Medical device display errors

It would be beneficial if those organisations procuring electronic prescribing and medicines administration systems ascertain whether the product they are procuring meets the definition of a medical device and, if so, whether the manufacturer meets the expected regulatory requirements and the product is either UKCA marked or CE marked to demonstrate conformity.

Concerns were raised regarding the device's Instructions for Use, which omitted a critical error message and the significance of disappearing control icons. Additionally, the unique alarm function was unknown to users, and manufacturer maintenance lacked a wear-and-tear identification process.

The coroner is concerned that medical devices are being used in non-emergency procedures outside manufacturer's instructions, which increases the risk of device failure and the need for high-risk emergency open surgery.

The coroner noted the lack of an alarm or warning system on a medical air mattress and turning device, which meant there was no alert when the power cable dislodged, causing deflation.

Packaging for intravenous fluids used with arterial line transducer sets lacks distinctiveness, leading to errors. Additionally, medical staff were not using the correct technique when drawing blood samples from arterial lines, which compounded the issue.

The coroner raises concerns that blood gas machine displays for unrecordably low blood glucose levels can be misinterpreted, potentially delaying appropriate clinical responses. The report notes the display '- - -↓' may be seen as an unanalysable sample rather than an extremely low reading.

HSIB recommends that the Medicines and Healthcare products Regulatory Agency reviews and acts on the available evidence to regulate for the use of pressure infusion bags that allow fluid labels to be read when inflated. The intention of this safety recommendation is to increase awareness of and action on known risks related to the design of the medical...

The Medicines and Healthcare products Regulatory Agency should strongly recommend the manufacturers of ophthalmology electronic patient record systems (including systems for making and storing ocular biometry measurements), where they fall under the remit of the Medical Device Regulations, undertake an assessment against the MHRA Human Factors and Usability Engineering guidance and this should form part of the documents...

National Association of Medical Device Educators and Trainers

It may be beneficial to explore the design of a visual alert which prompts healthcare professionals to the increased safety risks associated with in situ haemodialysis catheters and the access to this medical device by staff specifically trained in their use.

It may be beneficial if national organisations including the Medicines and Healthcare products Regulatory Agency, NHS Supply Chain and NHS England and NHS Improvement review arrangements for ensuring all medical device related incidents, Yellow Card reports, or other device safety related information, including any involving concerns with pH or X-ray in the context of nasogastric tubes, are shared...

NHSX and the Department of Health and Social Care should work to ensure that there is clinical engagement with the procurement of cardiac devices and that all devices are subject to systematic surveillance to ensure their safety and efficacy. a) Improve awareness of costs and product utilisation across the NHS by providing cardiology supply chain analytics. b) Work...

Concerns involved midwives' interpretation and escalation of abnormal CTG traces, particularly the inappropriate application of guidelines during a slow second stage of labour. The coroner also noted issues with CTG machines potentially displaying maternal heart rate as fetal heart rate due to an unknown multiplication factor, and the slow replacement of older models lacking differentiation.

The Government should increase the information available on the approval of medical devices to allow interested parties to see not only what devices are approved but the evidence base underpinning the decisions to approve them. (Recommendation, Paragraph 36)

The coroner noted the unavailability of previous medical records, the absence of a rapid-tilt trolley for anaesthetisation, and issues with equipment, including a faulty bronchoscope. Procedural concerns also included the non-use of cricoid pressure and NG tubes.

The coroner noted potential under-reporting of PEG allergy and a need for more research into its effects. Concerns were raised about the lack of clear information on medical product labelling regarding PEG's presence, dose, and molecular weight, compounded by inconsistent nomenclature.

The coroner identified concerns about the reliability, suitability, and ease of use of SATS machines provided for home monitoring, particularly after one machine ceased to function and alarms from another device were not responded to.

Regulatory bodies can improve patient safety by supporting standardisation across manufacturers in how information from ECG traces is displayed.

We recommend that Doncaster Prison develops a robust system for testing and ensuring that all medical devices, including defibrillators, are in full working order.

We are aware that the Medicines and Healthcare products Regulatory Agency (MHRA), the government’s regulatory body which approves medical devices, approved 51 https://www.gov.uk/government/news/staggered-rollout-of-coronavirus-testing-for-secondary-schools- and-colleges; https://www.gov.uk/government/publications/coronavirus-covid-19-asymptomatic-testing-in- schools-and-colleges/coronavirus-covid-19-asymptomatic-testing-in-schools-and-colleges; https://www.gov.uk/ government/news/all-students-offered-testing-on-return-to-university 52 Qq 13, 16–17, 118 53 C&AG’s Report paras 1.28–1.29 54 Q 117 55 For example:https://www.bma.org.uk/news-and-opinion/the-implications-of-rapid-testing-for-nhs-workers; https://www.bmj.com/content/371/bmj.m4436 56 See, for example, https://www.bmj.com/content/371/bmj.m4916 57 Q 116; https://www.gov.uk/government/publications/evidence-on-the-accuracy-of-lateral-flow-device-testing/ evidence-summary-for-lateral-flow-devices-lfd-in-relation-to-care-homes 58 https://www.liverpool.ac.uk/research/news/articles/covid-19-liverpool-community-testing-pilot-interim-findings- published/...

The coroner noted differing practices in the use of high-resolution screens for X-ray viewing and a tendency for clinicians to focus on expected findings. Concerns were also raised about the unclear process for escalating cases to consultant level and critical care.

It may be beneficial for manufacturers to further standardise product specifications to design out the potential for errors. For example, items such as Y-connectors, extension lines and needle-free connectors often look similar but may have differing specifications.

Continue to seek assurances that emergency medical equipment is properly maintained, in line with medical devices regulations.

The coroner noted concerns regarding a hoist sling's tendency to "bag" at the sides, which could allow a patient to fall if they leaned to one side during transfer.

The coroner noted damage to the liver from concentrated feeding fluid, potentially linked to the low-lying position of an umbilical venous catheter, a placement currently acceptable to most doctors. Concerns were raised about the risk of extravasation from UVCs and ongoing investigations into optimal catheter positioning.

The coroner noted the absence of an alarm on the oxygen concentrator to indicate a loss of oxygen flow if the humidifier screw cap was not properly engaged, along with insufficient training and literature on this specific risk.

The coroner identified a design and maintenance issue allowing a trolley's cot side to remain raised but unlocked, with uncertainty about its inclusion in maintenance schedules. It was also noted the MHRA did not escalate this known risk to other hospital trusts.

The coroner noted that CPAP machines use the same alarm for minor leaks and total oxygen cessation, which complicated identifying the cause of a patient's low oxygen saturations when multiple alarms were sounding simultaneously.

The coroner raised concerns that NICE and international guidance do not sufficiently caution clinicians about the risk of misidentifying abdominal aortic aneurysm and acute pancreatitis due to their similar presenting features. The guidance does not specifically require the exclusion of an aneurysm when a pancreatitis diagnosis is uncertain.

Clinicians regularly miss or misunderstand ECG readings, and there is no clear national guidance for the pathway of children with paediatric exercise-induced syncope. Additionally, the assessment for exercise-induced asthma was insufficient, delaying the diagnosis of an underlying cardiac condition.

Original safety recommendation: HSSIB recommends that the Centre for Perioperative Care (CPOC) and Association for Perioperative Practice (AfPP) work together with other key stakeholders to review and amend the process and standards for the reconciliation of swabs, using human factors expertise and user-centred design principles, to reduce the risk of retained swabs to as low as reasonably practicable....

HSSIB recommends that the Centre for Perioperative Care (CPOC) and Association for Perioperative Practice (AfPP) work together with other key stakeholders to review and amend the process and standards for the reconciliation of swabs, using human factors expertise and user-centred design principles, to reduce the risk of retained swabs to as low as reasonably practicable. Any changes to...

The coroner noted concerns regarding an operating table moving uncontrollably due to issues with its handset, including possible fluid ingress and a non-functional emergency stop button. There was also a lack of hospital review for similar equipment and insufficient pre-operative checks for handset integrity.

Independent expert testing found that the combined use of a specific tracheostomy tube and a particular Velcro strap compromised the tube's integrity, likely causing its detachment. The coroner also raised concerns about the broader implications for continued use of Velcro strap attachments with tracheostomy tubes.

The coroner noted the similar appearance of PEJ and PEG tubes could lead to confusion, suggesting a simple colour coding system to aid differentiation when the tubes are in situ.

The coroner raises concerns about the safety of Maplin N19KJ telescopic ladders, noting approximately 43,000 units were sold before withdrawal due to safety issues. Further investigation is sought regarding the accident ladder's origin and a review by Maplin.

The coroner raises concerns that standard tracheostomy tube lengths may be inappropriate for the increasing size of the population, potentially contributing to complications like dislodgement. The Intensive Care Society is encouraged to influence the industry to address this issue.

Concerns included a recurring problem with investigative test results not being available with patient notes or electronically uploaded, and the absence of a protocol or labels for intravenous lines, which contributed to an accidental disconnection.

The coroner notes that advice and guidance for insulin pumps do not adequately highlight dangers of misuse, and diabetic patient education lacks focus on the rapid life-threatening nature of unmanaged hyperglycaemia.

The coroner noted that the chair was not fitted with sensors to detect a foot in its mechanism, which could have prevented a crushing injury and released the foot.

The clinical decision support software system did not register a head injury for a patient receiving anticoagulant drugs. The coroner recommends reviewing the triage system to ensure all head injuries are recognised and treated as emergencies.

The coroner noted that genetic test results indicating a pathogenic gene mutation were misinterpreted, leading to a family being incorrectly informed the results were "absolutely normal." This situation carries a risk of similar miscommunications impacting other children.

A doctor prescribed morphine without knowing the dose already given by paramedics. The coroner identified a risk arising from the differing units of measurement for opiate medication used by pre-hospital and hospital services.

The patient was positioned out of sight from the nurses' station, and the dialysis equipment's alarm was insufficiently sensitive to promptly detect significant blood loss from a dislodged needle.

The coroner raised concerns regarding the interpretation of Public Health England guidance on patient movement to Covid-19 isolation wards, noting that varied interpretations across trusts could put vulnerable patients at risk of infection.

Coroner noted insufficient product description and sales staff training regarding an enteral tube's restricted bore, impacting hospital evaluation and nursing staff's response to drainage issues. Concerns also highlighted the product's continued promotion despite safety notices.

The coroner noted an Enteral 14FR tube's en-fit connector restricted its effective bore, causing insufficient drainage, raising concerns about inadequate product description, insufficient manufacturer and hospital evaluation, and nursing staff not aspirating tubes.

The coroner identified challenges in reliably confirming NG tube placement in infants, particularly with pH testing when medication is used and limiting X-ray exposure. Concerns also included staff misunderstanding individualised policy adjustments.

The coroner noted concerns about the non-standardised colour coding, numerous types, and variable optimal positions of breathing system filters and HMEs, leading to widespread confusion and a lack of knowledge among ICU staff. This situation requires review, simplification, and standardisation.

The coroner raises concerns about Philips central cardiac monitoring stations (model M3151) where alarms self-terminate when certain abnormal heart rhythms correct themselves, risking future deaths if not addressed by the manufacturer.