To reduce the risk of infection and help ensure patient safety, ambulatory surgery centers (ASCs) and hospitals must take all appropriate measures to preserve sterility of the operating field, including the proper sterilization of surgical instruments and other medical devices.
Sterilization is defined as a process of complete elimination or destruction of all forms of microbial life (i.e., both vegetative and spore forms) carried out by various physical and chemical methods.1
Note that there is a distinction between sterilization and disinfection. The latter is defined as a process of complete elimination of vegetative forms of microorganisms, except the bacterial spores, from inanimate objects.1
So, what’s the main objective of sterilizing surgical instruments and other medical devices?
The primary goal of cleaning, disinfection, and sterilization is to reduce the number of microorganisms on the surgical instrument or medical device to a level where the probability of transmission of infection will be zero.1
Failure to carry out this critical aspect of care not only jeopardizes patient health and violates public trust but can have harmful consequences for the healthcare facility. Repercussions may come in the form of financial costs, legal issues, and damage to reputation.
The U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) maintains an online database of voluntary consensus standards to which the FDA will accept a declaration of conformity from a medical device manufacturer regarding sterilization.2
Medical devices are sterilized in a variety of ways, including via the use of moist heat (steam), dry heat, radiation, ethylene oxide (EtO) gas, vaporized hydrogen peroxide, chlorine dioxide gas, vaporized peracetic acid, and nitrogen dioxide.3
The CDRH, which notes that the sterilization of medical devices is vital to help prevent serious infections, oversees these processes to ensure they are effective and used in amounts that are safe for patients and healthcare professionals.2
Now let’s look at the responsibilities of ASCs and hospitals in respect to sterilization of medical devices.
Surgical instruments and medical devices intended for reuse come with reprocessing and sterilization instructions from their manufacturer ― ASCs and hospitals are expected to reprocess and sterilize the devices or instruments per these instructions.4
Sterilization standards and guidelines help the healthcare community reduce the risk of contamination that may lead to surgical site infections (SSIs). As illustrated by the data presented below, beyond the many deleterious effects these post-operative infections can have on individual patients, they also have a significant negative impact on healthcare systems.
In 2022, Journal of Patient Safety published a retrospective study analyzing data from the Agency for Healthcare Cost and Utilization Project’s 2016 National Inpatient Sample, the largest all-payer U.S. inpatient database.7
The study analyzed data surrounding catheter-associated urinary tract infections, catheter- and line-associated bloodstream infections, surgical site infections, ventilator-associated pneumonias, and infection with Clostridioides difficile.7
According to the study’s findings, the most common healthcare-associated infection (HAI) among admissions with primary HAI diagnosis was surgical site infections, at a cost of 3.7 billion USD.7
The cost of infections is steep. If you are interested in learning more about sterilization standards, guidelines, and best practices, an array of helpful resources can be found on the FDA, CDC, TJC, and AORN websites.