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Early Alert: Insulin Pump Issue from Insulet
Early Alert: Surgical Stapler Issue from Intuitive Surgical
Dialysis Tubing Set Correction: Vantive Updates Use Instructions for Prismaflex and Oxiris Sets
Convenience Kit Needle Recall: Integra LifeSciences Removes Tuohy Needle
Insulet Initiates Voluntary Medical Device Correction for Certain Omnipod® 5 Pods in the U.S.
Early Alert: Flexible Cryoprobe Issue from Erbe USA
Wound and Burn Dressing Recall: Integra LifeSciences Removes Certain MediHoney and CVS Wound and Burn Products
Catheter Recall: Medline Industries Removes Reprocessed Electrophysiology and Ultrasound Catheters
Catheter Recall Expansion: Medline Industries Removes Reprocessed Electrophysiology and Ultrasound Catheters
Update: FDA Encourages the Public to Follow Established Choking Rescue Protocols - FDA Safety Communication
Stent Recall: Boston Scientific Removes Certain AXIOS Stents and Electrocautery-Enhanced Delivery Systems
Infusion Pump Software Correction: Fresenius Kabi Issues Correction for Ivenix Large Volume Pump Software
Early Alert: Heart Pump Purge Cassette Issue from Abiomed
Insufflation Unit Recall: Olympus Removes High Flow Insufflation Units
Translation without substitution: the need for responsible AI integration in patient instructions
Language barriers between healthcare professionals and their patients remain a persistent challenge. Patients with limited proficiency in the primary language of the country where they receive care face higher risks of adverse events, misdiagnosis and unplanned readmissions.1 2 In linguistically diverse countries, services often fall short of meeting the needs of patients who speak minority languages. This leads to inequities in care across inpatient, outpatient and emergency settings. While concern for language discordance in healthcare is by no means a novel development, guidelines have rarely progressed beyond recommending implementation of professional interpreter services.3 In-person interpretation is generally considered the gold standard for addressing language barriers during direct care delivery4 5 and is in line with regulatory and ethical standards.6 Other modalities of interpretation, including telephone and video, are alternative options, although the feasibility of providing timely written...
Evaluation of the accuracy and safety of machine translation of patient-specific discharge instructions: a comparative analysis
Machine translation of patient-specific information could mitigate language barriers if sufficiently accurate and non-harmful and may be particularly useful in healthcare encounters when professional translators are not readily available. We evaluated the translation accuracy and potential for harm of ChatGPT-4 and Google Translate in translating from English to Spanish, Chinese and Russian.
MethodsWe used ChatGPT-4 and Google Translate to translate 50 sets (316 sentences) of deidentified, patient-specific, clinician free-text emergency department instructions into Spanish, Chinese and Russian. These were then back-translated into English by professional translators and double-coded by physicians for accuracy and potential for clinical harm.
ResultsAt the sentence level, we found that both tools were ≥90% accurate in translating English to Spanish (accuracy: GPT 97%, Google Translate 96%) and English to Chinese (accuracy: GPT 95%; Google Translate 90%); neither tool performed as well in translating English to Russian (accuracy: GPT 89%; Google Translate 80%). At the instruction set level, 16%, 24% and 56% of Spanish, Chinese and Russian GPT-translated instruction sets contained at least one inaccuracy. For Google Translate, 24%, 56% and 66% of Spanish, Chinese and Russian translations contained at least one inaccuracy. The potential for harm due to inaccurate translations was ≤1% for both tools in all languages at the sentence level and ≤6% at the instruction set level. GPT was significantly more accurate than Google Translate in Chinese and Russian at the sentence level; the potential for harm was similar.
ConclusionThese results support the potential of machine translation tools to mitigate gaps in translation services for low-stakes written communication from English to Spanish, while also strengthening the case for caution and for professional oversight in non-low-risk communication. Further research is needed to evaluate machine translation for other languages and more technical content.
Investigators are human too: outcome bias and perceptions of individual culpability in patient safety incident investigations
Healthcare patient safety investigations inappropriately focus on individual culpability and the target of recommendations is often on the behaviours of individuals, rather than addressing latent failures of the system. The aim of this study was to explore whether outcome bias might provide some explanation for this. Outcome bias occurs when the ultimate outcome of a past event is given excessive weight, in comparison to other information, when judging the preceding actions or decisions.
MethodsWe conducted a survey in which participants were each presented with three incident scenarios, followed by the findings of an investigation. The scenarios remained the same, but the patient outcome was manipulated. Participants were recruited via social media and we examined three groups (general public, healthcare staff and experts) and those with previous incident involvement. Participants were asked about staff responsibility, avoidability, importance of investigating and to select up to five recommendations to prevent recurrence. Summary statistics and multilevel modelling were used to examine the association between patient outcome and the above measures.
Results212 participants completed the online survey. Worsening patient outcome was associated with increased judgements of staff responsibility for causing the incident as well as greater motivation to investigate. More participants selected punitive recommendations when patient outcome was worse. While avoidability did not appear to be associated with patient outcome, ratings were high suggesting participants always considered incidents to be highly avoidable. Those with patient safety expertise demonstrated these associations but to a lesser extent, when compared with other participants. We discuss important comparisons between the participant groups as well as those with previous incident involvement, as victim or staff member.
InterpretationOutcome bias has a significant impact on judgements following incidents and investigations and may contribute to the continued focus on individual culpability and individual focused recommendations observed following investigations.
Understanding patient safety during earthquakes: a phenomenological study of disaster response
Natural hazards, such as earthquakes, pose a significant risk to both the public and healthcare professionals, jeopardising patient safety due to the disruption of healthcare systems and services. This study aimed to explore the lived experiences of healthcare professionals concerning patient safety during natural hazards, specifically earthquakes.
MethodsEmploying a descriptive phenomenological approach, the study followed the Consolidated Criteria for Reporting Qualitative Research guidelines. 23 participants, including doctors, nurses and paramedics, were interviewed using purposive sampling. Data were gathered through semistructured interviews, which were audio recorded and transcribed. Ethical approval was obtained, and Colaizzi’s method was used for data analysis, with findings validated through researcher consensus and participant feedback.
ResultsNine overarching themes emerged, such as the emotional toll of communication breakdowns, struggles with patient identification, stress due to resource scarcity, operational chaos, ethical dilemmas and psychological impacts on both patients and staff. The study found that these factors collectively influenced patient safety during the earthquake.
ConclusionThe emotional strain caused by communication failures, patient identification issues and resource shortages compounded the challenges of providing safe care during the earthquake. Strengthening disaster preparedness through improved communication systems, resource management, psychological support, interagency coordination and regular realistic disaster drills is essential for safeguarding patient safety in future disasters.
Patient portal messaging to address delayed follow-up for uncontrolled diabetes: a pragmatic, randomised clinical trial
Patients with poor glycaemic control have a high risk for major cardiovascular events. Improving glycaemic monitoring in patients with diabetes can improve morbidity and mortality.
ObjectiveTo assess the effectiveness of a patient portal message in prompting patients with poorly controlled diabetes without a recent glycated haemoglobin (HbA1c) result to have their HbA1c repeated.
DesignA pragmatic, randomised clinical trial.
SettingA large academic health system consisting of over 350 ambulatory practices.
ParticipantsPatients who had an HbA1c greater than 10% who had not had a repeat HbA1c in the prior 6 months.
ExposuresA single electronic health record (EHR)-based patient portal message to prompt patients to have a repeat HbA1c test versus usual care.
Main outcomesThe primary outcome was a follow-up HbA1c test result within 90 days of randomisation.
ResultsThe study included 2573 patients with a mean (SD) HbA1c of 11.2%. Among 1317 patients in the intervention group, 24.2% had follow-up HbA1c tests completed within 90 days, versus 21.1% of 1256 patients in the control group (p=0.07). Patients in the intervention group were more likely to log into the patient portal within 60 days as compared with the control group (61.2% vs 52.3%, p<0.001).
ConclusionsAmong patients with poorly controlled diabetes and no recent HbA1c result, a brief patient portal message did not significantly increase follow-up testing but did increase patient engagement with the patient portal. Automated patient messages could be considered as a part of multipronged efforts to involve patients in their diabetes care.
