Common use of Epidemiology Clause in Contracts

Epidemiology. Clostridium difficile infection (CDI) is now firmly established as a significant healthcare issue and is the leading cause of infectious nosocomial diarrhoea in the developed world. The unprecedented rise in prevalence in recent years, starting in the late 1990s with outbreaks in the US and Canada, has resulted in CDI becoming endemic in the North American and European healthcare systems. In the USA, the CDC reported a total of 350,000 cases in 2010 (Figure 2: Data from HCUP Statistical Brief #124 and CDC National Vital Statistic Reports) although reliable estimates put the annual number of cases at around 500,000. Although the rise in prevalence seems to have halted in the US, figures over the last few years suggest that a plateau has been reached at around 4 fold more cases than reported in 1993. Overall, this has placed an enormous financial and human welfare burden on the healthcare system. Healthcare costs in the US are estimated at >$1bn p.a and the individual cost of each CDI case in the EU is €33,840. The management of patients with CDI often requires isolation and environmental decontamination and in the case of outbreaks may necessitate cohort isolation and waxx xlosure. Although CDI is a disease that disproportionally affects the elderly or immunocompromised, increasing numbers of cases are being reported in previously low risk groups such as the young. There is increasing awareness of CDI as an emerging community issue with community onset CDI now being linked with higher risk of associated colectomy. A similar picture has been reported in the UK where a dramatic rise in prevalence resulted in a peak of >55,000 cases in 2006 and although significant efforts in the UK have reduced the number of cases, recent data suggests a stabilisation at around 20,000 p.a. The wider European picture continues to show an increasing number of cases in Denmark, Finland, Germany and Spain and an on-going north to south spread of the disease across the continent. Although now endemic in the EU and USA, CDI in Eastern Asia and Australia has recently started to emerge as a significant issue. Although Australia has historically had a relatively well controlled level of CDI with few cases progressing to severe disease in 2011 the first cases of CDI due to hypervirulent BI/NAP1/027 strains were encountered and a similar picture has been emerging in Japan.