Who remembers working in a central supply (our old name) and using paper to document all the sterilization loads, quality audits, mobile equipment management, and more? It was a labor-intensive task to handwrite on a small 5″ x 3″ index card all the items that were in the sterilization load.

If there was a load recall, it became exceedingly difficult to determine which items were in the load as the written document was not legible at times. To make matters worse, the information on the load record did not have specific tray details, and the name of the tray was the only identifier.

manual instrument tracking sheet

Other hospitals used an envelope system in which they handwrote the load contents in an exceedingly small area, and the sterilizer strips were stored inside the envelope. The envelope had space to record four loads, and if the department processed more than four loads, they would continue to write on the back of the envelope making it illegible and disorganized.

Difficult to document or trace

Another challenge for a manual recordkeeping system is that is difficult to trace an instrument set in real time, as the sets are not traced at any point, making it difficult to determine on which case the tray was used unless the end user manually recorded the sets. Furthermore, it is not practical to manually document some stages of the process like the decontamination area.

Maintaining a manual documentation system in the decontamination area would require the team to remove their full personal protective equipment (PPE) to write the information. Removing PPE every time they must document a tray that enters the decontamination area or is going into the washers is labor intensive and would create a backlog in the process. In addition, the paper would become contaminated.

Unbelievably, there are still hospitals maintaining manual processes in the sterile processing department (SPD), and why is that? We passed the time of manual surgery scheduling systems to make the operating room more efficient, yet we still have SPDs using a manual system with huge file cabinets filled with instrument count sheets. What are the benefits of installing an instrument management system (IMS)? What are the steps for a successful IMS implementation?

Why does SPD need an IMS?

Every task we perform to render sterile instruments to the operating room (OR) involves multiple steps to

manual instrument tracking sheet

ensure the set has been thoroughly cleaned, assembled, sterilized, and transported to the OR safely. We must have evidence that the equipment used to render the sets bioburden free and sterile is functioning according to the manufacturer’s specs and achieves the established parameters.

We have policies and procedures that dictate how to perform the tasks in an efficient manner and comply with regulatory and recommended standards. The US Food and Drug Administration (FDA) also requires that we follow reprocessing steps found on each medical device manufacturer’s written instructions for use (IFU).

Each facility could have hundreds of IFUs on file and maintaining up-to-date IFUs manually is a labor-intensive task that requires regular monitoring. I remember going to a facility to help them after they were issued an immediate threat to life (ITL) violation, and their SPD was shut down. Upon further investigation, their IFU book had 2005 IFUs and they were using sterilization parameters not listed in the IFU. When the surveyor asked for the IFU for the items she had selected, unknowingly, an old IFU was provided. This IFU had different parameters listed from what they were using. It took days to download IFUs for all the items they were processing. It was evident that someone would need to spend time ensuring that the binder contents remain current. 

In today’s SPD, we submit data for everything. If we need capital equipment, we submit a capacity report proving the reason we need it; if we need staffing, we submit a volume/productivity report, and so on. Documentation is essential in the SPD to generate reports to support our needs, to comply with the requirements of the organization, and to ensure the safety of our patients. Maintaining and collecting the data manually is a labor-intensive process that could consume hours we could use more efficiently if the department had an IMS.

Steps for a successful IMS implementation
  1. Select the instrument management system: This is the first step of the process that will require research and capital dollars allocation to complete.
    • Research: There are multiple IMSs available in the market and each has its unique features and benefits. Create a list of the desired processes to improve with the help of the IMS (i.e., updated count sheets, trace instruments through the process, document trays at the point of use, etc.). The surgical scheduling system interfacing with the IMS will provide an electronic list of needs for the next day’s OR schedule as trays are being scanned for processing in the SPD. Other features to consider for managing the daily SPD operation are productivity modules, quality audits, reprocessing 
manual instrument tracking sheet

equipment interfacing, and integration of the HLD process.

    • Financial allocation: There are different financial models to obtain an IMS. For instance, there are subscription-based IMSs, some have a licensing fee, and others provide a fee-based basic system that can manage count sheets depending on the size of the organization and their number of users. There are also companies that will offer a basic IMS if the hospital purchases their capital equipment (i.e., sterilizer, washer, etc.). The organization should discuss with the IMS vendor the purchasing options that are best, keeping in mind the application features needed to improve the processes in the SPD.
    1. Assessment of equipment needs: Each IMS will require the purchase of electronic equipment such as computers, scanners, servers, label and laser printers, and real-time production monitors (optional but helpful). Having the real-time production monitors is extremely useful, as we can see the OR schedule and its progression. The quantity of equipment depends on the number of workstations and scanning points in the SPD.
    2. Current equipment interfaces: An IMS that is not interfaced with the OR surgical scheduling system generates count sheets and may not improve the production and forecasting needs in the SPD. At minimum, your IMS should interface with the surgical scheduling system, the IFU database electronic application, and the biological test readers. An interface with the processing equipment (sterilizers, washers, etc.) would be ideal and it will get you to be paperless, but it is not necessary in the first year of the installation.
    3. Instrument data cleansing: Once the IMS vendor is selected and the equipment has been purchased, the most labor-intensive part of the installation is the data cleansing process. A thorough review and update of the database will help you save time and make the department efficient and productive. In this phase, you should have an accurate inventory list of sets that includes an updated list of count sheets, consignment and loaner trays, and an accurate list of the total inventory of items that are peel pouched. Other information needed will be the updated list of vendors, instrument catalog numbers, internal users’ names, and storage locations.
    4. Secure internal support: Installing an IMS is not a simple task, and it requires experts to ensure all necessary steps are completed. In our case, our information technology team took the lead in managing the project and coordinating all the trades needed to successfully complete the installation. There were weekly meetings that included the IMS vendor, OR, SPD, and a slew of IT experts that included IT specialists, network specialists, network and systems administrators, the director of IT clinical systems, and a project manager. Our installation was a bit more complex, as it included a system-wide IMS installation and collaboration. IT managed all the required trades, evaluated the equipment needed, anticipated the network cabling needs, and performed installation. They also completed the computer drive build, installed the server, and provided access to the IMS vendor. In addition, IT provided support during the installation process and helped the SPD manage the project from the IT perspective. Others also participated, such as engineering installing computer arms and other mechanical aspects of the installation; purchasing, who expedited and followed up on all purchase orders; and our administrators, who provided the resources required to achieve a successful IMS implementation.
    5. External support: It is important to maintain an open line of communication with other existing SPD equipment manufacturers in your organization. For instance, if there are going to be software interfaces with the OR scheduling system and the biological readers, the SPD vendors must have discussions with the IMS vendor early in the process. These interfaces may require purchasing additional licenses and equipment. The selected IMS vendor can significantly help navigate this process.