“A Checklist For Purchasing New Surgical Instruments Part II”

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:

 

• Materials are written and presented at an appropriate learning level

 

• Learning activities incorporate a variety of learning styles

 

• Visuals (PowerPoint presentations, videos) are provided as appropriate

 

• Components include narration, lecture, discussion, and question/answer

 

• Study materials (e.g., IFUs, handouts) are provided

 

• Hands-on/lab/simulation is incorporated as appropriate

 

• Instructor is well trained to comprehensively deliver the materials

 

Environment is conducive to learning:

 

• Staff is provided sufficient time to cover the material

 

• Learning sessions do not conflict with daily workload assignments

 

• Classroom is appropriate with comfortable seating and audio/visual support

 

• Potential for distractions is minimized (avoid high-traffic areas such as the cafeteria or the employee lounge)

 

Capable learners:

 

• Academic preparation is appropriate to the material for physicians, nurses, sterile processing department technicians, environmental technicians, and/or supervisors

 

• Course level is directed to the particular audience and that the audience members are fluent in the language of the course

 

Device orientation:

 

• Is mandatory and is delivered by a trained instructor

 

• Describes the device application and describes any unique characteristics that differentiate the device from similar devices (if learners have experience with similar devices)

 

• Defines responsibilities related to preventing contamination and device-related HAIs

 

• Introduces other stakeholders and their responsibilities for the device

 

• Defines roles and responsibilities of all stakeholders related to device-specific contamination risks 2

 

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.