In a world where healthcare is more complex and interconnected than ever, ECRI stands as a trusted, independent nonprofit organisation dedicated to improving the safety, quality, and cost-effectiveness of care across all healthcare settings. With a foundation in evidence-based evaluations, patient safety expertise, and cutting-edge innovation, ECRI is reshaping the way healthcare systems approach risk, safety, and care delivery. At the heart of this transformation is a bold, holistic initiative: Total Systems Safety (TSS)
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Understanding Total Systems Safety
Healthcare is inherently human. It is a dynamic, collaborative practice reliant on people—clinicians, patients, caregivers, administrators—interacting within increasingly complex systems of care. As healthcare technologies evolve and settings diversify, the potential for risk and error grows. ECRI’s Total Systems Safety framework provides a comprehensive, programmatic solution designed to align clinical and safety operations in order to support high-reliability, resilient care delivery. This is not simply a methodology—it is a movement toward a truly human-centred healthcare system.
TSS focuses on redesigning how care is delivered, embedding principles that promote safe, efficient, and effective practices across every aspect of the system. ECRI's approach examines the total care ecosystem, identifying vulnerabilities and providing strategies to address them in a proactive, structured, and sustainable way.
The ECRI Difference
ECRI distinguishes itself through its transformative, systemic approach that centres around people. With a mission to Assess, Innovate, and Evaluate, ECRI operates at every scale—from individual departments to entire health systems. At every step, people are at the core of the analysis and design, ensuring that outcomes are rooted in real-world practice and needs.
As the first and only organisation capable of fully developing and implementing Total Systems Safety programs, ECRI provides end-to-end support: from initial assessments to innovation, execution, and long-term sustainability. This is supported by ECRI’s status as one of the largest Patient Safety Organisations (PSOs), providing data-driven insights based on the world’s largest adverse event database.
Pillars of TSS: Human Factors Engineering and Just Culture
Two critical components of ECRI’s TSS framework are Clinically Informed Human Factors Engineering (HFE) and the integration of a Just Culture philosophy. Each represents a transformative step toward building systems that truly support healthcare workers and protect patients.
Clinically Informed Human Factors Engineering
Human Factors Engineering is an applied science that merges psychology, engineering, and design principles to optimise human performance within systems. ECRI uniquely applies HFE to healthcare, creating environments and workflows that enable providers to deliver care safely and efficiently.
ECRI is the only nonprofit, independent safety organisation with formally trained Human Factors Engineers, whose collective experience spans healthcare, aviation, military, transportation, and academia. Their hands-on expertise enables ECRI to translate complex research into actionable strategies that improve system design, safety and reduce risk.
“ECRI’s team of independent, clinically informed human factors engineers has over 125 years of experience helping improve complex work systems,” said Patrice D. Tremoulet, PhD, HFE director. “We identify hidden barriers to healthcare quality and safety, resulting in workflows, technologies, care environments, and policies that support the work of healthcare providers, which results in enhanced patient outcomes and reduced provider burnout.”
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HFE underpins every aspect of Total Systems Safety. It ensures that training programs, clinical tools, workflow designs, and policies are all aligned with how healthcare professionals actually operate—reducing friction and preventing errors before they happen.
Building Resilience for the Future
“TSS equips organisations to build resilience against future challenges, such as staffing shortages, patient surges, and regulatory changes,” added Shannon Davila, MSN, RN, CPPS, CPHQ, CIC, FAPIC, executive director of TSS. “As a future-proofing strategy, this offers leaders a proactive approach to address long-term challenges and strengthens their organisation’s readiness for tomorrow’s demands.”
Just Culture: A Core Element of TSS
Within ECRI’s Total Systems Safety, Just Culture plays an essential role. It drives efficiencies, improves healthcare and reduces preventable patient harm by designing systems for impact and sustainability.
The Just Culture Company assists organizations in deploying a balanced system of accountability between the organization and employee that fosters a fair, learning culture – referred to as a “just culture” – by implementing its proprietary algorithm through advisory services, educational programs and coaching.
“Too many healthcare staff, through no fault of their own, are operating in poorly designed systems, with hierarchical cultures that prevent staff from speaking up about safety hazards and ‘near misses,’” explained Schabacker. “Not only does this lead to more incidents of patient harm, but it fuels high rates of burnout and stress among overworked healthcare personnel. We can’t train our way to improved safety and quality. Only through a cultural transformation can we adopt a completely new way of supporting and collaborating with our healthcare workforce.”
According to Schabacker, joining forces with The Just Culture Company is a milestone that reflects ECRI’s strategy to identify and mitigate the root causes of harm and inefficiency in healthcare.
The synergy between TSS and Just Culture ensures that human errors are contextualised and learned from. ECRI provides Just Culture across all levels of a healthcare organisation—from C-suite executives to frontline clinicians.
This approach is increasingly seen as essential by regulatory bodies. The CMS Patient Safety Structural Measure, taking effect in 2025 for US acute care hospitals, specifically mandates that hospitals demonstrate a culture prioritising patient safety, explicitly referencing Just Culture as a critical element.
home.ecri.org/pages/the-just-culture-company
The Just Culture Company: Cultural Transformation at Scale
The Just Culture Company helps organisations across industries create accountable, safe, supportive cultures. For 30 years, they have helped transform work systems that erroneously demand perfection from fallible human beings. CEO and founder David Marx worked as an engineer and human factors leader in the aviation industry, where he established an award-winning error investigation process in use by airlines around the world to this day. He led a research and consulting practice focused on the management of human error through the integration of systems engineering, human factors and the law. He advised the Federal Aviation Administration’s Human Factors Research Program and the NASA Space Shuttle Program. He developed novel risk modelling methods that have been used to model risk in high-consequence industries worldwide.
The Just Culture Company has helped healthcare institutions and regulatory agencies reduce the risk of iatrogenic patient harm. In the area of system design, David Marx’s novel error investigation process has been used to model and mitigate risks from wrong site surgery to medication errors.
The Just Culture Company assists organisations in deploying a balanced system of accountability between the organisation and employee that fosters a fair, learning culture – referred to as a “just culture” – by implementing its proprietary algorithm through advisory services, educational programs and coaching.
“Our just culture model is founded on the principle that workforce learning, holistic system design, mentoring, and coaching are stronger interventions than the ‘shame and blame’ culture that’s so prolific in healthcare,” said David Marx, CEO of The Just Culture Company. “Errors must be recognized and addressed in a way that become learning opportunities for all the people in the system.”
“Alarming rates of preventable harm are inflicted on patients every day. By offering Just Culture programs throughout ECRI’s global network, we can prevent harm before it happens,” said Marcus Schabacker, PhD, president and CEO of ECRI. “To create lasting change and improve patient and workforce safety, we must shift from evaluating accidents and errors after they’ve taken place, to designing systems and cultures that prevent harm from happening in the first place.”
home.ecri.org/pages/the-just-culture-company
Real-World Application and Impact
Several major health systems have already begun implementing TSS in partnership with ECRI. These initiatives are delivering measurable improvements in patient safety outcomes, workforce morale, and operational efficiency.
“Despite tireless efforts, serious risks persist within our fragmented healthcare system, with rates of preventable harm alarmingly high,” said Dheerendra Kommala, MD, chief medical officer at ECRI. “Traditional safety methods often fail to uncover and address the root causes of preventable harm. A systems-based approach goes further, tackling these underlying issues. This represents a transformative, integrated strategy—one that includes human factors and a commitment to equity—to establish a better, safer healthcare landscape for patients and the workforce.”
Complementary Safety Services: Extending the TSS Vision
Total Systems Safety integrates and amplifies ECRI’s broader suite of patient safety services, including:
- Infection Prevention & Control: Led by certified infection preventionists and epidemiologists, this service helps healthcare organisations reduce HAIs, manage outbreaks, and enhance sterilisation protocols through evidence-based practices. home.ecri.org/pages/infection-prevention-and-control-consulting-services
- Medication Safety: Through the Institute for Safe Medication Practices (ISMP), ECRI leverages decades of expertise in preventing medication errors. Confidential, objective assessments help organisations improve prescribing, dispensing, and administration practices. home.ecri.org/pages/ismp-about-us
- Device Safety: As the world’s only independent medical device testing laboratory, ECRI provides rigorous, hands-on evaluation of medical technologies. This ensures hospitals select the safest, most cost-effective tools for care delivery.
Shaping the Future of Healthcare
By placing people at the centre of system design, ECRI’s Total Systems Safety offers more than incremental improvement—it represents a paradigm shift in how healthcare is delivered and experienced. It empowers organisations to move from reactive models to proactive, resilient, and equitable systems that foster continuous learning and improvement.
As healthcare evolves, ECRI is committed to leading this transformation. Through a unique blend of data-driven insights, multidisciplinary expertise, and human-centred design, ECRI is not just imagining a better future for healthcare—it is building it.
Let’s think differently. Let’s think human-centred. Let’s think ECRI.