Preventing HAIs

The Importance of Validated IFUs in Preventing Reusable Device Related HAIs According to the Centers for Disease Control, hospital acquired infections (HAIs) are one of the leading causes of morbidity and mortality among hospital patients in the United States. According to HealthPeople.gov, HAIs are a leading cause of preventable deaths in the U.S. The fight against HAIs is a major focus for all healthcare personnel and departments in hospitals everywhere. Five categories of infections account for the majority of HAIs in acute care hospitals. Ranked in terms of their frequency of occurrence and their impact on patient morbidity and mortality, the five major infection categories are:

1. Surgical site infections
2. Ventilator-associated pneumonia
3. Central line-associated bloodstream infections
4. C difficile infections
5. Catheter-associated urinary tract infections

Given that surgical site infections (SSIs) are the leading cause of HAIs and account for one-third of the overall costs of treating HAIs, any and all steps taken to reduce the risk of an SSI should be taken to reduce patient harm and improve patient outcomes. A major source of SSIs is contaminated reusable devices that are still contaminated after reprocessing and are then returned to surgery. According to AAMI, “Preventing reusable medical device contamination has become an essential public health issue. Since device contamination can occur at any time, infection prevention must be a shared responsibility—a collaborative, coordinated process in which all stakeholders participate. Such participation involves effective communication, education, proper usage, transportation and storage, cleaning and disinfection, and overall maintenance of often expensive and very delicate reusable equipment essential for proper care of the most important stakeholder: the patient.”¹ As was pointed out in an earlier blog (8/11/17), 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 "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 is contaminated with dead, sterile bioburden following reprocessing. What steps can and should your facility take to reduce your patients’ risk of contracting an SSI from a contaminated instrument? The first step begins with the purchasing process for reusable devices and instruments. When considering the acquisition of new instruments, the AAMI “checklist” states that: “Preventing reusable medical device–related HAIs begins with the active and committed participation in the purchasing process to identify the resources that each stakeholder must have in order to prevent contamination.”³ The ECRI Institute in their "Top Ten Technology Hazards for 2017" report states that the number two patient hazard is: "Inadequate Cleaning of Complex Reusable Instruments Can Lead to Infection."⁴ In order to help solve this major patient hazard, the ECRI Institute recommends that healthcare facilities consider "Purchasing only instruments for which the manufacturer has validated its cleaning instructions. They also recommend that “When applicable, request written information explaining the validation process."⁵ The first step in reducing SSI begins when purchasing new surgical instrumentation. To reduce your patients’ risk of an SSI, your healthcare facility should be demanding validated cleaning IFUs from ALL of your instrument suppliers, including even suppliers that offer instrument that come apart. According to the ECRI Institute report, failure to demand validated cleaning IFUs from your instrument manufacturers is a tremendous patient safety issue. Healthcare facilities have a legal, ethical, financial and moral obligation to only use instruments whose IFUs have been validated using FDA validation protocols. 1. AAMI publication ”Checklists for Preventing Healthcare-Associated Infections” 2. “Guideline For The Prevention Of Surgical Site Infection” Center For Disease Control 3. Op cite AAMI 4. https://www.ecri.org/Pages/2017-Hazards.aspx 5. Op Cite ECRI