Resource Page
Arterial Catheter Recall: Medline Industries, LP, Removes Integrated Arterial Catheters due to Excess Material at Catheter Hub that May Detach
Early Alert: Atherectomy Catheter System Issue from Bard Peripheral Vascular
Oxygen Concentrator Recall: JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD Removes JMC5A Ni/TruAire-5 Oxygen Concentrator due to the devices spontaneously catching fire
FDA Alerts Patients to Regularly Check Diabetes-Related Smartphone Device Alert Settings, Especially Following Phone Hardware or Software Changes
Continuous Ventilator Correction: Baxter Healthcare Corporation Issues Correction for Life2000 Ventilator due to a nonconforming battery charger, which triggers a battery alarm and renders the ventilator inoperable
Pressure Monitoring Device Recall: Medtronic Neurosurgery Issues Correction for Becker and Exacta External Drainage and Monitoring Systems Due to Cracks And/Or Leaks in Stopcocks
Alvogen Issues Voluntary Nationwide Recall for One Lot of Fentanyl Transdermal System 25 mcg/h Due to a Defective Delivery System
Update on Alert: Extracorporeal Blood Circuit Issue from Nuwellis
Update on Alert: Fluid Delivery Set Issue from Medline
Update on Alert: Nephroscope Sheath Issue from Trokamed GmbH
Gas Powered Emergency Resuscitator Recall: Mercury Medical Removes Neo-Tee T-Piece Resuscitator Due to An Undersized Spring in The Controller That May Prevent the Device from Delivering the Required Pressure Levels Needed for Effective Ventilation
Update on Alert: Infusion Pump Issue from Fresenius Kabi USA
Update on Alert: Endoscope Accessories Forceps/Irrigation Plug Issue from Olympus
Olympus Issues Medical Device Advisory Notice to Use Alternative Devices to the MAJ-891 Forceps/Irrigation Plug
Glucose and Glucose/Ketone Meter Correction: Nova Biomedical Corporation Issues Software Correction for StatStrip Glucose and Glucose/Ketone Hospital Meters Due to Risk for Transmission of Incorrect Patient Results
Cybersecurity Vulnerabilities with Certain Patient Monitors from Contec and Epsimed: FDA Safety Communication
Understanding the challenges and successes of implementing 'hybrid interventions in healthcare settings: findings from a process evaluation of a patient involvement trial
‘Hybrid’ interventions in which some intervention components are fixed across sites and others are flexible (locally created) are thought to allow for adaptation to the local context while maintaining fidelity. However, there is little evidence regarding the challenges and facilitators of implementing hybrid interventions. This paper reports on a process evaluation of a patient safety hybrid intervention called Your Care Needs You (YCNY). YCNY was tested in the Partners at Care Transitions (PACT) randomised controlled trial and aimed to enhance older patients and their families’ involvement in their care in order to achieve safer transitions from hospital to home.
MethodsThe process evaluation took place across eight intervention wards taking part in the PACT trial. 23 interviews and 37 informal conversations were conducted with National Health Service (NHS) staff. Patients (n=19) were interviewed twice, once in hospital and once after discharge. Interviews with staff and patients concerned the delivery and experiences of YCNY. Ethnographic observations (n=81 hours) of relevant activities (eg, multidisciplinary team meetings, handovers, etc) were undertaken.
ResultsThe main finding relates to how staff understood and engaged with YCNY, which then had a major influence on its implementation. While staff broadly valued the aims of YCNY, staff from seven out of the eight wards taking part in the process evaluation enacted YCNY in a mostly task-based manner. YCNY implementation often became a hurried activity which concentrated on delivering fixed intervention components rather than a catalyst for culture change around patient involvement. Factors such as understaffing, constraints on staff time and the COVID-19 pandemic contributed towards a ‘taskification’ of intervention delivery, which meant staff often did not have capacity to creatively devise flexible intervention components. However, one ward with a sense of distributed ownership of YCNY had considerable success implementing flexible components.
DiscussionHybrid interventions may allow aspects of an intervention to be adapted to the local context. However, the current constrained and pressured environment of the NHS left staff with little ability to creatively engage with devising flexible intervention components, despite recognising the need for and being motivated to deliver the intervention.
Artificial intelligence-powered chatbots in search engines: a cross-sectional study on the quality and risks of drug information for patients
Search engines often serve as a primary resource for patients to obtain drug information. However, the search engine market is rapidly changing due to the introduction of artificial intelligence (AI)-powered chatbots. The consequences for medication safety when patients interact with chatbots remain largely unexplored.
ObjectiveTo explore the quality and potential safety concerns of answers provided by an AI-powered chatbot integrated within a search engine.
MethodologyBing copilot was queried on 10 frequently asked patient questions regarding the 50 most prescribed drugs in the US outpatient market. Patient questions covered drug indications, mechanisms of action, instructions for use, adverse drug reactions and contraindications. Readability of chatbot answers was assessed using the Flesch Reading Ease Score. Completeness and accuracy were evaluated based on corresponding patient drug information in the pharmaceutical encyclopaedia drugs.com. On a preselected subset of inaccurate chatbot answers, healthcare professionals evaluated likelihood and extent of possible harm if patients follow the chatbot’s given recommendations.
ResultsOf 500 generated chatbot answers, overall readability implied that responses were difficult to read according to the Flesch Reading Ease Score. Overall median completeness and accuracy of chatbot answers were 100.0% (IQR 50.0–100.0%) and 100.0% (IQR 88.1–100.0%), respectively. Of the subset of 20 chatbot answers, experts found 66% (95% CI 50% to 85%) to be potentially harmful. 42% (95% CI 25% to 60%) of these 20 chatbot answers were found to potentially cause moderate to mild harm, and 22% (95% CI 10% to 40%) to cause severe harm or even death if patients follow the chatbot’s advice.
ConclusionsAI-powered chatbots are capable of providing overall complete and accurate patient drug information. Yet, experts deemed a considerable number of answers incorrect or potentially harmful. Furthermore, complexity of chatbot answers may limit patient understanding. Hence, healthcare professionals should be cautious in recommending AI-powered search engines until more precise and reliable alternatives are available.
Role of remediation in cases of serious misconduct before UK healthcare regulators: a qualitative study
The raison d’etre of healthcare profession regulators across the globe is to protect patients and the public from the risk of harm. In cases of serious misconduct, remediation is deemed to be an important factor when considering the risk of harm from a practitioner under investigation. Yet, we know very little about how regulators account for remediation in their decision-making, and whether it is consistent with the aim of risk reduction. This paper explores the role of remediation in decision-making in cases of serious misconduct before UK healthcare regulators.
MethodsWe conducted interviews with 21 participants from across eight of the nine UK healthcare profession regulators, covering a range of roles in the decision-making process in misconduct cases. Interviews were conducted remotely by video call and digitally transcribed. Data were analysed using the framework analysis method. The initial framework was developed from existing literature and guidance documents from the regulators, and was subsequently refined through the various rounds of coding.
ResultsRemediation influenced decision-making in three ways: (1) Some types of misconduct were deemed more inherently remediable than others. In cases involving dishonesty or sexual misconduct, remediation was less likely to serve as a mitigating factor. (2) Decision-makers often view remediation as a proxy indicator of practitioner insight. (3) Whether a practitioner had demonstrated their commitment to change through undergoing remediation was more likely to feed into decision-making at the point where current impairment was under consideration.
ConclusionsRemediation plays a key role in decision-makers’ judgements in cases of misconduct, particularly when these cases relate to clinical misconduct. In such cases, remediation informs judgements on the levels of practitioner insight and the risk of such misconduct being repeated. Our results suggest a need to develop remediation interventions that are explicitly geared towards the regulatory function of developing practitioner insight. Regulators should also consider the structure of their fitness to practise processes and whether there are appropriate opportunities for judgements on remediation to feed into decisions and to facilitate balanced and proportionate outcomes.
Pages
