Endoscopy Certification

Q: “At our facility, we require sterile processing technicians to be certified within one year of employment, but there is no certification requirement for those who are reprocessing flexible scopes. Shouldn’t they also have a certification requirement?”

A:

You make an excellent point, and one that our industry tried to address with the most recent version of ANSI/AAMI ST91:2021.¹

In ST91 Section 6.3¹ – Education, training, and competency verification, it states, “All personnel performing endoscope processing shall complete formal training and competency verification in all aspects of endoscope processing prior to first assignment to perform these tasks independently. All personnel performing processing of endoscopes should be certified in flexible endoscope processing within two years of employment and should maintain that certification throughout their employment.” 

There are two parts to this statement that are important to break down. Let’s first talk about the standards themselves, the language used, and the difference between should and shall. 

The Association for the Advancement of Medical Instrumentation (AAMI) documents are consensus best practice standards. While hospitals should have them on hand and know what they say, there is no legal requirement for hospitals to follow them. For example, surveyors will not cite a facility for not following these standards unless the facility has them listed in their policies and/or procedures or the facility staff tells the survey team that they are following AAMI standards. This is in contrast to legal requirements from the city/county/state level and regulations like Occupational Safety and Health Administration (OSHA) with the OSHA Bloodborne Pathogens Standard,² which must be followed by all healthcare facilities.

However, consensus standard documents are best practice standards for our industry, and hospitals that are striving for best practice should be following them. Which, shouldn’t we all?

A.    Standards

Is your facility following AAMI or any other standards (i.e., AORN, SGNA, etc.) recommendations? If they are cited in your policies, procedures, or training documents (like competencies), then surveyors will use them to ensure you comply with certain statements in the standard.

B.    Shall and Should

1. The “shall” statements are the most important to follow, as they are requirements of the standard. Recalling ST91 Section 6.3¹ above, “All personnel performing endoscope processing shall complete formal training and competency verification in all aspects of endoscope processing prior to first assignment to perform these tasks independently.”
   1. This means it is a requirement if you are following AAMI ST91¹ standards.
   2. Basically, anyone who is responsible for processing flexible endoscopes, whether a dedicated processing technician or the tech in the patient room, is required to have competency training prior to working on their own.
2. The “should” statement stops short of this being a requirement of AAMI and falls into the next most important category. It applies to certification. “All personnel performing processing of endoscopes should be certified in flexible endoscope processing within two (2) years of employment and should maintain that certification throughout their employment.”
   1. “Should” statements are recommendations, and your facility should have a justifiable reason if they are not following them.
   2. The standard strongly recommends that processing personnel should be certified.

The reason behind this updated recommendation is simple. We want highly skilled and well-trained individuals to process our most complex devices, like flexible endoscopes.

There are some specialized studies that support the recommendation of ST91 Section 6.3.¹

A 2025 study by Cori Ofstead & Associates³ highlights how prevalent processing breaches or missed steps in the process are. I recommend reviewing this particular study, as it demonstrates how pervasive deficiencies are across all areas of sterile processing.

A collaborative study published by the Centers for Disease Control and Prevention (CDC) in 2020⁴ found that even when all processing steps were followed, there was still biological material found on processed endoscopes.

If you aren’t familiar with the U.S. Food and Drug Administration’s (FDA) Manufacturer and User Facility Device Experience (MAUDE) database,⁵ I strongly recommend exploring it. This database features thousands of adverse patient events caused by critical steps being overlooked during the cleaning/inspection process of flexible scopes or by damage to equipment before reaching any patients. We can learn from these missed opportunities in the profession.

I don’t cite these studies or point to the adverse patient outcomes to scare you. But the need is clear: a competent, well-trained individual is the best hope to avoid these tragic outcomes. This is where certification comes in. 

The definition of certification is when a professional organization validates that an individual has met specific, predetermined standards of knowledge, skill, and experience in a specialty area. This can usually be accomplished through a combination of real-world experience (often a 400-hour or 3-month hands-on experience requirement) and a competency exam.

Certification shows the professionalism of the processing technician. It shows the individual cares enough about the subject to pay, study, and sit for a competency exam. Each certification has a tremendous amount of information in their manuals, and it’s no easy feat to pass their accompanying exams. I would strongly recommend a course that can help distill the information and apply it to real-world processing. Just be careful of scams and exorbitant pricing on some of them!

While the exam process and book knowledge are important, perhaps the more important part of the certification process is to understand the risks associated with complex devices like flexible scopes and the importance of following instructions for use (IFU) and best practice standards. When someone is simply trained on the hands-on “nuts and bolts” of processing steps, there isn’t a clear correlation to the infection risks associated with skipping them. All the current certification methods make it clear that following the manufacturers’ IFU is of particular importance, and they do a great job of showing the “why” behind each of the processing steps. For instance, “Why is it important to leak test your scope?” might seem like an unnecessary step to those who have never learned about the “why,” but when you learn about the risks associated with fluid invasion, the importance of this step really hits home.

As for the certifications themselves, I have heard pros and cons with each, but both are excellent options. The Healthcare Sterile Processing Association’s (HSPA) CER⁶ is the most popular among them, but the Certification Board for Sterile Processing and Distribution (CBSPD) offers CFER,⁷ which is an excellent program as well. Endoscopy departments will likely hire certified technicians with either certification. (Note: I haven’t yet heard of a department that requires one over the other.) It’s up to the individual to examine each method and determine which will work best for them.

Certification is vital to patient health because it means that well-educated individuals are processing the scopes that will be used on them. Always remember that a patient undergoing a procedure is at their most vulnerable and cannot defend themselves against infections resulting from poor processing practices. Patients rely on sterile processing technicians who are properly educated, trained, and diligent in the steps of processing for every patient, every time.

References:

1. Association for the Advancement of Medical Instrumentation. (2021). ANSI/AAMI ST91:2021 Flexible and semi-rigid endoscope processing in health care facilities (Section 6.3—Education, training, and competency verification).

2. Occupational Safety and Health Administration. (2020). Occupational exposure to bloodborne pathogens (29 CFR 1910.1030). U.S. Department of Labor. https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1030

3. Ofstead, C. L., Smart, A. G., Hurst, L. L., Lamb, L. A. (2025, July). Endoscope processing effectiveness: A reality check and call to action for infection preventionists and clinicians. American Journal of Infection Control, 53(7), 785−793. https://doi.org/10.1016/j.ajic.2025.04.003

4. Benowitz, I., Beer, K. D., & Gierke, R. (2020). Gastrointestinal flexible endoscopes: Infection control risks, lessons learned from outbreaks, and Centers for Disease Control and Prevention guidance. Centers for Disease Control and Prevention. https://stacks.cdc.gov/view/cdc/104184

5. U.S. Food and Drug Administration. (n.d.) MAUDE - Manufacturer and User Facility Device Experience. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm

6. Healthcare Sterile Processing Association. (n.d.). Certified endoscope reprocessor (CER). https://myhspa.org/certification/certification-overview/certified-endoscope-peprocessor-cer/

7. Certification Board for Sterile Processing and Distribution. (n.d.). Certified flexible endoscope reprocessor (GI SCOPE). https://www.cbspd.net/gi-scope/