Dewei Medical Equipment is recalling DNA/RNA Preservation Kits because they were distributed to U.S. customers without FDA authorization, clearance, or approval.

Dr. Kedar Mate, President and CEO of the Institute for Healthcare Improvement (IHI), kicked-off the IHI Forum 2022 today by calling for collective action to address health equity. He urged the audience of health and health care professionals to change the narrative around inequities, “to understand them not as inevitabilities, but as things that we can, in fact, improve. Inequity in American health care is not our destiny, equity is.”

New labeling for AFX2 Endovascular AAA System (AFX2) includes information to better inform patients and health care providers of the risk of Type III endoleaks

Do not routinely use AFX2 endovascular grafts for patients with abdominal aortic aneurysms.

The FDA posts letters to health care providers about the safe use of medical devices.

The FDA is issuing this update to inform the health care community of the final PAS results and updated labeling for the Impella RP System by Abiomed.

The FDA is updating information about Getinge’s Maquet/Datascope IABP devices including information about three voluntary recalls.

The FDA is alerting health care facilities and providers of a shortage of Getinge Maquet/Datascope Intra-Aortic Balloon Pump (IABP) devices, including limited supplies of IAB catheters, new Cardiosave IABPs, and Cardiosave IABP parts.

Lenoir, North Carolina. Exela Pharma Sciences, LLC, (Exela) is expanding their recall, adding fourteen (14) lots to the ongoing voluntary recall of forty-nine (49) lots of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial, 20-count carton. A total of 63 lots are now being recalled to the c

The WatchCare IMS includes hospital beds and disposable incontinence pads. Radiofrequency emissions from the system may interfere with other medical devices.

FDA is investigating the risk of severe hypocalcemia with serious outcomes, including hospitalization and death, in patients with advanced kidney disease on dialysis treated with the osteoporosis medicine Prolia (denosumab).

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.

Over 20 years ago, in its enduringly impactful report To Err is Human, the US Institute of Medicine (IOM) claimed that healthcare is not unique among high-risk, high-reliability industries, pointing out that it too is concerned with learning how to prevent, detect, recover and learn from mistakes and accidents.1 That observation was based on research conducted by an interdisciplinary group at the University of California at Berkeley who were ‘curious about the seemingly theory-defying ability of some organizations to avoid catastrophic operational outcomes despite operating technologies that were fraught with exceptionally high levels of risk, uncertainty, hazard, and public intolerance of failures’.2 Although functionally different, these ‘high reliability organizations’ (HROs) achieved exceptionally high and sustained levels of performance as a consequence of deliberate, ongoing, organisational efforts characterised by the five principles of: preoccupation with failure, reluctance to simplify interpretations, sensitivity to operations, commitment to resilience...

Globally, societies are ageing, and elderly patients take many drugs. As such, medication safety has long been a major issue in long-term care. This group of patients has substantial comorbidity and typically takes many medications, some of which are poorly tolerated in the elderly.1 This population also frequently suffers from memory impairment, and often cannot advocate for themselves effectively. Behavioural issues are frequent, and overuse of psychoactive drugs is common. In addition, electronic health record use is not as widespread as in acute care or ambulatory settings. The net impact is that many patients suffer adverse drug events (ADEs) in long-term care, and these events can cause major morbidity lasting weeks or months, yet at the same time be harder to detect than in other populations.2 Most of the published studies in this area have come from Western countries such as the USA and UK,...

Person-centred care is considered essential to clinical practice by regulatory and professional bodies around the world. For example, in the UK, the General Medical Council, General Pharmaceutical Council, Care Quality Commission and National Institute for Health and Care Excellence strongly advocate for it. The paper by Thevelin and colleagues1, in this edition of BMJ Quality & Safety, offers us the opportunity to reflect on medication review from the perspectives of both patients and healthcare professionals. In addition, it challenges us to consider how we can do better for our patients using a patient-centred approach through making shared decisions about changes to their medicines.

The OPERAM trial2 evaluated the impact of a complex intervention of medication review with shared decision making on drug-related readmissions for older people with multi-morbidity and polypharmacy (>5 medicines) who were inpatients in four European countries (Belgium, Ireland, Switzerland and The Netherlands)....

In this month’s edition, Mandel and Cady draw on organisational change theories to argue that quality improvement (QI), as currently deployed, is self-limiting.1 In other words, if left untamed it will fail to produce valuable change and may have a raft of negative consequences, including stress, reduced engagement and burnout among healthcare staff. While acknowledging that some improvement methods (eg, appreciative inquiry, positive deviance) do address the emotional experience of staff as well as their performance, and focus on socio-behavioural (teamwork, cultures, etc) as well as process-technical design elements, Mandel and Cady call for these to be explicit elements of all healthcare QI initiatives.

We argue here that this article represents a theoretical framing for messages that ring loud throughout the QI and safety literature. These linked messages are (1) additive change means asking staff to do more and more, potentially creating safety clutter, and (2) improvement...

Total quality management activities have produced undeniable positive results. However, I predict that the way these activities are implemented will lead to the programs becoming self-limiting...seeds for the deterioration of total quality management lie in the very practices that today produce successful outcomes. (Chris Argyris, professor of organizational behavior, Harvard Business School)1

Introduction

Argyris’s contention above begs the question: Is quality improvement as a primary approach to change in healthcare potentially self-limiting? Our viewpoint is yes, particularly when fundamental underpinnings and mental models are not continually surfaced and challenged.1 2 We propose two imbalances underlie why quality improvement as a primary approach to change in healthcare can become self-limiting: prioritising performance (improving organisational-level quality measures) over participants’ (improvement leaders, facilitators, team members) emotional experience, and privileging process-technical over sociobehavioural design elements.3 Contributing to these imbalances are performance-driven cultures (eg,...

Background

Healthcare leaders look to high-reliability organisations (HROs) for strategies to improve safety, despite questions about how to translate these strategies into practice. Weick and Sutcliffe describe five principles exhibited by HROs. Interventions aiming to foster these principles are common in healthcare; however, there have been few examinations of the perceptions of those who have planned or experienced these efforts.

Objective

This single-site qualitative study explores how healthcare professionals understand and enact the HRO principles in response to an HRO-inspired hospital-wide safety programme.

Methods

We interviewed 71 participants representing hospital executives, programme leadership, and staff and physicians from three clinical services. We observed and collected data from unit and hospital-wide quality and safety meetings and activities. We used thematic analysis to code and analyse the data.

Results

Participants reported enactment of the HRO principles ‘preoccupation with failure’, ‘reluctance to simplify interpretations’ and ‘sensitivity to operations’, and described the programme as adding legitimacy, training, and support. However, the programme was more often targeted at, and taken up by, nurses compared with other groups. Participants were less able to identify interventions that supported the HRO principles ‘commitment to resilience’ and ‘deference to expertise’ and reported limited examples of changes in practices related to these principles. Moreover, we identified inconsistent, and even conflicting, understanding of concepts related to the HRO principles, often related to social and professional norms and practices. Finally, an individualised rather than systemic approach hindered collective actions underlying high reliability.

Conclusion

Our findings demonstrate that the safety programme supported some HRO principles more than others, and was targeted at, and perceived differently across professional groups leading to inconsistent understanding and enactments of the principles across the organisation. Combining HRO-inspired interventions with more targeted attention to each of the HRO principles could produce greater, more consistent high-reliability practices.

Background

Worldwide, the emergence of super-ageing societies has increased the number of older people requiring support for daily activities. Many elderly residents of nursing homes (NHs) take drugs to treat chronic conditions; however, there are few reports of medication safety in NHs, especially from non-western countries.

Objective

We examined the incidence and nature of adverse drug events (ADEs) and medication errors (MEs) in NHs for the elderly in Japan.

Design, setting, and participants

The Japan Adverse Drug Events Study for NHs is a prospective cohort study that was conducted among all residents, except for short-term admissions, at four NHs for older people in Japan for 1 year.

Measurements

Trained physicians and psychologists, five and six in number, respectively, reviewed all charts of the residents to identify suspected ADEs and MEs, which were then classified by the physicians into ADEs, potential ADEs and other MEs after the exclusion of ineligible events, for the assessment of their severity and preventability. The kappa score for presence of an ADE and preventability were 0.89 and 0.79, respectively.

Results

We enrolled 459 residents, and this yielded 3315 resident-months of observation time. We identified 1207 ADEs and 600 MEs (incidence: 36.4 and 18.1 per 100 resident-months, respectively) during the study period. About one-third of ADEs were preventable, and MEs were most frequently observed in the monitoring stage (72%, 433/600), with 71% of the MEs occurring due to inadequate observation following the physician’s prescription.

Conclusion

In Japan, ADEs and MEs are common among elderly residents of NHs. The assessment and appropriate adjustment of medication preadmission and postadmission to NHs are needed to improve medication safety, especially when a single physician is responsible for prescribing most medications for the residents, as is usually the case in Japan.