5 Big Changes for Product Evaluation Practices

Perioperative nurses are astute patient advocates, and they know the importance of quality in the products and medical devices they use in patient care.

To make sure nurses have an informed voice with the latest evidence for important product choices, AORN Guidelines Editor-in-Chief Erin Kyle, DNP, RN, CNOR, NEA-BC, is encouraging all perioperative nurses to review new recommendations in AORN’s latest revision to the Guideline for Product Evaluation. This new version of the guideline just published electronically on eGuidelines+ at aornguidelines.org.

“The product choices perioperative nurses make can affect a patient’s clinical outcomes related to how the product or device performs in the clinical setting, which can have a direct impact on the environment when they contribute to toxic emissions or result in large amounts of waste,” Kyle says. She also stresses that the product choices nurses make can heavily influence the financial health of the health care organization and ultimately the price of health care in their communities and nation.

As lead author of this guideline revision, Kyle is excited for nurses to review new evidence-based recommendations and practical studies that can help teams improve safety and cost savings in their work with evaluating OR products.

Here are five key updates from the guideline revision she highlights:

1. Invite More Experts to the Product Evaluation Team

Recommendation 1.3.1 includes a longer list of key stakeholder disciplines to include in the interdisciplinary team for product evaluation. For example, make sure to include health information technology professionals and inventory optimization and change specialists.

2. Follow Regulatory Guidance for Sharps Safety Devices and Respiratory Protection

Health care organizations are required by OSHA to establish a process that includes input from clinicians who will be using sharps safety devices and respirators for selecting and evaluating them. This process should be documented as part of the organization’s written bloodborne pathogens exposure control plan and respiratory protection program, as discussed in Recommendation 1.3.3 and 1.3.4.

Neither is a new regulation, but the respiratory protection requirement was not listed in the previous guideline and both requirements are important to recognize, Kyle stresses. “Safety is paramount and including clinicians who will be actually using sharps safety devices and respirators in the perioperative setting is essential to selecting the best option.”

3. Take a Closer Look at Products That Save Money

Product evaluation teams should evaluate the clinical performance of medical devices and products that are introduced for purchase consideration as a result of a cost-savings initiative, according to Recommendation 2.3.2. This recommendation is based on the numerous studies (more than 20) cited in the revised guideline that detail product- and device-related cost improvement initiatives that resulted in positive outcomes for a variety of health care organizations, perioperative teams, and patients, Kyle explains. For example, a 2019 study by Goldberg et al found logistical and economic advantages, such as saving $994 per case and time savings equating to an extra procedure, when using sterile-packed, single-use instruments for total knee arthroplasty.

4. Evaluate Technology Interoperability and Security

Recommendation 2.4 explains how product evaluation teams should handle evaluation for relevant technology products to ensure the products provide interoperability and security. “Nurses know the very real patient safety factors associated with interoperability, such as having access to patient records across departments,” Kyle explains. She also notes the cybersecurity vulnerabilities that have been recognized by the FDA with certain medical devices that use Bluetooth energy.

5. Cross-Check Regulatory Reporting Systems to Better Catch Recalls and Safety Concerns

A new Recommendation 3.1.1 says a product evaluation team should include a review of regulatory reporting systems listed in the guideline as part of the quality assurance and performance improvement process.

“There are many reports and studies of medical device recalls and safety concerns that describe instances of patient harm related to device failure. The interdisciplinary team responsible for purchase and quality assurance in the organization should be well-informed about adverse events related to any product that is being considered for patient use,” Kyle notes.

Search for these specific recommendations and review the full revised (released end of July) Guideline for Product Evaluation through eGuidelines+.

Read the Guideline First Look for Product Evaluation in your July issue of AORN Journal.