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The TOSI™, a diagnostic challenge device and the winner of the 2010 Excellence in Surgical Products Awards, allows surgical facilities to ensure automated instrument cleaning equipment is working effectively, helping to improve efficiency, infection control, and patient and staff safety.

Interview by Amanda Hankel

November 24, 2010

How do you know that your automated instrument cleaning equipment is effectively cleaning surgical instruments and preparing them for sterilization?

How do you know that your automated instrument cleaning equipment is effectively cleaning surgical instruments and preparing them for sterilization? Until recently, not many surgical facilities could confidently confirm their washers were working properly. Enter the TOSI™, Healthmark Industries Company, Inc.’s Test Object Surgical Instrument (TOSI), a challenge device that works to test automated instrument washers and diagnose potential problems. Here, Ralph J. Basile, Vice President of Marketing at Healthmark discusses the device that has proven to make such an impact on surgical facilities that it is the winner of the 2010 ESP Award.

Surgical Products: How was the idea for the TOSI developed? What needs were you looking to meet with this product?

Basile: We introduced the TOSI in 2001. What we recognized in talking to our customers was that while a great deal of effort, and rightly so, was going into monitoring sterilizer performance and sterilization, that kind of effort, or nothing close to it, was going into making sure that instrumentation was getting properly cleaned. Before you can effectively sterilize, you need to effectively clean.

Our approach was to look at the primary object of cleaning in a sterile processing department, and that’s typically a stainless steel instrument soiled with blood. Depending on how long it takes for the instrument to get to sterile processing, usually it’s dry blood. Dry blood is a major challenge to cleaning because as soon as blood dries, it denatures, becoming highly water insoluble and a challenge to clean. We recognized there was a need to be able to monitor or verify the cleaning process, so we worked to come up with a surrogate device – something that would be similar to what the department is trying to clean – and that is typically dried blood on a stainless steel instrument.

Our approach was to look at the primary object of cleaning in a sterile processing department, and that’s typically a stainless steel instrument soiled with blood. Depending on how long it takes for the instrument to get to sterile processing, usually it’s dry blood. Dry blood is a major challenge to cleaning because as soon as blood dries, it denatures, becoming highly water insoluble and a challenge to clean. We recognized there was a need to be able to monitor or verify the cleaning process, so we worked to come up with a surrogate device – something that would be similar to what the department is trying to clean – and that is typically dried blood on a stainless steel instrument.

What we developed is a challenge device. It’s the same test every time. It’s comprised of dry blood soil on stainless steel inside of a plastic holder. It’s plastic so you can see through it. You can see the stainless steel surface and the blood soil, but it provides a physical challenge to the cleaning process, which is similar to the areas of instruments that are blocked from direct spray action. The idea is you run the TOSI just like you would a surgical instrument, so you place it inside an automated instrument washer, run it through a normal instrument cycle and the test should come clean. If it doesn’t, the test is diagnostic, so depending on what kind of soil is left, it suggests the possible problem with the washer.

Surgical Products: What are some potential problems that can occur with automated instrument cleaning equipment?

Basile: 1. The water is at the wrong temperature at the wrong time. For instance, the initial rinse in a washer is cold. It’s very important that indeed it be cold water and not heated water, because heat denatures proteins. If it’s heated water – 110° F or hotter – it will almost instantly denature the proteins, which renders them water insoluble and very difficult to clean. In the detergent stage, the detergent being used must be at the optimal temperature as indicated by the manufacturer. In the thermal disinfection stage, the water must be hot to kill most of the microbes and render the instruments safe for handling.

2. The detergent is at the wrong concentration. One of the biggest issues we see is that the right amount of detergent is not being delivered to the chamber or the washer. This can happen, for example, if the tube is kinked, there is air in the line, or the pump is not working properly.

3. Problems with mechanical efficiency or functioning of the washer, such as blocked spray nozzles or a bushing on a washer rack is broken.

4. The human element, or how the machine is loaded. The machine can be working absolutely perfectly to the manufacturer’s specifications, but if the machine is overloaded − if instruments are stacked up on one another, or the trays are loaded with instruments with the cover on top − it’s not being used properly.

Surgical Products: How does the TOSI help diagnose problems?

Basile: The TOSI is comprised of two types of proteins – water soluble proteins and water insoluble proteins. It’s comprised percentage-wise by weight at the same ratio as human blood, which is approximately 95 percent water soluble and 5 percent water insoluble.

On the TOSI, the red soil is the water soluble hemoglobin. If any hemoglobin is left, it’s usually an indication of a mechanical problem that is preventing water from getting in there. It’s a water-soluble soil, so as long as you get water, the hemoglobin will wash away. That is, with one exception – if the cold water rinse is hot, it will bake the blood on. So, it’s indicative of either a mechanical issue or an initial water temperature issue.

The other soil is fibrin, a translucent soil that is the coagulating agent in blood. By nature, it is water insoluble and it requires detergents to break it down. If fibrin is left, it’s usually an indication that it’s a chemistry problem – exposure time to detergent is too short, the water temperature was wrong for that detergent, or not enough of the detergent went into the chamber.

Surgical Products: How often should a facility use this product?

Basile: Association for the Advancement of Medical Instrumentation (AAMI) ST79 guidelines now state that automated instrument cleaning equipment should be tested at least weekly, preferably daily. In the Association of periOperative Registered Nurses’ (AORN) recommended practices, it’s recommended to test automated cleaning equipment weekly.

Surgical Products: How can using the TOSI help facilities improve patient safety, infection rates and overall efficiency?

Basile: A colleague of mine always says, “Quality doesn’t cost, quality pays.” When you have a tray of instruments, it’s really hard to say that one dirty instrument has caused an infection in a patient. Yet, we know that if one dirty instrument is used on a patient, the patient is likely to have a reaction to it.
Particularly when we are talking about introducing blood from one patient to another because the instrument was not properly cleaned, we have a very high chance for surgical site infection. We have heard of patients being operated on and the surgeon is using a lumened instrument. They’re flushing, they’re sucking and something comes out of an instrument in the middle of a surgery, as in a chunk of dried blood. If those instruments have not been properly cleaned, now, the patient has been compromised and a foreign body has touched them.

Secondly, when the washers are not functioning properly or not being used properly, the staff spends a great deal of time manually cleaning. That is a lot of time and money spent when the role of the washer is to do the cleaning. If your machine is functioning properly, it means less staff-time spent cleaning instruments, so the facility can save money and be efficient.

It’s also very costly if an instrument comes through decontamination, gets to the clean side, and somebody says, ‘Hey, this instrument is dirty.’ The instrument needs to go through the process again, which costs money. Even worse, if a set of instruments is opened in the OR and the surgeon or nurse discovers that an instrument is dirty, that whole set is assumed not sterile. Increasing the incidence of clean instruments literally can save tens of thousands, if not hundreds of thousands, of dollars a year in operating costs because you don’t have a situation where operating time is lost or staff time has been wasted.

 

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