Primum Non Nocere

IFMBE Participates in the Launch of the World Alliance for Patient Safety


Primum non nocere – first do no harm! Under this motto, attributed to Hippocrates (ca. 460-370 BC), the World Health Organization (WHO) and its partners launched the World Alliance for Patient Safety on October 27, 2004, in Washington, D.C. WHO representatives, lead by the Director-General Dr. LEE Jong-wook, ministers of health and senior government officials, NGOs, and patients' groups came together from all corners of the globe to advance patient safety by implementing a series of key actions to reduce the number of illnesses, injuries and deaths suffered by patients during medical treatment. By invitation of the WHO, IFMBE was represented at this event by its President, Prof. Dr. Joachim Nagel.

The creation of the World Alliance took place two years after the Fifty-Fifth World Health Assembly Resolution on Patient Safety in 2002 called on Member States to pay the closest possible attention to the problem of patient safety and to establish and strengthen science-based systems necessary for improving patient safety and quality of health care, including the monitoring of drugs, medical equipment and technology. The resolution urged WHO to take the lead in developing global norms and standards, encouraging research, and supporting efforts by Member States in developing patient safety policy and practice.

Adverse events in health care delivery cause many cases of illness, injury and death. Studies in a number of countries have shown a rate of adverse events ranging from 3.5% to 16.6% among hospital patients in industrialized countries. An average of one in every ten patients admitted to a hospital suffers some form of preventable harm that can result in severe disability and even death. Added to the considerable human misery is the economic impact of adverse effects. Several studies have shown that additional hospitalisation, litigation claims, hospital-acquired infections, lost income, disability and medical expenses cost some countries between US$ 6 billion and US$ 29 billion a year.

In developing countries and countries in economic transition the situation is far more serious. WHO reports that 77% of all reported cases of counterfeit and substandard drugs occur in developing countries and that at least 50% of all medical equipment in many of these countries is unsafe or unusable.

The Alliance has the firm objective to deliver six programs within the next two years:

  • A key element will be the Global Patient Safety Challenge, focusing over 2005-2006 on the challenge of health-care associated infection;
  • Patients for Patient Safety involving patient organizations and individuals in Alliance work;
  • Taxonomy for Patient Safety ensuring consistency in the concepts, principles, norms and terminology used in patient safety work;
  • Research for Patient Safety developing a rapid assessment tool for use in developing countries and undertaking global prevalence studies of adverse effects;
  • Solutions for Patient Safety promoting existing interventions and coordinating activity internationally to ensure new solutions are delivered;
  • Reporting and Learning generating best practice guidelines for existing and new reporting systems, and facilitating early learning from information available.

The World Alliance for Patient Safety will build on existing national efforts and initiatives sharing the same vision and link with programs for improving patient safety. It is expected that its work will eventually lead to much greater long-term safety in health care. The impact of well-developed and well-applied strategies on patient safety is expected to include a dramatic decrease in adverse effects in health care and a decline in expenditure in the order of billions of dollars of saved costs annually.

In parallel and as part of the activities of the World Alliance for Patient Safety, the WHO’s Department of Essential Health Technologies is dealing with the issue of safety as well. Health technologies, from the simplest health care systems to the most sophisticated, are viewed as the backbone of each country’s health services, a strong mesh of which is one of the most fundamental prerequisites for the sustainability and self-reliance of health systems. Essential health technologies supported by EHT are:

  • Blood transfusion safety
  • Blood products and related biologicals
  • Diagnostic imaging
  • District hospital surgery
  • Laboratory services
  • Medical Devices and equipment
  • Transplantation services

Health technologies are seen as essential when they

  • Meet basic needs
  • Have been proven to be cost-efficient and
  • Are evidence-based.

The use of any technology calls for carefully evaluated procedures and the availability of well-trained personnel. Some technologies are inherently safe, but the vast majority are not and require systematically established quality assurance and quality control measures. One of the major achievements of EHT has been to provide norms, standards, guidelines and training material that match a substantial number of the elements that are now included in the Basic Operational Frameworks.

IFMBE is in the position to substantially contribute to the initiative to improve patient safety, specifically, but not limited to, the areas of medical devices and equipment, essential health technologies, management and maintenance of healthcare technology, access to medical devices and norms and standards, all areas where IFMBE has demonstrated significant involvement in patient safety matters in previous and ongoing cooperative projects with WHO, both in developing and developed countries.

IFMBE is closely cooperating with WHO in the areas of medical devices, specifically policy and planning, quality and safety, norms and standards, technology management and capacity building. Medical devices and equipment safety is comprehensively dealt with in a set of guidelines for improved management of physical resources in health care, including a software-based resource-planning methodology and management tool, the Essential Healthcare Technology Package.

IFMBE has the expertise, the resources, the research capabilities and delivery potential to tackle all patient safety issues related to medical devices and equipment, and technological aspects of the essential health technologies, including the management and maintenance of healthcare technology as well as means to facilitate the access to medical devices and to aid the transfer of technology. IFMBE is also active in the development and application of international norms and standards as essential tools to ensure the quality and safety of medical devices.

At the moment the Federation is planning several workshops on the issue of patient safety, the first one to be held at the 13th Nordic- Baltic Conference on Biomedical Engineering & Medical Physics (NBC '05) in Umeå, Sweden, June 13 - 17, 2005.

For more detailed information please refer to www.umu.se/conference/nbc2005 for NBC '05 and www.who.int/patientsafety/worldalliance/en/ for the World Alliance for Patient Safety.

This article is based on documents that WHO has published on the occasion of the launch of the World Alliance for Patient Safety and on WHO publications on the Internet.

Monika Nagel
Email: jn@bmt.uni-stuttgart.de