Visual inspection of surgical instruments and medical devices for bioburden or damage is a critical safety practice that both central sterile/sterile processing department (CS/SPD) professionals and end users of the equipment (e.g. OR, GI Lab, etc.) can perform when an item is in their hands. But the moment an item is cleaned and ready for subsequent processing steps (e.g. sterilization, HLD), is when the CS/SPD has a specific opportunity – and responsibility – to use visual inspection to verify the cleaning process, as indicated in ANSI/AAMI ST79.
“Although decontamination and manual cleaning are undeniably the most important step of medical device reprocessing, I would argue that visual inspection comes in a close second,” said Brandon VanHee, CRCST, CER, CHL, GTS, Clinical Education Manager at Key Surgical. “Visual inspection is the final opportunity to identify damage/defects in medical devices and remove them from service before they are sterilized and prepared for clinical use. Unfortunately, this integral step in the medical device reprocessing cycle is often overlooked due to the lack of time, tools, education and resources in the sterile processing department.”
While inspection with the naked eye can identify obvious problems (e.g. significant contamination or damage), a quick glance will not uncover imperceptible issues that can jeopardize patient care and safety, such as microscopic bioburden that could lead to the spread of infection. The increasing complexity of medical devices has escalated this challenge.
“Until we find a way to automatically ensure cleanliness and sterility, visual inspection will remain a very important aspect of sterile processing’s quality assurance program,” said John Kimsey, National Director, Professional Services, STERIS. “The complexity of instrumentation, such as cannulated and lumen items, multi-part instruments, robotic instruments and vendor specific instruments, continue to increase the difficulty facing our sterile processing industry in providing quality products.”
Therefore, CS/SPD professionals require adequate time, training and technology in order to sufficiently perform this critical step and thereby deliver to end users effective and safe instruments and devices for patient care.
“If instruments and devices are not thoroughly inspected for damage and debris, not only externally but internally as well, any subsequent process (e.g. sterilization, high-level disinfection) may not be effective,” said Seth Hendee, CRCST, CIS, CHL, CER, CSPDT, CFER, IAHCSMM Approved Instructor, Clinical Education Coordinator, SPD, Healthmark. “Device complexity affects inspection greatly. Requiring enhanced visual inspection using higher magnifications (e.g. 4X) and having the ability to visualize internal surfaces and channels that cannot be seen with the naked eye greatly helps to increase patient safety.”
In this article, HPN explores how CS/SPDs can use visual inspection to contribute to high-quality cleaning, disinfection and sterilization performance. It includes insights from CS/SPD professionals and manufacturers, as well as a sampling of products in this area.
Start with the standards
Ron Banach, Ruhof’s Director of Clinical Education, explains how the importance of visual inspection of instruments for both surfaces and lumens by using lighted magnification has been strongly emphasized by:
- Association for the Advancement of Medical Instrumentation (AAMI)
- Association of periOperative Registered Nurses (AORN)
- International Association of Healthcare Central Service Materiel Management (IAHCSMM)
- Society of Gastroenterology Nurses and Associates (SGNA)
- U.S. Centers for Disease Control and Prevention (CDC)
- U.S. Food & Drug Administration (FDA)
“The ultimate goal is to provide a clean device for HLD or sterilization that is safe to use on a patient,” said Banach. “Visual assessment has limitations because the human eye cannot detect micro-contamination or bioburden thus other tools and processing steps need to be performed to confirm that the outside surface and inside channel of a medical device is clean. Recent studies have reported findings that the use of a borescope high definition camera to inspect endoscopes and instruments after cleaning identified both bioburden residue and device damage.”
Amanda H. Coss, BBA, CRCST, CIS, CER, CHL, National Education Coordinator, Mobile Instrument Service & Repair, points specifically to AAMI ST 79 7.6.4.5 Verification of the cleaning process, which states:
“After completing the cleaning process, personnel should visually inspect each item carefully to detect any visible soil. Inspection using enhanced visualization tools such as lighted magnification and video borescopes might identify residues not observable by the unaided eye. Visual inspection alone might not be sufficient for assessing the efficacy of cleaning processes; the use of methods that are able to measure or detect organic residues that are not detectable using visual inspection should be considered in facility cleaning policy and procedures.”
“The importance of visual inspection has grown through the years as devices have become more technical, advanced and multidimensional with the innovation of smaller devices for better patient outcomes,” said Coss. “With the development of more intricate instrumentation, we must adhere to the standards set forth for patient safety.”
Mary K. Lane, MHA, CSPDM, CSPDS, CSPDT, MK Lane SPD Consulting, notes how AAMI ST 79 Section 3.3.5.6 details the information related to lighting to ensure the CS/SPD has adequate lighting necessary during the inspection process.
“Inspection of instrumentation has always been a key function of all SPD technicians in the decontamination and assembly areas of SPD,” said Lane. “AAMI ST 79 also details the importance of the inspections process in Section 7.6.4.5 stating: ‘Inspection using enhanced visualization tools such as lighted magnification and video borescopes might identify residues not observable by the unaided eye. Visual inspection alone might not be sufficient for assessing the efficacy of cleaning processes…’ There is also additional information in Annex D of ST 79 related to inspection and its importance in the processing of surgical instrumentation.”
Specifically related to endoscope reprocessing, Coss references AORN’s Guideline for Processing Flexible Endoscopes, which states:
“Tools such as video borescopes of an appropriate dimension (length and diameter) may be used to visually inspect the internal channels. Internal channels of endoscopes may be inspected using a borescope. Borescopes penetrate the lumen and allow for improved visual inspection.”
“With a common survey question such as, ‘How many of you have a flexible inspection scope (borescope) to inspect internal lumen devices (e.g. shavers, GI endoscopes),’ we need to be vigilant for the patient’s safety and use visual inspection on medical devices with lumens to ensure a clean and sterile product,” Coss added.
Give the CS/SPD what it needs: Time, training and technology
While the standards support use of visual inspection in the CS/SPD, the demands of the profession, department limitations (e.g. time, technology) and other pressures can present significant challenges to performing it.
“The heightened awareness of the importance of visual inspection in the sterile processing arena has greatly increased over the last few years,” said Loraine Durigan, ST, CRCST, CHL, CIS, CER, AGTS, Sterile Processing Manager at AdventHealth Altamonte Springs in Orlando, and Administrator of the Central Florida Association of Central Service Personnel (CFACSP). “The overall complexity of minimally invasive instrumentation, for example, cannot be properly inspected for possible cracks, damage or potential debris. Having the time to perform a proper inspection is critical. When there isn’t enough inventory and the demand to turn an item over for a same day procedure will lead to steps being missed and this is an easy one to skip.”
Lane explains how inadequate visual inspection has a snowball effect, impacting the CS/SPD’s relationship with OR and other clinical teams.
“Visual inspection is critical to instrumentation,” said Lane. “Two of the most critical aspects of inspection are related to cleanliness and functionality. If the instrumentation is not clean then it is rendered unsterile after the sterilization process, which is a huge patient safety issue. Further when the instrumentation is not functioning properly it creates a patient safety issue. Both of these scenarios inevitably create tension amongst the surgeons, OR staff and SPD staff due to potential case delays.”
Time and training
According to Kimsey, the most important best practice is to allow CS/SPD staff the time to visually inspect instruments and devices. He states:
“Staff shortages and pressure to push through as many instruments as possible often lead to inspection being the first thing staff stop doing. Once you’ve decided to provide the time needed to inspect, we recommend three best practices of Standard Work, adequate lighting, and technology assistance. Standard Work details what inspection is needed for each instrument and how to perform and removes the staff’s personal decision on what to do.”
Banach urges healthcare organizations to invest in the education training of CS/SPD professionals to support safe and effective instrument and device processing.
“In an effort to enhance the ability to diagnose and treat patients, the design of medical devices, including endoscopes and instruments, has become more complex and thus more difficult to clean,” said Banach. “To remedy this situation, closer attention needs to be paid to the education and training of cleaning professionals. It is important for these individuals to understand and follow the manufacturers’ instructions for use (IFU), use proper cleaning techniques and document their results.”
Banach points out how responsibility for effective processing of instruments and devices is not solely on the shoulders of the CS/SPD. Clinical staff too must play their part in the process, specifically with the performance of point of use (POU) cleaning.
“Research has proven that preparation for decontamination must begin at the POU to help prevent bioburden from adhering to the surfaces of instruments and scopes,” said Banach. “If bioburden is not removed a biofilm, a matrix of various types of bacteria and extracellular material, can form which is most difficult to remove.”
“After POU cleaning, effective enzymatic cleaning chemistries need to be utilized for pre-cleaning at the sink, as well as an ATP Cleaning Verification Testing System and Visual Inspection Camera, which all contribute to safe and effective cleaning results.”
Technology – Human eye is not enough
Recognizing how visual inspection with the naked eye is not sufficient for effective cleaning verification, suppliers have developed a broad range of products and CS/SPDs have implemented numerous best practices to support this critical step.
Coss offers the following list of technologies to help in this area:
- Lighted magnification inspection
- Inspection scopes
- Borescopes
- ATP testing
- Automated cleaning testing devices
- Residual soil testing
- Detergent testing
Among those CS/SPD professionals and manufacturers interviewed for this article, most recommended lighted magnifiers and borescopes as key technologies for visual inspection.
“A simple visual examination is not adequate for today’s complex instruments and resistant organisms,” said Jonathan A. Wilder, Ph.D., Managing Director, Quality Processing Resource Group. “Lighted magnifiers and borescopes are critical weapons in the battle against residual instrument soil/bioburden. At a minimum, a lighted magnifier should be used, with a borescope critical for examining the interior of lumened instruments or those with areas that are difficult to visualize.”
“Having a borescope is a must for proper lumen inspection and having more than one size scope is beneficial,” said Durigan. “Digital magnifiers have been a great help for my team versus the old lighted magnifier. The visualization on a digital magnifier is not only better, you are also able to capture images to verify your findings when there are cracks or damage on instrumentation.”
“Adequate lighting is frequently undervalued but extremely important as staff attempt to see microscopic traces of bioburden on instruments,” said Kimsey. “Technology assistance using standard lighted magnifying glasses or electronic borescope viewers provide the ability to see where the human eye cannot.”
“Technologies, such as flexible inspection scopes (borescopes), USB (digital) handheld microscopes, lighted magnifiers with interchangeable lenses and small magnifiers, will increase quality in any CS department’s inspection practices,” said Hendee. “Nearly all professional society organizations agree that internal inspection of flexible endoscopes will help to identify defects and inadequate cleaning giving an opportunity for removal or recleaning of endoscopes before they can cause issues for the patient. IFUs of other devices, such as arthroscopic shavers, are calling for internal inspection. Also other IFUs, such as for robotic instruments, call for a higher magnification of 4X.”
“Although there are a wide range of visual inspection practices used around the world today, there are several that I would consider best practices,” said VanHee. “As with any other step in the reprocessing cycle, there is a tool for every job, and this rings true for visual inspection as well. For external surface visual inspection, utilize lighted magnification to get a closer look and identify small cracks, corrosion or retained debris. When inspecting cannulated instruments, a final passthrough with a verification tool or borescope can alert you to any residual soil, retained debris or damage to internal channels of devices.”
“Proper overhead lighting and lighted magnifying at the workstations is absolutely essential to ensure that the SPD technicians are able to perform the inspection of surgical instrumentation adequately,” said Lane. “In addition to these required items in SPD there are also new technologies in the industry that aid the SPD technicians in inspecting lumens and flexible scopes. The lighted borescope has increased in popularity especially since its inclusion in ST 91 as a recommend practice in the inspection of lumened instrumentation.”
