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.

Smiths Medical recalls Medfusion 3500 syringe pump due to software issues affecting delivery alarms, infusion restarts, screen locks, and critical functions.

EVair Air compressors recalled due to increased formaldehyde emissions at high temperature and low gas flow conditions when used with certain ventilators.

Wipro Ge Healthcare Private Ltd. is recalling its Care Plus and Lullaby Incubators because the bedside panel or porthole may not latch properly.

Learn more about recommendations for patients who are considering a Hintermann Series H3 TAR system or who have one; recommendations for health care providers.

Problems may occur if electrical operating room table best practices are not followed. Read the FDA’s recommendations to avoid complications.

Megadyne issued a Class 1 Medical Device Correction to hospitals to limit the use of MEGA SOFT Universal and Universal Plus Reusable Patient Return Electrodes to patients aged 12 years or older after receiving reports of adult and pediatric patient burns following surgical procedures in which MEGA S

FDA is informing the public of adverse events reported with the use of BioZorb Marker including pain, migration, erosion, and others.

In direct response to the Nurse Assist, LLC voluntary recall of pre-filled syringes and other sterile water products, Avanos Medical, Inc. (NYSE: AVNS) voluntarily recalled specific lots of MIC* Gastric – Jejunal Feeding Tube Kits on Jan. 16, 2024. These kits include Nurse Assist supplied syringes,

Brassica Pharma Pvt. Ltd. is voluntarily recalling Eye Ointment products listed in the table below with expiration date ranging from February 2024 to September 2025. The products are being recalled due to lack of sterility assurance at the facility noted during an inspection conducted by the Food an

The NIM CONTACT and Standard Reinforced EMG Endotracheal Tubes may obstruct the patient’s airway.

Do not use smartwatches or smart rings to measure blood glucose. They are not authorized by the FDA. Using them could result in inaccurate blood glucose measurement, which can lead to serious injury or death if used to make medical decisions. Only use FDA-authorized devices to measure blood glucose.

Medtronic initiates recall for silicone-based EMG endotracheal tubes due to the risk of airway obstruction and ventilation failure.

The challenge

Despite progress in many areas, the world continues to face significant and growing challenges to the delivery of high-quality healthcare. Consistently high levels of avoidable harm are reported internationally.1 Inequities in quality persist and solutions are in short supply.2 Implementing initiatives to increase the uptake of effective care and de-implement ineffective technologies has also proven difficult.3 4 Patient-centred care is on the ‘to do’ list for healthcare systems but in too many instances it is deprioritised by decisions that seem arbitrary and not connected to any clear ethical framework.5 Delayed care is another widespread problem and we have long known that crude top-down solutions such as targets are unlikely to work.6

These challenges are formidable and exist against a backdrop of demographic pressures, staffing crises and financial constraints. In the context of these challenges,...

Safety cases in industry

In the UK and several other countries, including Norway, Australia and New Zealand, operators of safety-critical systems, such as nuclear power plants, public transportation systems and defence equipment, must develop a safety case to demonstrate that their systems are acceptably safe to operate.1 In these countries, the development, review and maintenance of safety cases are regulatory requirements. In the UK, this regulatory practice extends as of October 2023 to high-rise residential buildings following the Grenfell Tower fire in 2017, during which 72 people died.

So, why are these countries promoting the safety case approach across their safety-critical industries? The most tangible reason is the shift from a prescriptive regulatory regime towards a goal-based approach.2 In this approach, regulators establish overall safety goals, offering developers and system operators flexibility to determine the most suitable methods for ensuring compliance. A safety argument...

It is widely known—among healthcare professionals as well as patient safety researchers—that transfers of care are a high-risk area in relation to patient safety.1 And even more importantly, the experience of patients and their families suggests likewise. For example, in a research priority setting exercise focusing on safe care for adults with complex health needs, 6 of the top 10 priorities related to transfers of care, either within or between organisations.2 While care transitions affect all elements of a person’s care, medication safety is a particular cause for concern, with a Cochrane review finding that 56% of patients are at risk of having at least one medication discrepancy as part of standard care.3 Accepted wisdom among many people working in the quality and safety field is that measurement is essential both to understand the risks and to target and evaluate interventions to address...

Classification—the process of sorting people or things into groups according to shared qualities or characteristics—is increasingly used within healthcare as a means of identifying patients with particular needs and/or risks. This is important because receiving care in hospital can expose some particularly vulnerable groups of patients to increased risk of harm and poor outcomes, for example, the systemic safety inequities experienced by people with learning disabilities.1

Identifying and responding to patients with additional needs

In order to deliver care that meets individual patients’ needs, health services must, first, be able to identify those with additional needs and, second, be able to mobilise an appropriate response to these. Various ways of identifying patients with additional needs and/or risks have been developed. One obvious example is the use of wristbands for those with drug allergies, although the potential for confusion between different schemes at different hospitals has been...

Background

The Safety Case is a regulatory technique that requires organisations to demonstrate to regulators that they have systematically identified hazards in their systems and reduced risks to being as low as reasonably practicable. It is used in several high-risk sectors, but only in a very limited way in healthcare. We examined the first documented attempt to apply the Safety Case methodology to clinical pathways.

Methods

Data are drawn from a mixed-methods evaluation of the Safer Clinical Systems programme. The development of a Safety Case for a defined clinical pathway was a centrepiece of the programme. We base our analysis on 143 interviews covering all aspects of the programme and on analysis of 13 Safety Cases produced by clinical teams.

Results

The principles behind a proactive, systematic approach to identifying and controlling risk that could be curated in a single document were broadly welcomed by participants, but was not straightforward to deliver. Compiling Safety Cases helped teams to identify safety hazards in clinical pathways, some of which had been previously occluded. However, the work of compiling Safety Cases was demanding of scarce skill and resource. Not all problems identified through proactive methods were tractable to the efforts of front-line staff. Some persistent hazards, originating from institutional and organisational vulnerabilities, appeared also to be out of the scope of control of even the board level of organisations. A particular dilemma for organisational senior leadership was whether to prioritise fixing the risks proactively identified in Safety Cases over other pressing issues, including those that had already resulted in harm.

Conclusions

The Safety Case approach was recognised by those involved in the Safer Clinical Systems programme as having potential value. However, it is also fraught with challenge, highlighting the limitations of efforts to transfer safety management practices to healthcare from other sectors.