Damien S. Berg BA, BS, CRCST

There are 3 things that continually haunt sterile processing mangers and departments—Staffing, Productivity and Products. This article specifically discusses how to bring new Products into your department.

Many health care systems have robust purchasing departments that guard against waste, focus on standardization/compliance, and of course, secure the best price. With all of these factors to consider and navigate, Sterile Processing Managers and staff can be left with feeling of disillusionment and frustration when trying to get needed products into the hands of the people who utilize them.

In an environment where hundreds of products are vying to get into your department, it’s important to know who to work with and how to best communicate the needs of your department. The task of wading through reams of sales information sheets and determining how to present your needs to the decision makers in your department and your healthcare system can seem overwhelming. But, before you give up due to frustration, remember that you know more than anyone about what is needed and what will work best in your department. So the challenge is to effectively articulate your department’s needs and present a factual case to the ultimate decision makers.

Most purchasing departments within large health care systems have a specified product evaluation and selection group that will help review and inform the strategic purchasing decisions with input from the end user. Whether or not your facility or system has such a group, a best practice is to form your own internal Sterile Processing / OR product consensus group that will look at all products that are presented to or requested by SPD or the OR. The charge of this group is to bring together all stakeholders and perform a repeatable, systematic evaluation. This process should include assembling the following information relating to the new product:

  • Proposed product plan (What is the product, who requested it, how will it be used, and what departments it will impact).
  • FDA documentation (clearance, IFU’s that cover use, cleaning, sterilization, storage).
  • Use related information (case studies, product reviews, articles)
  • Maintenance requirements and ongoing service costs
  • Any supporting products
  • Compatibility with current equipment or products
  • Educational needs and in-services

You can add to or subtract from this list as is appropriate for your facility and your available resources. Note that for consistency, the same list should be applied each time a product is evaluated.

Using these inputs, you can then develop a business case for the product that can be shared with purchasing and/or administration. A well-constructed business case will greatly help your efforts and reduce the delay in getting a new product into your department.

The following components should be in every business case for new products:

  • Patient safety contribution
  • Cost analysis
  • Benefit analysis
  • Time line for trial or implementation
  • Follow up analysis (user satisfaction, physician satisfaction, performance measures)

There is a never ending wave of products that are presented to you and your organization every year. Developing a strong consensus group that brings facts and figures to the decision makers makes everyone’s job easier and helps you get the right products in the right hands.

For more comprehensive information on the evaluation of new products see;

AORN (2014a)

AAMI ST79 section 15 new product evaluation (2012)

One thought on “Getting Products Approved For CSS

Leave a Reply

Your email address will not be published. Required fields are marked *