News / June 5, 2020
The first step in reducing your 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
The rollout and use of new reusable surgical instruments requires a well-designed training and in-servicing program from the manufacturer. Your reprocessing staff must be capable of learning and following the manufacturer’s validated cleaning and sterilization IFUs. It is up to you to ensure that your staff is properly reprocessing the instruments according to the manufacturer’s validated IFUs to minimize the risk of a contaminated instrument being returned to surgery and harming a patient.
When evaluating various manufacturers, it is up to you and your team to ensure that the following components are in place prior to the purchase of new surgical instruments:
Structure of the Program:
Environment is conducive to learning:
As was pointed out in Part I of this blog, the most important item on the 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 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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Elmed Incorporated is a wholly owned American company and is not associated with any other “Elmed” company based outside the United States.