News / June 19, 2020
The first step in reducing patients’ risk of a surgical site infection (SSI) caused by a contaminated surgical instrument begins with an in-depth assessment of the various brands and options that are available prior to making the final purchasing decision. According to the Association for the Advancement of Medical Instrumentation (AAMI):
“Every reusable medical device has the potential to be related to transmission of pathogenic agents due to contamination. Contamination of a reusable medical device with subsequent patient transmission is an important risk factor for healthcare-associated infections (HAIs) and continues to be a serious threat to patient safety. HAIs have increased morbidity and even mortality among patients, concurrently increasing healthcare delivery costs.” 1
When evaluating various surgical instrument manufacturers it is up to the hospital’s clinical managers and infection control personnel to ensure that the manufacturer can provide the following AAMI recommended components prior to the purchase of new surgical instruments. Not all of the following recommendations apply to all instrument purchases (i.e., the requirements for endoscopes vs hemostats vs towel clamps will vary significantly).
Criteria for demonstrating competence with the training material
Successful implementation of the device
As was pointed out in Part I and Part II of this blog, the most important item on the new surgical instrument checklist is to ensure that the manufacturer’s IFUs have been validated to prove that they actually provide clean, sterile, moisture-free instruments on every reprocessing cycle. If the manufacturer can’t, or won’t, provide you with cleaning and sterilization IFUs that have been independently validated using FDA testing protocols, then you need to look for another surgical instrument manufacturer. Without validated IFUs, you and your team cannot guarantee that your patients won’t be harmed by a contaminated instrument.
1 AAMI 2017 publication “Checklists for Preventing Healthcare-Associated Infections (HAIs)”
2 Op. Cite.
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