Director of Professional Practice Mr. Stewart Whitley reports on “WHO NGOs meeting on medical technologies (Med dev and IVDs)  and infrastructure , during the Executive Board 146.- 5th February 2020 – Patient safety and Global action on patient safety”.

Through the modern medium of WebEx technology, I was able to join remotely a meeting held in Geneva of NGOs associated with medical technologies. This catch up meeting focused on a variety of topics and initiatives for NGOs during 2020.

Uppermost was a discussion was the WHO’s 72nd World Health Assembly (WHA72) resolution on Global Action of Patient Safety and the WHO Director General report.

Report Abstract:-
1.    In January 2019, the Executive Board at its 144th session noted an earlier version of this report;1 the Board then adopted resolution EB144.R12.

2. The global landscape of health care is changing, and health systems operate in increasingly complex environments. While new treatments, technologies and care models can have therapeutic potential, they can also pose novel threats to safe care. Patient safety is now being recognized as a large and growing global public health challenge. Global efforts to reduce the burden of patient harm have not achieved substantial change over the past 15 years despite pioneering work in some health care settings. Safety measures – even those implemented in high-income settings – have had limited or varying impact, and most have not been adapted for successful application in low- and middle-income countries.

3. All Member States and partners are striving to achieve universal health coverage and the Sustainable Development Goals. However, the benefits of increased access to health care have been undermined by service structures, cultures and/or behaviours that inadvertently harm patients and may lead to fatal consequences. Global action on patient safety will enable universal health coverage to be delivered while reassuring communities that they can trust their health care systems to keep them and their families safe. Policymakers will want to assure that, in planning and resourcing their vision of universal health coverage, they are not presiding over flawed and wasteful models of care


4. It is estimated that 64 million disability-adjusted life years are lost every year because of unsafe care worldwide. This means that patient harm due to adverse events is probably one of the top 10 causes of death and disability in the world.2 Available evidence suggests that annually 134 million adverse events due to unsafe care occur in hospitals in low- and middle-income countries, contributing to
2.6 million deaths.1 Approximately two thirds of the global burden of adverse events resulting from unsafe care, including the disability-adjusted life years lost from them, occurs in low- and middle-income countries.2 Estimates indicate that in high-income countries, about 1 in 10 patients is harmed while receiving hospital care.3

5. Many medical practices and risks associated with health care are emerging as major challenges for patient safety and contribute significantly to the burden of harm due to unsafe care. For example:

• Medication errors are a leading cause of injury and avoidable harm in health care systems: globally, the cost associated with medication errors has been estimated at US$ 42 billion annually;4

• Health care-associated infections prevalence in mixed patient populations of high-income countries is about 7.6% and about 10% in low- and middle-income countries, according to data from a number of countries.5 In addition, people with methicillin-resistant staphylococcus aureus are estimated to be 64% more likely to die than people with a non-resistant form of the infection;6

• Unsafe surgical care procedures cause complications in up to 25% of patients; almost 7 million surgical patients annually suffer significant complications, 1 million of whom die during or immediately after surgery;7

• Unsafe injections practices given in health care settings can transmit infections, including HIV and hepatitis B and C, and pose direct danger to patients and health care workers; they account for an estimated 9.2 million disability-adjusted life years lost per year worldwide;2

 Diagnostic errors occur in about 5% of adults in ambulatory care settings, more than half of which have the potential to cause severe harm; most people will suffer a diagnostic error in their lifetime;1

• Unsafe transfusion practices expose patients to the risk of adverse transfusion reactions and transmission of infections;2 data on adverse transfusion reactions from a group of 21 countries show an average incidence of 8.7 serious reactions per 100 000 distributed blood components;3

• Radiation errors involve overexposure to radiation and cases of wrong-patient and wrong-site identification;4 a review of 30 years of published data on safety in radiotherapy estimates that the overall incidence of errors is 1500 per 1 million treatment courses;5

 Sepsis is frequently not diagnosed early enough to save a patient’s life; as these infections are often resistant to antibiotics, they can rapidly lead to deteriorating clinical conditions, affecting an estimated 31 million people worldwide and causing over 5 million deaths per year;6

• Venous thromboembolism is one of the most common and preventable adverse events, contributing to one third of the complications attributed to hospitalization; annually, there are estimated to be 3.9 million cases in high-income countries and 6 million cases in low- and middle-income countries;4

• Unsafe care in mental health settings has special features, with concerns about avoidable harm principally linked to seclusion and use of restraint, self-harming behaviour and suicide, absconding and reduced capacity for self-advocacy.7

The important news to learn is that Dr María del Rosario PEREZ and Adriana Velazquez Berumen, Group Lead Medical Devices and In Vitro Diagnostics,  MDD Health Product Policy and Standards Department of the WHO are collaborating with colleagues from the WHO Patient Safety Programme , who are developing a comprehensive Global Patient Safety Action Plan for the decade 2020-2030 under the vision “A world where every patient receives safe health care, without risks and harm, every time, everywhere”.

This is expected to be an action driven change package to address all casual factors that may lead to unintended harm in healthcare settings with focus on systems approach. They aspire to include all system elements, clinical safety programs, patient care (e.g. blood safety, medication safety, radiation safety (diagnosis and treatment), vaccination safety, safety of  medical devices and technology, infection prevention and control , work place safety, WASH and infrastructure safety, etc.  This will have close linkage and overlaps with quality of care, product safety, environmental safety, AMR, safety in traditional medicines, human resource planning and staffing and will EXCLUDE intentional harm, security issues, safety in research settings and idiosyncratic healthcare risks.

This Global Action on Patient Safety will provide new opportunities for ISRRT collaboration with WHO in the coming years.

Stewart Whitley, Director of Professional Practice  

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