Of all the weak links, which may be the weakest?

Oct. 28, 2019

When it comes to ranking all of the weak links in what Healthcare Purchasing News defines as the 10-segment endoscope reprocessing process, the weakest links as determined by 15 sterile processing experts and executives becomes rather evident.

In fact, the weakest links appear to be front-loaded at the beginning of the process and take place initially outside of the Sterile Processing and Distribution (SPD) department, which tends to get blamed for breakdowns in performance and production.

HPN defines the endoscope reprocessing process this way:

  • Pre-cleaning and treating (which typically takes place in the Operating Room or patient room)
  • Leak testing
  • Manual vs. automated cleaning
  • Visual inspection techniques and technology
  • Cleaning verification testing
  • HLD and rinsing
  • Sterilization and aeration
  • Drying
  • Storage and handling
  • Maintenance and repair (which can take place outside of SPD at an OEM or ISO)

For this month’s cover story, HPN reached out to nearly 40 sterile processing experts spanning providers, suppliers and service companies, asking them to identify the weak links in each segment of the process. Then HPN asked them to rank the weakest link among the weak links.

The winner (?): Pre-cleaning and treating

“The weakest link in endoscope reprocessing is pre-cleaning and treating at the patient bedside because that is the only segment that is routinely performed outside the supervision of the experts in the Sterile Processing department. Furthermore, there is currently no standard operating procedure for bedside pre-cleaning. Some facilities use multi-enzymatic cleaners while others use only water. Some use a sponge to wipe down the outer surface and the remaining detergent to suction through the device.

“When pre-treatment is inadequate, or even entirely absent, remaining bioburden begins to form biofilm, making decontamination much more challenging. Facilities can enact policies that mandate training for personnel responsible for endoscope pretreatment and subsequent reprocessing. Required training will reinforce policies, create process consistency, and increase effectiveness, ultimately preparing instruments for successful decontamination.

“Facilities should stock endoscope pre-treatment kits, such as the Case Solutions® Endoscope Bedside Kit, in all endoscope procedure rooms. These kits allow immediate pre-treatment, in accordance with standards and guidelines from AAMI, AORN and SGNA, while the flexible endoscope is still connected to the video processor and light source. With a three-pack of Penta Wipes single-use multi-enzymatic wipes, use one wipe at a time for a single pass from the clean end to soiled end of the endoscope, then discard. A 250-ml container of PentaZyme Multi-Enzymatic Detergent is then suctioned through lumens and channels. In this way, the endoscope can be prepared for further processing while the enzymes work to break down any remaining bioburden.

“Begin with the end in mind. For the sake of patient safety and overall infection prevention, leadership teams need a data-based plan of action. The first step is to measure the actual time required for reprocessing in alignment with the manufacturers’ IFUs, ensuring all proper tools are available.

“From this baseline data, the team can – assess or adjust their procedure scheduling and determine if additional staffing or endoscopes are required to meet both scheduling and reprocessing needs. As we know, lack of equipment is not an excuse for shortcuts

– Lisa Forsell, Marketing Director, Case Medical

“Pre-cleaning is the most important and most dangerous weak link. It is very simple: You have to have a clean device to allow for sterilization to take place. By not starting that process immediately after use, you risk letting the bioburden dry, which makes it more difficult to clean and reprocess.

“Secondly, when you utilize an independent service organization and not the OEM, you immediately go against the IFU. When products are repaired by a third party, recommended reprocessing methods are nullified. The reason for this is the biocompatibility of materials a third party uses. Similar, but not the same, is material compatibility of components with the myriad of cleaning, high-level disinfection and sterilization chemical agents available in the marketplace. FDA requires proof of this testing from the OEM, but third-party repair companies are not subject to this same high level of testing. In short, there is no guarantee that a device repaired by your chosen repair provider is safe to use and will withstand the cleaning, high-level disinfection, and sterilization processes used within your facility – or if the device can be rendered sterile at all.”

– Crit Fisher, Director, Onsite Service & Operations, KARL STORZ Endoscopy-America Inc.

“Statistically speaking, improper bedside cleaning is still the most dangerous step to have improper practices in place. A properly functioning AER or EtO sterilizer will not be capable of overcoming large amounts of gross contamination left behind due to poor manual cleaning.  That coupled with water remaining in the channels, provides the perfect storm for bacterial growth.”

– Shaun Sweeney, Vice President, Cygnus Medical

“Pre-cleaning and cleaning (manual or automated) is the weakest link. Unless you remove all of the organic debris prior to sterilization, you’re going to have a contaminated endoscope that has the potential to cause patient harm.”

– James Schneiter, Founder, America’s MedSource Inc.

“I believe the most dangerous weak link is an inadequate pre-cleaning process, which can compromise the effectiveness of the remaining reprocessing steps.”

– Fouad Bahout, Vice President, Sales & Marketing,  Surgmed Group

The runner-up (by a hair): Manual cleaning

“Manual cleaning and dedicated inspection – to include cleaning verification. If manual cleaning is not performed correctly or completely, complete HLD or sterilization is not possible. If enhanced visual inspection and cleaning verification is not performed, there is no way to effectively measure success of manual cleaning.”

– John Whelan, R.N., Clinical Education Coordinator, Healthmark Industries

“Although every step in the endoscope reprocessing cycle is incredibly important, inadequate manual cleaning poses the most significant risk to patients. Every single other step can be performed perfectly, but if effective manual cleaning is not achieved, the endoscope cannot be deemed safe for patient use. Whether the endoscope is high-level disinfected, or terminally sterilized, residual clinical soil can shield microorganisms from contact with the high-level disinfectant or sterilant and lead to infection in the next patient.”

– Brandon VanHee, CRCST. CER. GTS. Clinical Education Manager, Key Surgical

“Comprehensively considering all of the common mistakes listed, my gut instinct is to rank improperly or partially completed cleaning steps as the most dangerous. I feel obligated to choose this due to the cleaning process, especially as it relates to high-level disinfection, can only reduce a limited amount of log reduction even when the cleaning requirements are followed perfectly. Sterilization provides a greater log reduction and destruction of infection causing organisms, but the outcome is still only as good as the cleaning process in its entirety. This makes it difficult to identify any one role, sole responsible party, or single act that does not affect the entire outcome.”

– Melissa Kubach, National Specialty Educator, Mobile Instrument Service & Repair

“Cleaning is the most dangerous weak link that can occur during endoscope reprocessing. Studies show that when manual cleaning is not performed correctly, the entire cleaning process may also be ineffective. If soils and bioburden remain on the endoscope after manual cleaning, high-level disinfection and/or sterilization methods may not be effective. The use of an endoscope that is not properly reprocessed could pose an infection prevention risk.”

– Melinda “Mindy” Benedict, CIC, CFER, Senior Manager, Infection Prevention, Gastroenterology & Pulmonary Reprocessing Strategy Office, Olympus America Inc.

“The cleaning process is known to be the most important element of the reprocessing process as it removes the bioburden that is present and improves the effectiveness of the high-level disinfection process. Is those reprocessing the flexible endoscope do not properly clean all aspects of the device, then potentially dangerous bioburden can be left behind and result in the development of biofilm, which will not be removed by traditional reprocessing efforts.”

– J. Hudson Garrett Jr., Ph.D., Global Chief Clinical Officer, Pentax Medical

“Manual cleaning with its multiple steps that take time can lead to complacency in the process. Any area of this process could be skipped or shortened or IFUs not followed such as water temperature, enzyme to water ratio, flushing or brushing.

Robert Dybec, R.N., CPSN, CNOR, EMT-B, Nurse Manager, Operating Room, NYU Winthrop Hospital, for Ruhof Corp.

The rest of the field (but still notable):

“Technician training/ specialization is the greatest weak link because if the technician is not highly trained and knowledgeable then there are no assurances that the IFU was followed and that the endoscope is safe to use.  Particularly for SPD, the current practice of training every technician to perform every job for every instrument in the hospital is a recipe for failure. With the high turnover rates for SPD and the challenges of processing complex instruments like MIS, endoscopes, video equipment, robotics and power tools, it is almost impossible to ensure 100 percent achievement of processing goals if everyone ‘takes a turn.’ SPD is mass manufacturing and by definition, mass manufacturing does not have every worker perform every job during a build. Specialists at each step in the process perform specific jobs and become expert at them.

“Cottage industries have the same person perform all or most steps in the manufacture of the product. Variation in the product is expected and acceptable for products where these exceptions are seen as adding value. Think of a potter who hand-creates each piece.

“For mass manufacturing this variation is a bad thing, and in SPDs this variation shows up as instruments missing, not properly cleaned, inspected or malfunctioning. Facilities that do not have a segmented/specialized work force by general and complex instruments will be at a significant disadvantage and will likely not be able to produce results of 100 percent on goals of instrument availability, functionality and safety. To be successful, hospitals must have qualified management for both work groups that are knowledgeable and experts with all equipment that they are responsible for.  If a hospital is having trouble meeting any of the three goals, they should contact a reputable company for an assessment of their current practices and suggested solutions.  

“The second greatest weak link is with current regulations and standards in that none yet require notification of the physician when a leaking endoscope is discovered post procedure. As noted, AAMI is considering adding this change to ST-91. We hope that all other regulatory and standards organizations will make this same change and call for the notification of the physician should an endoscope be discovered post case with a leak.”  

– Gregg Agoston, Vice President, Minimally Invasive Surgical Support, SpecialtyCare

“Visual inspection techniques and technology and cleaning verification testing, are most important and weakest link as that is the determinant that the scope will be safe for use on the next patient.”

– Jean Sargent, President, Sargent Healthcare Strategies

“Leak testing. Flexible medical endoscopes are an important and integral part of disease diagnosis and treatment but are also sources of patient cross infection. The process of testing the endoscope can be called many different things depending on manufacturer and/or facility. Leak test, sheath integrity test, waterproof test and bubble test are all ways that describe the same function. The object of the exercise is threefold:

  1. To eliminate the risk of cross infection between patients by contaminated fluid leaks during the procedure.
  2. To minimize the level of damage caused to an endoscope by submersion in fluids with a leak in the endoscope.
  3. To minimize the cost of repairs caused by submersion in fluids with a leak in the endoscope.

“If a small leak goes undetected fluid can accumulate inside the endoscope during each procedure and each reprocessing cycle. If the leak is in one of the more common places, such as the bending section rubber, fluid can accumulate in the tip of the endoscope near the source of the leak and potentially leak out during subsequent procedures.

“Leak testing is crucial to the success of the reprocessing cycle. In the event that an endoscope with a leak is used for a patient procedure, the risk of cross infection due to patient contamination with this fluid is enormous (The Importance, 2017).”

– Christian Ezagui, CER, CST, CRCST, Technical Resource Manager, Paces MedEquip LLC

“The most dangerous weak link is the wide-scale lack of quality assurance across the spectrum of reprocessing, and we need to prioritize what we can do to improve reprocessing outcomes:

  • “Allocate time and resources so techs can follow every step for every scope every time!
  • The process should include key quality assurance indicators:
  • Leak testing carefully, slowly…
  • Visual inspection—inside and out
  • Cleaning verification tests
  • MEC tests for HLD or CI for sterilization
  • Drying verification inspection or test
  • Frequent reprocessing audits and visual inspections of the endoscope fleet by qualified experts
  • Provide QA reports to the entire team of stakeholders, including techs, CS/SPD/endo managers, periop services, infection prevention, risk management and endoscopists.”

– Cori Ofstead, President and CEO, Ofstead & Associates

“It is hard to rank one item higher than another as they all contribute significantly to creating barriers to adequate cleaning. If pressed to prioritize, I would list the inadequacy of HLD as the lynchpin in the system. If the cleaning process of HLD is unable to reliably sterilize scopes, then the rest of the segments are rendered irrelevant until the cleaning technique is perfected. At a minimum we recommend transition to sterilization when single-use is not available.”

– Stephen Spanos, Medical Director, Ambu Inc.

About the Author

Rick Dana Barlow | Senior Editor

Rick Dana Barlow is Senior Editor for Healthcare Purchasing News, an Endeavor Business Media publication. He can be reached at [email protected].

Photo 77197506 © Korn Vitthayanukarun | Dreamstime.com
Image courtesy of Kat Velez, LeeSar Regional Service Center, Fort Myers, FL, HPN’s 2017 SPD of the Year
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