Managing biorisk

World Health Organization (WHO) data and statistics for the European Union show that “medical errors and healthcare-related adverse events occur in 8 % to 12 % of hospitalizations”. According to the WHO, infections associated with healthcare also take their toll with, on average, an estimated one in 20 hospital patients affected every year (estimated at 4.1 million patients overall). The UK’s National Audit Office has estimated the cost of such infections at one billion pounds a year.

What tools are at hand to reduce the risks associated with medical devices, including the risk of human error? ISO 35001, which is under development, focuses on management of biorisks, namely the management of risks that organizations confront when handling biological agents and toxins. As well as manufacturers of in vitro medical devices, relevant organizations also include medical centres, hospitals and clinics; universities and research institutes; and veterinary diagnostic laboratories and animal facilities.

Gary Burns is a biosafety and biosecurity consultant and convenor of working group WG 5, Laboratory biorisk management, of technical committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems. He points to the rapid growth of biotechnology applications, particularly in developing countries: “Technical capabilities that were previously concentrated in highly developed countries are increasingly being employed in other countries around the world. This expansion is driven in large part by the need to combat naturally occurring infectious diseases, which do not recognize national borders.”

To address these risks, Burns says the proposed standard will support organizations to “continually improve performance and comply with legal requirements through a voluntary biorisk management policy and process; implement globally accepted approaches to identify and control biorisks; monitor and evaluate the effectiveness of biorisk control measures; and assist management in decision making regarding biorisks”.

Other benefits to organizations in implementing the standard, he says, include a reduction in accident and incident rates, compliance with legal obligations and an ability to demonstrate to external partners a commitment to a high standard in biorisk management. Another plus is that “organizations will have the flexibility to implement the standard in a manner that is appropriate for their size and complexity” – good news for small organizations as well as large.

Burns says: “The risks are also constantly evolving, as novel pathogens continually emerge”. He cites recent examples of the emerging biological agents that have caused disease outbreaks in humans, which include “several pathogenic influenza A virus strains (H1N1, H5N1, and H7N9), a novel coronavirus that is the causative agent of Middle East Respiratory Syndrome (MERS), and a novel coronavirus that was the cause of Severe Acute Respiratory Syndrome (SARS)”.

As the number of organizations that work with biological agents and toxins and the scope of international collaboration among these organizations continue to grow, Burns says there will be continued and increasing demand for an international biorisk management standard.

This article is an excerpt from the March-April 2019 edition of ISOfocus