Reprocessing vendor or loaner instrument trays is one of the greatest challenges a sterile processing department must deal with daily. Most times the vendor or courier shows up late in the evening with as many as 60 loaner trays that need to be ready for 7:00 a.m. surgical procedures. At smaller hospitals, where there is no supervisor on duty, technicians usually have no choice but to handle the situation themselves. Already overwhelmed with instrumentation from the day’s caseload, they do their best to get the trays completed; however, they don’t always succeed.
Due to time and staffing constraints, crucial trays may not get sterilized. Additionally, trays are rushed through the multiple steps of the process, leaving residual soil that is discovered during the surgical procedure. The surgeons get distracted by the situation and the tension created by the soiled instrument escalates into dissatisfaction channeled through social media where technicians voice unsympathetic feelings about the hospital and their managers.
Regrettably, this is the situation most sterile processing departments (SPDs) across the country routinely experience. There is a complete disconnect between the surgeon’s scheduling office, the operating room (OR), the manufacturer providing the loaner trays, and the SPD.
Most vendor trays consist of multilevel trays with complex instruments that must be disassembled for proper cleaning, yet adequate time to follow the steps listed in the manufacturer’s instructions for use (IFU) or cleaning is not allotted. Some of the carriers are plastic, which retains water and is not a good thermal conductor. Other systems have multiple drawers of screws, plates, and instruments, making the set difficult to dry and weighing more than 18 lbs. Upon inspection, instruments are found to be rusty, displaying the years of rushed cleaning and water retention.
Despite this, when brought into healthcare facilities, SPD technicians are expected to process the instruments without raising concerns; if they do, they are frowned upon for trying to delay a case. Obviously there is a disconnect between the OR, surgeon, patient safety, and wanting to maintain the volume of cases at the facility
Most recently, a set of reamers was brought into a facility. The manager brought to the vendor’s and OR’s attention that the reamers were rusty and unsafe for patient use. The tray was finally replaced, but the OR seemed to be more concerned about whether or not the case was going to be on schedule. Are physicians aware of these incidents or are they being kept uniformed to avoid unpleasant situations?
The Food and Drug Administration’s (FDA) guidance document, titled Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, outlines the requirements a manufacturer must follow to ensure the user community reprocesses medical devices safely, yet it seems that manufacturers overlook the guidance. This guidance is the foundation of the medical device IFU, which determines the reprocessing steps that must be followed at the healthcare facility. But how can we adhere to these directions if, when at the hospital, technicians are rushed to get trays done? These devices take time to clean, dry, inspect, and assemble. It is not that we are trying to be sticklers to rules or are trying to be difficult asking for the IFU, but we must follow the process to ensure our patients’ safety.
The FDA defines reprocessing as the “validated processes used to render a medical device, which has been previously used or contaminated, fit for a subsequent single use.”1 Just like a manufacturer of medical devices, SPDs must have validated processes for cleaning, disinfection, packaging, and sterilization to consistently deliver quality surgical instrument trays
To establish consistency and ensure all soil is removed from the medical device, it is essential for the SPD to strictly adhere to the steps outlined in the IFU, without any deviation or modification. Understanding this guidance can help the OR to ensure that proper reprocessing time is allocated prior to the scheduled surgical procedure and to be able to explain to the physician when there is delay in the process because the tray was delivered late.
Below, we outline a few required elements for reprocessing medical devices, as set by the manufacturer’s IFU:
- Special accessories: A variety of accessories is required to properly clean surgical instrumentation. For instance, since lumens vary in size, the appropriate size brush must be used to create cleaning friction inside the lumen. If the IFU lists a custom brush or accessory, the healthcare facility should not substitute the item without approval from the medical device manufacturer. Some trays or surgical instruments require special equipment to clean them (i.e., a sonification step or flushing of lumens at a determined pressure and length of time). These devices may require adapters, valves, or ports to connect to specialized equipment for cleaning. The IFU may also specify the kind of packaging material that should be used, such as a specific sterilization wrap weight or a rigid container, to ensure a proper sterility barrier for the tray. Why does the IFU require specific equipment, components, or packaging materials? The manufacturer uses scientific methods to validate the process. In other words, they qualified specific methods and steps to ensure the device can be cleaned and the process duplicated at a hospital site. The manufacturer uses this information on their 510(k) application, guaranteeing the steps to use to clean the device. Deviating from the IFU steps is rendering a device that potentially holds harmful contaminated materials.
- Point-of-use cleaning: The IFU outlines essential steps to be completed at the initial cleaning of the medical device to prevent soil residue on device surfaces and lumens. Disassembly of components and removal of gross soil from instruments is an essential step in the pretreatment process that must be completed by the surgical team at the end of the procedure. Device manufacturers require these steps in the cleaning process to be initiated within 60 minutes Pretreatment of devices facilitates cleaning and expedites the decontamination process in the SPD. To help the team adhere to this step, bottles of hospital-approved wetting agent should be included in the case cart for each procedure; however, adding a wetting agent and a moist, lint-free towel is acceptable.
- Disassembly of instruments: Most vendor-loaner trays are complex instruments that must be disassembled for cleaning. The healthcare facility must thoroughly review the IFU to ensure proper disassembly and reassembly of these devices. Multilevel trays must be separated before they are placed in the washer-decontaminator for cleaning to ensure the mechanical cleaning action touches every instrument. This is an important factor to consider when scheduling multiple orthopedic procedures and coordinating the delivery of the trays, as the washer capacity may be exceeded. For instance, a total joint system may be composed of 8 to 12 trays. If each tray has two levels, this amounts to a total of 12 to 36 components or layers, including one lid, one bottom, and two layers of instruments. Most washer-decontaminators can only accommodate 4 to 6 trays per load; therefore, it will take multiple loads to complete the task of cleaning 12 multiple-layer trays. Another way to mitigate this problem is if you are in the process of replacing your cart washer, select one with an instrument cleaning cycle. This cart wash cycle will help processing the excess volume of loaner trays.
- Methods of cleaning: It is critical to follow the manufacturer’s recommendations for appropriate cleaning methods and parameters. If using manual cleaning, use the appropriate tools for cleaning (i.e., brush sizes), the sequence, and the timing listed in the IFU. If automated cleaning equipment is used, the temperature, heat, detergent, and time settings must adhere to parameters validated by the medical device manufacturer. An example of automated instructions may look like this:
- Enzyme wash with hot water, using a disinfecting (enzymatic) solution, for a minimum of 5 minutes (use manufacturer’s recommended dilution rate).
- Wash with neutral pH or similar detergent for 15 minutes at set point temperature of 60°C (140°F).
- Final rinse with heated water for 5 minutes at approximately 43°C (109°F).
- Cleaning agents: It is critical to use the indicated proportions, types of detergents, and soaking times listed in the IFU. Detergents can cause damage to the medical device if exposed for prolonged periods. Ensure the technicians know what the appropriate soaking time for the detergent is, as the accreditation surveyor may ask them.
- Rinsing: Regardless of how quickly an instrument is needed, thorough rinsing is necessary to prevent detergent and soil residues from remaining on the instrument. Specific instrumentation requires repeated flushes and a final rinse with critical water, as tap water may contain endotoxins that can be detrimental to the surgical outcome.
- Lubrication: Consult the IFU to ensure the lubricant does not interfere with the sterilization process. It’s critical to avoid oil-based lubricants as they may leave a residue that can negatively impact the surgical procedure. Follow the IFU when reprocessing orthopedic systems in the automated washer-decontaminator as some manufacturers require a “no lubrication” cycle. Your washer-decontaminator manufacturer can help you program an “ortho instrument” cycle without lubrication. Train the team members to ensure the cycle is used correctly.
- Visual inspection: An essential step in the preparation process is to visually inspect surgical instruments for residual soil, functionality, and integrity. Although this step is labor-intensive, it’s extremely important since multilevel ortho trays contain numerous lumens and parts that must be individually inspected. Devices like a borescope can be used to inspect lumens, but at minimum the inspection process should include a lighted magnifying glass inspection.
- Drying: Trays must be thoroughly dried before they are wrapped or placed inside a rigid container. Make sure to follow the IFU and the recommended PSI when using pressurized air to dry instrumentation. Excess water can create moisture that can compromise the sterility of the package. Carefully dry the rivets of the trays because they hold water. A power drill’s rotary attachments hold water and must be thoroughly dried before sterilization.
- Sterilization methods: Although not as often, we may still find some manufacturer loaner trays that require an extended sterilization cycle. Always consult the IFU to ensure the correct parameters for sterilization are chosen. Do not add components to caddies with tray laminates, as the medical device system is calibrated according to labeling specifications, materials, and the weight of the tray.
Reprocessing multilevel manufacturer loaner surgical instrument trays is a complex process, and technicians should not be rushed. To ensure that trays are free of residual soil and safe for the next patient, technicians must diligently follow IFU steps as validated by the medical device manufacturer. This process also requires precision, timing, effort, and the right accessories and equipment.
There must be careful coordination between the surgeon’s office, the OR, and the manufacturer to allow enough time for all the steps listed in the IFU to be completed. The hospital’s supply chain can step in and set contractual rules for loaner instrumentation (e.g., requiring that trays for elective surgeries be delivered at least 48 hours prior to the scheduled surgical procedure).
It is essential to review the OR schedule a week in advance to assess if a vendor loaner tray is needed. This is a step usually completed by the OR team; however, the SPD must be in continuous communication with the OR and notify them immediately of late arrivals and the impact on the scheduled procedure. Sterile processing must have an estimated time of completion that includes cleaning, preparation, sterilization, and cooling process.
All team members in a healthcare facility bear the responsibility of ensuring that manufacturer trays are processed in a timely and safe manner. Late loaner tray arrivals should be documented to further investigate and correct variances in the process. Engage your team and conduct a root cause analysis of the process to safeguard the safety of your patients
Implement a process of accountability where everyone is equally responsible for a successful solution. This may mean keeping logs for delivery time prior to the surgical procedure and picking up the trays after the procedure is completed. These records can help enforce established protocols, because as Hellen Keller said about teamwork, “Alone we can do little; together we can do so much.”
- Food & Drug Administration (FDA). Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. (Rockville, MD: FDA, 2015), 33. Appendix E updated June 9, 2017. https://www.fda.gov/media/80265/download.