One of the fundamental principles of medicine "primum non nocere" or "first do no harm" can be traced back almost 2500 years to the Ancient Greece and Hippocratic oath.
Preventing healthcare associated infections is one of the essential components of fulfilling this medical practitioners’ promise to patients. Healthcare Associated Infections (HAI) are still a major threat affecting on average 1 in 20 hospital patients and causing around 37,000 deaths a year in Europe alone. Invasive procedures including surgical interventions and endoscopic treatments are especially risky in terms of HAIs as they break natural protective barriers such as skin and mucous membranes exposing vulnerable body interior to a possibility of contamination by pathogenic microorganisms.
Proper decontamination of Reusable Invasive Medical Devices (RIMD) is essential for safety of invasive procedures, however surgical instruments and endoscopes are not always adequately decontaminated. Decontamination failures are known to cause surgical site infections leading to procedure complications, extended hospital stays, financial and reputational damage to hospitals and, most importantly, loss of quality of life and loss of life itself. Proving sterility of reprocessed instruments is crucial for patient safety.
Internationally acceptable sterility assurance level (SAL) for invasive instruments is defined as less than one in a million chance of a pathogen surviving sterilization process. SAL must be confirmed for each and every instrument used in an invasive procedure. Depending on a sterilization process SAL can be proven by parametric release of a validated load, by using Biological Indicators (BI) with Process Challenge Devices (PCD) or combination of both.
BIs expose at least one million of most resistant test organisms such as bacterial spores to a sterilization process. Passed BI means all test organisms were killed during sterilization. Failed BI means some organisms survived sterilization. PCDs challenge sterilizer to greater or equal measure as the most challenging instrument suitable for sterilization in a particular machine and in a particular cycle. Validated BI/PCD combination challenges sterilizer with combination of the most-difficult-to-reprocess device and hardest-to-kill microorganism. Thus, passed BI/PCD provides ultimate confirmation of successful sterilization of a load.
EU MDR 2017/745 and the UK Medicines and Medical Devices Act 2021 both require reusable invasive medical devices to be traceable through decontamination cycle with proof of SAL. Even though including BI/PCD combination in every load is the best available proof of instrument sterility, biological indicators traditionally had to be incubated for several hours or even days to get the results leading to delays in instrument release putting pressure on hospital inventory and case management. In modern high-paced hospital environment ASP Velocity 15’ BI/PCD system virtually eliminates waiting time with the BI results available in 15 minutes. This ultimate confirmation of successful sterilization can be digitally recorded and linked with all instruments in the load thus assuring clinicians, patients, and regulatory authorities of the best practice in instrument reprocessing and safe procedures. ASP Velocity 15’ BI/PCD system represents the best practice in sterility assurance by providing rapid and traceable confirmation of sterilization.
