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.

Blood gas machines display unrecordably low glucose in a way that can be misinterpreted as an unanalysable sample, potentially delaying appropriate clinical response to critical patient conditions.

Indistinctive packaging for IV fluids used in arterial lines causes confusion, while medical staff's incorrect blood sampling technique from arterial lines further exacerbated errors.

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...

A critical genetic test result, indicating a pathogenic mutation, was misread as normal, leading to a diagnostic error that could have significant consequences for other children.

The SystemOne computer program risks abnormal blood test results being missed due to a minimised display, lack of a scroll feature, and inability to prominently flag out-of-range values.

Critical error messages and equipment defect indicators are not documented in user instructions or known to staff. Machine maintenance procedures also fail to identify component wear and tear.

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 combined use of a specific tracheostomy tube and a particular Velcro strap attachment compromised the tube's integrity, likely causing detachment and posing risks with similar devices.

Unavailable medical records, inadequate equipment (missing bronchoscope part, no tilt trolley), and unutilised standard procedures (cricoid pressure, NG tubes) compromised patient care during anaesthesia.

A surgical cuff device was used outside manufacturer guidelines in a non-emergency procedure, increasing the risk of device failure and the need for high-mortality open surgery.

Concerns involve potential under-reporting of PEG allergy, insufficient research into its effects, and the lack of clear labelling on medical products regarding PEG's presence, dose, and various synonyms.

Oxygen cylinders with a confusing two-valve system led to delayed oxygen delivery during resuscitation. Despite repeated incidents and training, the design remains unsafe for high-pressure medical emergencies.

Supply chain issues led to a sub-optimal cannula being used, which dislodged and contributed to the patient's death. Surgeons were restricted in their choice of appropriate medical equipment.

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/...

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 death was caused by liver damage from parenteral nutrition extravasation, likely due to a low-lying umbilical venous catheter, highlighting risks associated with currently acceptable UVC placement practices.

Oxygen flow was lost due to an improperly engaged humidifier screw cap, exacerbated by the absence of an alarm on the concentrator and insufficient training regarding equipment setup.

Critical ECG test results were unavailable pre-surgery due to systemic record management issues. An unlabelled intravenous line was accidentally disconnected, highlighting a lack of clear labelling protocols.

Inconsistent use of high-resolution X-ray screens and clinician confirmation bias led to missed abnormalities. There were also unclear processes for reinforcing learning and escalating patient deterioration to consultants.

Inadequate patient monitoring due to a frail, restless patient being out of sight, combined with an insufficiently sensitive dialysis alarm, delayed detection of a critical bleed.

CPAP machine alarms do not distinguish between minor leaks and critical oxygen cessation, causing confusion and delays in responding to serious patient deterioration, especially with multiple alarms.

Alarms on ICU monitors were disengaged, preventing staff from being alerted to critical patient deterioration, which resulted in a cardiac arrest.

Unreliable and difficult-to-use home SATS machines, coupled with inadequate parent training on specific models, created a false sense of security and failed to alert parents to critical oxygen drops.

Clinicians frequently misinterpret ECGs and lack clear national guidance for paediatric exercise-induced syncope. The national asthma scoring system is insufficient, leading to misdiagnosis and missed cardiac conditions in children.

Heart monitors have a critical design flaw where disconnected leads do not continuously re-alarm after initial acknowledgement, risking unobserved and fatal cardiac events in other hospitals.

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...

A malfunctioning operating table and emergency stop, potentially linked to a damaged, improperly positioned handset, highlight inadequate pre-operation checks and a lack of training or hospital-wide review for similar equipment.

Midwives failed to timely escalate abnormal CTG results due to misapplication of guidelines and inadequate training. Concerns also arose about CTG machines potentially misinterpreting maternal heart rate as fetal heart rate.

The patient's fall from a hoist was attributed to the sling's tendency to "bagging" at the sides, creating a fall risk if the patient shifted their weight.

The cot side on a trolley could remain in an unlocked position due to design and maintenance issues, which were not clearly highlighted. The MHRA failed to escalate this known hazard to other hospital trusts.

PEJ and PEG tubes are easily confused due to their similar appearance, highlighting the lack of a simple colour-coding system for differentiation.

There are safety concerns regarding Maplin N19KJ telescopic ladders, with 43,000 sold, warranting investigation into a potential catastrophic failure and the origin of the accident ladder.

Tracheostomy tube manufacturers may not be keeping pace with population changes, leading to tubes of potentially inappropriate length which could increase dislodgement risk.

Insulin pump guidance inadequately highlights misuse dangers from incorrect cartridge insertion, and patient education fails to emphasize the rapid life-threatening nature of hyperglycaemia.

The absence of safety sensors on a chair mechanism led to a crushing injury, as it failed to detect a foot's presence and prevent operation.

Emergency service triage software failed to register a head injury in an anticoagulant patient after a fall, risking severe complications and highlighting the need for a review of head injury recognition protocols.

The coroner raises concerns about the lack of an alarm on a Nimbus 3 air mattress, which deflated when its power cable was dislodged, contributing to the patient's death.

A hospital doctor was unaware of morphine administered by paramedics due to inconsistent unit notation (mls vs. mgs), risking opiate overdose. Lack of standardised units between services creates a significant safety concern.

The Trust misinterpreted Public Health England guidance, exposing vulnerable patients to COVID-19 by moving them to isolation wards. Concerns remain as the unamended guidance might lead other trusts to similar unsafe practices.

Product description for a 14Fr feeding/drainage tube was misleading due to a restrictive connector, leading to inadequate drainage. Hospital evaluation was insufficient, and staff lacked training on product changes and alternative actions.

An enteral feeding and drainage tube's product description and staff training were insufficient, leading to confusion about its reduced bore size. This caused inadequate drainage, and the product is still misleadingly promoted.