Guidelines and Safety Practices for Improving Patient Safety

This chapter explains why clinical practice guidelines are needed to improve patient safety and how further research into safety practices can successfully influence the guideline development process. There is a description of the structured process by which guidelines that aim to increase the likelihood of a higher score are created. Proposals are made relating to (a) the live updating of individual guideline recommendations and (b) tackling challenges related to the improvement of guidelines.

Patient Safety in the World

Patient safety is a fundamental principle of health care. However, many medical practices and risks associated with health care are emerging as major challenges for patient safety globally and contribute significantly to the burden of harm due to unsafe care. Available evidence suggests hospitalizations in low- and middle-income countries lead annually to 134 million adverse events, contributing to 2.6 million deaths. About 134 million adverse events worldwide give rise to 2.6 million deaths every year. Estimates indicate that in high-income countries, about 1 in 10 patients is harmed while receiving hospital care. This problem affects both high-income countries and low- and middle countries even if priorities and issues may differ. The most important adverse events concern medication procedures, healthcare-associated infections, surgical procedures, injection safety, blood transfusions, venous thromboembolism, sepsis, and diagnostic and radiation errors. Since 1999 when the Institute of Medicine (IOM) published its report “To err is human,” some progress has been made but patient harm is still a daily problem in healthcare. As a matter of fact, new threats are emerging due to population aging, along with new treatments and technologies which must be dealt with in addition to still-unresolved, long-standing problems. In this context, it is very important to adopt an international common strategy that creates networks, shares knowledge, programs, tools, good practices and develop and track indicators focusing on the specific priorities of each country and region.

From Theory to Real-World Integration: Implementation Science and Beyond

The increasing complexity and dynamicity of our society (and world of work) have meant that healthcare systems have and continue to change and consequently the state of healthcare systems continues to assume different characteristics. The causes of mortality are an excellent example of this rapid transformation: non-communicable diseases have become the leading cause of death, according to World Health Organization (WHO) data, but at the same time there are new problems emerging such as infectious diseases, like Ebola or some forms of influenza, which occur unexpectedly or without advanced warning. Many of these new diseases diffuse rapidly through the different parts of the globe due to the increasingly interconnected nature of the world. Another example of the healthcare transformation is the innovation associated with the introduction and development of advanced communication and technology systems (such as minimally invasive surgery and robotics, transplantation, automated antiblastic preparation) at all levels of care. Consequently, the social and technical dimensions of healthcare are becoming more and more complex and provide a significant challenge for all the stakeholders in the system to make sense of and ensure high quality healthcare. These stakeholders include but are not limited to patients and their families, caregivers, clinicians, managers, policymakers, regulators, and politicians. It is an inescapable truth that Humans are always going to be part of the healthcare systems, and it is these human, who by their very nature introduce variability and complexity to the system (we do not necessarily view this as a negative and this chapter will illustrate). A microlevel a central relationship in focus is that between the clinician and the patient, two human beings, making the health system a very peculiar organization compared to similarly high-risk organizations such as aviation or nuclear energy. This double human being system [1] requires significant effort (good design) in managing unpredictability through the development of personal and organization skills, such as the ability to react positively and rapidly to unexpected events and to adopt a resilient strategy for survival and advancement. In contrast to other similar industries, in terms of level of risk and system safety, healthcare settings are still plagued by numerous errors and negative events involving humans (and other elements) at various levels within the system. The emotional involvement is very high due to the exposure to social relationships daily and results in significant challenges to address both technical and non-technical issues simultaneously.

Patients for Patient Safety

Unsafe care results in over 2 million deaths per year and is considered one of the world’s leading causes of death. In 2019, the 72nd World Health Assembly issued a call to action, The Global Action on Patient Safety, that called for Member States to democratize healthcare by engaging with the very users of the healthcare system—patients, families, and community members—along with other partners—in the “co-production” of safer healthcare.The WHO’s Patients for Patient Safety (PFPS) Programme, guided by the London Declaration, addresses this global concern by advancing co-production efforts that demonstrate the powerful and important role that civil society, patients, families, and communities play in building harm reduction strategies that result in safer care in developing and developed countries. The real-world examples from the PFPS Programme and Member States illustrate how civil society as well as patients, families, and communities who have experienced harm from unsafe care have harnessed their wisdom and courageously partnered with passionate and forward-thinking leaders in healthcare including clinicians, researchers, policy makers, medical educators, and quality improvement experts to co-produce sustainable patient safety initiatives. Although each example is different in scope, structure, and purpose and engage different stakeholders at different levels, each highlights the necessary building blocks to transform our healthcare systems into learning environments through co-production of patient safety initiatives, and each responds to the call made in the London Declaration, the WHO PFPS Programme, and the World Health Assembly to place patients, families, communities, and civil society at the center of efforts to improve patient safety.

Organ Donor Risk Stratification in Italy

The permanent gap between organ demand and supply has prompted use of organs from extended criteria donors (ECD). These carry a higher risk of disease transmission, with regard to infections and malignancies. We present herein the donor risk stratification algorithm implemented in Italy since 2004 for identification management of donor-to-recipient risk of disease transmission. The principles underlying this algorithm are: (1) the risk of disease transmission must be assessed against the potential benefit for the transplant recipient (i.e., no donor can be excluded from evaluation and their organs might benefit potential candidates); (2) patients awaiting organ transplantation must be informed that the risk of disease transmission is small but finite (standard risk); and (3) risk evaluation is an ongoing process based on information collected longitudinally after transplantation. Regional and national transplant authorities are committed to regular updating of guidelines based on clinical data derived from clinicians and on evaluation of posttransplant graft and patient survival rates.

Infection Prevention and Control

Healthcare-associated infections (HAI) are adverse events exposing patients to a potentially avoidable risk of morbidity and mortality. Antimicrobial resistance (AMR) is increasingly contributing to the burden of HAIs and emerging as of the most alarming challenges for public health worldwide. Practically, harm mitigation and risk containment demand cross-sectional initiatives incorporate both approaches to infection prevention and control and methodologies from clinical risk management.

Patient Safety in Pediatrics

Since the publication of the 1999 IOM report “To Err Is Human: Building a Safer Health System,” much has been learned about pediatric patient safety. However, adverse events still affect one-third of all hospitalized children [1]. The main areas of adverse events are hospital-acquired infections, intravenous line complications, surgical complications, and medication errors [2].

Medication Safety

Pharmacotherapy is the most common therapeutic intervention in healthcare to improve health outcomes of patients. However, there are many instances where prescribed medications resulted in patient morbidity and mortality instead. Medication errors can happen at any step of the medication use process, but a substantial burden of medication-related harm is focused primarily on three priority areas of healthcare delivery: transitions of care, polypharmacy and high-risk situations. This chapter highlights prevalence of issues concerning these three core areas and describes common medication errors as well as risk mitigation strategies to improve service delivery. An appreciation of these inherent risks will enable healthcare providers to navigate the pitfalls better and make efforts to ensure medication safety while providing health services.

Patient Safety in Orthopedics and Traumatology

Orthopedics is a clinical branch considered to be at a high risk for medical malpractice claims. The aim of this work is to analyze the clinical risk and alleged malpractice in order to map professional risk and identify recurrent pitfalls.

Digital Technology and Usability and Ergonomics of Medical Devices

Trying to identify what digital medical technologies are today is a practically unresolvable task. Over the last few years, we have seen a radical change in these technologies; they have become not only extremely sophisticated and complex but also capable of maintaining evolving relationships with their users.