Standards, Guidelines or Recommendations: Do We Really Need to Follow Them?

There are many published standards guidelines and recommendations related to reprocessing reusable medical devices. As evidence becomes available, these publications are often updated to reflect most current best practices. So, does that mean we must follow them? Let’s start by discussing what the Association for the Advancement of medical instrumentation (AAMI), the Association of periOperative Registered Nurses (AORN) and the Society of Gastroenterology Nurses and Associates, Inc. (SGNA) has to say.


AAMI recommended practices reflects the conscientious efforts of health care professionals, in cooperation with medical device and equipment manufacturers, to develop recommendations for optimum performance levels in the processing of reusable medical devices.1 Guidelines are intended to provide comprehensive information and direction for health care personnel in processing devices and accessories 2. It is not the intention that these recommendations be construed as universally applicable in all circumstances. AAMI recognizes that in many cases some recommendations might not be immediately attainable. The AAMI documents should be used to guide towards desirable performance objectives, and all of its requirements should be considered and applied.1

We also need to consider the specific wording in recommendations. In the context of AAMI documents:

  • “Shall” indicates requirements should be strictly followed to conform to the recommended practice;
  • “Should” indicates that among several possibilities one is recommended as particularly suitable, or that a certain course of action is preferred but not necessarily required, or that (in the negative form) a certain possibility or course of action should be avoided but is not prohibited;
  • “May” is used to indicate that a course of action is permissible within the limits of the recommended practice.
  • “Can” is used as a statement of possibility and capability; and
  • “Must” is used only to describe “unavoidable” situations, including those mandated by government regulation (e.g., OSHA, FDA, EPA).1,2

The concepts incorporated in AAMI standards should be considered flexible and dynamic. The recommendations set forth are reviewed and updated periodically to assimilate progressive technological developments. Suggesting for improving recommended practices are invited. Written comments and suggested revisions should be sent to Technical Programs, AAMI Technical Programs, AAMI, 4301 N. Fairfax Dr., Suite 301, Arlington, VA 22203-1633.1,2.


AORN’s Guidelines and Recommended Practices are based on evidence which is rated. Evidence rating is done with research and non-researched evidence used to support recommendations that provides a rigorous and comprehensive appraisal of the available evidence and link evidence-based recommendations to clinical practice. Recommendations are statements representing what is believed to be optimal and achievable perioperative nursing practice.3

Policies and procedures will reflect dissimilarities in practice set¬tings that determine the extent to which the recommended practices can be implemented. AORN recognizes diverse settings and as such, these recommended practices are guidelines adaptable to all areas where operative and other inva¬sive procedures may be performed.4


SGNA standards are to be used for all settings where gastrointestinal endoscopy is practiced. “Proper reprocessing of endoscopes and accessories is critical to the safe and successful treatment of patients. Although endoscopes reprocessed in accordance with manufacturer’s reprocessing instructions and infection prevention guidelines pose low risk of transmission of patient-borne or environmental microorganisms, any deviation from the reprocessing protocol can lead to the survival of microorganisms and increased risk of infection (ASGE, 2014; Rutala & Weber, 2015)”4

As a consultant, I am often asked if it is necessary to follow these documents. I have even be told by a person that they work in an ambulatory surgery facility so the standards guidelines and recommended practices do not apply to them. My response was how do the bugs know where they are?

Organizations spend a large amount of time and research creating publications to help healthcare facilities strive for what is the best and safest practices for both patients and personnel. Therefore, it seems clear to me. If facilities want to provide the safest care for their patients’ and employees, shouldn’t they follow Best Practices? If one of my loved ones or I am a patient in your facility, I want you to do the best practices that you possibly can to help ensure a favorable outcome. I am sure you would too.


1. ANSI/AAMI ST79 – Comprehensive guide to steam sterilization and sterility assurance in health care facilities (Forward), ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013

2. ST91 – Flexible and semi-rigid endoscope processing in health care facilities (forward). Arlington, VA, ANSI/AAMI ST91: 2015

3. Guide to AORN Evidence-Related Recommended Practices. In: Perioperative Standards and Recommended Practices. Denver, CO: AORN, Inc; 2014

4. Guidelines for Cleaning and Care of Surgical Instruments. In: Guidelines for the Perioperative Practice. Denver, CO: AORN, Inc; 2017

5. Standards of Infection Prevention in Reprocessing of Flexible Gastrointestinal Endoscopes. SGNA, Chicago, IL; 2016

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