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instructions for use (IFUs) because they just don’t understand the instructions. Either the instructions aren’t clear enough or the specific steps are so vague that they can be interpreted differently. I’ve brought this up with our clinical edu- cator, my supervisor, and our director and nothing has been done so far. What else can I do?”
A
IFU confusion Q
by Stephen Kovach
“Some of my fellow techs in SPD have a hard time following certain
Sounds like not much has changed based on your question. It’s a complicated process. Many people do not understand the FDA regulations that medical device manufactur- ers must follow.
I have heard similar statements during my 40-plus years in the Healthcare Industry. “They are too long, too many steps;” “… too short, not enough steps;” “…don’t give me enough information;”; “…too hard to follow….” I have also heard many people try to explain the IFU, but few look at the history and talk about the standards and regula- tions that medical device manufacturers must follow.
I attended and presented my paper on the Parametric Release from a Hospital Perspective at the 1999 World Symposium for CSSD (Central Sterile Services Department) in Orlando, Florida. “A quality system for the cleaning process will require implementation of standard procedures based on device manufacturers’ recommendations along with documented competency of staff. Two prevalent fac- tors make this a difficult task. any device manufacturers have considered the ques- tion of how an item should be cleaned as the concern of the hospital. The United States Food and Drug Administration (FDA) has required manufacturers since 1996 to furnish this information to the users. However, many reports still indicate that it is difficult to get this information from the manufacturer.”1
In April 1996, the FDA issued a document called “Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance” for manufactur- ers to use to develop their instructions for reprocessing clinically used reusable medical devices. This document, along with others, was the road map followed to get medical devices cleared to market, and all that infor- mation was to be included in the Directions for Use (or IFU). Between 1996 and 2015, users were still making statements like the one in your ques- tion. In 2015, the FDA updated its guidance and then also revised it in 2017 (Fig. 1).2 This revision is excellent! However, any older medical devices given approval before this new document are not required to be resubmitted to meet the updated guidance document. This means older items do not necessarily have to follow this new docu- ment. Thus, any medical device that goes to the FDA after the issue date of March 17, 2015, must follow this updated document. This would help explain why some items’ IFUs are more complete than others. Also, AAMI (Association for the Advancement of Medical Instrumentation) has also been working on updating its various standards about medical device reprocessing to help make IFUs more user friendly. So, to answer, you need to know when the
item was cleared to be marketed by the FDA. If you have issues with an IFU, regardless of when it was approved, work with the company to update the IFU. You can always use the MAUDE (Manufacturer and User
Figure 2
Facility Device Experience) reporting system to help make the changes, too.
As in many of my replies, critical thinking skills must be used and applied to resolve any concern. This is a great question. Here’s an example for you: I bought a Frazier Suction Tube (STR 6 Fr). Here is what came with the device. (Fig. 2). Important information:
leaned and sterilized before first use. • Lubricated after every cleaning and before autoclaving.
• (Ratchet type) Never locked during autoclaving. It gets back to you (the user) and your facil- ity’s Standard Operating Procedure (SOP). Here are some questions you need to ask about your own SOP: • Do you have an SOP for cleaning lumens/ cannulated medical devices?
• What does it say about cleaning lumens/ cannulated devices at your facility?
• Is it based on reviewing various IFUs on lumens/cannulated devices in your department and putting an SOP in place that addresses all types of lumens/can- nulated devices?
• Does it cite various standards (e.g., ANSI/ AAMI ST79 sections 6.3.1, 7.6.1, 7.6.2, 7.6.4.2, 7.6.4.3.4, 7.6.4.4.1, 7.6.4.4.2, 7.6.4.5, 8.2) and other information (e.g., articles) to support your practice at your facility? (f not, a surveyor could have a field day of your area for not having the correct SOP in place.)
I understand your frustration on review- ing IFUs and how you can adapt them to your department to provide a clean and functional medical device that can either be sterilized or high level disinfected. There is not a simple answer, and I just touched the surface concerning/adapting IFUs to your practice. Your management team has been made aware of the concern and should address it ASAP, or you might not have clean and functional lumens/can- nulated medical devices. HPN
For more information. check out #IFUcan on LinkedIn.
References
1. Kovach, S.M. (1999, June). Parametric Release from a Hos- pital Perspective. Zentre Steril 7(6), 383–392.
2. U.S. Food and Drug Administration (FDA). (2015, March 17). Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff. U.S. Department of Health and Human Services.
https://www.fda.gov/me- dia/80265/download.
Figure 1
hpnonline.com • HEALTHCARE PURCHASING NEWS • September 2022 43
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