Need Approval for a New Products or Technology? Multidisciplinary Risk Assessments Help Facilitate the Process

Safe patient care is the most important issue to healthcare professionals. New products and new technology for the healthcare field are continuously being created.  Most new products are designed to improve patient or employee safety. However, given potentially significant benefits, adoption of new products or ideas often runs into obstacles, especially when it comes to getting approval to purchase.  The barriers are usually budgetary, but can also be a lack of understanding of what the product can do for the patient and the organization, or the fact that current published standards and guidelines have not yet addressed the new technology.

Healthcare facilities need an avenue to evaluate and adopt newly developed products and technologies.  One proven method is to initiate a multidisciplinary risk assessment (MDRA) inclusive of all representative stakeholders that may be affected.  For example, if considering a new endoscope storage cabinet(s), the committee representatives should include, at least, the GI lab, the Operating Room, Sterile Processing, Infection Prevention and Control, Risk Management, Facilities, and Supply Chain. If it involves capital dollars, a champion at the administrative level may be helpful in navigating the budgetary process.

The MDRA committee should establish a goal and ensure the new product can help to advance patient care, reduce operating costs or make a significant improvement in current processes.

After stating the goals for the new product, the committee should collect and discuss the following information:

  • FDA 510 (k) clearance letters
  • Device manufacturer literature and written instructions for use (IFU)
  • Reviews from key opinion leaders
  • Experiences from current users
  • Policy templates for product use
  • Product validation studies
  • Peer-reviewed articles

Instructions for use (IFU) may not include new technology, it is necessary to ensure the technology satisfies all criteria and thoroughly review the validation studies and the Food and Drug Administration (FDA) 510K clearance IFU for the device (if applicable).

Committee members can also discuss new technologies with colleagues at conferences and trade shows etc. The health and safety of patients and staff, the effectiveness of the product, materials compatibility, and cost-effectiveness should be considered.

If possible, the committee should also test the product in-house to allows stakeholders to evaluate firsthand how the new product will affect the organization.

During a product trial, the committee  should:

  • State desired outcomes
  • Plan and complete any necessary pre-trial in-service
  • Develop a product evaluation tool
  • Establish a time limit for the trial
  • Conduct trial
  • Gather data
  • Analyze data
  • Determining the degree to which desired outcomes were met.

At the completion of the trial, the committee should produce a written report that addresses the findings to include goals, benefits, weaknesses, financial impact, and justification for the decisions.  A written record provides an easily referenced and clear-cut system for both internal and external process review.  Products and technology for healthcare will continue to advance. An internal evaluation process that includes an MDRA can be very instrumental in making purchasing decisions. When purchasing any new products or technology you should ask, does this benefit our patients and our organization?

REFERENCES:

  1. ANSI/AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities. Section 14 Quality process improvement, Section 15 New product evaluation
  2. ANSI/AAMI ST91:2015 Flexible and semi-rigid endoscope processing in healthcare facilities. Section 12.11 Quality process improvement
  3. ANSI/AAMI ST58:2013 Chemical sterilization and high-level disinfection in healthcare facilities Section 10 Quality Process Improvement
  4. AORN Guidelines for product selection. In: Guidelines for the Perioperative Practice. Denver, CO: AORN, Inc; 2016

 

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