Insight Pharmaceuticals, a Prestige Consumer Healthcare Inc. company (“Insight”), is voluntarily recalling two lots of TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid to the consumer level. A recent review by our manufacturer and their third-party lab found that samples from two lot

Cardinal Health Monoject syringes have demonstrated recognition and compatibility issues with certain infusion pumps.

The FDA is warning not to use recalled Cardinal Health Monoject syringes, including Luer-Lock and enteral.

Find answers to frequently asked questions on Philips Respironics ventilators, BiPAP, and CPAP machines recall

This update provides additional information on the recall and recommendations for people who use repaired and replaced devices.

Maquet Express Chest Drain recalled over sterility concerns. When used without the provided syringe, the Express chest drains are safe to use.

Globus Medical, Inc. is recalling the ExcelsiusGPS, an imaging device, due to a calibration algorithm error that may affect the accuracy of implant placement.

Neptune Resources, LLC is voluntarily recalling All lots of Neptune's Fix Elixir, Neptune's Fix Extra Strength Elixir, and Neptune's Fix Tablets to the consumer level. Neptune Resources LLC's distribution channels have not reported any adverse events from the use of its products. The products are be

Woburn, Massachusetts, Azurity Pharmaceuticals, Inc. is voluntarily recalling one (1) lot (F230169A) of Zenzedi® CII (dextroamphetamine sulfate tablets, USP) 30 mg to the consumer level. The product is being recalled due to a report from a pharmacist in Nebraska who opened a bottle of Zenzedi® 30 m

Haleon is voluntarily recalling eight lots of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult to the consumer level. The product is being recalled due to microbial contamination. In immunocompromised individuals, the use of the affected product could potentially result

On December 22, 2023, Aligned Medical Solutions, Billings, MT, initiated a nationwide recall of Nurse Assist Sterile Saline packaged into medical device kits including AMS10833 Local Lower Extremity Pack I, AMS12947 In House Ocular Pack, AMS12947A In House Ocular Pack and AMS13043 Closure Kit. Produ

Mumbai, Maharashtra, Kilitch Healthcare India Limited is issuing an amendment in the last Nationwide press release dated November 13, 2023 issued for nationwide recall of various eye drops. There are corrections in product NDC No for the below mentioned products. These products were distributed nati

FDA Adds Boxed Warning for Increased Risk of Severe Hypocalcemia in Patients with Advanced Chronic Kidney Disease Taking Osteoporosis Medicine Prolia (Denosumab): FDA Safety Communication.

Over 200 health journals call on the United Nations (UN), political leaders and health professionals to recognise that climate change and biodiversity loss are one indivisible crisis and must be tackled together to preserve health and avoid catastrophe. This overall environmental crisis is now so severe as to be a global health emergency.

The world is currently responding to the climate crisis and the nature crisis as if they were separate challenges. This is a dangerous mistake. The 28th Conference of the Parties (COP) on climate change is about to be held in Dubai while the 16th COP on biodiversity is due to be held in Turkey in 2024. The research communities that provide the evidence for the two COPs are unfortunately largely separate, but they were brought together for a workshop in 2020 when they concluded that: ‘Only by considering climate and biodiversity as parts of the same...

Equity is one of the six core healthcare quality domains in ‘Crossing the Quality Chasm’, published by the Institute of Medicine in 2001.1 While substantial quality measurement and improvement work has focused on improving safety, patient-centredness, timeliness, efficiency and efficacy (the other five domains), far less has focused on health equity measurement and improvement. This is in part due to limited adoption of standardised definitions of racial and ethnicities and therefore limited availability of high-quality data on race and ethnicity.2 Having accurate data is a key first step in addressing health inequities, since what is measured influences what is done.3 There are substantial efforts to improve these data availability and quality by healthcare systems, nationally and internationally.2 Currently, adequate efforts require several steps: the decision to collect data, ensuring the quality of data being collected, and reconciliation of race and ethnicity...

Within healthcare services worldwide, there is a continual emphasis on innovation, including the development, evaluation and improvement of new and existing healthcare interventions and services to improve patient outcomes. In addition to evaluating efficacy, it is also important to evaluate how innovations are used in ‘real-world’ settings. A key part of this is process evaluation: understanding how interventions and services are implemented and engaged with. For example, recent Medical Research Council guidance on researching the effectiveness of complex interventions highlights the importance of measuring implementation and context, including the measurement of ‘fidelity’.1

‘Fidelity’ has been proposed to have five related domains, including fidelity of design, training, delivery (whether intervention components, as outlined in the intervention protocol, are delivered as planned), receipt (whether participants understand and are able to perform required skills) and enactment (whether participants use skills in daily life).2 Both receipt and enactment have...

The seminal report To Err is Human focused on a wide range of serious patient safety concerns; diagnostic error was mentioned only in passing.1 Very little data were available on the magnitude of harm related to diagnostic errors at that time, except for a back-of-the-napkin estimate that diagnostic error could be responsible for 40 000–80 000 in-hospital deaths annually.2 The problem finally received its due 15 years later, when the National Academy of Medicine asserted that "... most of us will experience at least one diagnostic error in our lifetime, sometimes with devastating consequences".3

In this context, the paper by Newman-Toker et al in this issue of BMJ Quality & Safety is a welcome contribution, presenting an extensively researched set of estimates that proposes that harm may be an order-of-magnitude larger.4 The paper is the third part of a larger study,...

Background

Emerging evidence has shown racial and ethnic disparities in rates of harm for hospitalised children. Previous work has also demonstrated how highly heterogeneous approaches to collection of race and ethnicity data pose challenges to population-level analyses. This work aims to both create an approach to aggregating safety data from multiple hospitals by race and ethnicity and apply the approach to the examination of potential disparities in high-frequency harm conditions.

Methods

In this cross-sectional, multicentre study, a cohort of hospitals from the Solutions for Patient Safety network with varying race and ethnicity data collection systems submitted validated central line-associated bloodstream infection (CLABSI) and unplanned extubation (UE) data stratified by patient race and ethnicity categories. Data were submitted using a crosswalk created by the study team that reconciled varying approaches to race and ethnicity data collection by participating hospitals. Harm rates for race and ethnicity categories were compared with reference values reflective of the cohort and broader children’s hospital population.

Results

Racial and ethnic disparities were identified in both harm types. Multiracial Hispanic, Combined Hispanic and Native Hawaiian or other Pacific Islander patients had CLABSI rates of 2.6–3.6 SD above reference values. For Black or African American patients, UE rates were 3.2–4.4 SD higher. Rates of both events in White patients were significantly lower than reference values.

Conclusions

The combination of harm data across hospitals with varying race and ethnicity collection systems was accomplished through iterative development of a race and ethnicity category framework. We identified racial and ethnic disparities in CLABSI and UE that can be addressed in future improvement work by identifying and modifying care delivery factors that contribute to safety disparities.

Background

In many quality improvement (QI) and other complex interventions, assessing the fidelity with which participants ‘enact’ intervention activities (ie, implement them as intended) is underexplored. Adapting the evaluative approach used in objective structured clinical examinations, we aimed to develop and validate a practical approach to assessing fidelity enactment—the Overall Fidelity Enactment Scale for Complex Interventions (OFES-CI).

Methods

We developed the OFES-CI to evaluate enactment of the SCOPE QI intervention, which teaches nursing home teams to use plan-do-study-act (PDSA) cycles. The OFES-CI was piloted and revised early in SCOPE with good inter-rater reliability, so we proceeded with a single rater. An intraclass correlation coefficient (ICC) was used to assess inter-rater reliability. For 27 SCOPE teams, we used ICC to compare two methods for assessing fidelity enactment: (1) OFES-CI ratings provided by one of five trained experts who observed structured 6 min PDSA progress presentations made at the end of SCOPE, (2) average rating of two coders’ deductive content analysis of qualitative process evaluation data collected during the final 3 months of SCOPE (our gold standard).

Results

Using Cicchetti’s classification, inter-rater reliability between two coders who derived the gold standard enactment score was ‘excellent’ (ICC=0.93, 95% CI=0.85 to 0.97). Inter-rater reliability between the OFES-CI and the gold standard was good (ICC=0.71, 95% CI=0.46 to 0.86), after removing one team where open-text comments were discrepant with the rating. Rater feedback suggests the OFES-CI has strong face validity and positive implementation qualities (acceptability, easy to use, low training requirements).

Conclusions

The OFES-CI provides a promising novel approach for assessing fidelity enactment in QI and other complex interventions. It demonstrates good reliability against our gold standard assessment approach and addresses the practicality problem in fidelity assessment by virtue of its suitable implementation qualities. Steps for adapting the OFES-CI to other complex interventions are offered.

Background

Diagnostic errors cause substantial preventable harms worldwide, but rigorous estimates for total burden are lacking. We previously estimated diagnostic error and serious harm rates for key dangerous diseases in major disease categories and validated plausible ranges using clinical experts.

Objective

We sought to estimate the annual US burden of serious misdiagnosis-related harms (permanent morbidity, mortality) by combining prior results with rigorous estimates of disease incidence.

Methods

Cross-sectional analysis of US-based nationally representative observational data. We estimated annual incident vascular events and infections from 21.5 million (M) sampled US hospital discharges (2012–2014). Annual new cancers were taken from US-based registries (2014). Years were selected for coding consistency with prior literature. Disease-specific incidences for 15 major vascular events, infections and cancers (‘Big Three’ categories) were multiplied by literature-based rates to derive diagnostic errors and serious harms. We calculated uncertainty estimates using Monte Carlo simulations. Validity checks included sensitivity analyses and comparison with prior published estimates.

Results

Annual US incidence was 6.0 M vascular events, 6.2 M infections and 1.5 M cancers. Per ‘Big Three’ dangerous disease case, weighted mean error and serious harm rates were 11.1% and 4.4%, respectively. Extrapolating to all diseases (including non-‘Big Three’ dangerous disease categories), we estimated total serious harms annually in the USA to be 795 000 (plausible range 598 000–1 023 000). Sensitivity analyses using more conservative assumptions estimated 549 000 serious harms. Results were compatible with setting-specific serious harm estimates from inpatient, emergency department and ambulatory care. The 15 dangerous diseases accounted for 50.7% of total serious harms and the top 5 (stroke, sepsis, pneumonia, venous thromboembolism and lung cancer) accounted for 38.7%.

Conclusion

An estimated 795 000 Americans become permanently disabled or die annually across care settings because dangerous diseases are misdiagnosed. Just 15 diseases account for about half of all serious harms, so the problem may be more tractable than previously imagined.