Sanford Health’s Instrument Quality Conundrum

In 2021, Sioux Falls, S.D.-based Sanford Health’s sterile processing department (SPD) received a conditional level finding from the Joint Commission due to poor instrument quality. The finding came with an increase in executive leader engagement and pressure to fix the problem. The Sterile Processing leadership team worked 6-7 days a week for several months to go through all of the instrumentation, repair, replace and educate to new practices. The Joint Commission conducted the revisit, and the team was successful in showcasing the work they had done and plans to continue the work in the future.

With the addition of about $2.5 million of new instrumentation in the department, 2022 was off to a great start. Or so it seemed, that is until some instruments started to show signs of rusting and staining. Following the education provided the year prior, team members brought forward the instruments and a thorough investigation started. This investigation started with looking at techniques for washing instruments, assembling, and sterilizer practices. Sanford SPD equipment vendor Getinge was assembled and found no deviation from IFU guidelines or equipment functionality. Still, rusting was happening before sets were ever used on patients.

Healthcare Purchasing News (HPN) spoke with Lori Buskol, lead coordinator, Central Processing/Surgical Services at Sanford Health about this very situation to gain her perspective.One of the main challenges after the visit from the Joint Commission, Buskol says, was that Sanford Health has tens of thousands of instruments and thousands of instrument sets. She comments, “We had to start making spreadsheets immediately on everything that we owned and that wasn't even everything that we owned that is used in the operating room, it was everything that we used at our clinics too.”

Teamwork makes the dream work

“We had one person on our team who was really good at getting these spreadsheets put together and a few team members that were really good at finding instruments, which can be very challenging when you have a facility of our size,” Buskol adds. “We had 30 days to do this process before the Joint Commission was rescheduled to do their revisit. That is not a lot of time to ensure we got through everything. The staff was very engaged in this process, there was a ton of information given out to them. We do three reports per day for each shift, and we would talk about what the instruments needed to look like.”

Buskol notes that there was a lot of education for the team, even so much so as having their mobile repair vendors come in and help by educating staff as to what to look for and what needed to be done. Even the purchasing team was educated on what instruments to order.

“This was extremely challenging because this was also during COVID, so everything was on back order,” she says. “We had to come up with a process for instruments that were still good to use but needed to be replaced fairly soon—how we kept track of those to make sure we could gather them later when the replacements came in.”

Buskol goes on to explain that when new instrumentation came into the facility, they were put through a unique device identifier process that was very time consuming. As she was working on this process, the team realized that the new instruments were just not holding up as well as they should. There were issues with rusting before instruments were even used.

This lead Buskol’s team to a water investigation. She tells HPN that she ran numerous tests and increased their reverse osmosis (RO) water to have a longer run cycle in their washers, which helped a bit. But she still couldn’t pinpoint where the problem was. “The more I looked into this, I noticed people on sterile processing websites talking about their instruments rusting and water quality being an issue,” she comments. “So, I started doing a lot of research on water quality.”

The investigation

Through experimenting, rusting was isolated and found to be happening from the wash cycle. Sanford’s instrument repair partner Agiliti started putting an additional passivation layer on the instruments to try and protect them, but rusting was still showing up. It wasn’t happening to every instrument, but it was happening to all of the new instrumentation throughout a variety of manufacturers. The SPD team leaned into the project trying to figure out what was happening but also trying to communicate to all customers to alert them of the issues.

At the end of 2022, an Aesculap Technical Process Analysis (TPA) was conducted to see what was happening. The results concluded that the water conductivity was three times as high as it should be. To remedy this problem, Aesculap has recommended switching to all critical/RO water for the entire washer cycle. In experimenting, this has eliminated the rusting on the instrumentation that hasn’t built up the passivation layers.

Buskol is now known as a water quality expert at Sanford Health. The advice she gives to SPDs? “All over the nation, people right now don't even realize that maybe the situation that they're having with their instruments involves water,” she states. “But it does a lot of times. It often goes to that whether it's the steam coming out of the boilers, whether it's your RO system, whether it's your water that you use straight from the sink, your city water that comes in, those were all things that I looked at investigated with. I tried to find the leading experts around our area to pick their brains and figure out what kind of information there is.”

Buskol concludes, “And don't be afraid to have a voice. You have a voice in sterile processing. You just need to be brave enough to use it.”

Q&A: Air/Steam/Water Quality

Healthcare Purchasing News had the opportunity to connect with Jonathan A. Wilder, Ph.D., managing director, Quality Processing Resource Group, LLC on air, water, and steam quality, as well as his experience contributing to AAMI ST108

By Janette Wider

What are the risks of contaminated air/water/steam?

The most important thing in instrument processing is not to put anything into or leave anything in the patient that doesn’t belong there. This includes lubricating oil or water condensate from air compressors, high levels of water-borne or steam-borne chemical impurities and water-borne biological contaminants like bacteria and endotoxins. Any of these can result in pyrogenic or infectious outcomes for the patient. These can lead to infection, pain due to local poisoning or even death.

What contributes to contaminated air/water/steam in a hospital/facility?

The starting materials for air, water, and steam are never ideal for the end use of each. Each must be cleaned up before it is used.

Before air is compressed, it should be filtered to remove dust, bacteria and other contaminants. Compressing air generally involves using compressors that require oil for their proper function. This oil can be taken up into the compressed air. Similarly, humidity in the air that is compressed tends to condense as the air is compressed and can rust the compressed air tank.

Air as delivered to points of use by the HVAC system should always be suspected as a carrier of pathogenic organisms. Because it can carry them.
Water as it comes from municipal or well supplies is generally good for drinking, but even that is sometimes questionable. Water that meets the EPA drinking water standards can have far too much in the way chemical or biological contaminants to be appropriate for patient use. High chemical loads hinder the action of detergents or require using a lot of detergent which can be difficult to remove from the instruments. High biological loads can cause pyrogenic reactions (endotoxins) or infection (bacteria).

Steam is made from water. But how it is made requires attention to the end use. In normal usage in healthcare, large, central boilers are used that need chemical additives to be used to maintain the boiler’s integrity and avoid corrosion. Some of these have no effect on patients or instruments. Some, like amine additives, can be problematic leading to staining of instruments if there is an overdose. The needs of sterile processing are more exacting than the needs of the rest of the steam system. For local boilers, using tap water is not a good idea since any chemical contaminants will tend to be left in the boiler or sterilizer or on instruments, leaving a stain or encrustation that compromises instrument function.

What are the main challenges/solutions to dealing with this problem?

Like anything else, the details matter. But everyone in the chain of provision of compressed air, HVAC air, water and steam must be aware of these details, i.e., the requirements for these utilities as they apply at the point of use to ensure that they are supplied in accordance with what is needed.

Have there been any advancements recently in this area?

Some solutions are old, and some are new. For air, the use of UV to eliminate disease-carrying organisms is relatively new as applied in HVAC systems. Older solutions are valid solutions to the problem of keeping air safe for its use. These include HEPA filtration for local delivery of HVAC air to critical areas, coalescing filters and chillers for compressed air.
For water, it’s a matter of attending to filtration and modifying chemistry if needed. This is not new, but it is becoming more and more evident that it is needed.

For steam, the story is mostly the same as always except that some sterile processing departments are migrating to process (clean) steam that is generated from RO or better water. This requires adequate supplies of deaerated RO or better water and stainless steel boilers, piping, and sterilizer plumbing, valves, and chambers.

Can you tell me about air/water/steam quality when it comes to hospital audits?

AAMI ST79, “Comprehensive guide to steam sterilization and sterility assurance in health care facilities” and AAMI ST108, “Water for the processing of medical devices” set the acceptance criteria for these utilities. Auditing on the technical side requires that the different utilities be measured for the quantities listed as critical in these standards. Sometimes, the measurements show that some items are compliant, but on the margin of acceptability. In these cases, an audit should recommend that measures are taken to get the item in question away from the margin and provide a safety margin to ensure that things don’t go wrong if a minor disturbance to the supply takes place.

Can you share your experience with your contribution to AAMI ST108?

Helping to create ST108 was an honor and a lot of fun, because I was able to help create something that will help many people get their instrument processing to a better place. My specific contributions included but were not limited to being instrumental in creating new language around risk analysis, structure of the document, water quality for steam, and, in collaboration with a team of other experts, creating at least one of the annexes.

Any parting words of wisdom?

Good processing begins and ends with good utilities like air, water and steam. Sterile processing’s needs are different than other parts of the healthcare facility. Sterile processing is the only place in the healthcare facility where these utilities actually contact things that are used on and in patients. So, the bar is higher, because patient outcomes can be affected.