A Checklist For Purchasing New Surgical Instruments Part III

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

• Verbalizes critical information related to the device
• Verifies competency in the classroom setting
• Shows competency with processing or use of device
• Can verbalize behaviors that facilitate success
• Demonstrates behaviors that prevent contamination of the device and device-related HAIs
• Documents individual mastery of material and competent performance

Successful implementation of the device

• Policies/standard operating procedures (SOPs) are in place and enforced
• Clinician users are trained and understand their responsibility to prevent HAIs
• Appropriate clinical use is verified
• Infection prevention practices are verified
• Behaviors that promote the success of other stakeholders are verified
• Resources are available for remediation
• Processes are in place for recognizing success

Risk assessment

• Published evidence documents the risk of improper processing associated with the device (or device type)
• Published best practices and/or practice standards are associated with proper use of this device (or device type)
• Findings are followed up to ensure that they can be addressed (or an alternate device is selected)

Personnel considerations

• Device can be processed with current staff OR Additional staffing is available for processing
• Current staff has the necessary expertise to process the device
• Among current staff, language barriers or cultural issues will not interfere with learning to process the new device

Resources

• Resources (equipment, personnel, time) exist to process the device appropriately. If not, and additional resources are required, then a plan is put in place to acquire the needed resources

Policies/procedures 

• Site-specific procedures are in place for reprocessing this device
• SOPs are distributed to staff by supervisors and/or other authorities
• SOPs are dated and signed by responsible staff
• If policies and procedures need to be created, the necessary resources (individuals and information) are defined to write, review, approve, and update them (e.g., IFU, technical data sheets, safety data sheets, evidence-based best practices, manufacturer competency based training)
• Policies, procedures, and SOP revisions are part of the maintenance of the reusable medical device 2

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.