Considering Technological Advancement Purchases? First Step: Create a Multidisciplinary Risk Assessment Committee
By Rose Seavey, MBA, BS, RN, CNOR, CRCST, CSPDT
Advancements in healthcare technology are vitally important as new discoveries can improve the quality of patients’ lives and reduce risks or costs to the organization.
Organizations that accredit healthcare facilities, such as the Centers Medicare and Medicaid Services (CMS) and The Joint Commission (TJC) audit healthcare organizations to ensure that their practices and procedures align with the nationally published standards, such as the Association for the Advancement of Medical Instrumentation (AAMI) and the Association of Perioperative Registered Nurses (AORN).
Many national standards, including AAMI and AORN, are on a five-year update cycle. While still applicable, some guidelines or standards can be a key barrier to the adoption of promising technologies. New devices and equipment are frequently introduced, which the existing standards or guidelines don’t recognize. This can leave the facility between a rock and a hard place when considering a new technology that the current standards do not mention.
Even though there are important benefits of implementing new technology advancements, healthcare organizations may not consider purchase or implementation until the updated standards and manufacturer’s instructions for use (IFUs) of other compatible devices address the new technology in the guidelines.
Because of this issue, healthcare organizations require a way to be able to evaluate and adopt newly developed products and technologies that standards presently do not address. According to AAMI, “When any product is being considered for use within a facility, it is the responsibility of the intended users to evaluate the product using a systematic process of product evaluation…. This is especially true when the health care organization is considering a product for which there are no guidelines from AAMI or other similar professional organizations.”1
If a healthcare facility decides to adopt a new product or technology that surpasses current standards, personnel should provide evidence that they have carried out a meticulous process of evaluation, commonly called a risk assessment (RA), before making the change.
The facility should create aninclusive, multidisciplinary RA committee comprised of all stakeholders. For example, representatives for a new sterilization technology should include sterile processing, operating room, infection prevention and control, risk management, and facilities. An administrative-level champion would be helpful in the navigation and budgetary process.2
The committee’s established goal shouldhelp ensure the new product or technology will help advance patient care, decrease risks, reduce operating costs, or make a consequential enhancement in existing processes.
Once the committee is formed and it has agreed upon the specific goals for the new product or technology, the RA committee should collect and converse about the following information:
- FDA 510(k) clearance letters
- Device manufacturer literature and written IFU
- Reviews from key opinion leaders
- Experiences from current users
- Model policies for product use
- Product validation studies
- Peer-reviewed articles, if available
Published peer-reviewed articles may not be available for products or technology that are new to the market. For that reason the RA committee may be dependent on the data generated by the product manufacturer and key opinion leaders.
Current IFUs may not include new products and technology, so be sure the product or technology satisfies any other criteria and thoroughly review the validation studies and the U.S. Food and Drug Administration (FDA) 510(k) clearance IFUs for the device, if relevant.
The RA committee members should discuss up-and-coming products and technologies with peers when attending conferences, trade shows, etc. In these discussions, they should weigh considerations such as the health and safety of patients and employees, the usefulness of the product (does it do what it promises it can do), materials compatibility, and cost effectiveness.
In-house testing of the product will allow stakeholders to evaluate how the new product or technology will affect the institution. When conducting a trail, the RA committee should:
- State desired outcomes
- Establish a time limit for the trial
- Develop a product evaluation tool
- Plan and complete any necessary pretrial in-service
- Conduct trial
- Gather data
- Analyze data
- Determine the degree to which desired outcomes were met
The RA committee should develop a written report that addresses the trial findings, taking into account the goals, benefits, weaknesses, financial impact, and justification for the final decision. A documented record of all of this information provides an easily referenced and straightforward system for both internal and external process review.
It is a given that technology will continue to advance; as a result, healthcare organizations should institute internal evaluation policies that include a multidisciplinary risk assessments and guidelines on how to conduct them. The committee should ask the big questions, such as, “What is the benefit of the product to our patients?” That answer should determine the next steps to take.
- ANSI/AAMI ST79:2017. Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. Section 15.
- AORN Guidelines for product selection. In: Guidelines for the Perioperative Practice.Denver, CO: AORN, Inc; 2018.
Rose Seavey, MBA, BS, RN, CNOR, CRCST, CSPDT, is president/CEO of Seavey Healthcare Consulting and formerly the director of the SPD at The Children’s Hospital of Denver. Rose served on the AORN board of directors and is a past president ASHCSP. She received numerous awards and was named as one of the Who’s Who in Infection Prevention by Infection Control Today. Ms. Seavey is the author of Sterile Processing In Healthcare Facilities: Preparing for Accreditation Surveys, published by AAMI. She serves on several AAMI committees helping to write national standards.
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