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Discussing new device sterilization standards

por Lisa Chamoff, Contributing Reporter | June 03, 2022
Endoscopy Risk Management
Susan Klacik
From the May 2022 issue of HealthCare Business News magazine

Medical devices have increased in complexity over the years, which has led to new guidance for sterilization, particularly of flexible endoscopes. HealthCare Business News recently talked with Susan Klacik, a clinical educator at the International Association of Healthcare Central Service Materiel Management (IAHCSMM), about new sterilization standards, including an amendment to ANSI/AAMI ST79, as well as the impact of COVID-19 on sterile processing.

HCB News: Can you tell us about your background and how you became an expert on medical device sterilization?
Susan Klacik: I worked my way through college (in the sterile processing field), got my bachelor's degree in-state. I liked it so much, I stayed.

I worked at a hospital in sterile processing and was very involved in my local sterile processing association. Any time they would ask me to do something, I always said yes. There was an opening for an alternate member for the AAMI committees. Then I became a voting member.

I read [the documents] cover to cover. We make comments on them, so I do the research on the comments. We get lot of input from members. I make the comments and then we've discussed them at the meetings.

I had the passion for it, and a lot of research went into it.

I enjoy helping patients and preventing infections. We’re behind-the-scenes people, and so we need to do the best that we can so that the surgeons can have what they need. That's our job, and it just makes you feel good when you know that by doing the best job you can, the surgeons can do the best job that they can do.

It’s really interesting because you're always seeing new technology, new processes, new designs of medical devices, all the regulations, how they've changed over the years.

HCB News: An amendment to ANSI/AAMI ST79 was recently added in response to the increasing complexity of devices. In what ways are newer devices more complex, and how does that complexity create sterilization vulnerabilities?
SK: With that amendment, we’re really talking a lot about insulation testing and how vitally important that is. What happens with that is when we prepare electrosurgical instrumentation, the laparoscopic instruments have insulation on them, and that prevents burns to the patients. If there is a breach in that insulation, it can have a negative impact on patient care — it could actually burn a patient. So, in the amendment, it is recommended that insulation testing is performed each and every time that we prepare those instruments. It’s very important.

It's interesting to note some of the feedback that I've been getting since this has come out. What it says in the document is that we inspect the instrument shaft for cuts, cracks and abrasions. There's a device that's called an insulation tester, and that's what we need to use. You have some older instruments that do not have the IFU (instructions for use). Some questions I’ve gotten are, “Why do I have to test these instruments?” Well, we can certainly go beyond the IFU. This is a quality improvement process. Many years ago, these devices weren't as readily available and so some older IFUs may not specify to use [insulation testers]. But it doesn't mean we shouldn't use them. When we do have an IFU for those devices, we should look and see exactly how to perform the insulation testing, if they have any recommendations in there. And if it's not in the IFU, the first thing I would do is contact the manufacturer for guidance.

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