Monoject U-100 1 ml Insulin Syringe Luer-Lock with Tip Cap Soft Pack is used for IV insulin. Certain lots are incompatible with needleless connectors.

2024 Medical Device Recalls

Use of Baxter AK 98 hemodialysis machines with less than 500 hours of run time may expose patients to higher than allowable NDL-PCBAs.

Use of Baxter MiniCap Extended Life PD Transfer Sets during peritoneal dialysis may expose patients to higher than allowable NDL-PCBAs.

FHC microTargeting Insertion Tube Sets guide instruments during neurosurgery. The reducing cannula in a specific lot is 20mm too long.

Disposable Biopsy Needle Kit is used in neurosurgery but a specific batch of kits may have microscopic stainless steel debris inside.

MXBBB is voluntarily recalling 1 lot of UMARY ACID HYALURONIC, 30 CAPLETS 850 MG to the consumer level. The products have been found to have omeprazole and diclofenac. FDA laboratory analysis confirmed that Umary contains diclofenac and omeprazole

‘Safety netting’ refers to a range of activities to manage clinical uncertainty during consultations. This can include uncertainty about diagnosis, how disease may progress or whether or not a treatment will work. It is frequently delivered along the lines of ‘come back and see me if this does not get better’, but can also include more specific advice and steps to monitor the patient through lists or codes in the patient record. The desired effect is for patients to seek medical attention again if needed and to be reassured if not. Ten years of safety netting research has established that safety netting is ubiquitous and inconsistently practised. It is invariably delivered with missing details about how quickly symptoms may resolve or reappear, and what the implication would be.1 Requests to ‘come back’ are often made without clear instructions for how and when to do so.1...

Dealing with uncertainty is an inherent part of scientific discovery. One of the ways in which scientists have tried to overcome uncertainty is through the concept of measurement—defined as the act or the process of finding the size, quantity or degree of something.1 Over centuries, standardised and consistent measurement systems have assumed fundamental importance in societies in parallel with the increasing dominance of the scientific paradigm. The 11th century proposal by Henry I of England to standardise the measurement of a yard as the distance from his nose to outstretched thumb2 may appear egotistical and humorous by modern standards. But the reader does not need to stray far outside of the scientific paradigm to appreciate the range of philosophical standpoints on the nature of measurement and the ongoing debate over the concept of measurable quantity.3 4 Examples of outcomes that cannot...

Our population is ageing and with increased age, comes more frequent presentation of people living with multiple long-term conditions (MLTCs), who are likely to experience polypharmacy and the risk that accompanies taking multiple medications. These risks disproportionately affect the most socioeconomically deprived people in our communities, including those from minority ethnic groups, among whom the incidence of MLTCs is higher1 and acquired at an earlier age.2 Polypharmacy increases the prevalence of errors relating to the medicines use process, defined as including prescribing, dispensing, administration and monitoring of medication. Estimates in England report around 237 million medication errors per annum with avoidable errors costing around £98 million each year resulting in 1700 deaths.3 In the USA, around 7 million people per year are affected by medication errors at a cost of around US$21 billion.4 While not all of these errors are clinically significant,...

Background

Safety-netting is intended to protect against harm from uncertainty in diagnosis/disease trajectory. Despite recommendations to communicate diagnostic uncertainty when safety-netting, this is not always done.

Aims

To explore how and why doctors safety-netted in response to several clinical scenarios, within the broader context of exploring how doctors communicate diagnostic uncertainty.

Methods

Doctors working in internal medical specialties (n=36) from five hospitals were given vignettes in a randomised order (all depicting different clinical scenarios involving diagnostic uncertainty). After reading each, they told an interviewer what they would tell a ‘typical patient’ in this situation. A follow-up semistructured interview explored reasons for their communication. Interviews were recorded, transcribed and coded. We examined how participants safety-netted using a content analysis approach, and why they safety-netting with thematic analysis of the semistructured follow-up interviews using thematic analysis.

Results

We observed n=78 instances of safety-netting (across 108 vignette encounters). We found significant variation in how participants safety-netted. Safety-netting was common (although not universal), but clinicians differed in the detail provided about symptoms to be alert for, and the action advised. Although many viewed safety-netting as an important tool for managing diagnostic uncertainty, diagnostic uncertainty was infrequently explicitly discussed; most advised patients to return if symptoms worsened or new ‘red flag’ symptoms developed, but they rarely linked this directly to the possibility of diagnostic error. Some participants expressed concerns that communicating diagnostic uncertainty when safety-netting may cause anxiety for patients or could drive inappropriate reattendance/over-investigation.

Conclusions

Participants safety-netted variously, even when presented with identical clinical information. Although safety-netting was seen as important in avoiding diagnostic error, concerns about worrying patients may have limited discussion about diagnostic uncertainty. Research is needed to determine whether communicating diagnostic uncertainty makes safety-netting more effective at preventing harm associated with diagnostic error, and whether it causes significant patient anxiety.

Background

Polypharmacy is frequently used as a quality indicator for older adults in Residential Aged Care Facilities (RACFs) and is measured using a range of definitions. The impact of data source choice on polypharmacy rates and the implications for monitoring and benchmarking remain unclear. We aimed to determine polypharmacy rates (≥9 concurrent medicines) by using prescribed and administered data under various scenarios, leveraging electronic data from 30 RACFs.

Method

A longitudinal cohort study of 5662 residents in New South Wales, Australia. Both prescribed and administered polypharmacy rates were calculated biweekly from January 2019 to September 2022, providing 156 assessment times. 12 different polypharmacy rates were computed separately using prescribing and administration data and incorporating different combinations of items: medicines and non-medicinal products, any medicines and regular medicines across four scenarios: no, 1-week, 2-week and 4-week look-back periods. Generalised estimating equation models were employed to identify predictors of discrepancies between prescribed and administered polypharmacy.

Results

Polypharmacy rates among residents ranged from 33.9% using data on administered regular medicines with no look-back period to 63.5% using prescribed medicines and non-medicinal products with a 4-week look-back period. At each assessment time, the differences between prescribed and administered polypharmacy rates were consistently more than 10.0%, 4.5%, 3.5% and 3.0%, respectively, with no, 1-week, 2-week and 4-week look-back periods. Diabetic residents faced over two times the likelihood of polypharmacy discrepancies compared with counterparts, while dementia residents consistently showed reduced likelihood across all analyses.

Conclusion

We found notable discrepancies between polypharmacy rates for prescribed and administered medicines. We recommend a review of the guidance for calculating and interpreting polypharmacy for national quality indicator programmes to ensure consistent measurement and meaningful reporting.

Background

The consultation process, where a clinician seeks an opinion from another clinician, is foundational in medicine. However, the effectiveness of group diagnosis has not been studied.

Objective

To compare individual diagnosis to group diagnosis on two dimensions: group size (n=3 or 6) and group process (interactive or artificial groups).

Methodology

Thirty-six internal or emergency medicine residents participated in the study. Initially, each resident worked through four written cases on their own, providing a primary diagnosis and a differential diagnosis. Next, participants formed into groups of three. Using a videoconferencing platform, they worked through four additional cases, collectively providing a single primary diagnosis and differential diagnosis. The process was repeated using a group of six with four new cases. Cases were all counterbalanced. Retrospectively, nominal (ie, artificial) groups were formed by aggregating individual participant data into subgroups of three and six and analytically computing scores. Presence of the correct diagnosis as primary diagnosis or included in the differential diagnosis, as well as the number of diagnoses mentioned, was calculated for all conditions. Means were compared using analysis of variance.

Results

For both authentic and nominal groups, the diagnostic accuracy of group diagnosis was superior to individual for both the primary diagnosis and differential diagnosis. However, there was no improvement in diagnostic accuracy when comparing a group of three to a group of six. Interactive and nominal groups were equivalent; however, this may be an artefact of the method used to combine data.

Conclusions

Group diagnosis improves diagnostic accuracy. However, a larger group is not necessarily superior to a smaller group. In this study, interactive group discussion does not result in improved diagnostic accuracy.

Background

Therapeutic relationships are a key domain in healthcare delivery. While well-understood in in-person interventions, how therapeutic relationships develop in more complex contexts is unclear. This study aimed to understand (1) how therapeutic relationships are developed during the telehealth delivery of a group-based, complex intervention and (2) the perceived impact of these relationships on intervention processes, such as intervention delivery and engagement, and patient outcomes, such as patient safety and satisfaction.

Methods

This qualitative study, nested within a randomised controlled trial, used an interpretivist approach to explore the perceptions of 25 participants (18 patients with shoulder pain and 7 clinicians) regarding developing therapeutic relationships in a group-based, complex intervention delivered via telehealth. Semi-structured interviews were conducted within 4 weeks of the telehealth intervention period and then analysed through in-depth, inductive thematic analysis.

Results

We identified six themes: (1) ‘Patients trust clinicians who demonstrate credibility, promoting the development of therapeutic relationships’; (2) ‘Simple features and approaches shape the therapeutic relationship’, including small talk, time spent together and social observation; (3) ‘A sense of belonging and support fosters connections’, facilitated by clinicians providing individualised attention within the group; (4) ‘Developing therapeutic relationships can impact the delivery of core intervention components’, reflecting challenges clinicians faced; (5) ‘Therapeutic relationships can facilitate intervention engagement’, through enhanced patient understanding and confidence and (6) ‘Therapeutic relationships can contribute to patient safety and satisfaction’, with patients feeling more comfortable reporting intervention-related issues.

Conclusions

Therapeutic relationships were developed during group-based telehealth sessions through a set of factors that may require additional skills and effort compared with in-person interactions. While these relationships have a perceived positive impact on intervention engagement and patient outcomes, clinicians need to find a balance between building relationships and delivering the telehealth intervention with fidelity.

Trial registration number

ACTRN12621001650886.

Introduction

Pharmacist-led medication reviews are an established intervention to support patients prescribed multiple medicines or with complex medication regimes. For this systematic review, a medication review was defined as ‘a consultation between a pharmacist and a patient to review the patient’s total medicines use with a view to improve patient health outcomes and minimise medicines-related problems’. It is not known how varying approaches to medication reviews lead to different outcomes.

Aim

To explore the common themes associated with positive outcomes from pharmacist-led medication reviews.

Method

Randomised controlled trials of pharmacist-led medication reviews in adults aged 18 years and over were included. The search terms used in MEDLINE, EMBASE and Web of Science databases were "medication review", "pharmacist", "randomised controlled trial" and their synonyms, time filter 2015 to September 2023. Studies published before 2015 were identified from a previous systematic review. Risk of bias was assessed using the Cochrane risk of bias 2 tool. Descriptions of medication reviews’ components, implementation and outcomes were narratively synthesised to draw out common themes. Results are presented in tables.

Results

Sixty-eight papers describing 50 studies met the inclusion criteria. Common themes that emerged from synthesis include collaborative working which may help reduce medicines-related problems and the number of medicines prescribed; patient involvement in goal setting and action planning which may improve patients’ ability to take medicines as prescribed and help them achieve their treatment goals; additional support and follow-up, which may lead to improved blood pressure, diabetes control, quality of life and a reduction of medicines-related problems.

Conclusion

This systematic review identified common themes and components, for example, goal setting, action planning, additional support and follow-up, that may influence outcomes of pharmacist-led medication reviews. Researchers, health professionals and commissioners could use these for a comprehensive evaluation of medication review implementation.

PROSPERO registration number

CRD42020173907.

Diagnostic error: the problem

Failures in the diagnostic process are thought to affect at least 15% of patient encounters, cause 34% of adverse events in hospitals, are a leading cause in major malpractice claims and payouts and are recognised as a top priority in patient safety research.1–3 The National Academies of Science, Engineering and Medicine defines diagnostic error as a failure to establish an accurate and timely explanation of a patient’s medical problem and has been shown to contribute to the morbidity and mortality of an estimated 795 000 patients each year in the USA.1 Although diagnostic error has received significant research attention across multiple clinical settings over the last several decades, it continues to pose consequential challenges and requires improvement in systematic investigation and operational intervention.3 4 Additionally, few effective mitigation strategies have been designed for...

Endo USA, Inc. is expanding its previously announced voluntary recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) due to potential product carton strength mislabeling.

A manufacturing error to the Atlan A350, A350 XL anesthesia workstations may cause mechanical ventilation to stop.

Inline nebulizers in certain configutations on Trilogy Evo continuous ventilators may lead to inaccurate flow measurements which may cause patient injury.

Battery casing damage on CADD-Solis battery packs, which provide alternate power to infusion pumps, may cause a circuit short and prevent recharging.