding of AHP roles, from senior leadership to frontline staff, led to AHPs being disempowered and excluded from conversations/decisions, and patients not getting sufficient access to AHPs, contributing to safety incidents. A central thread ‘organisational culture’ ran through five subthemes: (1) (lack of) effective multidisciplinary team (MDT) working, evidenced by poor communication, siloed working, marginalisation of AHPs and a lack of psychological safety; (2) (lack of) AHP involvement in patient care including care and discharge planning, and risk assessment/management. Some MDTs had no AHPs, some recommendations by AHPs were not actioned and referrals to AHPs were not always made when indicated; (3) training needs were identified for AHPs and other professions; (4) staffing issues included understaffing of AHPs and (5) senior management and leadership were found to not value/understand AHP roles, and instil a blame culture. A need for cohesive, well-led and nurturing MDTs was emphasised.

Conclusion

Understanding and recognition of AHP roles is lacking at all levels of healthcare organisations. AHPs can be marginalised in MDTs, presenting risks to patients and missed opportunities for quality improvement. Raising awareness of the essential roles of AHPs is critical for improving quality and safety in inpatient mental health, learning disability and autism services.

Background

Countries with resource-poor health systems have struggled to improve access to and the quality of caesarean section (C-section; CS) for women seeking care in public health facilities. Access to C-section in Bihar State remains very low, while access has increased in many other contexts.

Methods

We used quality improvement (QI) combined with targeted resource management to test and implement changes that were designed to increase C-section delivery. We compared C-section delivery percentages after the interventions across eight intervened (QI) hospitals and between QI hospitals and the remaining 22 non-intervened (non-QI) hospitals with baseline CS <10%. We linked patterns of improvement and sustainability to theoretical drivers of improvement and timing of interventions.

Results

In QI hospitals, C-section percentage increased from 2.9% at baseline to 5.9% in the intervention phase and 4.6% in the post intervention phase. In non-QI hospitals, we observed a small change (2.6–3.3%) during the same time period of the interventions in the QI hospitals. Addition of skilled personnel resulted in increased C-section percentage in QI hospitals (3.6–5.9%) but not non-QI hospitals (3.4–3.2%).

Conclusions

C-section availability increased for a population of women giving birth following initiation of QI BTS collaborative in a low-income country public sector setting that has historically struggled to provide this service. Addition of obstetric and operating room resources alone, without interventions to support system changes, may not result in additional increase in C-section delivery. The adaptive implementation model may contribute to efforts to provide more access to C-sections in other very resource-limited settings.

The investigation of incidents and accidents, together with subsequent reflection and action, is an essential component of safety management in every safety-critical industry, including healthcare. A number of formal methods of incident analysis were developed in the early days of risk management and patient safety, including the London Protocol which was published in 2004. In this paper, we describe the development of a new edition of the London Protocol. We explain the need for a revised and expanded version of the London Protocol, addressing both the changes in healthcare in the last two decades and what has been learnt from the experience of incident analysis across the world. We describe a systematic process of development of the new edition drawing on the findings of a narrative review of incident analysis methods. The principal changes in the new edition are as follows: increased emphasis and guidance on the engagement of patients and families as partners in the investigation; giving more attention to the support of patients, families and staff in the aftermath of an incident; emphasising the value of a small number of in-depth analyses combined with thematic reviews of wider problems; including proposals and guidance for the examination of much longer time periods; emphasising the need to highlight good care as well as problems; adding guidance on direct observation of the work environment; providing a more structured and wide-ranging approach to recommendations and including more guidance on how to write safety incident reports. Finally, we offer some proposals to place research on incident analysis on a firmer foundation and make suggestions for the practice and implementation of incident investigation within safety management systems.

The FDA and the CDC are recommending a pause in the use of Ixchiq (Chikungunya Vaccine, Live) in individuals 60 years of age and older while the Agencies investigate postmarketing reports of serious adverse events, including neurologic and cardiac events, in individuals who have received the vaccine

The FDA is alerting consumers, tattoo artists, and retailers of the potential for serious injury from use of tattoo inks that are contaminated with bacteria, including Pseudomonas aeruginosa.

EnShiShiXiangNiShangMaoYouXianGongSi is voluntarily recalling one lot of ENDURANCE BOOST WITH HORNY GOAT WEED (20 Count)

Heart Pump Accessory Removal: Abbott Removes HeartMate Mobile Power Unit due to Instances of Sudden Power Loss

FDA is alerting health care providers and lab staff of reports of false positives when using certain Micro Capillary Blood Collection tubes with the LeadCare Testing Systems.

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