Product Evaluation

Purpose

This practice guideline provides recommendations intended to optimize perioperative patient care by engaging the right group of professionals in evidence-based practices for evaluating products to be used in the perioperative setting. The recommendations are informed by a systematic review of the evidence and an assessment of the benefits and harms of alternative options in the area of medical device and product selection and evaluation in the perioperative setting. Specifically, this document provides guidance to perioperative team members for developing and implementing a process to evaluate US Food and Drug Administration (FDA)-cleared medical devices and products for use in the perioperative setting.

The selection and use of products, equipment, and devices in the operating room (OR) setting has considerable financial consequences because much of the cost of an operative or other invasive procedure is influenced by the cost of the supplies and equipment used during the procedure.^1,2  In an analysis of Medicare claims in 2014, researchers found that total payments for surgical care represented 51% of total program spending at $124.9 billion.² 

The FDA is responsible for medical device regulation in the United States.^3-11  Innovation in the development of medical devices has been key to advancements in surgery, but not all new devices have demonstrated improvements in patient outcomes, and some have caused patient harm.¹²  This balance of the benefits of efficient innovation and the potential for harm associated with devices whose risks are unknown is one that the FDA and global regulatory bodies consistently navigate under the current regulatory framework.^12,13 

The evidence regarding best practices for product evaluation in the perioperative setting is limited. The health care system is complex, with many variables that make it difficult to perform research on product selection that is generalizable to all settings. These variables include the size of the organization, financial constraints, group purchasing organization relationships, and contractual agreements.

The following subjects are outside the scope of this guideline: comparisons of and recommendations for specific products, equipment, and devices; medical device labeling; 3D-printed implants and products; specific processes for cleaning, disinfection, and sterilization; management of products and devices after purchase (eg, equipment maintenance, inventory control); selection of electronic health records and other software (eg, health information technology); processes for product waste disposal; and purchasing processes (eg, supply chain).