The Guideline for Medical Device and Product Evaluation, approved by AORN, is meant to help perioperative teams develop and implement a process for evaluating FDA cleared medical devices and products for use in the operating room.  There are four cornerstone standards: 

  1. patient safety
  2. perioperative team member safety
  3. patient outcomes
  4. product quality

This product evaluation thing? Far from an easy task. Certain variables make it difficult to perform research on product selection that will be useful in all settings, including differences in organization size, financial constraints, group purchasing relationships, and contractual agreements, the Guideline concedes.

Outside the scope of the Guideline are yet other variables, including:

  • specific process for cleaning, disinfection, and sterilization
  • equipment maintenance
  • inventory control
  • health information technology
  • processes for waste disposal
  • supply chain (purchasing processes)

The Guideline does, however, suggest criteria for nurse members to use in determining whether to purchase single-use or reusable products, a discussion of interest to us at Action Products.

  • On the reusable side, our company revolutionized the reusable positioning product market through the introduction of our proprietary Akton® viscoelastic polymer gel, addressing a number of the concerns named in the Guideline, including the reduction of disposal, disposable waste, reduction of inventory space, and safety (the products are self-extinguishing).
  • On the disposable side, Action’s DryMax Fluid Management products, which are single-use, help reduce laundry costs and shrink turnover times.

The findings of a study conducted in five UK hospitals revealed that the main stakeholders in the hospital purchasing process included clinical engineers, clinical end users, healthcare industry representatives, and risk managers. ”Responsibility for purchasing safe medical devices is shared among clinical end users and financial and technical stakeholders,” the study concluded.