New Regulations & Focus on Sepsis Prevention in Italian Hospitals
In Italy, 500,000 to 700,000 patients (5-8% of all hospital patients) contract infections during hospitalization annually, leading to complications like sepsis, increased mortality, prolonged hospital stays, and higher healthcare costs.To address this, a new directive from the Italian Ministry of Health, effective August 31st, restricts the use of medical-surgical antiseptics for skin disinfection prior to procedures. this change, implementing European Biocidal Regulation (n.528/2012), aims to enhance patient safety through improved traceability and stricter product controls.
“This decree is a significant step forward for patient safety, introducing more rigorous checks on antiseptics,” states Massimo Sartelli, President of the italian multidisciplinary society for the prevention of infections in health organizations (SIMPIOS). “the challenge now is ensuring a smooth and sustainable transition for the healthcare system.”
Sepsis, a life-threatening complication of hospital-acquired infections, affects approximately 50,000 people in Italy each year, with a mortality rate of 3-8%. Proper disinfection of access points for medical procedures is crucial to prevent contamination. Chlorhexidine remains a cornerstone of antisepsis.
Currently, there is reduced availability of the “gold standard” – 2% chlorhexidine in alcoholic solution.Thus, clinical decisions regarding antiseptic choice must be guided by scientific evidence demonstrating the effectiveness and safety of lower concentration alcoholic chlorhexidine solutions for specific patient risk profiles and clinical settings.
The Lazzaro Spallanzani National Institute for Infectious Diseases in Rome is joining the global effort to combat sepsis by participating in World Sepsis Day on September 13th. This initiative, promoted by the Global Sepsis Alliance (GSA), aims to raise awareness about sepsis – a serious, dysfunctional response to infection – which affects 48.9 million people worldwide annually, resulting in over 11 million deaths (roughly one person every 3 seconds) and accounting for 20% of global mortality. The 2030 Global Sepsis Agenda seeks to prevent 12 million new cases and save 2 million lives within the next five years.