AbstractObjectivesTo evaluate the accuracy and completeness of adverse event summary reports for medical devices and compliance of the reports with the Food and Drug Administration (FDA) requirements.DesignCross sectional study.SettingThe FDA manufacturer and user facility device experience (MAUDE) database.ParticipantsAll adverse event summary reports filed in MAUDE from July 2019 to June 2025.Main outcome measuresIdentification of device problem codes, appropriate identification as summary reports in the submission form, concordance between the number of events data field and the report narrative, and compliance with FDA reporting deadlines.Results6308 summary reports were submitted to MAUDE containing 159?503 adverse events. Use of summary reports increased from 808 to 1757 between 2020 and 2024, a factor of 1.21 per year (P<0.001). Most (91%) adverse events in summary reports were for class 3 high risk devices. Summary reports lacked descriptions of potential device related problems: 57% of reports denoted an “adverse event without identified device or use problem” and 38% of reports selected “insufficient information” in the device problem code data field. Manufacturers incorrectly checked “N” (no) in the summary report (Y/N, reporting yes/no) field for 694 summary reports (11%) and erroneously listed “n=1” under the number of events field for 423 summary reports (7%), causing an undercount of 11?902 adverse events. The majority (55%) of summary reports failed to comply with the FDA reporting deadline of 30 days after the manufacturer became aware of the adverse event.ConclusionsAdverse event summary reports in MAUDE are frequently incomplete, inaccurate, and delayed. Improvements are needed to ensure timely identification of device safety signals and uphold FDA transparency standards.

Medical devices often enter clinical practice on the basis of premarket studies that are smaller and shorter than those required for medicines, while device performance may depend on operator experience and real world use. Postmarketing surveillance is used to identify emerging hazards and determine whether they represent genuine increases in risk.Individual medical device reports are important in identifying hazards, providing public visibility and alerting regulators, clinicians, and researchers to previously unrecognised problems. Direct reports to the US Food and Drug Administration’s (FDA’s) Medical Device Reporting programme have provided the initial signal for many FDA medical device safety communications.1 However, spontaneous reporting systems are limited by underreporting, incomplete information, uncertain causality, and a lack of reliable information on how many patients received each device.23 These systems can generate hypotheses but cannot reliably estimate incidence or compare device performance.In the linked study (doi: 10.1136/bmj-2026-100812),4 Zhou and colleagues identify important shortcomings in adverse...

The rapid expansion of testosterone prescribing risks broadening treatment from men with well characterised hypogonadism to people with non-specific symptoms and borderline biochemical findings, for whom the balance of benefit and long term risk are less certain.The testosterone replacement market in the UK was valued at around $205m in 2024 and is projected to grow substantially, reaching $365m by 2032.1 Testosterone prescribing in the NHS is rising rapidly: data from the NHS Business Services Authority show community dispensing rose by 52% between 2020-21 and 2024-25.2 In England, 429 women aged 50 or older received NHS prescriptions for testosterone gel in November 2015, compared with 4675 in November 2022.3 These figures count recipients, not prescriptions, and cannot establish whether treatment was appropriate.Private prescriptions are not recorded nationally, so the scale of private testosterone provision is unknown. However, several indicators suggest rapid growth: a proliferation of private and online clinics,2 subscription pricing...

Hospitals and ambulance services have been warned that blood ketone testing—vital for patients at risk of diabetic ketoacidosis (DKA)—may be disrupted amid recalls of testing strips.The NHS supplier Nova Biomedical has withdrawn and recalled specified lots of its StatStrip ketone test strips because of quality control failures and is continuing to test its stock. New shipments are not expected to reach the UK until the end of the month.In response, a national patient safety alert has been issued by the Medicines and Healthcare Products Regulatory Agency.1 It warned that “loss of testing capacity may result in delayed recognition or assessment of DKA, delayed escalation or hospital transfer, delayed treatment decisions, or impaired monitoring of response to treatment.”“DKA is a potentially life threatening condition, and such delays may contribute to severe clinical deterioration, critical illness, permanent harm or death,” it added.The testing strips are used across primary, community, and secondary care,...

Ministers have been warned by their own independent adviser of potential problems surrounding federated data platform (FDP) and its supplier, Palantir, as the government considers its future.1The national data guardian (NDG) for health and social care, Nicola Byrne, issued the warning in a letter to minister for health innovation James Frith.Byrne listed three major concerns: a lack of public and professional trust; the absence of clear, objective evidence of the platform’s benefits and limitations; and problems with interoperability, vendor lock-in, and data sovereignty.She added that the recent increase in the national data opt-out rates “is a significant concern,” noting that the rise coincided with growing public concern and media coverage of the FDP and Palantir.“Even modest bursts of increases in opt-out rates accumulate over time, potentially introducing bias and reducing the value of data for research, service improvement, and life sciences innovation,” she wrote.As of 22 September, around 3.6 million...

The International Criminal Court (ICC) has been urged to investigate whether Israeli doctors, as well as the Israeli Medical Association and officials from the Israeli ministries of health and defence, have been involved in the “death, torture, and ill treatment of Palestinian detainees.”1The Hind Rajab Foundation (HRF) has filed a communication under article 15 of the Rome Statute—a mechanism that allows anyone to submit information relating to alleged crimes for assessment by the Office of the Prosecutor—with the ICC, regarding events at the Sde Teiman detention facility.Natacha Bracq, the HRF’s head of litigation, said, “The evidence shows that medical participation in torture and abuse at Sde Teiman was structural. The medical system kept detainees alive to endure further torture and interrogation while ensuring their injuries could not be traced through clinical records.“HRF’s article 15 submission calls on the ICC prosecutor to investigate this system for what it is: a chain...

Health professionals must be protected from attacks in times of conflict, the World Medical Association (WMA) has reaffirmed in a declaration1 adopted at its general assembly on 10 October.Known as the Declaration of Rotterdam, the statement calls on states and armed groups to protect medical workers, patients, and healthcare infrastructure during war. It also reiterates that doctors and other healthcare professionals have a duty to provide impartial care to all patients, regardless of their roles in a conflict, and must not participate in military operations.The WMA president, Jung Yul Park, said, “The principles of medical ethics do not change in times of war. Physicians must be free to treat patients regardless of their role in the conflict, without fear of sanctions, intimidation, or interference.”Healthcare facilities are protected under international humanitarian law,2 but attacks on medical staff and infrastructure have risen markedly in the past six years.3 Reporting by The BMJ...

Doctors must be more transparent with patients and families about the role of antimicrobial resistance (AMR) in deaths, especially among cancer patients, the UK’s special envoy on AMR says.Speaking at the World Health Summit in Berlin, Sally Davies—England’s previous chief medical officer—said it was common for families to understand a death as being caused by cancer without being told that an untreatable infection had contributed.Instead, greater openness and patient advocacy were needed to urge political action on AMR, she argued.“When patients die … the relatives think of cancer and they had an infection. No one says actually it was untreatable; it was AMR,” she said.“AMR is much more common in cancer patients, and one in four have serious infections. We’ve got to be much more open. We’ve got to communicate; we’ve got to get the patients talking about it.”Davies was speaking at the launch of the Lancet commission on 21st...

Bangladesh’s measles death toll could now be as high as 1144,1 with most of the deceased being children.These figures come amid an investigation into the country’s national immunisation programme and the current deadly outbreak.The latest update from the government (8 October) showed that, since mid-March, there were 201 625 suspected measles cases and 22 116 confirmed cases.2There have also been 1040 suspected and 104 confirmed deaths.But Bangladeshi officials warned that these were likely an underestimate.In April, a senior official at the Directorate General of Health Services told The BMJ that the case and death toll was probably higher owing to a lack of laboratory capacity to confirm cases, as well as delayed treatment, and deaths being recorded as the result of other causes.3The current outbreak started in January, with the first case detected in the Cox’s Bazar camp for Rohingya refugees, but cases began spiking in March.Writing in The BMJ,...

Any government that sells patient data is “betraying the trust” of its people, a leading expert on AI in health has said.Speaking at the European Health Forum Gastein earlier this month, Ricardo Baptista Leite, chief executive officer of HealthAI—a non-profit group focused on promoting the safe, responsible, and regulated use of AI in healthcare—urged governments not to buy or sell patient data and to condemn those that do.Leite, a Portuguese-Canadian doctor, also warned of a knowledge and power imbalance between the “tech bros” running AI companies and civil society—an imbalance he said could lead to greater health inequalities.His comments come as pressure mounts on NHS England to end its health data contract with Palantir.1 The US company has been handling the NHS’s federated data platform since it won the contract in 2023. Doctors have said that they do not trust the company to handle health data, in the light of...

Mike Tyson and Russell Brand were among those who spoke at last week’s MAHA (“Make America Healthy Again”) Summit. The platforming of Tyson, a man convicted of violent sexual assault, and another, Brand, charged and due to stand trial for similar offences (charges which he denies), should discredit MAHA in the eyes of anyone interested in making America healthier. Inviting Tyson and Brand reveals a potential and important fissure in the MAHA movement, where problematic celebrity endorsements are prioritised over the concerns of its political supporters.Mike Tyson, heavyweight boxer and convicted rapist,1 joined Ultimate Human founder Gary Brecka, Ultimate Fighting Championship fighter Michael Chandler, and baseball player Noah Syndergaard as part of “The MAHA Athlete” panel at the 2026 MAHA Summit. Tyson has become a poster boy of the MAHA movement. He featured in a Super Bowl MAHA advert in 2026 where he told how his sister died of a...

I watched the surgeons make practised movements, bright lights illuminating each mesmerising flick of their wrists. A curtain formed a vital barrier between us. I was there only to assist, holding an instrument ready for the critical moment.Sweat poured down their faces. It was almost time.In perfect sync, they completed the final steps. For a single, breathless moment, they were still.The audience exploded with applause. Darkness swept the stage as the dancers ran off and I scurried on, rushing to set up the keyboard for the next act.I was nowhere near a hospital: I was a stagehand for The BMJ’s Medics’ Revue 2026.After being on hiatus since 2000, the revue was revived this year, taking place at the Shaw Theatre in London. As a BMJ Clegg Scholar, I joined the organising team for the final month of preparations and discovered the value of the event from behind the scenes.Around two...

The Leng Review became a deep disappointment after it was first published in summer 2025.1 Instead of being the moment when physician and anaesthesia assistant roles were reined in and refocused on supporting members of healthcare teams, it simply became another example of delaying tough decisions.As the BMA said at the time, it was an inadequate response to a patient safety scandal, particularly in its lack of support for a national scope of practice for physician assistants (PAs), and its failure to clearly reject PAs seeing undifferentiated patients.It was the latter that was most ominous—we have seen far too many examples of patient harm resulting from PAs being put in the position of being the only staff member that saw gravely ill patients when it could make a difference. The case of Emily Chesterton was only the most prominent of these.2Although the prescription fell well short, Leng’s diagnosis was accurate....

Health officials are warning of “ominous” signs of winter pressure already building in hospitals in England, as new data show flu levels soaring for this time of year.The UK Health Security Agency (UKHSA) said that flu levels were currently higher than the previous four years at the start of the agency’s winter reporting season.The UKHSA’s first weekly winter respiratory virus surveillance report1 shows that, while still at very low levels, flu has been rising since August, suggesting a potential early influenza season.The weekly reports are based on a range of indicators provided by GPs, hospitals, laboratories, and the wider community. This first report recorded that flu positivity—based on a percentage of people who test positive for the virus in hospital—was 6.5% in the week ending 4 October, up from 5% the week prior. In comparison, the previous four years have seen figures of about 1-3% at this time of year.Overall,...

Has the flu season started early?For the second year in a row, it looks like the influenza season has started early in England.“It is very early in the season, but the number of hospital admissions for flu are the highest that I can remember seeing at this time of year,” says Frankie Swords, national medical director at NHS England, speaking at a briefing on winter viruses on 8 October.The latest surveillance report from the UK Health Security Agency (UKHSA)—covering 28 September to 4 October 2026—shows that influenza activity is increasing, with a flu test positivity rate of 6.5%, up from 5% the previous week.1Meanwhile, hospital admissions for flu are at 1.97 per 100 000. As this is the first week of reporting on this figure, there is no comparison.The agency says that, although levels are still low, “flu trends have been rising since August, and there are possible signs that...

ADHD and autism diagnosis in England needs a “fundamental shift,” say the authors of a major government backed review.The Fonagy review1 was tasked with investigating rising demand for mental health, attention deficit/hyperactivity disorder (ADHD), and autism services in England and the factors driving this.Chaired by the clinical psychologist Peter Fonagy, the review was commissioned by then health and social care secretary Wes Streeting, against a backdrop of surging demand for NHS services in these areas. It found that more than 254 000 people were on the autism assessment waiting list in December 2025, while 560 000 were waiting for an assessment for ADHD.The report adds that estimates using NHS data suggest that autism has increased among 6-11 year olds more than 20-fold and among 12-17 year olds more than 40-fold.Published today, the almost 600 page report warns that “continuing as we are is not sustainable.” It advises, “The current system...

Dozens of people claiming to have sustained eye damage from using GLP-1 medications are suing Eli Lilly and Novo Nordisk, the makers of the blockbuster drugs.1Semaglutide and tirzepatide are now among the most widely used drugs to treat type 2 diabetes and promote weight loss.Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist marketed by Novo Nordisk under the brand names Ozempic, Wegovy, and Rybelsus. Tirzepatide, which acts on GLP-1 and glucose dependent insulinotropic polypeptide (GIP) receptors, is produced by Eli Lilly and available under the brand names Mounjaro and Zepbound.The condition at the centre of the lawsuits is non-arteritic anterior ischaemic optic neuropathy (NAION). It is sometimes described as a “stroke” of the optic nerve and is the most common acute optic neuropathy in people over 50.2Kevin Gendreau, an obesity medicine physician at the Weight & Wellness Center at Signature Healthcare in Brockton, Massachusetts, said of NAION: “Blood flow to...

A lack of equity, diversity, inclusion, and accessibility (EDIA) considerations is a well described challenge that threatens the scientific and ethical integrity of healthcare research.1 Underrepresentation is costly, unjust, and harms patients.1 Unintentional exclusion of patients who may most benefit from trial evidence is a central focus of many efforts to improve EDIA considerations in research, with the exclusion of black participants from cancer trials being an important example.1 Intentional exclusion of pregnant23 or cognitively impaired45 participants from trials that may most benefit these populations is an emerging area of concern. Further, a lack of understanding of structural discrimination relevant to the trial discipline can lead to erroneous conclusions. An important example is attributing findings from observational studies showing worse outcomes from covid-19 infection in black populations6 to biological mechanisms7 without considering how systemic overestimation of blood oxygen by pulse oximetry used on skin of colour8 influences access to treatments...

Oliver makes a valid point about the false binary of the “home good, hospital bad” credo.1 He rightly points out that the UK has the fewest beds per 1000 population of all developed countries and that community services for facilitating early discharge are sadly lacking. In addition to these points, most home discharges of patients who are “medically stable” but still requiring rehabilitation are heavily dependent on the presence of a fit and willing carer at home. In an increasingly ageing population, this frequently means an elderly spouse, often with their own medical needs.There is an alternative to direct discharge to home: community hospital rehabilitation care. There are still hundreds of community hospitals in the UK, providing skilled multidisciplinary inpatient rehabilitation.2 The UK government ignored the contribution of these hospitals during the covid-19 pandemic and continues to display astonishing ignorance of how many hospitals still exist and what potential they...

Last month the final report of the Thirlwall inquiry was published.1 The inquiry investigated the events at the Countess of Chester Hospital that surrounded the arrest and subsequent conviction of paediatric nurse Lucy Letby for the murder and attempted murder of several neonatal patients from 2015-16.I took an especially keen personal interest in the findings as I had been asked to give detailed written evidence to the inquiry on a range of issues around governance, safety culture, and regulation, all of which is online.2Among her observations and conclusions, Kathryn Thirlwall highlighted the role and attitude of senior managers at the trust.3 Doctors on the neonatal unit had repeatedly raised concerns about the possible role of Letby in unexplained patient harms and unexpected deaths. Yet these doctors had been ignored (p 14)4 and silenced (p 6),4 their concerns dismissed (p 58),3 and they had even been threatened with referral to the...