As a sterile-processing professional, I’m often asked, “Which standards or guidelines should I follow in endoscopy?”
It’s no wonder people get confused when there are so many healthcare organizations that develop guidelines for endoscopy, such as the Association for the Advancement of Medical Instrumentation (AAMI), the Association of peri-Operative Registered Nurses (AORN), the Society of Gastroenterology Nurses and Associates (SGNA), the Association for the Practitioners in Infection Control (APIC) and multi-society guidelines, among others.
People often want to know which to follow in their practice setting. It has been my experience that most facilities follow guidelines developed by the professional organization to which they belong. In a hospital setting, the operating-room staff most likely will follow AORN’s guidelines for processing flexible endoscopes, while the endoscopy department will follow SGNA. Much of the content of various guidelines have similar recommendations, but there can be practices not covered in the guidelines or that are in contrast to guidelines from another organization.
According to the National Institute of Health (NIH), “U.S. Standards are authoritative statements that articulate minimal, acceptable or excellent levels of performance or that describe expected outcomes in health care delivery, biomedical research and development, [healthcare] technology, or professional [healthcare]. Guidelines are statements of principles or procedures that assist professionals in ensuring quality in such areas as clinical practice, biomedical research, and health services. Practice guidelines assist the [healthcare] practitioner with patient care decisions about appropriate diagnostic, therapeutic, or other clinical procedures for specific clinical circumstances.”
Healthcare professionals utilize the guidelines from their respective organizations to guide their practice. Often these practices relate to clinical matters. However, there is a difference between the two.
Standards
According to the Association for the Advancement of Medical Instrumentation, requirements, specifications, guidelines or characteristics can be used consistently to ensure that materials, products, processes and services are fit for their purpose. AAMI develops standards documents
aimed at enhancing the safety, efficacy, safe use and management of medical devices and health technologies (www.AAMI.org).
AAMI is not a regulatory agency and its standards are voluntary. AAMI committees that develop these standards consist of representation from both industry (manufacturers) and users (healthcare professionals from agencies such as HSPA, APIC, AORN and SGNA). Each committee is cochaired by a manufacturer representative and a user representative. In addition, the Food and Drug Administration (FDA) has representation on every AAMI committee to provide additional guidance when documents are being developed.
There is an opportunity for members to communicate their concerns to manufacturers and to learn the science behind the products and processes. For example, for a very long time, users asked for ultrasonic cleaners with greater capacity. It took a while, but now most ultrasonic manufacturers offer multilevel sonic machines.
When a document is developed, a proposal for a new document must be submitted by a member in good standing. Then the need for the new document is distributed to the members to determine if there is a need for this document. If the majority feel the document is needed, a call for committee members is made.
The committee members develop the document over a period of time (depending on the topic, this can take two years or more). A new document might take longer to develop. At each committee meeting (regular meetings are held each spring and fall) the progress on the document is discussed and reviewed by all members. Comments regarding content are submitted in writing and designated as technical or editorial.
However, all comments are discussed and either accepted, accepted with modification, or not accepted. This review process continues until the document is completed and all comments have been resolved. Then the document is placed out for ballot by the committee members. A majority of votes are needed to pass. If passed, the document is then reviewed by the public for comments. Following the successful comments/approval process for the public review, the document is sent to the AAMI board of directors for its review/approval. Since the document is a standard, it also needs approval from the American National Standards Institute (ANSI).
Then the document is known as ANSI/ AAMI [title of the document]. Standards always have a ST designation and a number as part of the document’s title (e.g., “Flexible and semi-rigid endoscope processing in health care facilities,” ST-91 2021). All standards are reviewed every five years and either reaffirmed (document still needed but no changes are needed); discontinued (no longer relevant), or needs updating (with changes).
Of Note …
Like standards and recommended practices, an AAMI technical information report (TIR) addresses a particular aspect of medical technology. However, a TIR differs markedly from a standard or recommended practice in terms of the process followed leading up to publication. This process of consensus is supervised by the AAMI Standards Board and, in the case of American National Standards, by the ANSI. A TIR is not subject to the same formal approval process and reflects primarily a technical committee opinion rather than a national standard.
Summary
I believe there should be standardization of practices for endoscopy regardless of the clinical setting. For clinical issues, clinical guidelines excel, as they are specialty-specific. However, when it comes to processing, that is where the confusion comes in, and confusion has no place in healthcare. If a national standard carries more weight than a clinical guideline, then how can we justify not following it?
According to an American Journal of Law article, “What we are learning, however, is that, in addition to varying in scope and quality, many CPGs [clinical practice guidelines] (such as those created for utilization review by payors or those promulgated by specialty societies, which may conflict with other specialty societies’ standards) are designed to meet the needs of the drafting organization, rather than defining a specific, applicable standard of care for every case.
“This has complicated the adoption of CPGs in establishing the standard of care in particular cases.”
In my opinion, when developing policies relating to care, handling and testing of endoscopes, AAMI ST-91 should be the reference for the reprocessing protocols since it is a national standard. Having more than one reference in a policy is acceptable and, in this case, recommended.
