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Related Recalls - Plastic Syringes Made in China for Potential Device Failures
Ventilator Correction: Breas Medical Updates Use Instructions for Vivo 45 LS due to Potential Elevated Formaldehyde Levels in Newly Manufactured Ventilators
Continuous Glucose Monitoring (CGM) Sensor Recall: Abbott Diabetes Care Inc Issues Recall for Certain FreeStyle Libre 3 Sensors due to Risk for Inaccurate High Glucose Readings
Laryngoscope Recall: Medtronic Removes Certain McGrath MAC Video Laryngoscopes, Updates Use Instructions for Others due to Increased Risk for Battery Overheat and Explosion
Smiths Medical Issues Urgent Medical Device Notification Informing Customers of a Potential Issue with Certain Bivona® Tracheostomy Tubes
Lung Therapy Component Recall: Baxter Healthcare Corporation Recalls Certain Volara System Single-Patient Use Circuits and Blue Ventilator Adapter Assemblies Due to Disconnection Risk That May Prevent Proper Ventilation
Tandem Diabetes Care, Inc. Recalls Version 2.7 of the Apple iOS t:connect Mobile App Used in Conjunction with t:slim X2 Insulin Pump with Control-IQ Technology Prompted by a Software Problem Leading to Pump Battery Depletion
2023 Safety Communications
Voluntary Recall of SoClean Equipment Intended for Use with CPAP Devices and Accessories: FDA Safety Communication
Clot Removal Device Correction: Inari Medical Updates Use Instructions for ClotTriever XL Catheter due to Reports of Patient Injury and Death from Device Entrapment and Pulmonary Emboli
Convenience Kit Component Recall: Medline Industries, LP, Removes Convenience Kit Syringes Manufactured in China that May Be Contaminated, Break, Leak, or Otherwise Fail
Chest Compression Device Recall: Defibtech, LLC, Removes RMU-2000 ARM XR Chest Compression Device due to Risk of Device Stopping Compressions
Infusion Pump Battery Correction: ICU Medical Updates Instructions for Use Regarding Batteries in Plum 360, A+ and A+3 Infusion System due to Diminished Battery Life that May Impact Infusion Delivery
Whats in a name? On the rhetorical harm of 'never events
It has been 22 years since the introduction of ‘never event’ to the discourse surrounding patient safety. Originally coined by then-CEO of the National Quality Forum (NQF) Kenneth Kizer, MD,1 the term refers to errors so egregious that they are intolerable, and thus, should never happen.2 Although interventions and regulatory muscle have been directed at eliminating them, never events continue to occur. Against this backdrop, in this issue of BMJ Quality and Safety, Zaslow and colleagues3 argue that the power of the concept to improve patient safety is undercut because there is no standardised definition and because not all never events are preventable. They call for the development of a consensus-based universal definition and a common list of never events to promote standardisation and improve safety.
I am not optimistic that these changes will improve the usefulness of the concept of the never...
Role of knowledge and reasoning processes as predictors of resident physicians susceptibility to anchoring bias in diagnostic reasoning: a randomised controlled experiment
Diagnostic errors have been attributed to reasoning flaws caused by cognitive biases. While experiments have shown bias to cause errors, physicians of similar expertise differed in susceptibility to bias. Resisting bias is often said to depend on engaging analytical reasoning, disregarding the influence of knowledge. We examined the role of knowledge and reasoning mode, indicated by diagnosis time and confidence, as predictors of susceptibility to anchoring bias. Anchoring bias occurs when physicians stick to an incorrect diagnosis triggered by early salient distracting features (SDF) despite subsequent conflicting information.
MethodsSixty-eight internal medicine residents from two Dutch university hospitals participated in a two-phase experiment. Phase 1: assessment of knowledge of discriminating features (ie, clinical findings that discriminate between lookalike diseases) for six diseases. Phase 2 (1 week later): diagnosis of six cases of these diseases. Each case had two versions differing exclusively in the presence/absence of SDF. Each participant diagnosed three cases with SDF (SDF+) and three without (SDF–). Participants were randomly allocated to case versions. Based on phase 1 assessment, participants were split into higher knowledge or lower knowledge groups. Main outcome measurements: frequency of diagnoses associated with SDF; time to diagnose; and confidence in diagnosis.
ResultsWhile both knowledge groups performed similarly on SDF- cases, higher knowledge physicians succumbed to anchoring bias less frequently than their lower knowledge counterparts on SDF+ cases (p=0.02). Overall, physicians spent more time (p<0.001) and had lower confidence (p=0.02) on SDF+ than SDF– cases (p<0.001). However, when diagnosing SDF+ cases, the groups did not differ in time (p=0.88) nor in confidence (p=0.96).
ConclusionsPhysicians apparently adopted a more analytical reasoning approach when presented with distracting features, indicated by increased time and lower confidence, trying to combat bias. Yet, extended deliberation alone did not explain the observed performance differences between knowledge groups. Success in mitigating anchoring bias was primarily predicted by knowledge of discriminating features of diagnoses.
Patient safety in remote primary care encounters: multimethod qualitative study combining Safety I and Safety II analysis
Triage and clinical consultations increasingly occur remotely. We aimed to learn why safety incidents occur in remote encounters and how to prevent them.
Setting and sampleUK primary care. 95 safety incidents (complaints, settled indemnity claims and reports) involving remote interactions. Separately, 12 general practices followed 2021–2023.
MethodsMultimethod qualitative study. We explored causes of real safety incidents retrospectively (‘Safety I’ analysis). In a prospective longitudinal study, we used interviews and ethnographic observation to produce individual, organisational and system-level explanations for why safety and near-miss incidents (rarely) occurred and why they did not occur more often (‘Safety II’ analysis). Data were analysed thematically. An interpretive synthesis of why safety incidents occur, and why they do not occur more often, was refined following member checking with safety experts and lived experience experts.
ResultsSafety incidents were characterised by inappropriate modality, poor rapport building, inadequate information gathering, limited clinical assessment, inappropriate pathway (eg, wrong algorithm) and inadequate attention to social circumstances. These resulted in missed, inaccurate or delayed diagnoses, underestimation of severity or urgency, delayed referral, incorrect or delayed treatment, poor safety netting and inadequate follow-up. Patients with complex pre-existing conditions, cardiac or abdominal emergencies, vague or generalised symptoms, safeguarding issues, failure to respond to previous treatment or difficulty communicating seemed especially vulnerable. General practices were facing resource constraints, understaffing and high demand. Triage and care pathways were complex, hard to navigate and involved multiple staff. In this context, patient safety often depended on individual staff taking initiative, speaking up or personalising solutions.
ConclusionWhile safety incidents are extremely rare in remote primary care, deaths and serious harms have resulted. We offer suggestions for patient, staff and system-level mitigations.
Temporal structures that determine consistency and quality of care: a case study in hyperacute stroke services
Temporal structuring is determined by practices and social norms and affects the quality and timing of care. In this case study of hyperacute stroke wards which provide initial stroke investigation, treatment and care, we explored temporal structuring patterns to explain how these may affect quality of care.
MethodsThis paper presents a thematic analysis of qualitative interviews with hyperacute stroke staff (n=76), non-participant observations (n=41, ~102 hours) and documentary analysis of the relevant service standards guidance. We used an inductive coding process to generate thematic findings around the concept of temporal structuring, with graphically illustrated examples.
ResultsFive temporal structures influence what-happens-when: (1) clinical priorities and quality assurance metrics motivate rapid activity for the initial life-prolonging assessments and interventions; (2) static features of ward organisation such as rotas and ward rounds impact consistency of care, determining timing and quality of care for patients; (3) some services experimented with staff rotas to try to meet peaks in demand, sometimes unsuccessfully; (4) implicit social norms or heuristics about perceived necessity affected staff motivation to make changes or improvements to consistency of care, particularly around weekend work; and (5) after-effects such as bottlenecks or backlogs affect quality of care, which are hard to measure effectively to drive service improvement.
ConclusionsPatients need temporally consistent high quality of care. Temporal consistency stems from the design of services, including staffing, targets and patient pathway design as well as cultural attitudes to working patterns. Improvements to consistency of care will be limited without changes to structures such as rotas and ward rounds, but also social norms around weekend work for certain professional groups.
Patient and family contributions to improve the diagnostic process through the OurDX electronic health record tool: a mixed method analysis
Accurate and timely diagnosis relies on sharing perspectives among team members and avoiding information asymmetries. Patients/Families hold unique diagnostic process (DxP) information, including knowledge of diagnostic safety blindspots—information that patients/families know, but may be invisible to clinicians. To improve information sharing, we co-developed with patients/families an online tool called ‘Our Diagnosis (OurDX)’. We aimed to characterise patient/family contributions in OurDX and how they differed between individuals with and without diagnostic concerns.
MethodWe implemented OurDX in two academic organisations serving patients/families living with chronic conditions in three subspecialty clinics and one primary care clinic. Prior to each visit, patients/families were invited to contribute visit priorities, recent histories and potential diagnostic concerns. Responses were available in the electronic health record and could be incorporated by clinicians into visit notes. We randomly sampled OurDX reports with and without diagnostic concerns for chart review and used inductive and deductive qualitative analysis to assess patient/family contributions.
Results7075 (39%) OurDX reports were submitted at 18 129 paediatric subspecialty clinic visits and 460 (65%) reports were submitted among 706 eligible adult primary care visits. Qualitative analysis of OurDX reports in the chart review sample (n=450) revealed that participants contributed DxP information across 10 categories, most commonly: clinical symptoms/medical history (82%), tests/referrals (54%) and diagnosis/next steps (51%). Participants with diagnostic concerns were more likely to contribute information on DxP risks including access barriers, recent visits for the same problem, problems with tests/referrals or care coordination and communication breakdowns, some of which may represent diagnostic blindspots.
ConclusionPartnering with patients and families living with chronic conditions through OurDX may help clinicians gain a broader perspective of the DxP, including unique information to coproduce diagnostic safety.
Assessing quality of direct-to-consumer telemedicine in China: a cross-sectional study using unannounced standardised patients
Direct-to-onsumer telemedicine (DTCT) has become popular as an alternative to traditional care. However, uncertainties about the potential risks associated with the lack of comprehensive quality evaluation could influence its long-term development. This study aimed to assess the quality of care provided by DTCT platforms in China using unannounced standardised patients (USP) between July 2021 and January 2022. The study assessed consultation services on both hospital and enterprise-sponsored platforms using the Institute of Medicine quality framework. It employed 10 USP cases, covering conditions such as diabetes, asthma, common cold, gastritis, angina, low back pain, child diarrhoea, child dermatitis, stress urinary incontinence and postpartum depression. Descriptive and regression analyses were employed to examine platform characteristics and compare quality across platform types. The results showed that of 170 USP visits across 107 different telemedicine platforms, enterprise-sponsored platforms achieved a 100% success in access, while hospital-sponsored platforms had a success rate of only 47.5% (56/118). Analysis highlighted a low overall correct diagnosis rate of 45% and inadequate adherence to clinical guidelines across all platforms. Notably, enterprise-sponsored platforms outperformed in accessibility, response time and case management compared with hospital-sponsored platforms. This study highlights the suboptimal quality of DTCT platforms in China, particularly for hospital-sponsored platforms. To further enhance DTCT services, future studies should compare DTCT and in-person care, aiming to identify gaps and potential risks associated with using DTCT as alternatives or supplements to traditional care. The potential of future development in enhancing DTCT services may involve exploring the integration of hospital resources with the technology and market capabilities of enterprise-sponsored platforms.