At the University of Iowa Hospitals and Clinics (UIHC), our mission is patient care, teaching and research. Many of our physicians have research grants with vendors and we do a multitude of ortho and neuro cases, which means we trial a lot of new devices. So, when the OR asked the central sterilizing/sterile processing and distribution (CS/SPD) department to sterilize loaner instrumentation, quite a task developed.
In the old days, a vendor would bring in a tray at the last minute and tell the nursing staff it was needed for a case. Nursing would take the tray and prepare it for surgery.
At that time, trays were flash sterilized because they needed to be used immediately. No sterilization instructions were asked for and none were provided. Everything was sterilized at the same time and temperature, and life was good. Or so I thought.
When CS/SPD took over the process, I had a multitude of questions. How many trays were processed daily? How many of those trays were cleaned and processed properly? What was the minimum and maximum number processed? If nursing did not prepare trays properly, how much additional time and effort would my staff spend? How many vendors were in the OR daily? What were the sterilization instructions for each tray?
Vendors had unlimited access to the OR surgical staff, which was a problem. There was no control over what trays were brought in—if vendors wanted a surgeon to trial something, in it came.
CS/SPD was averaging about 15 trays a day, which is a reasonable number; however, we quickly realized the number of trays ranged from 30 one day and three the next or 52 trays and then nothing the rest of the week.
CS’ policy is that any reusable item brought into the hospital must be broken down and decontaminated, reassembled, and then wrapped and sterilized. In the past, however, when trays were brought in by a vendor, I am sure the tray did not meet the Association for the Advancement of Medical Instrumentation’s storage regulations.
Then, after the enactment of HIPAA, questions were raised about who could be present during a surgical case and whether patients were aware of who was in the OR during their surgery. UIHC decided that each vendor had to sign a business agreement. One purpose was to allow only those authorized by a physician into the OR. Each sales representative was required to attend a meeting where the new rules regarding OR visitations and the new loaner tray policy was explained. All loaner trays were to be brought to the CS/SPD department prior to 7 p.m. the day before a case, and written sterilization instructions had to be included for each tray.
Trays without sterilization instructions were not processed until instructions were received. We would call the vendor rep to say that unless sterilization instructions were received by 8 p.m., the trays would not be ready for surgery the next day.
If instructions weren’t received, the surgeon was called at home and informed that the trays would not be available because the rep could not provide sterilization instructions.
When surgeons began finding out that sterilization instructions provided by the vendor were different than the manufacturer’s, they began to call the vendors. They also called researchers within the companies and asked questions CS helped prepare regarding sterilization.
Action should be taken when a vendor provides sterilization instructions different from a hospital’s. I speak with the quality assurance department and send a letter to the FDA.
After several months, we are beginning to see changes. A couple of large implant companies have changed sterilization instructions on some products. This may be attributable to something else, but I like to believe the letters to the FDA helped. Now, sales reps are much better about providing the information we need to do our job; and the communication between sales rep, surgeon and CS/SPD has improved significantly. Vendors, while very knowledgeable about products, are usually not as well versed about sterilization procedures. Trying to obtain the sterilization instructions from many of the manufacturers can be a trying experience, but it is improving slowly thanks to all of our efforts.
Michael Murphy is thr manager of central sterilizing at the University of Iowa Hospitals and Clinics, Iowa City.
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