World Patient Safety Day, observed annually on 17 September, is a vital global public health initiative by the World Health Organization (WHO). This day brings together patients, families, caregivers, communities, health workers, healthcare leaders, and policymakers, recognising the crucial role of patients and families in ensuring patient safety. Resolution WHA 72.6, ‘Global action on patient safety,’ established the day to highlight patient safety as a global health priority.

 

The Theme for 2024: Improving Diagnosis for Patient Safety

The theme for World Patient Safety Day 2024 is “Improving Diagnosis for Patient Safety”, with the slogan “Get it right, make it safe!”. This theme underscores the critical importance of correct and timely diagnosis in ensuring patient safety and improving health outcomes. Accurate diagnosis is the cornerstone of adequate healthcare, enabling access to the necessary care and treatment.

 

The Impact of Diagnostic Errors

Diagnostic errors are significant contributors to patient harm, but they are also largely preventable. They involve the failure to establish a correct and timely explanation of a patient’s health problem, which can include delayed, incorrect, or missed diagnoses or a failure to communicate that explanation to the patient. These errors are responsible for nearly 16% of preventable harm across health systems globally, with most adults likely to encounter at least one diagnostic error in their lifetime.

 

Systemic and Cognitive Factors

Addressing systemic and cognitive factors to improve diagnostic safety is essential. Systemic factors include organisational vulnerabilities such as communication failures between health workers and patients, heavy workloads, and ineffective teamwork. Cognitive factors involve clinicians' training and experience, biases, fatigue, and stress that can affect their decision-making processes.

 

WHO's Multifaceted Approach

WHO is committed to working with all stakeholders to prioritise diagnostic safety. This involves a multifaceted approach that includes:

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1. Strengthening Systems: Designing safe diagnostic pathways and addressing systemic issues.

2. Supporting Health Workers: Enhancing training and providing tools to help clinicians make accurate decisions.

3. Engaging Patients: Encouraging active patient participation throughout the diagnostic process.

Global Efforts in Ensuring Patient Safety through Ethical Practices and Regulatory Compliance

Ensuring patient safety extends beyond patient care to the very inception of life science products. Around the world, manufacturers and innovators are diligently developing medicines, medical devices, and digital health solutions that adhere to stringent patient safety policies and practices. These entities ensure that quality products are created to enhance the efficiency and effectiveness of caregivers, doctors, and healthcare professionals who deliver safe and ethical treatments.

 

Governments globally play a pivotal role in enforcing patient safety by mandating best practices and ethical quality standards. Regulatory frameworks such as the European Union Medical Device Regulation (EU MDR), In Vitro Diagnostic Regulation (IVDR), ISO 13485, and the Medical Device Single Audit Program (MDSAP) establish comprehensive guidelines for manufacturers to follow. These regulations encompass various aspects, including clinical trials, human factor requirements, and Unique Device Identification (UDI) systems, ensuring a high standard of patient safety.

 

In the United States, the Food and Drug Administration (USFDA) enforces rigorous standards for medical products, requiring extensive pre-market approval processes and post-market surveillance. Additionally, clinical trial requirements and Post-Market Clinical Follow-up (PMCF) activities are critical components of these regulations, ensuring ongoing assessment of product safety and efficacy.

 

Harmonising these global standards promotes a unified approach to patient safety, encouraging manufacturers to adopt ethical practices and adhere to quality compliance requirements. By aligning with international regulatory requirements, such as those established by Health Canada, Japan's Pharmaceuticals and Medical Devices Agency (PMDA), and Australia's Therapeutic Goods Administration (TGA), manufacturers can ensure their products meet the highest safety standards.

 

Patient safety is continuously improved through collaborative efforts between governments, manufacturers, and healthcare providers. This commitment to ethical practices and regulatory compliance enhances the quality of care and reinforces patients' trust and confidence worldwide.

 

Delivering Global Support Locally

Patient safety is a paramount concern that extends from regulatory frameworks down to local implementation. Companies like Global Regulatory Services (GRS) and Med-Di-Dia are at the forefront of delivering global support to ensure compliance with these stringent regulations.

 

GRS: Supporting Life Science Companies Globally

Global Regulatory Services (GRS) offers comprehensive support to life science companies worldwide, assisting them in meeting the diverse regulatory requirements established by governments across different regions. GRS provides expert guidance throughout the product lifecycle, from development and clinical trials to market approval and post-market surveillance. Their expertise spans a wide range of regulatory frameworks, including EU MDR, IVDR, ISO 13485, MDSAP, and USFDA regulations.

 

Apart from offering regulatory support services, GRS is also committed to enhancing patient safety through education. The company regularly provides educational resources to manufacturers and other economic operators within the life sciences ecosystem. These resources offer high-level insights into compliance and regulatory affairs, helping companies stay informed about the latest regulatory developments and best practices. By empowering manufacturers with this knowledge, GRS further supports the creation of safe, effective products that adhere to global standards, ultimately enhancing patient safety across the industry.

 

Bobby Deal, Founder of GRS, emphasises the company's mission: “Our goal is to bridge the gap between innovation and regulatory compliance, ensuring that life science companies can bring safe, effective products to market while adhering to global standards.”

 

Med-Di-Dia: Specialising in Medical Devices, Diagnostics, and Digital Health

Med-Di-Dia focuses specifically on supporting medical device manufacturers, diagnostics companies, and digital health innovators. They provide tailored services to help these companies navigate the complex regulatory landscape, ensuring compliance with both international and local requirements. Med-Di-Dia's expertise includes assisting with clinical trials, human factor requirements, UDI systems, and ongoing regulatory updates.

 

Given the increasing frequency of product recalls, it is evident that patient safety is a top priority for regulators worldwide. Med-Di-Dia’s focus on compliance and safety ensures that manufacturers not only meet these stringent regulatory demands but also maintain the highest standards of patient care. Greer Deal, Director and Co-founder of Med-Di-Dia states, “We are committed to empowering medical device and diagnostics companies to achieve regulatory compliance and deliver innovative solutions that enhance patient safety and healthcare outcomes.”

 

ALM Translations: Enabling effective communication to enhance patient safety

ALM Translations understands the need for enhanced patient safety and is actively delivering it through its translation services catered specifically for the life science and healthcare industry. Translations play a pivotal role in ensuring that critical information is accurately conveyed across different languages and cultures, thereby minimising the risk of miscommunication that could lead to patient harm. In the context of global healthcare, where medical devices, diagnostic tools, and treatment protocols are increasingly used across diverse populations, high-quality translations ensure that healthcare professionals, patients, and caregivers have access to clear, precise information.

 

ALM’s translation services are tailored to meet the stringent demands of the life sciences sector, ensuring that all documentation, from clinical trial protocols to user manuals for medical devices, is accurately translated and localised. This attention to detail not only supports compliance with international regulatory standards but also enhances patient safety by ensuring that healthcare instructions and safety guidelines are understood by all stakeholders, regardless of language barriers. By providing linguistically and culturally accurate translations, ALM Translations contributes to safer healthcare practices and better patient outcomes globally.

 

eg technology: understanding users during product development is key to patient safety

An essential part of patient safety is ensuring that medical devices are used correctly, and consideration of use risk should form the backbone of successful product development, particularly within the MedTech sector, where errors due to a lack of user understanding or poor usability design could have fatal consequences. It is, therefore, crucial that usability engineering (human factors) is employed early in the product development programme in order to derisk the process so that any problems can be identified, factored in and subsequently mitigated and tested. This includes gaining an understanding of reasonable ‘misuse’, which is often overlooked but is critical for the risk mitigation process and can be addressed through user testing. IEC 62366 application of usability engineering to medical devices specifies the process that must be followed.

 

It is worth noting that the level of usability testing and human factors employed should be commensurate with the level of risk identified. There are also commercial benefits to considering usability throughout the development process. A demonstrably safe, intuitive, and effective product that has been developed with the end-user will likely have increased commercial success. For those wanting to understand more about how to integrate usability into their product development, an eBook by eg technology, User-centred design; the key to successful medical device development, is a useful resource to help build a user-centric, integrated development roadmap and to facilitate the creation of a successful, market-ready medical device.

 

BeanStock Ventures: Ensuring Compliance and Cybersecurity for Patient Safety

In the complex landscape of healthcare innovation, regulatory compliance might not be the most glamorous aspect, but it is undeniably crucial—particularly when patient safety is on the line. BeanStock Ventures specialises in navigating the intricate web of regulations that govern the healthcare industry, ensuring that new products not only meet technical and design standards but also adhere to essential legal and regulatory requirements.

 

As one of only seven FDA-accredited Third Party Review Organisations globally, they offer unparalleled expertise in regulatory compliance, including adherence to FDA, IEC, ISO and NIST standards, GDPR, HIPAA, and other critical regulations. Their proactive approach ensures that products are compliant with current standards and prepared for future regulatory landscapes, minimising the risk of costly legal repercussions and delays.

 

Patient safety is at the forefront of BeanStock Ventures' mission, particularly in the realm of cybersecurity. In an era where digital health solutions are increasingly vulnerable to cyber threats, ensuring robust cybersecurity measures is essential to protecting patient data and maintaining trust. BeanStock Ventures integrates cybersecurity into its clients' software development processes, ensuring that healthcare products are secure and compliant with stringent regulatory requirements.

 

EIT Health: Leading Patient Safety through Community Collaboration

EIT Health is a dynamic and expansive community of leading health innovators supported by the European Union. With a mission to drive healthcare innovation and create positive societal impact, EIT Health brings together the brightest minds from business, research, education, and healthcare delivery across Europe. Through cross-border collaboration, the organisation creates an environment where innovation can thrive, addressing the most pressing health challenges that Europe faces today.

EIT Health’s vast community connects around 130 leading organisations, exceptional in the worlds of business, education, research, and health service delivery, with thousands of start-ups, entrepreneurs, and healthcare professionals.

 

The organisation funds a diverse range of projects and programmes focused on education, innovation, and business creation, all aimed at fostering healthcare. These activities are strategically aligned with flagship initiatives that tackle the fundamental drivers of health, ensuring that EIT Health’s impact is both deep and wide-reaching. Find out more about their current flagship call.

 

The organisation also influences policy and launches initiatives that make Europe a nurturing ground for talent and innovation. By doing so, EIT Health not only improves lives but also contributes to a robust and sustainable health economy. With a significant pan-European presence, EIT Health operates through seven Co-Location Centres and InnoStars. EIT Health Ireland-UK is one such co-location centre, connecting innovators across the region, contributing to the organisation’s goals of promoting better health of citizens, strengthening healthcare systems, and contributing to a sustainable health economy in Europe. Connect today to learn more about their open opportunities leading to safer patient experiences.

 

Xenon Health Solutions: Delivering Patient Safety with Research and Development

 Xenon Health Solutions is a leader in delivering evidence-based solutions for health projects, combining in-depth experience with practical expertise to ensure patient safety across all stages of product development. Specialising in supporting MedTech and Life Science startups, Xenon Health Solutions provides comprehensive support from research and development (R&D) through to commercialisation, ensuring that safety and efficacy are embedded in every step of the process. By offering tailored solutions that address the unique challenges faced by startups, Xenon Health Solutions helps to accelerate the development of innovative healthcare products while maintaining the highest standards of patient safety.

 

Robust clinical development and planning for health products are vital for ensuring patient safety. A well-structured clinical development process, including comprehensive trials and rigorous testing, helps identify potential risks, side effects, and efficacy issues early on. Careful planning ensures that clinical trials are ethically conducted, with proper monitoring and adherence to regulatory standards, minimising harm to participants. This approach allows for the collection of high-quality data, which is crucial for making informed decisions about product approval and patient use. Ultimately, it fosters the development of safer, more effective health products, enhancing patient trust and safeguarding public health outcomes.

 

By supporting startups through the commercialisation phase, Xenon Health Solutions ensures that emerging healthcare solutions are not only innovative but also safe and effective for patient use. This end-to-end support plays a critical role in advancing patient safety and fostering the successful introduction of new medical technologies into the healthcare market. 

 

A Unified Commitment to Patient Safety: The Global Impact on Local Implementation

As we conclude our reflection on World Patient Safety Day 2024, it is evident that the collective efforts of organisations like Global Regulatory Services (GRS), Med-Di-Dia, ALM Translations, eg technology, BeanStock Ventures, and EIT Health are pivotal in ensuring that global regulatory standards translate into tangible safety outcomes at the local level. These organisations not only navigate the complexities of compliance and regulation but also actively contribute to the creation of safer healthcare environments through their specialised services.

 

By supporting life science companies and healthcare innovators in adhering to rigorous international standards, these entities ensure that products and solutions brought to market are not only effective but also safe for patient use. Their work underscores the essential nature of regulatory compliance, usability, accurate communication, and cybersecurity—all of which are critical components in preventing patient harm and ensuring that healthcare advances do not come at the cost of safety.

 

In a world where the stakes of patient safety are higher than ever, these organisations exemplify how global standards can be effectively implemented locally, ultimately leading to improved healthcare outcomes. Their unified commitment to patient safety reinforces the core message of this year’s theme: “Get it right, make it safe.” Through their expertise and dedication, they help build a healthcare system that prioritises patient well-being at every step, ensuring that innovation and safety go hand in hand.