If Not Water Quality, What? Problem-Solving, Step By Step

As with any device-related issue that potentially impacts patient safety, the Biomedical Engineering Department did not try to solve it alone. Our OR manager formed a group comprising individuals who were either involved in the process or could offer guidance on this subject. The group consisted of representatives from the Maintenance Department, the Biomedical Engineering Department, the OR Coordinator of Patient Care (CPC), the OR Manager, the Infection Control Officer, the sterilizer company of the involved washer/sterilizer, and the detergent company.

The investigation started with the Maintenance Department. Maintenance is required to periodically check the steam quality from the steam generators. The group was quickly able to verify that the steam quality met or surpassed all parameters. They also confirmed that the sterilizing equipment in the OR did not have a water purifier, despite recommendations to the contrary.

Armed with this information, we had a meeting with Maintenance, Biomedical Engineering, the OR Director and a representative from the sterilizer company. In this meeting we discussed several options:

After much discussion and debate it was decided that water quality testing—the most likely cause and the one that could affect other areas of the OR and the hospital as well—must be the top priority.

When the test results came back the group was surprised to find that the water quality, despite a few parameters that were low, was rated overall as good. We then had an independent expert evaluate the parameters for verification of the water quality. They quickly evaluated our results and agreed that our water quality was good.

With steam quality and water quality eliminated as causes, we moved on to look at the type of detergent we were using. The OR CPC made the company manufacturing the detergent aware of the problem and had a representative come in to review the process. The representative made a few suggestions but believed that the issue did not stem from the detergent itself.

With detergent now eliminated, we had an engineer from the sterilizer company itself come in and review the investigation to that point. The engineer suggested switching to a liquid product that had a chelating agent in it to help purify the water. He also suggested that we have our service technician come in and do a service on the sterilizer to verify all parts are working correctly. That technician ultimately found no problems with the device or with our servicing techniques.

Susquehanna Health was still having the “rust” issue, and staff still had to clean instruments by hand after they went through the washer/sterilizer—a stop-gap measure that could not go on indefinitely. We were now down to looking at our staff's technique or putting in a whole new detergent system. It was the OR Manager's call at this point. With the bottom line in mind, she called the detergent company back in to verify again that the detergent not the issue.

The company reviewed everything once again and evaluated the whole process from the room to the clean side of the washer/sterilizer. It was through this review process that the problem was finally uncovered. Surprisingly, it was not the device, the water or steam quality, the detergent, or human error, but rather the process Susquehanna Health used. We are one of only a handful of hospitals that soak their instruments in an enzyme solution from the time the surgeon is done until they are rinsed and put in the ultrasonic washer. The company suggested eliminating this step and using only saline at that point in the process. The thought was that the product might be compromising the integrity of the instruments' surface. With today's sterilizing processes, we were really just wasting money—and, we learned, introducing a new problem—with this step.

They also suggested increasing our washer/sterilizer cycles: the enzyme wash soak time from 1 to 2 minutes, the rinse time from 15 to 45 seconds, and the dry time to 10 minutes. A meeting among Biomedical Engineering, the OR Manager, the OR CPC, and Infection Control verified we could make these changes without compromising any infection control policies or jeopardizing patient safety. The group decided to implement all of the changes that were suggested except increasing the dry time to 10 minutes. The OR Manager felt that we would back up the instrument room too much by adding 4.5 minutes to every cycle. Biomedical Engineering increased the dry time from 7 to 8 minutes, adding only 2.5 minutes to every cycle.

With the solution in place and everybody's concerns addressed, staff had to clean the “rust” off of the instruments that had been affected. This process took a couple of weeks, but restored to service instruments that were otherwise unusable.

Three months after the changes were implemented, Susquehanna Health has had no “rust” issues to report. The group will meet again in three months and make sure the new process is working.

We were lucky to have a group of individuals from many departments and outside companies that were all willing to work for the common good of the hospital and its patients to find a solution. Each individual brought unique knowledge and resources, strengthening the Biomedical Engineering Department's troubleshooting skills not only in this situation, but for the future. Finally, by thinking beyond the logical causes and double-checking what we'd already done, we didn't get stumped and take the easy (but expensive) way out by buying a new system.

Sometimes, all it takes to improve patient care is a simple change in process, not a major repair or device upgrade, we were pleasantly surprised to learn.