Medical device display errors
Clinician misinterpretation of unrecordably low critical values displayed on medical devices (e.g., glucose as '---↓').
85 items
8 sources
2 inquiries
Source spread
Where this theme appears
Medical device display errors has been flagged across 8 independent accountability sources:
2 inquiry recs
46 PFD reports
16 committee recs
3 CQC actions
5 patient safety alerts
1 Article 2 learning point
6 PHSO decisions
6 LGO/SPSO decisions
When the same issue appears across inquiries, coroner reports, and regulators independently, it indicates a recurring issue across the public record.
Browse by source
Source-grouped records are useful for tracing where a concern came from. Large sections show the 50 strongest matches for that source; counts still show the full theme total.
Inquiry Recommendations (2)
ANG- — Independent international research should be carried out to look more closely at the safety of …
Recommendation: Independent international research should be carried out to look more closely at the safety of Conductive Energy Devices.
No Response
No update 2+ yrs
BRIS-120 — NPSA to urgently apply engineering design approaches to reduce sentinel events.
Recommendation: The proposed National Patient Safety Agency should, as a matter of urgency, bring together managers in the NHS, representatives of the pharmaceutical companies and manufacturers of medical equipment, members of the healthcare professions and the public, to seek to apply …
Unknown
PFD Reports (46)
Kenneth Smalley
Concerns: 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.
Response (Wrightington Wigan and Leigh NHS): The Trust has reviewed operating tables and handsets, changed pre-operative checks and inspections, implemented a more robust system and matrix for training theatre staff, and expanded the data base within …
Overdue
Arthur Brockett-Deakins
Concerns: 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.
Response (N.I.C.E): NICE is currently updating its clinical guideline on Intrapartum Care (CG55) and the progress of the update can be monitored via their website. They will consult on the draft recommendations …
Response (Medicines Healthcare Products Regulatory Agency): The MHRA states that the incident was not reported to them and that the CTG model was placed on the market by Philips Healthcare and sold in the UK between …
Response (NMC): The Nursing and Midwifery Council (NMC) will treat the information about one of the midwives as a new referral and investigate. A local supervisory authority (LSA) would be alerted to …
Response (Department of Health): The Department of Health acknowledges the coroner's concerns and notes that NICE has responded on CTG interpretation. They explain the role of statutory supervision of midwives and state the NMC …
Responded
Archie Hames
Concerns: 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.
Response (Department of Health): Following concerns about tracheostomy tubes and velcro straps, MHRA issued a Medical Device Alert, and manufacturers Arcadia Medical and Smiths Medical clarified instructions for use to warn against using velcro …
Overdue
Marjorie Phillips
Concerns: 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.
Response: Sunrise Medical Limited states that their instruction manual is a comprehensive document which deals with the issues of purchase; maintenance and operation of equipment supplied by them, therefore no action …
Overdue
Jackson Mitchell
Concerns: 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.
Response (The Queen Elizabeth Hospital NHS Trust): The Trust conducted an internal review, shared findings at paediatric governance meetings, and introduced a new X-ray review checklist. Regionally, guidelines are being developed (King's Lynn is already following them), …
Overdue
Gaenor Moore
Concerns: 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.
Response (Dolby Vivsol): Dolby Vivisol is liaising with Salter Labs and Invacare to update product instructions regarding humidifier cap engagement, and will update their own training materials and patient instructions accordingly. Proposed amendments …
Response (Invacare): Invacare will update manuals provided to customers with concentrator units to include enhanced guidance on humidifier cap installation, with wording similar to confirming the cap is not cross-threaded. This update …
Response (Salter Labs): Salter Labs has offered to review Dolby Vivisol's updated literature and will ensure it includes reference to the safety valve. They are waiting for the humidifier to be returned for …
Responded
James Fyfe
Concerns: 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.
Response (Medicines Healthcare Products Regulatory Agency): MHRA has discussed the QA3 instructions for use with the manufacturer, advising them to review them again to ensure that they are still accurate and appropriate. MHRA contacted four other …
Response (AneticAid): AneticAid defends the design and safety record of its QA3 trolley, arguing that no retrospective changes are needed. They suggest the issue is localised to Royal Berkshire Hospital and will …
Response (Royal Berkshire NHS Trust): Royal Berkshire NHS Trust has contracted with Anetic Aid (AA) to undertake periodic inspection and maintenance on all of its QA3 trolleys. The Trust has further updated its Clinical Engineering …
Responded
Brian Marks
Concerns: PEJ and PEG tubes are easily confused due to their similar appearance, highlighting the lack of a simple colour-coding system for differentiation.
Response (Department of Health): The MHRA will bring the issue of tube misidentification to the attention of the Standards Committees and intends to include the risk of misidentification of similar devices in the next …
Responded
Steven Curtis
Concerns: 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.
Overdue
Dilys Jenkins
Concerns: Tracheostomy tube manufacturers may not be keeping pace with population changes, leading to tubes of potentially inappropriate length which could increase dislodgement risk.
Overdue
Geoffrey Parry
Concerns: 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.
Response: The University Health Board has reviewed systems for ECG storage, reinforced the use of the MUSE system, and implemented training on intravenous infusion labelling. The learnings from this incident will …
Responded
James Hedge
Concerns: Insulin pump guidance inadequately highlights misuse dangers from incorrect cartridge insertion, and patient education fails to emphasize the rapid life-threatening nature of hyperglycaemia.
Responded
Joseph De Pellergrino-Farrugia
Concerns: 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.
Response: The response explains that AJ Ways fits sensor strips or protective screens to chairs only upon request, and that the user instruction booklet highlights potential entrapment risks and user suitability. …
Overdue
Glenys Pollitt
Concerns: 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.
Response (Stockport NHS Trust): Stockport NHS Trust acknowledges that high-resolution screens should ideally be used for viewing X-rays. They note that a NEWS implementation plan is being developed, independent of the delayed launch of …
Responded
Peter Cotter
Concerns: 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.
Response (NHS England): NHS England (NHS Digital) acknowledges the coroner's concerns and states that NHS Pathways identifies and assesses head injuries, including whether patients are on anti-coagulant treatment. They assert that the triage …
Response (South Central Ambulance Service NHS Trust): South Central Ambulance Service acknowledges the coroner's concerns regarding the NHS Pathways triage system but states they cannot make changes to the software. They have notified NHS Digital of the …
Responded
Donald Till
Concerns: Unavailable medical records, inadequate equipment (missing bronchoscope part, no tilt trolley), and unutilised standard procedures (cricoid pressure, NG tubes) compromised patient care during anaesthesia.
Response (University Hospitals of North Midlands): The evidence base regarding risk assessment for patients with bowel obstruction will be presented to clinicians at the departmental mortality and morbidity meeting, to remind them to ensure the surgical …
Responded
Freddie Dobinson-Evans
Concerns: 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.
Response (Barts Health NHS Trust): Following concerns about miscommunication of genetic test results, the organisation met with the genetics lab at Great Ormond Street Hospital, who have changed the results format to address future directions …
Overdue
Norman Pirie
Concerns: 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.
Response (Barts Health NHS Trust): The Trust will implement enhanced MDT review of device selection including non-IFU treatments, document the decision in the patient's record, and inform the patient and GP about treatment options.
Responded
Jeanette Robinson
Concerns: 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.
Response (Cornwall Council): Cornwall Council has replaced all Nimbus mattress systems in the community with Elite systems. All Nimbus stock has been destroyed. The council states that the previous service records indicate that …
Response (Medicines and Healthcare Products Regulatory Agency): The MHRA explains CE marking and post-market surveillance processes for medical devices like mattresses, noting that the incident was not reported to them. They state that without a serial number …
Responded
Doris Clark
Concerns: 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.
Overdue
Susan Warby
Concerns: 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.
Response (Medicines and Healthcare Products Regulatory Agency): The MHRA will consider with the marketing authorisation holder whether improvements could be made to assist clinical staff to more easily assimilate the statutory information on intravenous fluid bags to …
Response (Dept. of Health and Social Care): West Suffolk NHS Foundation Trust implemented enhanced procedures and safeguards, including more robust processes for prescribing and checking fluid bags, introducing clear medication bags, and altering medication bag displays. They …
Responded
Ivan O’Neill
Concerns: 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.
Overdue
Leslie Harris
Concerns: 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.
Response (NHS England): NHS England contributed to updated Public Health England guidance published January 2021, strengthening messaging and providing further clarity on care pathways, testing, and exposure regarding COVID-19 in healthcare settings. The …
Response (UK Health Security Agency): The UK Health Security Agency (formerly Public Health England) updated its guidance several times during the pandemic and will further review it to tighten wording and prevent misinterpretation regarding COVID-19 …
Responded
Stephen Oakes
Concerns: 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.
Response (Medicines and Healthcare Products Regulatory Agency): The manufacturer has updated the product labelling for the Carefeed devices to remove the secondary intended use of drainage; MHRA will write to UK manufacturers of nasogastric tubes to advise …
Response (GBUK Group Ltd): GBUK has revised device labelling and instructions for use, removing all references to drainage and adding warnings about flow restrictions with ENFit connectors and has provided refresher training to its …
Response (University Hospitals of North Midlands NHS Trust): The Trust has designed a new proforma for evaluating equipment and has updated the Trust e-learning training package for the insertion and on-going management of Nasogastric/Orogastric tubes including troubleshooting guidance …
Response (NHS England NHS Improvement): NHS England and Improvement are working with the Healthcare Safety Investigation Branch (HSIB) testing and introducing national patient safety incident investigation training and developing a patient safety incident investigation training …
Responded
Peter Hussey
Concerns: 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.
Response (NHS England): NHS England and Improvement are working with the Healthcare Safety Investigation Branch (HSIB) testing and introducing national patient safety incident investigation training and developing a patient safety incident investigation training …
Response (GBUK Group Ltd): GBUK Enteral Ltd has revised device labelling and Instructions For Use (IFU) to remove references to drainage, add warnings about flow restrictions with ENFit connectors, and clarify the intended use …
Response (University Hospitals of North Midlands NHS Trust): The Trust has designed a new proforma for evaluating equipment and has updated the Trust e-learning training package for the insertion and on-going management of Nasogastric/Orogastric tubes including troubleshooting guidance …
Response (Medicines and Healthcare Products Regulatory Agency): The manufacturer has updated the product labelling for the Carefeed devices to remove the secondary intended use of drainage; MHRA will write to UK manufacturers of nasogastric tubes to advise …
Responded
Don Fernandes
Concerns: Concerns remain about the implementation of NG tube policy changes and staff competency reassessment. Policy variations to reduce x-ray exposure led to confusion about the need for confirmation, risking tube misplacement.
Response (Oxford University Hospitals NHS Foundation Trust): The Trust outlines actions taken following the RCA report, including policy changes and audits. They do not accept the recommendation that the nurse should have sought advice from a senior …
Responded
Kishorkumar Patel and Kofi Aning
Concerns: The non-standardised colour coding and varied types of breathing system filters create widespread confusion among ICU staff. This lack of simplification and standardisation risks incorrect filter usage and patient safety.
Response (Medicines and Healthcare Products Regulatory Agency): The MHRA will engage with the medical device safety officers (MDSO) network to raise awareness of possible incidents involving filters and encourage reporting and will write to known manufacturers of …
Response (Professor): The response provides background information on HME/filters, potential issues, and proposes solutions such as standardized color coding and clearer labeling, but does not commit to any specific action.
Response (Royal College of Anaesthetists and The Faculty of Intensive Care Medicine): The organisations will highlight key lessons about breathing circuit filters to their membership through the Safe Anaesthesia Liaison Group’s Patient Safety Update and FICM Safety Bulletin, and have suggested that …
Response (Medicines and Healthcare Products Regulatory Agency): The MHRA will work with manufacturers, other regulators, NHS England and Improvement and other stakeholders to explore the effects of actions such as reducing filter types and improving color coding, …
Responded
Chimezie Daniels
Concerns: 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.
Response (NHS England): NHS England notes that the concerns raised relate to the design of medical devices and fall under the remit of the MHRA, but they have worked with the British Thoracic …
Response (Medicines and Healthcare Products Regulatory Agency): The MHRA states that the audible alarm system in the Philips Trilogy 202 device is based on an internationally recognised standard and that there is currently no evidence to indicate …
Responded
Andrew Cook
Concerns: 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.
Response (Medicines and Healthcare Products Regulatory Agency): The MHRA will discuss labelling requirements with other regulators internationally, collect and review information from a range of data sources on PEG exposure, and raise the profile of PEG/macrogol working …
Responded
Ann Geraghty
Concerns: Cardiac monitors' alarms self-terminate upon rhythm correction, failing to alert staff to serious, self-resolving events like ventricular standstill, and the manufacturer has not provided a solution.
Response (Philips Healthcare): Philips Healthcare investigated the reported incident and concluded that the device operated per specification, that there is not a configuration available to enable asystole or any other red arrhythmia alarm …
Response (University Hospitals Birmingham NHS Foundation Trust): University Hospitals Birmingham NHS Foundation Trust will provide refresher training to nursing staff on the alarm systems, explore altering the software configuration with Philips, and explore the retention of trace …
Responded
Diana Reay
Concerns: Multiple doctors misread scans, mistaking a fluid-filled cyst for a full bladder, which resulted in unnecessary and repeated catheterisations of the patient.
Overdue
Mary Land
Concerns: The Philips Respironics AF 541 mask uses an insecure 'push-on' connection to the ventilator, prone to detaching, especially with a filter. A more robust docking mechanism is needed to prevent inadvertent disconnections.
Response (Mid Yorkshire Hospitals): The Mid Yorkshire Hospitals NHS Trust has already completed four actions identified in an RCA investigation, including scoping improvements for securing tubing circuit connections. They continue to use filters per …
Response (Medicines and Healthcare Products Regulatory Agency): The MHRA will agree an investigation plan with Philips Respironics, engage with them on standards compliance, and discuss updating guidance with the British Thoracic Society and NICE. They will also …
Response (Philips Electronics UK Ltd): Philips Respironics argues that the AF541 mask design meets standards, is not intended to prevent disconnection, and is contraindicated for life support. They state the facility failed to follow instructions …
Response (Department of Health and Social Care): The Department of Health and Social Care acknowledges the MHRA's actions, including requesting a final investigation report from Phillips Respironics and discussions with the British Thoracic Society and NICE on …
Responded
Van Tuyen
Concerns: Misplaced nasogastric tubes continue to cause avoidable deaths, despite being a 'never event', with no unified national approach to prevent recurrences across NHS Trusts.
Response (Department of Health and Social Care): The Department of Health and Social Care highlights existing guidance and resources related to nasogastric tube misplacement, including a patient safety alert and eLearning materials. They also mention the HSIB …
Responded
Sangeerth Girirathan
Concerns: Alarms on ICU monitors were disengaged, preventing staff from being alerted to critical patient deterioration, which resulted in a cardiac arrest.
Response (Department for Transport): The Department for Transport outlined existing GB domestic and working time regulations for drivers of light goods vehicles. They stated that if the driver fell asleep due to inadequate rest, …
Response (NHS Milton Keynes): NHS Milton Keynes University Hospital NHS Foundation Trust has communicated to all Registered Nurses (RNs) and senior staff via matrons and safety huddles, reiterating the importance of active monitor alarms …
Responded
Jade Revell
Concerns: 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.
Response (TPP LTD): TPP updated the SystmOne software to ensure the scroll bar resets to the top of the page when reviewing pathology results, preventing missed abnormal results. They also recommend clinicians use …
Responded
Devon Turner
Concerns: 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.
Response (NHS England): NHS England shared the report with patient safety and children & young people's teams and is in contact with the MHRA regarding the concerns raised about the SATS machine. Regional …
Response (Medtronic): Medtronic believes the PM100N device was functioning appropriately, accurately recording data, and suitable for home use, so no modification or change is required.
Response (Buckinghamshire Oxfordshire and Berkshire West Integrated Care Board): Buckinghamshire Oxfordshire and Berkshire West ICB held a Joint Agency Response meeting and a Child Death Review meeting with partner organisations and sought clarification from Berkshire Healthcare NHS Foundation Trust …
Responded
Lauren Smith
Concerns: Paramedics failed to correctly interpret an abnormal ECG and lacked fundamental knowledge of key indicators, despite auto-diagnostic warnings. Inadequate qualitative training assessment and lack of post-incident training pose a significant patient safety risk.
Response (West Midlands Ambulance Service): West Midlands Ambulance Service acknowledged the ECG was abnormal and that policy wasn't followed; clinicians received a case review, participated in a Serious Incident process, completed reflective practice, and are …
Response (Health and Care Professions Council): The Health and Care Professions Council acknowledges the concern but states that the individual in question is not registered with them, so the concerns do not fall within their remit …
Response (Health Services Safety Investigations Body): The Health Services Safety Investigations Body is undertaking exploratory work regarding paramedic interpretation of ECGs in the community and will consider the scope for a formal investigation by the end …
Response (University of Wolverhampton): The University of Wolverhampton will present case evidence to students, incorporate ECG interpretation into Objective Structured Clinical Examinations, liaise with coronary care units for anonymised ECG readings, add an ECG …
Response (CQC): The CQC has reviewed WMAS's actions following the death and found no evidence of provider-level failings, although they identified concerns regarding the timeliness of addressing the training needs of staff …
Responded
Thomas Wakefield
Concerns: Guidance for abdominal aortic aneurysm and acute pancreatitis lacks caution about their diagnostic overlap, risking fatal misidentification, even when imaging is advised for diagnostic uncertainty.
Response (NHS England): NHS England states that the responsibility for clinical guidelines lies with NICE and the Royal Colleges, and highlights existing guidance from those bodies on AAA and acute pancreatitis. They note …
Response (National Institute for Health and Care Excellence): NICE will review and consider changing the wording in section 1.2 of its guideline on pancreatitis regarding the confirmation of diagnosis by testing blood lipase or amylase levels.
Response (National Institute for Health and Care Excellence): NICE has amended its guideline for pancreatitis (NG104) to clarify the interpretation of blood lipase or amylase levels in diagnosis.
Responded
Ben Harrison
Concerns: 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.
Response (BOC): BOC apologizes for the late response, explains the regulatory background, and requests an extension to provide further information. BOC claims they did not receive the report until late June.
Responded
Michael Walton
Concerns: 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.
Response (NHS England): NHS England has engaged with Newcastle upon Tyne Hospitals NHS Foundation Trust, who have permanently suspended use of the cannula in question. All reports received are discussed by the Regulation …
Response (Department of Health and Social Care): The DHSC acknowledges the concerns, explains the roles of NHS England, MHRA and CQC, and outlines the NSDR's role in managing medical supply disruptions. They note that the supply disruption …
Responded
June Liddell
Concerns: 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.
Response (LivaNova): LivaNova does not agree that changes to their IFU would have led to a different outcome, arguing the device operated as intended and the perfusionist's actions were the primary cause.
Response (Medicines and Healthcare Products Regulatory Agency): Following an investigation, the MHRA recommended that LivaNova update the IFU for the S5 heart lung machine to include an explanation of the "Arterial clamp is defective" message, and LivaNova …
Responded
Sybil Morgan-Gray
Concerns: 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.
Response (Medicines Healthcare products Regulatory Agency): The MHRA will share details of the report with the manufacturer for post-market surveillance and work with the trust to resolve training issues. They will also engage with NHS England …
Responded
Jake Lawler
Concerns: 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.
Response (Department of Health and Social Care): NHS England are featuring the case of Jess Brady in the 2024 NHSE Primary Care Patient Safety Strategy to raise awareness of the need to ‘rethink’ when symptoms remain persistent …
Responded
Kathleen Gregory
Concerns: A paramedic misinterpreted a ReSPECT form, believing it precluded resuscitation for choking, which may be a reversible event, raising concerns about form application.
Response (Beccles Medical Centre): The medical centre will conduct a significant event analysis of the case focusing on the RESPECT form completion and wording and then disseminate the findings to the practice team. The …
Responded
Melanie Walker
Concerns: 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.
Response (Philips Electronics UK Ltd): Philips acknowledges the concerns, explains alarm configurations on its IntelliVue monitors, and states that the hospital has reset the "ECG Leads Off" alarm to the factory default. Philips says that …
Response (NHS England): NHS England states that the Greater Manchester ICB has reconfigured the monitors such that when an ‘ECG leads off’ alarm is generated, the monitor will give the visual yellow flashing …
Response (Department for Health and Social Care): The Department of Health and Social Care reports that Philips issued a Field Safety Notice for users of their IntelliVue line of Patient Monitors which highlights that alarm function is …
Responded
Margaret Grimsley
Concerns: The apparent absence or non-use of an upper alarm setting on bedside oxygen meters risks over-oxygenation, with unclear policies on its implementation or whether it is standard practice.
Response (Shrewsbury and Telford Hospital NHS Trust): The Trust explained that while patient monitors have upper oxygen alarm functionality, it is not used as the greatest risk is low blood oxygen levels, with focus on lower alarms …
Responded
Committee Recommendations (16)
#12 —
Recommendation: The Department of Health and Social Care should make primary care workers aware of the potential for a link between autoimmune conditions and breast implants to ensure that women presenting with symptoms following implantation are not dismissed. (Recommendation, Paragraph 47)
Response Pending
#11 —
Recommendation: The Government should commission research to better understand the health impacts of breast implants, including their potential impacts on women with pre-existing auto-immune conditions. The research needs to be a mix of clinical research, including on the health impacts of …
Response Pending
#10 —
Recommendation: Evidence of concentrations of siloxanes in women’s bodies outside of their implants is particularly concerning. The mental health impacts of knowing that chemicals, which are being banned in other uses due to their toxicity, are circulating in your body should …
Response Pending
#9 —
Recommendation: There is growing concern that a number of women are experiencing serious health impacts after receiving breast implants, with many reporting symptom improvements following explantation. While evidence of a definitive link between these symptoms and breast implants has not been …
Response Pending
#8 —
Recommendation: 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)
Response Pending
#7 —
Recommendation: The PIP implant scandal involved substandard implants being given to women for many years without detection. The new post-surveillance regime for breast implants must include regular testing of approved implants to ensure continued compliance with safety standards. (Recommendation, Paragraph 35)
Response Pending
#6 —
Recommendation: A mandatory cooling-off period of at least two weeks should be introduced between the initial consultation and surgery for breast implants, ensuring patients have sufficient time to consider risks and alternatives before making a commitment. (Recommendation, Paragraph 27)
Response Pending
#5 —
Recommendation: We note that the registry is currently overseen by the soon-to-be abolished NHS England. The Government should take steps to ensure that the improvements we call for are not delayed by internal reorganisation. (Recommendation, Paragraph 26)
Response Pending
#4 —
Recommendation: The Government should introduce mandatory recording of breast implant and explant procedures and instances of adverse outcomes in the Breast and Cosmetic Implant Registry by the end of 2026. We welcome the Government’s acknowledgement that the registry requires improvement. The …
Response Pending
#3 —
Recommendation: Without mandatory participation in the Breast Implant Registry and the regular publication of outcome data, surgeons cannot provide patients with comprehensive risk information. This undermines the principle of informed consent. Many individuals feel inadequately informed before surgery and the absence …
Response Pending
#2 —
Recommendation: While there is a judgement to be made over whether the NHS should offer replacement implants to women affected by the PIP implants scandal, women with PIP implants who wish to have them removed should be able to have that …
Response Pending
#1 —
Recommendation: The PIP implant scandal exposed failures that continue to affect women more than a decade later. Official assurances that PIP implants pose no health risks appear to be based on limited long-term research and underplay the mental health impacts on …
Response Pending
#17 —
Recommendation: 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 …
Gov response: 4.1 The government agrees with the Committee’s recommendation. Target implementation date: June 2021 4.2 Regular rapid tests are a vital tool in helping to identify cases of coronavirus that would otherwise not be found. Around …
Under Consideration
#16 —
Recommendation: A number of significant commentators, including the British Medical Association and British Medical Journal, have raised concerns about the effectiveness and risks of mass testing with LFD tests.55 A particular issue raised is the relative accuracy of LFD tests compared …
Gov response: 4.1 The government agrees with the Committee’s recommendation. Target implementation date: June 2021 4.2 Regular rapid tests are a vital tool in helping to identify cases of coronavirus that would otherwise not be found. Around …
Under Consideration
#5 —
Recommendation: The performance requirements on direct-to-consumer genomic tests under the current regulations focus on a genomic test’s analytical performance, not its clinical performance. For a medically-relevant test, however, clinical performance is fundamental to how the test will be used by a …
Gov response: Performance requirements for IVDs, including DTC genomic tests, are explored as part of MHRA’s public consultation and will help to inform future policy related to this recommendation. The National Institute for Health Care Excellence (NICE) …
Under Consideration
#8 —
Recommendation: The OPSS’s lack of data has slowed its response to some serious areas of harm, such as small, high-powered magnets that led to 40 paediatric admissions in the UK in 2020 alone. Issues with these magnets have been reported for …
Gov response: 1.1 The government agrees with the Committee’s recommendation. Target implementation date: Spring 2022 1.2 The Office for Product Safety and Standards (OPSS) agrees to write to the Committee within six months of the PAC report …
Under Consideration
CQC Inspection Actions (3)
Private Ultrasound Scan
The service must ensure that equipment used for providing care are safe for use and used in a safe way. This includes regular quality assurance testing of ultrasound scanners by sonographers.
Must Do
Cygnet Bury Hudson
The provider should ensure that all equipment used in the delivery of care and treatment is calibrated.
Should Do
Natasha Lucy Clinics
Continue to seek assurances that emergency medical equipment is properly maintained, in line with medical devices regulations.
Should Do
National Patient Safety Alerts (5)
Risk associated with adult breathing circuits lacking a patent exhalation route
Dec 2025
NatPSA/2025/008/NHSPS
Removal of Philips V60 and V60 Plus ventilators from service: risk of unexpected shutdown
May 2023
NatPSA/2023/005/MHRA
NIDEK EyeCee One preloaded Intraocular Lenses: risk of increased intraocular pressure
Feb 2023
NatPSA/2023/003/MHRA
Transition to NRFit connectors for intrathecal and epidural procedures
Jan 2024
NatPSA/2024/002/NHSPS
Use of oxygen cylinders where patients do not have access to medical gas pipeline systems
Jan 2023
NatPSA/2023/001/NHSPS
PHSO Casework Decisions (6)
P-003019 — South Tyneside and Sunderland NHS Foundation Trust
Mrs N complains the Trust’s emergency department did not take appropriate action when she presented with problems with a recently fitted cardiac device.
NHS in England
Oct 2024
P-003348 — Kettering General Hospital NHS Foundation Trust
Miss G complains that in October 2023 the Trust caused a deep tissue burn to her baby son by not correctly monitoring a foot monitor that had been placed on him to check his oxygen and heart rate.
NHS in England
Feb 2025
P-002622 — University Hospitals Sussex NHS Foundation Trust
Mrs D complains the Trust's emergency department caused a delay in her getting a deep vein thrombosis diagnosis because it did not follow the right process, it got her blood test results wrong and it did not take into account the medication she was taking.
NHS in England
May 2024
P-003340 — Maidstone and Tunbridge Wells NHS Trust
Mrs D complains about the treatment the Trust gave her husband for COVID-19. She also complains his oxygen mask disconnected from the machine giving him oxygen.
NHS in England
Partly Upheld
Feb 2025
P-003441 — Leeds Teaching Hospitals NHS Trust
Ms E complains that when the Trust completed her surgery it did not implant her chosen device but used a bulkier, non-rechargeable alternative. She also complains the Trust is not monitoring the device closely enough.
NHS in England
Mar 2025
P-002353 — A dental practice in the Westminster area
Mr H complains about the Practice's dental treatment and says it gave him a badly fitting mouthguard.
NHS in England
Dec 2023
LGO / SPSO Decisions (6)
201508133 — Greater Glasgow and Clyde NHS Board - Acute …
Mrs C complained to us about the care and treatment her son (Mr A) received at Queen Elizabeth University Hospital before his death. Mrs C said that the hospital had not been equipped to meet Mr A's needs. We took independent advice from a nursing adviser. We found that there …
SPSO (Scottish Public Se…
Health
Upheld
Feb 2017
201203665 — Tayside NHS Board
Mrs C complained about the children's waiting arrangements in a hospital accident and emergency department (A&E). She said that when she had to go there with her grandson she was appalled that children waited together with adults and were, therefore, exposed to bad language and inappropriate behaviour. She said that …
SPSO (Scottish Public Se…
Health
Partly Upheld
Dec 2013
201405493 — Ayrshire and Arran NHS Board
Mrs C complained to the board about how her elderly aunt (Miss A) had been cared for in University Hospital Ayr. Mrs C complained to us that Miss A was not given a bed with rails, that hospital staff did not monitor Miss A's movements, and that they did not …
SPSO (Scottish Public Se…
Health
Partly Upheld
Nov 2015
201404381 — Scottish Ambulance Service
Mrs C complained that the Scottish Ambulance Service (the service) did not have the appropriate equipment or vehicle to take her late husband (Mr C) to hospital for a scan. Mr C was terminally ill with cancer and had widespread pain which severely restricted his mobility. Mrs C was also …
SPSO (Scottish Public Se…
Health
Upheld
Dec 2015
201708492 — Lothian NHS Board - Acute Division
Mrs C complained that the board failed to prevent her baby (Baby A) developing hypothermia (the condition of having an abnormally and typically dangerously low body temperature) in the hours after their birth at the Royal Infirmary of Edinburgh. We took independent advice from a midwife. We found that Mrs …
SPSO (Scottish Public Se…
Health
Partly Upheld
Jan 2019
201300375 — Highland NHS Board
Mr C's young daughter (Miss C) suffers from a number of medical conditions and has serious mobility problems. She uses either a wheelchair or a gait trainer, both of which need a lot of space for turning. After a number of years during which the family waited for a suitable …
SPSO (Scottish Public Se…
Health
Partly Upheld
Oct 2013