Global shift toward increased biovigilance

A global movement toward increased biovigilance is resulting in the rapid rollout of Canadian, American and European initiatives aimed at developing national surveillance systems for cells, tissues and organs.

The Public Health Agency of Canada is leading the development of a reporting and surveillance system that will track and analyze adverse events in the transplantation of products of human origin. The system will collect data on moderate and severe adverse events —eventually expanding to include serious errors and near misses — to monitor trends in known and emerging risks and reduce the transmission of infectious diseases due to transplantation.

Nova Scotia, Quebec and Alberta were recently chosen as pilot provinces for the first phase of the initiative, which will primarily focus on tissues; the province’s blood coordinating program was selected to implement the system, after being singled out for its past success with the Transfusion Transmitted Injuries Surveillance System. (CMAJ 2010. DOI:10.1503/cmaj.109-3195).

The shift toward increased biovigilance — the systematic surveillance and analysis of untoward and unexpected events in blood transfusion and the transplantation of cells, tissues and organs —has only emerged in recent years, says Dr. Matthew Kuehnert, director of the Office of Blood, Organ and Other Tissue Safety for the United States Center for Disease Control (CDC).

“In hemovigilance, the United States has been behind Canada and Europe for quite some time now, but we’re rapidly catching up,” Kuehnert says. “However, when it comes to biovigilance, we’re all starting on the same level playing field, because until recently the emphasis for organs and tissues has always been on availability first and foremost.”

The CDC, in partnership with other public and private agencies in the US, launched a transfusion recipient surveillance system in February as part of phase one of a new national biovigilance network. It’s the first in a series of integrated surveillance systems that the network is developing to reduce adverse reactions and incidents in blood transfusions and other biological therapies.

The first phase of the network’s implementation will focus on hemovigilance, with a second surveillance system scheduled to launch later this year to track adverse reactions associated with the donation process at blood collection sites.

Transfusion services will be able to voluntarily and confidentially report data on adverse events to the CDC’s preexisting National Healthcare Surveillance Network for analysis, and will have the chance to compare their results with those of other facilities in the aggregate.

The second phase of the network’s implementation will see the development of a surveillance system for cells, organs and tissues in addition to the current hemovigilance module. But Kuehnert says there’s no definite timeframe for when those systems might launch.

Until recently, the US was one of the only developed countries in the world without a national hemovigilance program, says Dr. Barbee Whitaker, director of data and special programs for AABB, formerly the American Association of Blood Banks, which along with the CDC is spearheading the development of the biovigilance network.

“It’s not that we haven’t been categorizing transfusion reactions, we just didn’t have a centralized reporting system for everyone to use, largely because we are hindered by our medical system in ways other countries with national healthcare systems are not,” she explains. “The sheer size of our system alone means that if we can get even 10% of the transfusion services in the country to voluntarily join on, we’ll have the largest hemovigilance system in the world.”

As of mid-February, roughly 60 of the approximate 4000 transfusion sites in the US had volunteered to enrol with the new surveillance system, says Whitaker.

Former AABB president Dr. Michael Strong says the notion of creating vigilance and surveillance systems for various biological therapies first took hold in the US in 2005. “Around that time, there were a number of well-publicized cases of infectious disease transmission from organs and tissues and that really got the ball rolling. I remember one dentist had set up a tissue recovery program in a funeral home unbeknownst to families, and was falsifying documents and recovering something in the excess of 25 000 tissue grafts, many of which were exported outside the States and couldn’t be traced.”

Scandal, he suggests, has been a good motivating factor for change.

“Even going back to the hemovigilance programs pioneered in the early nineties, France was well ahead of its time partly because of a major scandal surrounding HIV-tainted blood,” Strong explains. “As a direct result, they funded a mandatory hemovigilance program and put transfusion safety officers in all their hospitals.”

Outside North America, changes in regulations have also led to considerable progress in the field of biovigilance, says Dr. Luc Noël, in charge of transplantation at the World Health Organization (WHO).

“In the last decade, the European Commission established directives requiring the vigilance and surveillance of cell and tissue transplantation and blood transfusions, and now there is a new directive for surveillance of organ transplantation practices that we hope will be put through in the coming months,” he says. “These directives have resulted in projects like the European Union Standards and Training for the Inspection of Tissue Establishments Project, which ran for three years and focused on inspection training and vigilance for tissue banks but also created tools that can now be used internationally for biovigilance and surveillance.”

The project developed tools and assessment grids for member states of the European Union that can help identify how an adverse event should be reported and calculate the appropriate level of national and international reaction.

Those tools have since been streamlined by the WHO for global application and were debuted at the Third Global Consultation on Regulatory Requirements for Human Tissues and Cells for Transplantation in Geneva, Switzerland in February.

WHO has also started development on a Global Knowledge Base on Transplantation, which lay people and regulatory authorities will be able to use to access information on biovigilance and surveillance.