Bioburden – more than meets the eye

While the quality of Central Service/Sterile Processing and Distribution (CS/SPD) operations is highly dependent upon those individuals performing the processes, in most cases equipment and tools are a critical part of the equation. This is particularly true in the visual inspection of surgical instruments as microscopic bioburden and/or biofilm is invisible to the naked eye. Furthermore, as instruments become more complex to facilitate minimally invasive procedures, internal components such as lumens make them more difficult to clean and impossible to thoroughly inspect without magnification and other visual aids.

“Year after year, the job has become increasingly challenging as new devices and technological advancements increase both the sheer numbers and the complexity of these devices,” said Lee Ann Purtell, Owner, Capital Medical Resources. “Minimally invasive techniques drive the demand for smaller and smaller instruments that, by nature, are more complex and require special knowledge and processes to clean, inspect and sterilize. Having tools to aid in visual inspection and functional testing help keep damaged and dirty instruments out of use, thus reducing incidences of healthcare-acquired infections (HAIs).”  

Times have changed

As instruments have changed so have the standard teaching points on visual inspections, as well as the equipment available to perform them, says Sharon Greene-Golden, BA, CRCST, CER, SME, FCS and oneSOURCE consultant. She stated:

“Standard teaching points given over the years focused on six review points used for visual inspection of instruments: Scissors, needle holders, suction devices, retractors, hemostatic forceps, and tissue and dressing forceps. Times have changed and how we meet the review points have changed in our visualization process because of the delicate, hard to check and minimally invasive instruments used in surgeries done in hospitals today.”

“Today, we have different equipment designed to aid a technician in the visualization of all instruments, Greene-Golden added. “These technologies include insulation testers, lighted magnifying glasses, borescopes for checking lumens, and the testing developed to aid in verifying cleaning quality standards are being  met. The verifying methods in place in the sterile processing department are needed because microorganisms are not seen, so we have a protein test and adenosine triphosphate (ATP) bioluminescence, which test for residual soils.”

“Visual inspection has come a long way in the past few years,” said Jonathan A. Wilder, Ph.D., Managing Director, Quality Processing Resource Group. “Gone are the days when finding the nearsighted person in SPD was how you improved visual checks for residual soil and debris. When I do audits with my associates, there are a few things that are high on the list of things we advise clients to use to properly do a visual inspection. These are: Enough light, magnifying glasses - preferably lighted and at least 5x magnification - and borescopes.”

Making the case for investment

From the purchase of a new visual inspection tool to the complete transformation of inspection processes, CS/SPD leaders must present the case for change to their healthcare organization’s C-suite. Improved quality, reduced costs, greater efficiency and lower risk for infection are some key benefit areas that can help secure the necessary resources.

The University of California San Francisco (UCSF) Health is currently implementing an advanced visual inspection program for its CS/SPDs, which includes visualization using a dedicated workstation, borescope and high resolution digital microscope. They are also working with a software developer that will be commercializing an artificial intelligence (AI)- based application that identifies functional defects or potential soils, which integrates with the equipment in real time.

“As we have three campuses and require a uniform standard of care, this initiative is somewhat costly. Our approach to securing executive support involves monetizing the cost of quality,” said Gene Ricupito, CRCST, CIS, CHL, CFER, PMP, Sr. Project Manager, Sterile Processing, UCSF Health. “When looking at defects, we can determine the costs associated with rework and OR case delays.”

When looking at quality events where undetected soils are found at the point of use (POU), organizations can quantify the costs associated with patient safety, such as breakdown of the sterile field and replacement of the potentially contaminated instruments and supply items, as well as the costs of infection control review, explains Ricupito. He adds that in a worst-case scenario, the costs of patient notification or litigation are “staggering.”

A single surgical site infection (SSI) costs a hospital an estimated $36,000 per infection (in 2020 adjusted dollars),¹ while legal defense for just a single lawsuit costs a hospital an estimated $83,000 per claim with indemnity payments.² Commenting on these figures Ricupito stated: 

“A well-developed justification, which includes the economics of the factors stated above compared to the frequency of internal incidents, can easily create a picture where the investment in technology to prevent defects is easily recognized as cost-effective.”

Before a new surgical instrument enters the doors of a facility, CS/SPD professionals must have the opportunity to evaluate whether it can be effectively and safely processed with the department’s current equipment, says Ken Pichulo, BSN, RN, CRCST, CER, CHL, Manager, Central Services, AdventHealth in Orlando. If it cannot, then the facility’s leadership must be willing to provide the CS/SPD with what it needs.

“I recommend that facilities have SPD representation on purchasing committees to assure that the items can be cleaned as validated and that the purchase of said items doesn’t require additional up-front cost in SPD processing equipment if required in the manufacturer’s instructions for use (IFU),” said Pichulo. “It’s not uncommon for an item to be approved for purchase, yet the facility does not possess the equipment necessary to process it in compliance to the IFU.”

Greene-Golden urges CS/SPD leaders to also involve infection preventionists when evaluating visual inspection tools and making the case for these resource investments, stating:

“The importance of visualizing while inspecting instruments has grown exponentially as technicians work with delicate minimally invasive products. What is done in the inspection of instruments is most important because our process as sterile processing technicians has a direct correlation with the end purpose to have no patient acquire a surgical site infection due to our inefficiency. Each processing department should work with their infection control team members to help in the procurement of equipment that aids our natural eyes as we process instruments for surgery.”

Boosting visual inspection efficiencies

Visual inspections are a vital but time consuming process that can place a significant burden on CS/SPD technicians. At Advent­Health, Pichulo and his team have taken a Lean approach to streamline decontamination and pack and prep processes from a direct visualization perspective.

“I teamed up with a Lean expert and we partnered on developing an SPD process and facility that addresses the work that these professionals are tasked to complete yet had been under-supported for many years,” said Pichulo. “The result has been a department that lends itself to good work and provides the technicians the tools necessary to achieve that goal.”

In the department, technicians first inspect point-of-use preparation. Non-conforming trays that arrive from the OR are recorded in the health system’s quality module in CensiTrac, its instrument tracking program. Staff members track non-conforming practices from both the OR and the CS/SPD and report this information on a monthly basis back to these teams.

Next, all lumened stainless steel instruments and other materialled instruments (if supported by the IFU) must pass through an ultrasonic process in the decontamination area. Once the ultrasonic process is complete, instruments with lumens are then flushed with a high pressure reverse osmosis (RO)/deionization (DI) water source. Prior to entering the washer/disinfector, staff members perform direct visualization using a lumen inspection scope. In the department, each third sink in decontamination has a borescope with monitor to support this task.

“We decided to perform this activity in decontam as the assembly area tends to lag behind decontam due to the time it takes to assemble and inspect a tray appropriately,” said Pichulo. “Instruments that do not pass direct visualization in decontam do not go to the washer but are manually cleaned until the defects are eliminated. We use direct visualization for endoscopes in decontam as well. Each of our sink lines have a free-standing ultrasonic unit built into the line, so the technician does not have to move to another part of the room to use an ultrasonic.”

Once instruments arrive in the prep and pack area, CS/SPD technicians take the instruments through a full inspection to test for cleanliness and function. For lumened instruments that have lumens that are too small to pass a borescope through, technicians flush them with sterile water to validate that cleaning was effective. Any instrument that does not pass visual inspection, along with the entire tray, is sent back to decontamination to be reprocessed there.

“We utilize high magnification digital magnifiers in addition to analog lighted magnifiers in the assembly area for hard to inspect instruments,” said Pichulo. “These provide an amazing image many times greater than our analog units can provide. We also have additional borescopes on the clean side for further direct visualization of lumened instruments if the technician desires a second look. We also perform traditional inspections for function, which are part of an annual competency the staff must complete.”

Visual inspection advances

Recognizing the limitations of the human eye, equipment manufacturers offer a variety of products aimed at helping CS/SPD professionals detect and destroy dangerous bioburden, identify and address instrument damage, and verify that cleaning processes have been effective.

“First, we need to add adequate illumination for better viewing, which will enable visual inspection of internal surfaces for debris and damage,” said Ron Banach, Director of Clinical Training, Ruhof Healthcare. “Secondly, there needs to be magnification of the image for easier identification of debris and damage. Then, there needs to be several lengths and diameters appropriate for many different types of devices. During inspection both still and video documentation and archive storage are necessary. Finally, added training that will support and comply with manufacturers’ IFUs.”

Light it up

A well-lighted work area is essential, explains Gregg Agoston, M.B.A., VP Business Development, SPD Transformation Services, SpecialtyCare. “Lighted magnifiers should be at each workstation, as well as visual cues to reinforce proper inspection techniques.”

Wilder points to ANSI/AAMI ST79: 2017 Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities where section 3.3.5.6 defines the range of light levels for each working area.

“How to you measure the light level? There’s an app for that, free ones, and for both Android and iPhone,” said Wilder.

Get closer

“Visual and enhanced inspections are more critical now than ever in the sterile processing and endoscopy areas,” said Cheron Rojo, AA, CRCST, CIS, CER, CFER, CHL, Clinical Education Coordinator for Healthmark Industries. “The technology advances alone in the power of magnification have skyrocketed by offering more advanced and specialized visualization from the magnification to the design. This can be used to view areas like lumens that cannot be seen with the naked eye or the standard magnification that sterile processing and endoscopy was used to over the years.”

“The purchase of enhanced magnification technologies and specific magnification stated in the IFU of the instrument or device is essential,” Rojo added. “But consideration also needs to be placed on the amount of magnification you purchase to maintain compliance with front-line technicians at each workstation. One type of magnification cannot be the save all and placed in the dark corner of the sterile processing department on either the decontamination or prep-n-pack areas. The type of magnification is determined by the type of instrumentation and devices in your inventory and all their IFUs.”

“Manufacturers have added not only the use of magnification to their IFUs, but also specific power of magnification,” said Rojo. He points to Intuitive robotic instrumentation, noting how the product’s IFU specifies 4x magnification in the decontamination area. Rojo adds that numerous arthroscopy shaver manufacturers specify the use of an endoscopic camera or (borescope) in their IFUs as well.

Specific to scopes

As noted by the U.S. Food and Drug Administration (FDA), clinicians perform over 75 million endoscopic procedures in the U.S. each year.³ While endoscopes are essential to many minimally invasive procedures, their use comes at a cost – the risk for contamination and infectious disease spread among patients. In studies performed by manufacturers on endoscopes used in clinics, about 2-5 percent have bacterial contamination.⁴

“In response to the spread of infections by contaminated devices, government agencies, standards committees and medical societies are calling for visually inspecting the internal mechanisms and lumens,” said Banach. “They advocate the use of inspection scopes for this purpose.”

With regards to rigid endoscopes used in visualization during laparoscopic procedures, Rojo says most manufacturers’ IFUs recommend visual inspection by looking through the eyepiece and rotating the endoscope. “This is a very subjective test,” he says. “There are better verification tools to identify damage to the optics that can obstruct the surgeon’s view during the procedure.”

Video borescopes are recommended in ANSI/AAMI ST79:2017 sections 7.6.4.5 and D.1, explains Wilder: “Borescopes can get into places where you can’t see, the same places that can hide patient soil residues. They belonged to the previous patient. We don’t want to give them to the next patient as a gift. And with the advent of better visual inspection, there is less of an opportunity to do that.”

“Borescopes are a great tool to see inside lumens and other small areas of an instrument,” said Agoston. “In addition, the various tests for cleanliness such as Healthmark’s ChannelCheck that test lumens for protein, carbohydrates and hemoglobin is an excellent way to verify cleanliness.”

For example, Ruhof Corporation’s VIB (Visual Inspection Borescope) features an HD digital camera to allow for instant visual detection of internal debris and damage inside the channels of an endoscope, reducing the risk of device-related infections. Ruhof VIB’s intuitive software provides high-resolution images and can build a reference-based library of images to assist CS/SPD to determine conditions of medical devices and instruments. The Ruhof VIB’s software labels and archives both images and videos for emailing and reporting.

A note on IFUs

As Greene-Golden explains, a manufacturer’s IFU is the official playbook for effectively and safely reprocessing instruments in the CS/SPD.

“All products found in our field of service help us in our quest to perform inspections of instrumentation used in surgical procedures,” she said. “It is our main goal to give our patients world class service by doing our due diligence to ensure instruments sets are meeting the parameters of cleanliness and workability. It is about reading and understanding IFUs. A digital tool like oneSOURCE makes accessing IFUs easy 24/7, as they guide you in what you are looking for as you check each instrument. All instruments are not created equal, what you see is important and we need the human factor to make the call.”

But as Pichulo points out, following the steps outlined in the IFU is not enough. CS/SPD professionals must validate that these steps resulted in a clean and sterile instrument.

“We’ve found that IFUs frequently do not adequately address cleaning procedures. SPD leaders must ask themselves ‘How do we validate that our cleaning and disinfection processes are effective?’ Additionally, ‘Is it enough that we follow the IFU…should we do more to verify that the process we utilize to decontaminate and then sterilize is effective?’ I believe the answer to that question is a resounding ‘yes’. We must validate our processes, even when those processes are part of the IFU. We must leave nothing to chance.”

Invest in people

“Tools are very valuable, but they rely on the competencies of the technician,” said Agoston. “This is where many fall short, as we have witnessed technicians who do not use the tools or test correctly. The complexity of instrumentation, combined with typical high turnover in SPD, makes ensuring that every set is visually inspected at all stages of preparation a very difficult job. Training and competency assessments are absolutely necessary.”

According to Agoston, 30 to 40 percent of a typical hospital’s surgery volume is comprised of minimally invasive surgery (MIS) procedures, with orthopedic procedures using implants representing another approximately 25 to 30 percent.

“Thus, approximately 60 percent of all surgical cases are performed using complex instruments,” notes Agoston. “It is generally accepted that for a technician to become competent with non-complex instruments (basic stainless steel handheld instruments) across all specialties is at minimum a 12-month process. The advanced skills required for complex instrument processing (robotics, flexible endoscopes, MIS instruments, power tools and complex orthopedic instruments) have a much longer learning curve.”

To help ensure the effective and safe processing of minimally invasive equipment, Purtell recommends healthcare facilities consider having dedicated CS/SPD endoscopy technicians who are trained and specialize in MIS instrumentation, such as rigid and flexible scopes, laparoscopic instruments, powered surgical devices, etc.

“Having a dedicated area equipped with a variety of inspection tools is also worthwhile to round out a well-equipped testing station,” she added.

Agoston notes how SpecialtyCare offers CS/SPD full staffing solutions, including specialists with the skills required to prevent common problems associated with MIS instruments, video equipment and robotics.

“Our specialists support instrument reprocessing, OR set up, troubleshooting and take down,” said Agoston. “We can also provide the MIS instruments and video equipment. Through our services we ensure that these cases are not delayed due to instrument availability, function or safety and that they go well for the nurses, surgeons and patients.”

References

1. [1] The Direct Medical Costs of HAIs in US hospitals and the benefits of prevention, R. Douglas Scott II, 2009)

2. N Engl Jrnl of Med 2012, 366:1354-1356, April 2012

3, 4. Quality Control: Stopping infections before they happen through safer endoscope reprocessing, FDA, January 9, 2020, https://www.fda.gov/science-research/fda-grand-rounds/quality-control-stopping-infections-they-happen-through-safer-endoscope-reprocessing-01092020