Technical activities

Injection safety

WHO estimates that in developing and transitional Member States, 16 billion health care injections are administered each year – an average of 3.4 injections per person per year. This figure, along with reports indicating inappropriate use of injections, suggests that injections are overused as a means of administering medications. In addition to being overused, injections may also be administered through unsafe procedures and cause infections.

A safe injection should not harm the patient, the health care worker or the community. Injections may harm the patient when injection devices are reused in the absence of sterilization. Injections may harm health-care workers when dirty needles are not collected in safety boxes. Injections may also harm the community at large when health-care facilities are surrounded by sharp health-care waste – mostly dirty syringes and needles.

Reuse of injection devices in the absence of sterilization is of greatest concern, since it leads to the heaviest burden of disease. A mathematical model developed by WHO suggests that in 2000, in developing and transitional Member States, reuse of injection devices accounted for an estimated 22 million new infections with Hepatitis B virus (one-third of all such infections), 2 million new infections with hepatitis C virus (40% of all such infections) and 260 000 new HIV infections (5% of all such infections). The infections acquired in 2000 alone are expected to lead to an estimated 9 million years of life lost (adjusted for disability) between 2000 and 2030.

Evidence shows that death and disability associated with unsafe injections are highly preventable. First, interventions that aim at improving communication between patients and doctors and at improving prescriptions through monitoring of providers have effectively decreased injection overuse. Second, interventions to make single-use syringes regularly available in each health care facility effectively prevent reuse of injection devices.

In addition to being highly effective, policies and plans for the safe and appropriate use of injections are a sound investment in health. WHO estimates that interventions implemented in 2000 for the safe and appropriate use of injections cost US$102 per year of life saved (adjusted for disability). This cost is less than the threshold value of 1 year of average per capita income in developing Member States used by the WHO Commission on Macroeconomics and Health as a criterion for an intervention to be considered very cost-effective.

WHO assists Member States in benchmarking, assessing, planning, implementing and evaluating national policies for the safe and appropriate use of injections through four key strategies:

• increasing population awareness regarding the risk of HIV and other infections associated with unsafe injections;
• making sure there are sufficient quantities of single-use injection devices and safety boxes in every health-care facility where injections are administered;
• ensuring that donors and lenders supporting the supply of injectable substances in developing and transitional Member States also support the provision of injection devices with reuse-prevention features and safety boxes;
• managing the waste associated with dirty syringes and needles in a safe and appropriate way.

- Injection safety

Blood safety

The mission of the Blood Transfusion Safety team within WHO is to promote the formation of national blood programmes ensuring the safety, quality and adequacy of blood and blood products to meet the needs of all patients, on the understanding that patients will receive blood transfusions only when they need them. Blood and blood products are provided as part of a sustainable blood programme within the health care system.

WHO has developed the following integrated strategy for blood safety:

• establishment of a nationally coordinated blood transfusion service that can ensure adequate and timely availability of safe blood for all patients in need;
• collection of blood from voluntary, non-remunerated blood donors from low-risk populations;
• testing of all donated blood for transfusion-transmissible infections, blood grouping and compatibility testing;
• appropriate clinical use of blood and blood products.

The strategy addresses all the steps in collecting, testing, processing, storage and use of blood and blood products that could directly or indirectly influence the safety of patients. It can be effective only if quality systems cover all aspects of transfusion, from recruitment and selection of blood donors to transfusion of blood and blood products.

Supporting the elaboration of national policy and guidelines, and monitoring and evaluation to assess the patterns of blood usage and their impact on transfusion practice are all part of approaches towards ensuring appropriate clinical use of blood and blood products. One of the tools that should be in place is a system for collecting and collating data on the hazards linked to the transfusion of blood and blood components, a process broadly termed haemovigilance. Activities carried out in this regard include the collection of information such as the prevalence of infection in blood donors and the occurrence among recipients of adverse events (including errors) associated with the transfusion of labile blood components. These data will help improve patient safety in relation to blood transfusion.

- Blood safety

Drug safety

The Quality Assurance and Safety of Medicines (QSM) team in WHO handles issues pertaining to drug safety and drug utilization. The QSM team ensures reliable exchange of information on medicines, promotes pharmacovigilance activities in Member States, encourages participation in the International Drug Monitoring Programme and assists countries in developing an adequate system for obtaining drug utilization statistics.

The WHO Collaborating Centre for International Drug Monitoring in Uppsala, Sweden, maintains a database that currently contains more than 3 million reports of suspected adverse drug reactions. These reports are from the 72 Member States participating in the Programme. The major objective of the database is to determine any new "signals" arising.

The WHO Collaborating Centre for Drug Statistics Methodology in Oslo, Norway, is responsible for the maintenance of the WHO classification system: the Anatomical, Therapeutic and Chemical (ATC) and Defined Daily Dose (DDD) for classified drugs. The Advisory Committee for this Centre is the WHO International Working Group for Drug Statistics Methodology.

- The global intelligence network for benefits and risks in medicinal products

Nursing

As regards the quality and safety of nursing care, the Nursing and Midwifery Group within WHO is currently focusing on the impact of staffing conditions on the quality and safety of patient care. The report of the Secretariat submitted to the Fifty-sixth World Health Assembly identified the negative impact of changing staffing conditions as a primary and growing concern among Member States. Since the human resources crisis – and particularly the shortage of nursing and midwifery personnel – is expected to deepen in the coming years, guidance on how to ensure quality and safety of care in resource-limited settings becomes vital. The Nursing and Midwifery Group has therefore recently been engaged in preparing a briefing document based on studies that have established a link between inadequate staffing conditions and patient status or outcome. The briefing document is intended to show how the organization of care, the various approaches to using the skill mix of staff, and the organizational climate all contribute to patient and provider outcomes.

Regional offices are equally active in moving the patient safety agenda forward. The Eastern Mediterranean Region has recently developed guidelines for the regulation of nursing and midwifery practice, the essential components of which refer to ensuring that outcomes of nursing and midwifery care are of high quality and that practices are safe. The region has also launched a comprehensive and standardized assessment of the quality of nursing services across its Member States.

In order to ensure the safety of care procedures, both the South-East Asia Region and the European Region have recently published training manuals and guidelines on infection control. These efforts are part of a worldwide initiative to strengthen nursing and midwifery services and will be complemented by further activities.

- Nursing and midwifery

Making pregnancy safer

The initiative Making Pregnancy Safer represents WHO's continued contribution towards the goals and objectives of the international Safe Motherhood campaign. Its strategy is designed to strengthen the capacity of health systems to improve the health of mothers and neonates by increasing equitable access, use, quality and safety of health services for mothers and neonates through concerted action at the policy, service and community level, with special attention to reaching the poor and most vulnerable.

The strategy, based on accumulated scientific evidence and experience, identifies cost-effective interventions that have been shown to improve quality and ensure safety during pregnancy, childbirth and postpartum. The WHO Making Pregnancy Safer initiative, which works with its partners and builds on the latter's experience, operates at global, regional and country levels. It focuses on the following key areas of work in which WHO has a United Nations mandate and can assist through its corporate and technical advantages:

• providing technical and policy support in order to strengthen government capacity in the planning, design and implementation of effective strategies to achieve improved maternal and newborn health;
• developing a package of evidence-based standards and tools for the integrated management of pregnancy and childbirth, including essential care and a safe approach to complications during pregnancy and childbirth;
• supporting Member States and partners in adapting and disseminating appropriate tools for local use;
• generating evidence crucial to the improvement of quality and safety in maternal and newborn health and disseminating research findings;
• monitoring relevant goals listed in the United Nations Millennium Declaration at global and regional level in order to provide information for better decision-making;
• undertaking advocacy at the global level in order to elicit the long-term financial and technical support to Member States needed to implement strategies to reduce maternal and newborn mortality, and to keep Safe Motherhood high on the global agenda;
• at global, regional and country levels, building efficient partnerships for Safe Motherhood committed to achieving the goals listed in the Millennium Declaration.

- Maternal and newborn health

Chemical safety

The WHO Programme for Promotion of Chemical Safety forms the Central Unit of the International Programme on Chemical Safety (IPCS), a joint activity of three cooperating organizations: WHO, UNEP and ILO.

IPCS activities on poisons information, prevention and management have the aim of promoting chemical safety:

• by establishing and strengthening poisons centres;
• through the development and provision of harmonized information and tools for monitoring, collecting and reporting information on poisonings.

Poisons centres can be a point of reference for patient safety issues.

There is significant variation in the number and capacities of poisons centres around the world; improvements are needed in many regions of the world. A World directory of poisons centres - Yellow Tox, World Directory of Poisons Centres (unpublished document available on request) has been compiled listing the poisons centres in over 80 countries (www.intox.org/firstpage.htm). In the context of the plan of action agreed at the United Nations Conference on Environment and Development(please check exact title of conference) (UNCED), governments all around the world committed themselves to establishing and strengthening poisons centres.

- The international programme on chemical safety

Transplant safety

Activities relating to safety in transplantation cover the safety of the recipient patient and therefore the fulfilment of safety requirements for material of human origin, as well as the safety of the live donor in the short term and the long term. Safety in transplantation is a prerequisite to ensuring ethics in transplantation. Transplantation safety requires proactive approaches such as implementing and maintaining standards for transplantation activities and material for transplantation. It also requires rigorous surveillance of the outcome and adverse events in recipients and live donors and the ability to react to newly identified threats. This is particularly important for recipients of xenotransplantation, where risks are more difficult to predict. Activities aimed at increasing global harmonization and helping Member States to improve safety in transplantation will follow the adoption by the 57th World Health Assembly of a resolution requesting action from WHO on the topic of human transplantation.

More information

- Transplantation

Clinical procedures

In the area of patient safety, the Clinical Procedures team in the department of Essential Health Technologies (EHT) assists countries to reduce the inappropriate use of clinical procedures and equipment.

Normative activities

Activities to promote the setting of standards for patient safety include tools to strengthen and support member states to improve the quality of care in health facilities at the first referral level, in the following areas:

• Policy
• Quality and safety
• Access
• Use.

Headquarters activities

Activities at WHO headquarters have resulted in:

1. checklist of basic minimum requirements for essential emergency surgical care at the district hospital, covering the procedures commonly undertaken, of the risks these entail and of the measures that can be taken to reduce those risks;
2. development of educational and training tools, including:
• training manual: Surgical care at the district hospital, dealing with essential clinical procedures in trauma, pregnancy-related complications, anaesthesia, resuscitation, and infection control;
• e-learning tools (best practice protocols, guidelines on basic minimum requirements to improve the quality of essential emergency and surgical care at the district hospital, training videos);
3. establishment of an Expert Panel for Clinical Surgical Procedures;
4. collaborative activities to improve the quality and safety of clinical procedures in health facilities at the first referral level:
• guidelines on essential trauma care;
• guidelines on clinical use of oxygen;
• generic list of essential emergency equipment and list of oxygen concentrators
• guidelines on the use of equipment (anaesthetic equipment, diathermy, the Haemoglobin Colour Scale to assess anaemia).

Country support

The Clinical Procedures team collaborates with the following organizations and societies of surgery, trauma, obstetrics, anaesthesia, orthopaedics to support the training programmes for essential emergency and surgical care in Member States:

• International College of Surgeons (ICS)
• International Society of Orthopaedic Surgery and Traumatology (SICOT)
• Health Volunteers Overseas (HVO)
• Associations of Surgeons of East Africa (ASEA)
• College of Surgeons of East, Central and South Africa (COSECSA)
• International Federation of Surgical Colleges (IFSC)
• World Federation of Societies of Anaesthesiologists (WFSA)
• Canadian Network International Societies of Surgeons
• Geneva Foundation for Medical Education and Research (GFMER)

The Clinical Procedures Team also engages in training of trainers in essential emergency and surgical procedures and the use of equipment for safe clinical practice.

- Essential health technologies

Medical devices and equipment

The devices group in WHO carries out activities to ensure the safety of patients, health-care workers and the community with regard to medical devices and equipment. Its activities are carried out within the following four strategic areas.

• Development of national policy: tools to assess and strengthen national regulatory authorities, including the recent medical device regulations: global overview and guiding principles, in order to promote national coordination and management of equipment.

• Quality and safety: elements such as the elaboration of new ISO standards and WHO performance specifications, the pre-qualification of suppliers, the development of standardized procedures for alerts and recalls, and tools to assess safety and performance of products, in order to reduce risks linked to substandard products and procedures.

• Access: quality management systems covering identification of equipment needs, and the selection, procurement and distribution process. Tools include the development of a model list of essential equipment, the WHO Essential Healthcare Technology Package, guidelines for good donation practices and increased collaboration with industry.

• Appropriate use of equipment in order to reduce risks: elaboration and diffusion of materials on information, education and communication and of training manuals for managers and users of equipment, particularly as regards preventive maintenance.
  

- Essential health technologies

Immunization safety

The Immunization Safety Team within WHO undertakes activities that include the assurance of vaccine safety and quality from production through to administration, the safety of injections and vaccine delivery systems, the management of sharps and waste disposal, and the monitoring and management of adverse events following immunization.

Immunization Safety Priority Project

The Immunization Safety Priority Project pages provide information on the background to the Project's establishment, its main objectives and progress made. They provide information on the background, operating mechanisms and membership of the WHO Steering Committee on Immunization Safety, as well as links to the reports of the Committee's meetings. Also included are links to the partners with which the Project Secretariat regularly collaborates.

Global Advisory Committee on Vaccine Safety

The Global Advisory Committee on Vaccine Safety is a scientific advisory body established by WHO to provide a reliable and independent scientific assessment of vaccine safety issues in order to respond promptly, efficiently and with scientific rigour to such issues. Membership includes experts from around the world in the fields of epidemiology, paediatrics, internal medicine, pharmacology and toxicology, infectious diseases, public health, immunology and autoimmunity, and drug regulation and safety.

- Immunization safety
- Global advisory committee on vaccine safety