Vigilance is derived from the Latin “vigilare”, to stay awake or to care for and is the process of paying close and continuous attention. Surveillance is defined as the systematic ongoing collection, collation and analysis of data for public health purposes and the timely dissemination of public health information for assessment and public health response as necessary. Vigilance and surveillance (V&S) are used in association to underline that the attitude of vigilance needs to be associated to the methods of surveillance. In practice a number of terms have been developed to describe V&S for specific types of products. Like pharmacovigilance describes V&S for medicinal products, “haemovigilance” was coined to be used for blood products. Haemovigilance is a set of surveillance procedures covering the entire transfusion chain (from the donation of blood and its components to the follow-up of recipients of transfusions), intended to collect and assess information on unexpected or undesirable effects resulting from the therapeutic use of labile blood products, and to prevent the occurrence or recurrence of such incidents. “Biovigilance” was incorporated into French law on 21 December 2003 with the publication of Decree no.°2003-1206. Its scope ranged from human organs, human tissues and cells to human cellular therapy preparations and ancillary products. In the United States, biovigilance has been extended to incorporate all MPHO including blood, tissues, cornea, cells, gametes and organs.
Haemovigilance systems have been implemented in most developed countries to monitor the adverse occurrences associated with the transfusion of blood and blood products. In the early stages of haemovigilance, the concept was little more than coordination of existing data. Over the years, analysis and process improvement have led to enhanced patient safety. Haemovigilance systems arose as a response to the threat of emerging infections, such as HIV, to the safety of the blood supply. The recognition of the AIDS epidemic, which resulted in the deaths of thousands of recipients of blood and plasma products, led to public debates, commissions of inquiry, and legal prosecution stemming from management of the nascent HIV risk of the 1980’s. The epidemic also provided additional stimulus to assess the safety of transfusion services through ongoing risk assessment measures. Haemovigilance was developed first in Japan and then in France in 1993, which featured mandatory reporting. The UK developed the first voluntary system in 1996. Since this time, countries around the world have established Haemovigilance systems and have formed the International Haemovigilance Network to share common definitions and data.
The basic elements of bio-vigilance include: adverse reaction (AR) identification and reporting, adverse event (AE) monitoring and reporting (for recipients and donors), product quality assurance (including processing controls and error management), and emerging threat assessment using epidemiologic and laboratory data (e.g., TTI bioinformatics, repositories). The WHO guideline on AE reporting emphasizes that the effectiveness of the systems should be measured, not only by data reporting and analysis, but also by the use of such systems to improve patient safety. WHO Guiding Principles on Human Cell, Tissue and Organ Transplantation, Guiding Principle 10, states “the level of safety, efficacy and quality of human cells, tissues and organs for transplantation, as health products of an exceptional nature, must be maintained and optimized on an ongoing basis”. This requires implementation of quality systems including traceability and vigilance, with adverse events and reactions reported both nationally and for exported human products. The guideline outlined the following core concepts:
- The fundamental role of patient safety reporting systems is to enhance patient safety by learning from failures of the healthcare system.
- Reporting must be safe. Individuals who report incidents must not be punished or suffer other ill-effects from reporting
- Reporting is only of value if it leads to a constructive response. At a minimum, this entails feedback of findings from data analysis. Ideally, it also includes recommendations for changes in procedures and systems of healthcare.
- Meaningful analysis, learning, and dissemination of lessons learned require expertise and other human and financial resources. The agency that receives reports must be capable of disseminating information, making recommendations for changes, and informing the development of solutions.