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As a leader in surgical instrument sterilization intelligence, we are pleased to share our knowledge and offer these educational seminars so you can earn CE credits at your convenience.
Complex, Clean & Compliant
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Please study the 20 curriculum questions below about IFU complexities and compliance challenges, then take the quiz to earn 1 CE credit.
1. Series Intro
If you had to guess, what percentage of instruments processed at your hospital were processed exactly according to the IFU (instructions for use)? Would you confidently tout 100% compliance? If so, you are likely in a rare minority for diligently prioritizing IFU-compliance. If Sterile Processing Departments were to review their instrument processing IFUs, many departments would find that their processes don’t match up to what has been validated by the manufacturer. As instruments are becoming increasingly complex, it is more important than ever that we get more intentional about following the exact steps in every single IFU.
In this 1 CE continuing education series, the Petriss team will highlight the dangers of IFU non-compliance, the challenges of complying with manufacturer IFUs, and some actionable steps you can take to work toward complete, efficient, and reliable instrument processing that’s consistent with each manufacturer’s IFUs.
2. Dirty Secrets of IFU Non-Compliance
In Sterile Processing, there is tremendous pressure from Accrediting organizations as well as hospital administrators for the department to be 100% compliant with IFUs. While this pressure exists for a good reason, an unfortunate result is that departments are hesitant to be open and honest about where they fall short and the opportunities to improve in this area. Those deficiencies go unresolved, and departments carry on with the status quo.
Honesty with ourselves and with our peers is an important step in the direction of solving the challenges of total IFU compliance. Sterile Processing professionals must work together and talk about the complexities of manufacturer IFUs, why compliance is a challenge in many departments, and how each of us can play a role in advancing the industry forward to a place where instruments are safer. Patient safety is at the center of what we do in Sterile Processing, and they deserve our diligent work in compliant reprocessing.
3. The Impact of IFU Non-Compliance
Manufacturers validate a cleaning and sterilization process that will ensure the device reaches a sterility assurance level of 10-6. This means that an item that is processed according to the IFU has “less than or equal to one chance in a million that a single viable microorganism is present on [the] sterilized item.” (AAMI ST79:2017, 2.114, page 10). Industry White Papers as well as industry standards and guidelines all clearly instruct hospitals to follow the IFU. When departments do not follow the science-based IFU, they potentially expose patients to instruments that do not meet the 10-6 level of sterility assurance.
When IFUs are not followed, patients are put at risk of Surgical Site Infections (SSIs). Skipping steps in the IFU can alter the life of a patient, sometimes even leading to a patient’s death. Improper processing can lead to the loss of accreditation, legal liability for the hospital, and damage to the reputation of the surgeon and the hospital. Surgical Site Infections have a 3% mortality rate and an associated annual cost of $3.3 billion.
4. Headlines demonstrate the devastation
There are headlines from all over the globe about breakdowns in reprocessing of medical devices. These news stories highlight the “Immediate Jeopardy” to the life and health of patients due to improper cleaning and sterilization of surgical equipment. The sobering reality of these news stories is that the majority of reprocessing issues in hospitals around the globe are not caught and reported on. As a Sterile Processing technician, you may even be aware of an event that happened in your hospital over the last year that could have become a national headline if media had become aware. Just because your hospital hasn’t hit the news yet is not proof that you are doing what it takes to comply with manufacturer IFUs. 3 out of 4 “Immediate Threat to Life” declarations by The Joint Commission are related to improperly sterilized equipment. Sterile Processing Technicians and leaders must work toward processing every instrument exactly according to the FDA-approved IFU.
5. What is IFU Compliance?
IFU Compliance means that every instrument is handled in exactly the way its manufacturer designed and intended. Manufacturers are required by the FDA to provide written instructions for the cleaning and sterilization of all surgical instruments based on their medical device classification. These manufacturers are held to strict quality standards and are required to perform validation testing before devices are proved for the market. In addition to the FDA, other governmental agencies, professional associations, and third-party surveryors set expectations for users to follow the most up-to-date published manufacturer IFU for every medical device. If the hospital fails to follow the steps outlined in the IFU, the hospital takes on the liability as manufacturer of the item.
6. Why Aren’t IFUs Followed?
If manufacturers’ instructions for use are so important in the field of Sterile Processing, why are they not always followed?
*Too Many to Count – There are hundreds of manufacturers around the world, with thousands of IFUs each. It is a challenge for Sterile Processing Departments to keep track of all these IFUs and ensure they have the correct IFU for each device in their facility.
*Too Hard to Interpret – IFUs are complex, and they can be lengthy (some are over 100 pages!). They do not follow a standard format, and so IFUs can be confusing to read as an end-user.
*Staff Turnover – Sterile Processing Departments are known to struggle with employee turnover, which makes educating team members on 100% of their products a nearly unachievable goal.
*Out of Date – IFUs are updated by the manufacturer, and the department is responsible for ensuring that they are following the most up-to-date manufacturer’s instructions. A department may be diligently following the IFU, but using an outdated version.
7. IFU Myth: All SPDs Are the Same
Manufacturers make the mistake of assuming all Sterile Processing Departments are the same. When manufacturers are creating the IFU, they have in mind a particular ideal department that is not necessarily representative of departments in the real world. The reality is that not all departments are created equal — there are significant differences in space, equipment, staffing models, and budgets. Many departments are struggling with increasing pressures to keep up with demand and are having issues complying with IFUs. The drive to push instruments through the process leaves enormous room for error such as skipping or shortening steps from IFUs to keep up with the workflow. Manufacturers can help by writing IFUs with the “real world” in mind, working to design instruments that can be cleaned in a consistent, simple, timely manner across a broad spectrum of department designs.
8. IFU Myth: Having the IFU is Enough
Technicians make the mistake that if IFUs are available to the team, then they are IFU compliant. The reality is that providing access to current IFUs is only part of the answer of IFU compliance. Utilizing IFUs daily as part of working with our instrument inventory is a different story. Simply having access to the IFU does not prove that the department is following that IFU. Providing training, education, and communication to technicians regarding the researching and interpreting of IFUs is a critical step in IFU compliance and for making certain the team does not miss crucial details in the processing of complex medical devices. Departments need to be able to demonstrate that technicians have received education and competencies for 100% of the devices used in the facility according to the manufacturer’s IFUs.
9. IFU Myth: Experience is Enough
There is a temptation to treat categories of instruments the same based upon personal experience and referencing other IFUs. Experienced technicians who are familiar with a particular pattern or type of instrument must not make the mistake of assuming they should all be processed according to the same processing method. Each manufacturer has a validating lab, and they test differently to obtain the sterility assurance level of 10-6. Even though two instruments from different manufacturers may look very similar, their processing instructions are likely to have differences. All technicians, whether new or experienced, should be referencing each exact instrument IFU and following the validated processing steps defined by the manufacturer.
10. The Challenge of Cleaning Complex Instruments
While every specialty of instruments deserves the same level of decontamination, complex instruments are much more difficult to clean and therefore require more precise details in the processing instructions from the manufacturer. Narrow cannulas, moving components, difficult-to-clean crevices, and design constraints preventing submersion in water present challenges to cleaning and are more likely retain contamination after processing. Devices are getting more complex with the increased utilization of minimally invasive surgical instruments and the advancement of medical technology. Compliance with the manufacturer’s instructions for complex devices is critical, as bioburden cannot always be visually detected and can be difficult to remove after improper processing of the device.
11. Complex Instruments: Orthopedics
Orthopedics specialties are notorious for their complex instrumentation. Many of these instruments are designed to reshape bone, repair musculoskeletal structural problems such as fractures and even replace joints. The instruments in this specialty are typically heavily soiled with blood and other bio-matter because they are reconstructing anatomical features of bones and the connective tissues that support those structures such as ligaments, tendons, muscles, and others that assist in ambulation and range of motion. Components that come apart in multiple pieces, cannulated instruments without visibility, and instruments that have moving parts but don’t disassemble all the way are examples of device types that are most likely to encourage biofilm formation and accrue residual bioburden. Examples of complex orthopedic devices include attachments for power equipment, shavers, flexible reamers, depth gauges, and double-action ronguers.
12. Complex Instruments: Vendor Managed Trays
Vendor-managed instrument trays present several challenges in reprocessing. Vendor-managed loaner instruments are often complex, with components that need to be disassembled for cleaning, implantable hardware, threaded instruments, and cannulated instruments. In addition to these cleaning challenges, Sterile Processing technicians are often not familiar with the instrumentation when they are dropped off. The vendor inventory is often shared among hospitals in the territory, so it may be dropped off at the hospital with little time for processing prior to the scheduled procedure. Rather than referencing the IFU for each device, loaner instruments are often processed according to the experience and instinct of Sterile Processing technicians. Departments must find a way to reference the IFU for these devices and treat them with the same degree of care in processing as the hospital-owned instrumentation.
13. Complex Instruments: Laparoscopy
Many of the risks involved with processing laparoscopic devices are due to their design. Devices in this specialty are only increasing in complexity as demand for design and engineering innovation push the boundaries of reprocessing abilities. One such example of laparoscopic instrument complexity is robotics devices: they have internal cable pulley systems for precision angulation abilities and are very time consuming to clean. Due to the nature of their function, many challenging laparoscopic instruments have graduated cannulation, inner components that disassemble into multiple parts, or accessories that assemble into a variety of configurations. Manufacturer IFUs for these devices are among the most detailed and complex, often requiring flushing and ultrasonic cleaning.
14. The Impact One Tray Can Make
A single instrument with retained contamination can be used on hundreds of patients over its useful life. In addition to the devastating effect contaminated instruments can have on patient outcomes, there are significant other ramifications for the hospital. There is a financial risk of lawsuits, readmission costs, increased anesthesia time for the procedure, as well as the erosion of trust between the OR and Sterile Processing. Improper processing leads to double work in Sterile Processing as errors have to be corrected and backup trays opened. IFU compliance is important 100% of the time, and not just most of the time.
15. Steps to IFU Compliance: Accessibility
One of the primary reasons departments do not follow IFUs is because technicians do not have practical access to them. Many departments do not yet have a system in place for keeping IFUs either as physical hard copies (in a binder or files) or as a digital record. For those departments that do have IFUs or subscription to a digital database, technicians do not have easy access to those IFUs at their workstation when they need the information. Technology can help bridge this accessibility gap by bringing the IFU closer to the technician and making it easy at access right at the sink. What is needed is a system that will look at the relevant IFUs for a tray and calculate, communicate, and document the details of that IFU for the technician.
16. Steps to IFU Compliance: Count Sheet Accuracy
The majority of instrument trays in Sterile Processing Departments contain instruments from a combination of manufacturers, each with different IFUs. Countsheets often do not accurately reflect this variety of instrument manufacturers and catalog numbers of instruments, and so departments process them all according to one general “one size fits most” process to try and meet the requirements of all the IFUs. The trouble is, each manufacturer has a distinct approach to validating their medical devices. What is needed is technology that can account for the correct manufacturer of instruments in a tray to ensure items are processed according to each individual IFU.
17. Steps to IFU Compliance: Documentation
One of the challenges to IFU compliance is that it is difficult to document. Without documentation of IFU processing steps, it would not be possible to prove to a surveyor or prove in a court of law that each step of the process actually happened. Following the IFU cannot be just a sweeping generalization that caters to the lowest denominator of IFUs; it must instead be comprehensive and account for the complexities of processing each individual instrument. What is needed is a system that will document IFU processing steps, guiding and educating technicians as instruments are being processed with built-in timers that help affirm that each step was followed correctly. This would ensure documented compliance, and also support struggling staff members as an intervention tool for further education.
18. The Role of Technology in IFU Compliance
If Sterile Processing Departments are going to adhere to manufacturer IFUs, they must invest in the appropriate technologies that will assist them with compliance. Examples of required technologies for processing could include lighted magnification, video borescopes to view internal channels of devices, timers to measure soak times, and tests to verify cleaning processes. In addition to these processing technologies, departments should use technology to help digitally organize IFUs in a structure that fits with the department workflow. What is needed is a technology that will pull out necessary information from IFUs while technicians are working so that the instructions can help them through the steps, rather than slow them down and cause confusion. This kind of organized structure in processing leads to organized, consistent, compliant workflows.
19. Your Department Can Change the World
The challenges with IFU compliance are real world issues faced by every Sterile Processing Department, yet there is little conversation in the industry about solutions to these challenges. Departments have become resigned that total IFU compliance is not practical or achievable. As professionals in this field providing safe instrumentation for patients, we must keep the goal fixed on 100% compliant processing in departments across the globe. That is a goal each Sterile Processing professional should press for by implementing best practices for processing instrumentation. You can press for change in this industry around the globe by implementing technology that empowers your team to properly process every single instrument.
20. Series Wrap Up
Thank you for viewing this continuing education series by Petriss. We hope you have considered some of the challenges departments face processing instruments according to manufacturers’ IFUs. Is your department one that keeps IFUs tucked away in binder, or one that has a digital record of IFUs? Wherever your team may be on the journey towards IFU compliance, we hope you will work toward implementing the IFU into your workflow so that every technician knows they are properly processing each instrument. We encourage you to consider the use of technology in organizing your IFU data that ensures the safest patient care possible.
Let’s Be Honest…
EARN 1 FREE CE CREDIT!
Listen to an asynchronous replay of this discussion between Petriss Co-Founder & CEO Andy Petrovich and Hank Balch of Beyond Clean as they discuss the dirty secrets of IFU non-compliance that pose risks to patients and staff. Upon completion of the virtual course, you will earn 1 CE credit.
