Background

Problems in intrapartum electronic fetal monitoring with cardiotocography (CTG) remain a major area of preventable harm. Poor understanding of the range of influences on safety may have hindered improvement. Taking an interdisciplinary perspective, we sought to characterise the everyday practice of CTG monitoring and the work systems within which it takes place, with the goal of identifying potential sources of risk.

Methods

Human factors/ergonomics (HF/E) experts and social scientists conducted 325 hours of observations and 23 interviews in three maternity units in the UK, focusing on how CTG tasks were undertaken, the influences on this work and the cultural and organisational features of work settings. HF/E analysis was based on the Systems Engineering Initiative for Patient Safety 2.0 model. Social science analysis was based on the constant comparative method.

Results

CTG monitoring can be understood as a complex sociotechnical activity, with tasks, people, tools and technology, and organisational and external factors all combining to affect safety. Fetal heart rate patterns need to be recorded and interpreted correctly. Systems are also required for seeking the opinions of others, determining whether the situation warrants concern, escalating concerns and mobilising response. These processes may be inadequately designed or function suboptimally, and may be further complicated by staffing issues, equipment and ergonomics issues, and competing and frequently changing clinical guidelines. Practice may also be affected by variable standards and workflows, variations in clinical competence, teamwork and situation awareness, and the ability to communicate concerns freely.

Conclusions

CTG monitoring is an inherently collective and sociotechnical practice. Improving it will require accounting for complex system interdependencies, rather than focusing solely on discrete factors such as individual technical proficiency in interpreting traces.

Clinical tools for use in practice—such as medicine reconciliation charts, diagnosis support tools and track-and-trigger charts—are endemic in healthcare, but relatively little attention is given to how to optimise their design. User-centred design approaches and co-design principles offer potential for improving usability and acceptability of clinical tools, but limited practical guidance is currently available. We propose a framework (FRamework for co-dESign of Clinical practice tOols or ‘FRESCO’) offering practical guidance based on user-centred methods and co-design principles, organised in five steps: (1) establish a multidisciplinary advisory group; (2) develop initial drafts of the prototype; (3) conduct think-aloud usability evaluations; (4) test in clinical simulations; (5) generate a final prototype informed by workshops. We applied the framework in a case study to support co-design of a prototype track-and-trigger chart for detecting and responding to possible fetal deterioration during labour. This started with establishing an advisory group of 22 members with varied expertise. Two initial draft prototypes were developed—one based on a version produced by national bodies, and the other with similar content but designed using human factors principles. Think-aloud usability evaluations of these prototypes were conducted with 15 professionals, and the findings used to inform co-design of an improved draft prototype. This was tested with 52 maternity professionals from five maternity units through clinical simulations. Analysis of these simulations and six workshops were used to co-design the final prototype to the point of readiness for large-scale testing. By codifying existing methods and principles into a single framework, FRESCO supported mobilisation of the expertise and ingenuity of diverse stakeholders to co-design a prototype track-and-trigger chart in an area of pressing service need. Subject to further evaluation, the framework has potential for application beyond the area of clinical practice in which it was applied.

Introduction

Perfection in this science, or rather art [i.e. medicine] takes longer to be mastered than human life [affords]—Maimonides, philosopher and physician, Middle Ages.1

A veritable quality improvement (QI) industry has emerged that centres around initiatives to improve patient outcomes or health system performance. These initiatives often target high-risk and high-cost disease states,2 with common foci of reducing waste,3 ‘hot-spotting’4 and readmissions.5 While these initiatives can help improve health system performance across the Quintuple Aim,6 they often fall short of achieving sustained improvements in outcomes at scale due to short attention spans, limited resources and shifting priorities or incentives.7–9 Furthermore, improvement initiatives can have unintended negative consequences that increase staff burnout and inadvertently exacerbate health human resource challenges,10 highlighting a need to clarify what we are trying...

Medline Industries recalls kits and trays due to sterility concerns linked to Nurse Assist's November 6, 2023, recall.

Vyaire recalls AirLife manual resuscitators because a manufacturing defect could result in patients not receiving enough ventilation, leading to injury or death.

The Impella device's catheter could cut through the wall of the left ventricle.

InfuTronix, LLC has announced a voluntary recall of the Nimbus Ambulatory Infusion Pump System, including Nimbus II PainPro, Nimbus II Flex, Nimbus II Plus, Nimbus II EpiD and Nimbus II EMS from the US Market due to a high number (3698) of customer complaints related to the Nimbus Infusion Pump sys

Pyramid Wholesale is issuing a recall of various brands of products sold as dietary supplements for sexual enhancement because they contain undeclared prescription drugs including Sildenafil (Viagra) and/or Tadalafil (Cialis).

Consider using plastic syringes not manufactured in China, if possible.

UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication

Hampton, NH – On March 1, 2024, Sleepnet Corporation initiated a worldwide recall for all CPAP and BIPAP masks with magnets due to potential interference with certain medical devices. When a magnet comes into close proximity to certain medical implants or metallic implants, it could interfere with t

Avanos Recalls Kits Containing Nurse Assist Saline

Endo International plc announced today that one of its operating companies, Par Pharmaceutical, Inc. (Par), is voluntarily recalling one lot of Treprostinil Injection 20mg/20mL (1mg/mL) to the consumer level. The product is being recalled due to the potential for the presence of silicone particulate

The Abbott HeartMate Touch Communication System is being recalled due to the risk of unintended communication with the HeartMate System Controller resulting in pump stop of the HeartMate 3 Left Ventricular Assist Device.

Windstone Medical Packaging recalls kits (Lower Extremity, Ocular, Closure) due to sterility concerns linked to Nurse Assist's November 6, 2023, recall.

2023 Medical Device Recalls

Cardinal Health is recalling Monoject Luer-Lock and Enteral Syringes due to recognition and compatibility issues with certain enteral syringe feeding pumps.

If the bonded spiral wrap detaches, it can compromise the structural integrity, functionality, or cause blockage, stoppage, or leaks in the breathing circuit.

Medtronic Neurosurgery is recalling Duet EDMS catheter tubing due to a potential for disconnection from the patient line stopcock connectors.

Baxter Healthcare is recalling the ExactaMix Pro 1200 and Pro 2400 for a software error causing potential over-delivery of ingredients in the final solution.