Product Evaluation & Purchasing: Sterile Processing

Chuck Hughes is the recently retired founder of SPSmedical Supply Corp. based in Rochester, N.Y.  He has 30-plus years of experience in healthcare, speaking at Conferences, contributing to national Standards on medical device reprocessing and providing mock surveys to hundreds of healthcare facilities globally. A respected educator and strong supporter of SPD, Hughes had received awards from numerous chapters, including IAHCSMM's Award of Honor in 2005. ICT spoke with Hughes regarding the imperatives of smart product evaluation and purchasing for the sterile processing department.

Q: What poses the biggest challenges in terms of evaluating products for the sterile processing department (SPD) in general?

A: I believe the biggest challenge for SPD in terms of evaluating new products, is ensuring they comply with best practices and Food and Drug Administration (FDA) regulations. For example, documentation must be provided by the medical device manufacturer that shows their new reprocessing process can be used with existing devices or in the case of a new device, that existing processes can be used with the device being evaluated.

Q: What are the specific challenges relating to evaluating chemistries; sterilization equipment and other consumables? Does the product itself represent unique challenges in this respect?

A: Evaluating chemistries are challenging, as pre-cleaning, cleaning and/or disinfection chemicals must be consistent with device manufacturers' instructions for use (IFU). For example, when evaluating a pre-cleaning or cleaning solution used to moisten contaminated devices prior to transport from point of use, there will be limitations placed on users as some device manufacturers call out the use of an enzymatic solution. This is true with many cleaning chemistries as well, along with the fact that many devices also call out for the use of a neutral pH solution. Knowing what has been validated by each device manufacturer, will help to ensure that proper evaluations are being done. New sterilization processes are also a challenge, as while they may offer faster cycle times, the process and/or cycle(s) may not have been validated with the reusable devices your facility uses. Too many healthcare facilities have purchased new processes over the years, only to find out later that they do not have proper documentation in place to process the intended devices. Consumables (i.e., indicators and packaging) are also a challenge as they too require FDA clearance for use with specific processes, as well as specific cycles. Long gone are the days when we processed everything in steam unless it melted, and if so we placed it in our low temperature sterilizer.  Chemical indicators, biological indicators and/or packaging systems that do not state the specific process and cycle(s) being used, should not be evaluated as their use would be considered "off-label" use by the FDA and thus provide users invalid results.

Q: Manufacturers make a lot of noise about their products; how can purchasing managers/SPD managers cut through the white noise and truly evaluate a product’s effectiveness?

A: Manufacturers who develop products that help users comply with best practices should be embraced. Those who make noise, i.e. do not have a validated IFU or recommend a use that is not supported by Standards, should not be evaluated or purchased. In fact, I recommend that every SPD consider four issues with regards to new purchases.  These are economics, science, regulatory and legal.  When evaluating a new product, each of these issues should be considered for an effective outcome. Economics always comes into play, as budgets must be adhered to in order to stay in business. Science always comes into play, as microbiology is the reason for our work. Regulatory always comes into play, as best practices must be adhered to and are defined by Standards from organizations such as AAMI and regulations issued by the FDA. Legal is the final issue, and should always be considered as we live in a very litigious society where patients can and do sue healthcare facilities when there are bad outcomes.

Q: Does the average hospital purchasing manager know enough about the processes that take place in the SPD to make smart purchasing choices for this department? And if not, how can sterile processing personnel/managers/directors help educate?

A: Healthcare purchasing Managers typically are experts at understanding economic issues, they may lack knowledge regarding science, regulatory and/or legal issues with regards to purchasing medical devices. For this reason, product review Committees should be encouraged so that all four issues (economic, science, regulatory and legal) are reviewed and weighed prior to new purchases. The same goes for existing products currently being purchased.

Q: What is the best way to trial/introduce a product into the SPD and then to educate around it?

A: The best way to introduce a new product that has received approval after a proper evaluation, is to schedule an in-service with all personnel who will come into contact with the new product. This requires a commitment from the product manufacturer to schedule enough time to train and educate all shifts and to return to catch those who may have been absent for the initial in-service. The SPD shift supervisors should ensure that best practices are encouraged and the product IFU is utilized when demonstration proper use of the new product.

Q: Is there a role for the hospital infection preventionist to play in all of this?

A: Hospital infection preventionists play a critical role in the purchase of new products, especially those that have complex IFUs. They should ensure that policies and procedures (P&P) have been updated and training logs complete prior to implementing the new product(s). The IP also should assist with compliance, if there is reluctance among any of the personnel as to the change(s) required with the updated P&P.