Taming the Wild, Wild West of Reprocessing

Taming the Wild, Wild West Cowboy

Did you know?

When I began my career in surgical services and sterile processing a few decades ago, things sure were much simpler. Those were “the good old days”. Back then, reprocessing of reusable medical devices was a lot less complicated. We did not have all the regulations, standards and recommended practice we have today.  Of course, we also had the increased potential for infections.

We cleaned and sterilized instruments by a routine approach based on our experience or orientation, even if that orientation was 20 years ago. Today’s healthcare environment demands we abide by a new set of “territorial laws” (a.k.a published standards, recommended practices and proven best practices) as we work to reduce healthcare acquired infections (HAI) and surgical site infections (SSI).

In the old days, if we wanted to know how to reprocess something we would ask our colleagues or supervisors how to clean or sterilize an item or a set of instruments. We would even reprocess single use devices (SUD) in an effort to save money, especially if the item was expensive or contaminated before it was even used once. Sometimes, we even opened sterile single use items (e.g. Q-tips or cotton balls) and repackaged them into smaller quantities thinking we were saving dollars. This is bad practice because SUD’s usually do not come with validated instructions for use (IFU). The Food and Drug Administration (FDA) regulates the reprocessing of SUD and require that all applicable premarket requirements are followed.

Doing things because of tradition or because that is how we have always done it is no longer an option for health care facilities. We cannot continue to use the old “sheriff” or “gunslinger” way or “this is how we do it in my town” type of processing. We have moved into a new frontier. We live in a more complicated and high tech world where evidence-based recommendations, sophisticated instrumentation and complex designs have created enormous challenges and barriers to reprocessing. However, these best practices have made patient care safer.

Reprocessing practices are high on the hit list for accreditation surveyors such as The Joint Commission (TJC) or the Centers for Medicare and Medicaid Services (CMS). A red flag for TJC is if a facility reprocesses reusable devices in more than one area (e.g. Sterile Processing (SP) and GI Lab).  Surveyors want to see consistency and standardization on all processes and policies. If you are reprocessing reusable medical devices in SP, Operating Room, Ambulatory Surgery Center, GI Lab, a dental clinic, or a physician office you need to ensure you are using established best practices and that your procedures are standardized in all processing areas within your facility. According to CMS, “If manufacturers’ instructions are not followed, then the outcome of the sterilizer cycle is guesswork, and the ASC’s practices should be cited as a violation of 42 CFR 416.44(b)(5).”1

Today we must be cautious about doing things the right way, the safe way. With many resources available at our fingertips, there is no room for practicing by tradition, accepting excuses for not following best practices, for not being educated about published standards, or for not asking the right questions. Following current published standards and recommended practices can help standardize processes; settle “territorial disputes”; address regulatory, legal and safety issues; and provide a greater level of care and better patient outcomes.

We must all be deputies in upholding the standards (a.k.a “laws”) of reprocessing. If we see something that is not being done right or best practices not being followed, we owe it to our patients to speak up and question why. Always find out what is right—not who is right. Leave that old way of thinking in the dust of the ghost town.

President/CEO Seavey Healthcare Consulting, LLC 



1.       http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/downloads/SCLetter09_55.pdf