The capabilities of artificial intelligence (AI) have accelerated over the past year, and they are beginning to impact healthcare in a significant way. Could this new technology help address issues that have been difficult and recalcitrant problems for quality and safety for decades? While we are early in the journey, it is clear that we are in the midst of a fundamental shift in AI capabilities. It is also clear these capabilities have direct applicability to healthcare and to improving quality and patient safety, even as they introduce new complexities and risks. Previously, AI focused on one task at a time: for example, telling whether a picture was of a cat or a dog, or whether a retinal photograph showed diabetic retinopathy or not. Foundation models (and their close relatives, generative AI and large language models) represent an important change: they are able to handle many different kinds of problems without additional datasets or training. This review serves as a primer on foundation models’ underpinnings, upsides, risks and unknowns—and how these new capabilities may help improve healthcare quality and patient safety.

To date, most safety and quality improvement efforts to mitigate harm have focused on the single diagnosis for which the patient was admitted to the hospital. Most often, the objective has been to ensure patients receive the appropriate evidence-based therapies for their diagnosis using guidelines, checklists, learning from defect tools1 or other interventions. However, people often have multiple morbidities and the interactions between them may increase their risk of harm when hospitalised.

Approximately half of all Americans have a chronic disease.2 In addition, an estimated 100 million disability-adjusted life years were added between 2000 and 2019 from a global rise in diabetes, ischaemic heart disease and several other non-communicable diseases.3 However, healthcare has paid less attention to mitigating significant risks of harm from the chronic diseases or disabilities patients have when admitted for another health reason. For example, 63% of hospitalised patients with Parkinson’s...

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, voluntarily issued a field action starting on July 31, 2024, notifying global customers of its MiniMed™ 600 series or 700 series insulin pumps to follow their pump’s built-in alerts and alarms for battery status and to contact Medt

These vascular embolization devices’ instructions for use have been updated by Boston Scientific.

MiniMed pumps deliver insulin to people with diabetes who need it. Wiring damage from impacts may cause the battery to drain faster than expected.

10/8/24 – National City, CA, C&A Naturistics is voluntarily recalling all lots of AK Forte, 400 mg tablets, to the consumer level. FDA analysis has found the product to be tainted Diclofenac, Dexamethasone, and Methocarbamol. Products containing diclofenac, dexamethasone, and methocarbamol cannot b

Bennet, NE, STASKA PHARMACEUTICALS, INC. is voluntarily recalling 1 lot of Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL, 50mL vials to the user level. This is due to the presence of glass particulates in one lot of vials used in the production of this batch.

The FDA issues alert about risk of false results with Cue Health’s COVID-19 Tests due to modifications made without FDA authorization that have a strong likelihood to impact performance.

Zyno Medical Z-800 infusion pumps allow for infusions through the blood vessels but a software defect may allow air bubbles to enter the patient.

The use of in-line nebulizers placed in certain locations may lead to aerosol deposits forming over time on the ventilator flow sensor. Should this occur, there is a possibility of inaccurate flow measurements affecting therapy.

Neo-Tee Resuscitators are used for emergency breathing support for neonates and infants. The inline controller may come apart and impact ventilation.

IPV Phasitron 5 In-Line Valve helps provide therapy to promote ventilation. Users need to remove the expiratory port plug before direct ventilation.

Trilogy Evo, EV300, EvoO2 and Evo Universal ventilators support patient breathing. A mandatory software correction was issued to address previously reported issues.

Ivenix LVP allows for controlled administration of large volumes of fluids but software anomalies may lead to delay or underdosing of therapy.

paraPAC Plus P300 and P310 Ventilators are gas-powered emergency and transport portable ventilators. The tidal volume knob may move out of the set position.

Automated Compounding Device Inlets used with Exactamix Compounding Devices may contain particulate matter that poses a risk to patients.

Foster City, Calif., September 20, 2024 - Gilead Sciences, Inc. (Nasdaq: GILD) today announced it is issuing a voluntary recall of one lot of Veklury® (remdesivir) for Injection 100 mg/vial, to the consumer level. Gilead received a customer complaint and confirmed the presence of a glass particle in

paraPAC Plus P300 and P310 are emergency and transport portable ventilators. The patient outlet connector may be loose or detached, impacting ventilation.

Medications continue to represent a major cause of harm, both in inpatients and outpatients and in adults and children. In a recent large study, medications were the leading cause of harm in inpatient adults, and the same was true for adult outpatients.1 2 Medications were also the most frequent cause of harm in a large paediatric inpatient study.3 Despite these and other data, the magnitude of this issue has been systematically underestimated by healthcare organisations.

The main reason for this is that operational estimates of both medication harm and error rates have relied on spontaneous reporting, which is ineffective in this instance. We found in a study published 30 years ago that spontaneous reporting only finds about 1 in 20 harmful drug events.4 It almost certainly finds an even lower proportion of the total number of medication errors.5 But...

In this issue of the journal, Wegwarth et al report on a study that sought to identify general practitioner (GP) characteristics that predicted prescribing of potentially hazardous medications or, as the authors put it, ‘too much medicine’.1 An online survey of 304 English GPs measured their risk literacy, conflicts of interest, and perceived benefit-to-harm ratio in low-value prescribing scenarios. National Health Service record data were used to derive prescribing volumes for the participating GPs for antibiotics, opioids, gabapentin and benzodiazepines. The range of risk literacy scores was dichotomised and those GPs with low risk literacy were found to prescribe more opioids, gabapentin and benzodiazepines than GPs with high risk literacy—although no difference was found for antibiotics. The other two independent variables—conflicts of interest and benefit/harm perceptions—were not associated with prescribing volumes.

The risk literacy questions in the survey gauged GPs’ ability to interpret clinical trial results with...