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Beyond Compliance is a service to support the safe and stepwise introduction of new or modified implantable medical devices. An independent panel of experts, known as the Beyond Compliance Advisory Group, work with the implant manufacturer to assess the relative risk of any new product, and the rate at which it should be introduced to the market. The service collects data about patients who receive these implants and about their recovery following surgery. This data is made available to clinicians using the implant, to the manufacturer, and to independent assessors from the Beyond Compliance Advisory Group, to provide real-time monitoring of the implant’s performance. The clinicians who agree to joining the advisory group are drawn from the most experienced and respected members of their field. Beyond Compliance is an optional service available to implant manufacturers. The service commenced in the field of joint replacement implants. Following the success of the introduction of Beyond Compliance to Orthopaedic there are now plans for it to be extended for use with other implantable medical devices.

Diane Vaughan is an American sociologist who devoted most of her time on topics such as 'deviance in organisations'. One of Vaughan's theories regarding misconduct within large organisations is the normalisation of deviance. Here, she uses healthcare to explain how harmful behaviours can become normalised and offers up solutions.  Social normalisation of deviance means that people within the organisation become so much accustomed to a deviant behaviour that they don’t consider it as deviant, despite the fact they exceed their own rules for the elementary safety. People grow more accustomed to the deviant behaviour the more it occurs . To people outside of the organisation, the activities seem deviant; however, people within the organisation do not recognise the deviance because it is seen as a normal occurrence. In hindsight, people within the organisation realise that their seemingly normal behaviour was deviant. Diane Vaughan uses healthcare to illustrate why deviance is normalised in companies. She gives four major reasons why it happens: "The rules are stupid and inefficient." System operators will often invent shortcuts or workarounds when the rule, regulation, or standard seems irrational or inefficient. Knowledge is imperfect and uneven. System operators might not know that a particular rule or standard exists; or, they might have been taught a system deviation without realising it. "I’m breaking the rule for the good of my patient!" This justification for rule deviation is where the rule or standard is perceived as counterproductive. Workers are afraid to speak up. The likelihood that rule violations will become normalised increases if those who witness them refuse to intervene. Yet, studies show that people feel it is difficult or impossible to speak up. Solutions Vaughan offers the following suggestions for helping to prevent deviant behaviours from becoming normalised: Education is the best solution for the normalisation of deviance. Diane Vaughn states, "the ignorance of what is going on is organisational and prevents any attempt to stop the unfolding harm." Being clear about standards and rewarding whistleblowers is part of the education that should take place. A company must be transparent about their standards and consequences of not meeting them. Also, creating a culture that is less individualistic and more team-based is helpful to stop the normalisation of deviance. Each person should be looking out for the company and team as a whole. If it were more team-based, each person would feel like they were letting their colleagues down if they were to break the rules. A top-down approach is very important. If the employees see executives breaking rules, they will feel it is normal in the company's culture. Normalisation of deviance is easier to prevent than to correct. Companies must make sure they take the correct steps to prevent it.

Hospital Watchdog is a nonprofit patient advocacy organisation in the US that champions safe hospital care for patients. They are a diverse group that includes nurses, physicians, pharmacists, healthcare experts, attorneys and members of the public. Some of them have experienced or witnessed medical errors that led to an extremely serious or tragic outcome. They are committed to improving unsafe conditions in hospitals. In February 2019, Hospital Watchdog conducted an in-depth interview with Ms. Dena Royal, a former paramedic, and respiratory therapist. Dena’s mother, Martha Wright, bled to death following a colonoscopy and a series of tragic nursing mistakes at Cass Regional Medical Center in Harrisonville Missouri. Dena’s vigilance and persistence as a whistleblower led to an investigation by The Centres for Medicare and Medicaid Services (CMS). Based on interviews and a review of hospital records, CMS found specific events contributing to her mother’s death and issued findings in a Summary Statement of Deficiencies. Among the key problems, Martha had not been thoroughly assessed when changes in her condition occurred. In one instance, at 10:15pm, (14 hours after the procedure), the Registered Nurse failed to perform a thorough assessment, that included vital signs and notifying the doctor. The CMS report also showed how after Martha’s death the hospital tried to cover up what happened.

The Montgomery case in 2015 was a landmark for informed consent in the UK. Nadine Montgomery, a diabetic woman and of small stature, delivered her son vaginally; her son experienced complications owing to shoulder dystocia, resulting in hypoxic insult with consequent cerebral palsy. Her obstetrician had not disclosed the increased risk of this complication in vaginal delivery, despite Montgomery asking if the baby's size was a potential problem. Montgomery sued for negligence, arguing that, if she had known of the increased risk, she would have requested a caesarean section The Supreme Court of the UK announced judgement in her favour in March 2015. It established that, rather than being a matter for clinical judgment to be assessed by professional medical opinion, a patient should be told whatever they want to know, not what the doctor thinks they should be told. This ruling means that patients can expect a more active and informed role in treatment decisions, with a corresponding shift in emphasis on various values, including autonomy, in medical ethics

‘Letter from America’ is a Patient Safety Learning blog series highlighting fresh accomplishments in patient safety from the United States. The series will cover successes large and small. I share them here to generate conversations through the hub, over a coffee and in staff rooms to transfer these innovations to the frontline of UK care delivery. Colour is a hallmark of Autumn across the US. A more spectacular set of colours, in a variety of shapes and sizes, paint the sky at daybreak every October in New Mexico. The Albuquerque International Balloon Fiesta is the largest gathering of its kind. In 2019, its 48th year, the fiesta hosted 550 hot air balloons, 650 pilots and entertained close to 900,000 visitors. The event holds a place on the bucket lists of travellers around the world. It is hard to describe the feeling of glee standing amid a mass ascension until you’ve been there amongst the early morning crowds. You might think it’s all fun, funnel cakes and floating but—like any aviation activity—ballooning entails risk. Make no mistake, the balloonists and their teams, the organisers, law enforcement, and even participants play a role in the safety of the event. Before sunrise each day, the “dawn patrol” of 8–10 hot air balloonists lift off. These experienced pilots gage the safety of the sky prior to the authorities giving the signal for the assent to begin. Only after that, does the wave after wave of multiple balloons unpack, gear up, inflate and take off from the field. Crews mull about, patiently navigating their designated space amongst onlookers and their cameras to get ready for flight. They implement standard procedures to safely gear-up for flight. Healthcare, too, prepares teams for complex situations to ensure safety through standardisation and practice. The US healthcare accreditation agency, the Joint Commission, shared insights on reducing maternal harm due to postpartum haemorrhaging that summarises best practices centered on readiness, recognition, response and reporting to support systems learning. Stanford Medicine in California recently held a series of “dress rehearsals” prior to opening a new hospital. The test of the space gave clinicians, administrators and patient advisors a chance to make sure conditions were right for a safe opening day. The fiesta organisers also deploy tactics to learn from what doesn’t go well. They use technology to gather input from crews and the public to identify areas for improvement. Traffic into the 360-acre launch site creates ineffective and potentially dangerous situations given the swell of people arriving in town. Attendees almost double the size of the city for the 10-day event. Public input gathered online helped planners to redesign this year’s park and ride shuttle system after it failed in 2018 to reliably get people to the festival. Hospitals also use information technology to learn how to improve the safety of the care experience. Researchers in Washington State developed a 4-step model built on inpatient experiences with undesirable events. They used patient and family knowledge to design informatics solutions that engage patients as contributors to safety. The model supports raising awareness of problems, encouraging prevention actions, managing emotional harms and reducing barriers to reporting .A rare situation stalled the festival this year: fog. Yes, fog is not something New Mexican’s encounter often but it shut down opening day morning—none of the balloonists could take off. This unique occurrence would have been all the more problematic had teams not heeded safety advice in this less-than-ideal situation. Practices and protocols keep patients safe too but only if they are followed. A unique set of circumstances led to the death of a patient awaiting care in a Pennsylvania emergency department. Protocols weren’t followed limiting situation awareness, communication and process completion. Balls were dropped and the results were tragic. Complex systems can manifest unintended consequences from strategies designed to protect people. Balloon fiesta has its share of mishaps. Pilots end up in the Rio Grande, drift into powerlines, bones get broken and, rarely, lives are lost. The expert crews mean well but failures happen. A nurse in Tennessee who made a medication mistake that resulted in patient death was charged criminally. While lawmakers may feel this is a just approach, it is a threat to healthcare transparency. A series of incidents involving misdiagnosis of child abuse is raising concerns in the US. While specialised paediatricians can readily identify patient conditions that indicate abuse, sometimes those judgements are made in error. The decisions made to protect children instead accuse innocent parents or family members of harm. The safe flight of those families then tumbles to the ground. The pace is back to normal in Albuquerque. Balloons still float above us in the morning and afternoon—'tis the season. They brighten the clear blue skies with the Sandia mountains as a backdrop. But you can bet that what did go wrong this year will be folded into the event planning so all that participate in the 2020 festival will be as safe as possible.

In this BMJ article, James Reason discusses how the human error problem can be viewed in two ways: the person approach and the system approach. Each has its model of error causation and each model gives rise to quite different philosophies of error management. Understanding these differences has important practical implications for coping with the ever present risk of mishaps in clinical practice. Key learning points Two approaches to the problem of human fallibility exist: the person and the system approaches. The person approach focuses on the errors of individuals, blaming them for forgetfulness, inattention, or moral weakness. The system approach concentrates on the conditions under which individuals work and tries to build defences to avert errors or mitigate their effects. High reliability organisations—which have less than their fair share of accidents—recognise that human variability is a force to harness in averting errors, but they work hard to focus that variability and are constantly preoccupied with the possibility of failure.