Can Validated IFUs Help In The Fight Against Sepsis?

Sepsis is a leading cause of death in U.S. hospitals, according to the Sepsis Alliance, a nationwide advocacy group committed to fighting sepsis throughout the country. More than 1 million people contract a severe case of sepsis each year in the United States. Tragically, up to 50 percent of patients diagnosed with sepsis die from it. It is also one of the most expensive conditions for hospitals to treat, costing over $24 billion annually.

Sepsis is frequently difficult to diagnose, however, if it’s caught quickly it can usually be treated effectively. If not caught early and treated rapidly, patients are placed at risk of septic shock, which can lead to multiple system organ failure and death.

In an effort to help combat this major health risk, the Centers for Medicare & Medicaid Services (CMS) in 2015 began requiring hospitals to measure and report on their sepsis treatment efforts. They must make sure that specific steps are completed within the first critical hours after sepsis is identified. These required steps include getting blood cultures, giving intravenous fluids and starting patients on a broad-spectrum antibiotic.

Fighting sepsis is a major issue and expense in ALL hospitals. The staff at St. Joseph Hoag Health system in Orange County, California is mounting a concerted effort to improve patient outcomes in patients who contract sepsis.

“St. Joseph Hoag Health, an integrated medical system in Orange County, Calif., that operates St. Joseph and six other hospitals, began employing dedicated sepsis nurses throughout the system in 2015. Hoag Hospital in Newport Beach and its namesake sister facility in Irvine were the first to try out the nurses about seven years ago, and four other hospitals have since followed.

The hospitals in the St. Joseph Hoag Health system treat about 8,000 cases of sepsis each year, at a cost of $130 million, according to Andre Vovan, a critical care physician who oversees St. Joseph Hoag’s anti-sepsis programs.”1

So, how can validated IFUs help in the fight against sepsis? As we noted in an earlier blog “an IFU is a step-by-step reprocessing guide to ensure that a reusable device is properly decontaminated, cleaned of all biomaterial, sterilized and that any residual moisture is voided before the device is returned to surgery.”

Failure to follow manufacturers’ validated cleaning IFUs can lead to instruments that are contaminated with microbial biomaterial being returned to the OR after reprocessing. According to a report from the Centers for Disease Control and Infection (CDC) Microbial contamination of the surgical site is a necessary precursor of a surgical infection.”2 One of the more common sources of microbial contamination in a surgical case is a surgical instrument that remains contaminated with dead, sterile bioburden following reprocessing.

When dead, sterile bioburden gets deposited into the body from a contaminated instrument, the foreign, organic material begins to decompose inside the body and is attacked by phagocytes. This process is frequently seen in a post-surgical patient who presents with a fever of unknown origin and an elevated white blood cell count within 24 to 48 hours of surgery.

Phagocytes are the white blood cells that protect the body from harm by ingesting (phagocytosing) harmful foreign particles, including dead, organic, sterile cells. Part of this process involves the production of lysozymes that break down the cell walls of the organic material. Frequently those dead, sterile cell walls contain endotoxins that are then released into the blood stream. The release of endotoxins into the bloodstream is a frequent cause of life-threatening septic shock.

The release of endotoxins in the body stimulates cytokine production. In turn, cytokines can trigger the systemic inflammatory response syndrome that sometimes leads to multiple system organ failure. One of the most common causes of multiple system organ failure in modern surgical care is intra-abdominal infection.”3

The CDC report goes on to point out that even more troubling is that when patients died from a surgical infection “77% of the deaths were reported to be related to the infection, and the majority (93%) was serious infections involving organs or spaces accessed during the operation.”4

Just because an instrument is sterilized is no guarantee that it can’t harm a patient. The old adage that “If it isn’t clean, it can’t be sterile” is just as true today as it was 75 years ago. The more accurate version of that statement is “If it isn’t clean, it can’t be safe!

Inadequate, incomplete or improper cleaning also has the potential to allow for residual bioburden to be sequestered in bodily fluids that may be contaminated with gram-negative bacteria. You can sterilize the instrument but you may fail to destroy microbial endotoxins that are heat-stable and can survive the sterilization process. This is yet another source of patient contamination from an instrument whose cleaning IFUs have not been validated to ensure a thoroughly decontaminated, clean, sterile, moisture-free instrument after every reprocessing cycle.

All of this is why it is crucial to patient safety that hospitals only use instruments whose cleaning IFUs have been validated. Without validation, reprocessing personnel have no way of knowing if they have actually removed all of the organic bioburden, including blood and gram-negative bacteria.

By following manufacturers’ validated cleaning IFUs on every reprocessing cycle, a patients’ risk of contracting sepsis from a contaminated instrument drops significantly.



1 “The New War On Sepsis?” Anna Gorman, Surgical Products Magazine, June 2017


2 “Guideline For The Prevention Of Surgical Site Infection” Center For Disease Control And Prevention


3 Ibid


4 Ibid



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