IWD and patient safety

Ensuring patient safety for women

Anna Paisley explores the impact of systemic gender bias in healthcare

Male bias in healthcare affects outcomes for women and gender-diverse individuals. Historical and ongoing systemic biases in medical research, diagnosis, treatment and clinical decision-making contribute to disparities that compromise patient safety. 

Bias in medical research

In Invisible Women: Exposing Data Bias in a World Designed for Men, Caroline Criado Perez highlights several medical disparities arising from a gender data gap. Research indicates that women are 50% more likely to be misdiagnosed following a myocardial infarction because of failure to recognise signs, formerly attributed as ‘atypical,’ and biomarkers geared towards men. Underrepresentation of women in medical research is a major contributor to patient safety risk. Clinical trials traditionally relied on male participants, leading to a gap in understanding how diseases and treatments affect women. Guidelines, drug dosages and treatment protocols are often based on male physiology, which can lead to misdiagnosis, ineffective treatments and harmful side-effects for women.

Disparity in drug reactions

A 2020 study found that women experience almost twice as many adverse drug reactions than men. Many medications developed and tested primarily on male subjects lack sufficient consideration of hormonal, metabolic and body composition variations between sexes.

Adverse outcomes for women with heart failure highlight the evidence gap inherent in such research due to gender bias. Between 1987 and 2012, women made up only 25% of participants in more than 31 major trials in treatment of congestive heart failure, thus many heart medications are less effective in women than in men. The thalidomide tragedy of the 1960s was partly caused by a lack of appropriate drug trials but, in 1977, the Food and Drug Administration in the US issued a precautionary ban on women of child-bearing age being included in clinical trials, thus perpetuating their underrepresentation and the risk of harm from medication. A 2011 study found this lack of trial data on pregnant women meant the teratogenic risk of up to 98% of drugs is ‘undetermined’.  

Gender bias in medical devices 

Medical devices, designed with male physiology as the default, increase risks for female patients. Similar to the use of crash-test dummies, medical implants such as artificial heart valves and hip replacements have been modelled and tested primarily on men, leading to complications and poor outcomes in female patients.

Dismissal of women’s symptoms

Studies have shown that women’s pain and symptoms are often underestimated or dismissed. Women reporting pain are more likely than men to be prescribed antidepressants or inadequate interventions rather than effective pain relief. This bias can lead to delay in the diagnosis and treatment of serious conditions.

First Do No Harm, Baroness Julia Cumberlege’s 2020 report into pelvic mesh implants, sodium valproate and hormone pregnancy tests, uncovered patient safety failings leading to avoidable harm from these interventions over several decades. Women involved reported years of dismissal by clinicians and regulators. This landmark report led to the appointment of the first Patient Safety Commissioner for England.

A 2024 UK parliamentary enquiry into women’s reproductive health conditions, including endometriosis, concluded that clinicians often exhibit ingrained beliefs that women, especially those from ethnic minority groups, are exaggerating their symptoms, describing this as unacceptable misogyny and racism.

This report also recommended that the NHS monitor and enhance protocols governing healthcare procedures that cause severe pain in some women, such as IUD fitting and hysteroscopy, in response to patient groups reporting long-lasting trauma from such procedures but often feeling belittled or patronised when raising concerns.

Impact of informed consent

Both the above enquiries heard from women who described a lack of information to allow them to make informed choices about treatment.

The UK Supreme Court ruling Montgomery versus Lanarkshire Health Board in 2015 embedded the principles of informed consent in law. Despite this, many women taking sodium valproate in pregnancy did so without knowing the risks to their unborn child. Patients experiencing severe pain during hysteroscopy were often not aware of the option of anaesthesia. Many women spoke of being met with parentalistic, sexist and misogynist attitudes when seeking further information on alternatives or, concerningly, when trying to withdraw consent. Failure of informed consent, traumatic experiences and the inherent loss of trust can have long-lasting effects on the health of women who frequently need important further tests or ongoing treatment.

IWD provides a focus for us all to accelerate the changes needed to rectify the gender gap in health and social care that leads to poorer outcomes for our patients.

Inspirational leaders

Meet some of the dedicated women driving forward patient safety

The patient safety community is fortunate to have many inspirational, talented and dedicated women working towards safer outcomes for all patients. These leading women work with government, medical organisations and patient groups. Through their tireless advocacy and dedication, they strive for continuous improvements in patient safety and changes in healthcare policy. Here we celebrate some of these leaders and their associations with our College.

Many national organisations engaged in patient safety have women in prominent leadership positions. Helen Hughes is the Chief Executive of Patient Safety Learning, a UK-based charity dedicated to improving patient safety and reducing avoidable harm in healthcare systems. Hughes has been as valued member of the RCSEd Patient Safety Group (PSG) since 2023. Professor Scarlett McNally, Consultant Orthopaedic Surgeon, is Deputy Director of the Centre for Perioperative Care. She advocates for the consistent application of National Patient Safety Standards for Invasive Procedures (NatSSIPs), which aim to enhance patient safety and teamwork across various medical settings, expanding on the World Health Organization (WHO) checklist. Dr Annie Hunningher, Consultant Anaesthetist, has been instrumental in NatSSIPs implementation.

In government, leading women are driving national policy. Dr Henrietta Hughes was appointed England’s first Patient Safety Commissioner in 2022, an independent role established following the recommendations of the First Do No Harm report. Dr Hughes has been instrumental in developing and promoting the Patient Safety Principles, a framework designed to facilitate collaborative efforts with patients in planning and decision-making processes.

Several women leaders in patient safety have links and associations with our College and have been influential in shaping our patient safety culture and portfolio. Professor Rhona Flin, Professor of Industrial Psychology at Robert Gordon University in Aberdeen, together with Consultant Anaesthetist Dr Nikki Maran, has been instrumental in developing RCSEd’s Non-Technical Skills for Surgeons taxonomy, integrating NTS into medical education and practice to improve patient safety outcomes. Furthermore, both the Chair and Deputy Chair of the PSG are women.

Many advocates for patient safety have suffered personal loss or experienced adverse outcomes. Their experience and insight provide some of the most powerful drivers for change. These women share a determination to cascade learning and help prevent future tragedies, turning adverse events into catalysts for systemic change. By their advocacy, they promote a safer, more transparent, inclusive and compassionate healthcare environment.

Merope Mills became a prominent patient safety advocate following the death of her 13-year-old daughter, Martha, from sepsis in 2021. Martha’s death occurred after a series of medical oversights, when her condition deteriorated without appropriate escalation to intensive care despite her parents’ concerns. Mills initiated the campaign for Martha’s Rule to empower patients and their families to request an additional urgent clinical review if they feel their concerns are not being adequately addressed. 

Leilani Schweitzer’s advocacy stems from the loss of her son, Gabriel, who died in 2005 due to a series of medical errors. She emphasises the critical need for honest disclosure and empathetic responses following medical errors, advocating for a healthcare environment where patients and families feel heard and supported.

Nadine Montgomery is known for her landmark legal action, which significantly reshaped the standards of informed consent in medical practice. A type-one diabetic, pregnant with her first child in 1999, she was not informed about all options for delivery. Subsequently, shoulder dystocia occurred, her son suffering brain damage and cerebral palsy. The UK Supreme Court established that healthcare professionals have a duty to disclose all material risks associated with treatment options, enabling patients to make informed decisions about their care.

Clare Bowen’s journey into patient safety advocacy began in 2007 when her five-year-old daughter, Beth, died during laparoscopic splenectomy for spherocytosis. Damage to Beth’s aorta by an instrument, not previously used by the operating team, caused major uncontrollable bleeding. Determined to prevent future such tragedies, Bowen became an advocate for patient safety, focusing on the importance of human factors in healthcare. We are delighted that she was able to join the PSG in 2024.

Margaret Murphy has been a prominent patient safety advocate since 1999 when her son, Kevin, aged 21 died due to misdiagnosis and inappropriate care. In 2005, Murphy joined the WHO Patients for Patient Safety programme and is now its Lead External Advisor. She kindly contributed to RCSEd’s Dealing with Mistakes workshop in October last year.

The PSG is delighted that so many leaders in patient safety work with us at RCSEd to develop our patient safety culture and portfolio. We look forward to ongoing collaborations towards a safer more equitable future.