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The sterile processing departments (SPD) face a formidable task in
managing the multitude of surgical instrument trays in their inventory. This challenge is further compounded by introducing vendor-loaned instrument trays for specific surgical procedures. The hundreds of instrument trays require a sophisticated approach to
provide the necessary information for disinfecting, preparing, and sterilizing. It's a testament to our technicians' skills and dedication that they can handle this complexity daily, ensuring the safety and efficiency of our surgical procedures.
The challenges of vendor-loaned instrument trays are complex and continue
to overburden a department that traditionally has inadequate staffing and equipment. In many instances, surgeons are unaware of the work required to provide them with sterile vendor-loaned instrument trays. Indeed, those who have had to process these trays
can identify with issues such as the availability of the trays, the condition of the instruments and trays received, the complexity of the instructions for use, and the sales representative's limited familiarity with the reprocessing steps of their trays. Although
many other issues are related to these trays, this writer will try to condense facts about these three categories.
Availability of vendor-loaned trays
Hospitals have policies and procedures outlining the delivery process
of vendor-loaned instrument trays, yet very few companies adhere to them. The untimely arrival of these trays, often the night before or the day of the case, significantly disrupts the SPD workflow, leading to a backlog. Depending on the procedure type, as
many as 19 trays may be delivered for one case. Each tray must be inspected when received, labeled, and assigned to a patient before entering the decontamination areas. Once in decontam, prioritization is imperative to prepare them for a 7:00 am case. Traditionally,
vendor companies have a few sets going from one hospital to another. They bring it today, pick it up tomorrow, and only bring it back two days later, and the process starts all over again. These trays rarely go to a location to be cleaned, inspected, and deemed
ready for use by the manufacturer. It is an inefficient and expensive process for SPD that seems not to have been noticed by the supply chain experts of the organization who oversee cost containment. SPD incurs labor hours to clean, prepare, and sterilize
the trays and the consumables used to prepare the trays, as well as costs related to equipment testing and utilities. Consignment trays are the best solution; the trays stay at the facility and are always available to the surgeon. However, when asked for
consignment trays, the vendors often answer that they do not have enough to leave them at a facility. They give the hospital the option to purchase these costly systems. But if we compare this scenario to life outside healthcare, for instance, if you hire
a contractor to build an addition in your house, they bring the nails and the tools to install those nails. The contractor does not ask you to purchase the tools they need to do the work. They get all the tools they need to perform the job. Then why do healthcare
facilities need to purchase instrument trays to install costly nails and plates to profit a specific company? We can also ask why the hospital must invest labor, time, and consumables processing trays that will be used to benefit a company that is not the
hospital. Some may say they are used to help a patient. Indeed, but perhaps there can be some restitution for the hospital's expenses. A potential solution would be for healthcare facilities to charge these vendor-loaned instrument companies a fee for reprocessing
their instrumentation. We can be sure that if that were the case, 19 trays would turn into 5, only having the necessary components for the procedures.
Condition of the trays received
Let’s consider this scenario: it is 5:00 pm; you receive vendor-loaned
trays for a shoulder revision, and upon inspection, you find the following:
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Each tray has two or three labels. These labels are wrinkled, peeling off, or adhered over the carrier's holes. Hospitals
adhere their instrument tracking barcode labels to the carriers and do not remove them before returning the trays. After many sterilization cycles, these labels degrade, and label particles fall inside the tray. In addition, the back of these labels retains
bioburden material.
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The inside carrier's inserts have undergone a nylon coating process, which, after many reprocessing cycles, becomes brittle,
breaks down, or peels off, making cleaning and removing any prior bioburden difficult.
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The instruments were not properly cleaned, and when we checked them, we find the depth gauges full of bioburden from the
previous case performed at another hospital.
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Screw graspers full of bone and blood.
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Screws and plates that were implanted full of bone, blood, and broken pins were put back inside the caddy. The rule is
anything that goes inside the patient gets thrown out, but occasionally, these are found in the vendor-loaned trays.
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Rusty and stained instruments.
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Trays that weigh more than 25 lbs. with multiple levels of instruments and screws that must be inspected. There is a tray
called the “mini monster” as it is humongous, making it very difficult to successfully sterilize it without being wet or having holes in the wrap.
These are only a few things you may find in vendor-loaned trays, but
the list can be a lot longer. SPD staff must then handle these issues quickly to ensure the trays are completed and on time for the procedure. The operating room's only priority is to get the instruments for the procedure, diminishing the fact that these are
real issues that can have detrimental effects on the outcome of that procedure. To successfully support the caseload, the SPD team must ensure that labels are removed and hundreds of instruments are inspected to ensure microbial contamination does not reach
the surgical site. These tasks may be required to be completed late in the evening when staffing is a challenge in most places, but we must complete them regardless of the department's limitations.
Most vendor-loaned instrument trays are picked up at one hospital
and taken to the next one. They never go to a central location to be cleaned and inspected before being used at the next hospital. Are contaminants being spread through the region? Are patients and hospitals at risk? Should law and policymakers be concerned
about this process and establish mandates for it?
Complex instructions for use
I most recently read the
APIC
Modernizing Medical Device Instructions For Use (IFUs) document, in which the Infection Preventionists voiced their
concerns about the complexity and availability of medical device instructions. This document explains in detail what it takes to secure, read, understand, and implement the steps necessary to follow IFUs. They also call for standardization of IFUs, how they
are written, and a “public repository of IFUs.” The fact is that many IFUs do not take into consideration a real-life SPD where items need to move very quickly through the process, and equipment like an ultrasonic cannot stay in the cycle for 15 minutes while
multiple trays are waiting to be processed. Anyone in the decontamination area at 3:00 pm in a hospital that performs joint procedures can sympathize with the fact that hundreds of instruments must be cleaned and ready for the next day. We must brush, rinse,
inspect, and repeat hundreds of times. Add to that, select the correct brush and remember the specific process for the medical device; if not, check the IFU; if disassembled something, remember how it goes back together, etc. The staff gets overwhelmed by
the many tasks they must perform to thoroughly, timely, and sequentially clean a tray.
Sales representatives have limited familiarity with the reprocessing
steps of their trays.
When a new set is brought into an organization, we ask the sales representative
to give the SPD staff an in-service. However, most sales reps can only speak about how the instruments are used in the OR and not how they are cleaned or sterilized. They are not trained to in-service SPD on how to clean, prepare, and sterilize these trays. I
have had some bring-in trays late, and they asked me to “flash” them when the instrument set IFU says, “No flashing is recommended.” Most have never read the IFU and struggle to find one when asked to provide it or cannot answer questions during an in-service. Furthermore,
many sales representatives operate off-label by redesigning their company trays, adding instruments to the graphic-validated trays, and removing multiple graphic trays to place the instruments into one carrier to make it easier for the OR staff or peel-pouching
the set components. These reps work independently from their corporate office's protocols, creating rules and placing patients and organizations at risk. Who is overseeing these practices? Processing is secondary to the company’s representatives as surgeons
are promised the instruments for their surgical procedure, and if they are not ready, the answer is… SPD did not process them on time. SPD must make it happen; otherwise, chaos occurs.
Accrediting agencies require us to have IFUs for every instrument
we reprocess, regardless of whether they are in a tray or peel pouch. We must have evidence that the cleaning and sterilization parameters are being followed; otherwise, how can we be sure that the process renders a medical device sterile? We cannot make
rules as we go and must adhere to those rules and guidelines for our processes. The
FDA
Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling gives manufacturers the procedures
to follow to validate medical devices and requires that these processes be able to be duplicated in a healthcare setting. Then why is the process short-changed when the product goes to the market?
Vendor-loaned instruments are a real problem in our industry, and
to make a noticeable impact on healthcare, considerable changes and perhaps legislation will be required. In the meantime, healthcare facilities must create systems and processes to protect the patient, the surgeon, and the SPD team.
Mary Olivera
OSPECS Consulting, LLC, President/CEO
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