From the April 2017 issue of HealthCare Business News magazine
By Thom Wellington
Endoscopic procedures involve a flexible or rigid tube with a light and camera attached to it which is inserted into an organ cavity. This invasive imaging technique is sometimes combined with specific surgical procedures. Endoscopes fall into categories based on the area of the body that they investigate. The Food and Drug Administration states that in the U.S., duodenoscopes are used in more than 500,000 endoscopic procedures annually. The advancement in these medical devices for the treatment of gastrointestinal diseases is evident.
However, there is a link between infections and inadequately cleaned endoscopes, specifically duodenoscopes due to their complex design, which remains unsettling among many health care organizations. According to the Centers for Disease Control and Prevention, outbreaks of bacterial infections are associated with endoscopes being improperly reprocessed. Due to duodenoscopes containing many small working parts over other types of endoscopes, the instrument can be more difficult to clean and disinfect. If not thoroughly cleaned and disinfected after each use, tissue or fluid from one patient can remain in the device when it is used on a subsequent patient, causing an infection to be acquired via patient-to-patient or environment-to-patient.
Failing to clean endoscopes correctly can also result in the instrument channels becoming blocked, leading to inadequate functioning. After an agency-led expert panel meeting in 2015 regarding concerns with endoscope reprocessing, the FDA published a guidance that provides a detailed list of reprocessing measures, in addition to meticulously adhering to the manufacturer instructions for health care facilities to follow. The purpose of this guidance is for health care facilities to take one or more additional steps to further reduce the risk of infection, maximize patient safety and increase the safe handling of these medical devices. The FDA encourages health care facilities to understand the importance of their role in reprocessing the device as well as maintaining proficiency in performing these reprocessing tasks.
As a supplement to the manufacturer reprocessing instructions and the recent FDA guidance, health care facilities should consider the following six steps when assessing the adequacy of reprocessing common endoscopy devices:
Staff training
Ensuring personnel performing the endoscope reprocessing procedures have received appropriate training with competency verification will enhance patient safety. Training should be introduced at the initiation of employee duties, and then reevaluated on an annual basis, anytime a breach is identified or a new technique or equipment is introduced. When developing an endoscope reprocessing education and training program, there may be different needs for the various types of personnel who are cleaning and reprocessing endoscopes.
