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Manufacturer Instructions for Use: Can We All Do Better?
By Sara Freiberg

Many articles, opinions, and conversations surround the topic of medical device manufacturer instructions for use (IFU). While both the user and the manufacturer have voiced feedback, it is important to note that both sides have valid concerns.

Compliance with manufacturer instructions for use is important for patient safety and is crucial to understanding the device. Medical device manufacturers perform studies to validate each protocol within the IFU and submit to the U.S. Food and Drug Administration (FDA) prior to the device being sold at the hospital. The IFU document describes how to properly inspect, use, preclean, clean, lubricate, sterilize, transport, package, and properly maintain prior to, during, and after a surgical procedure. In addition to these important steps, manufacturer IFUs also alert the user of any potential risks, warnings, limitations, or contraindications, which are imperative to patient safety and to understanding the device’s intended use and performance.

The risk associated with deferring from the IFU is high. The FDA, Association for the Advancement of Medical Instrumentation (AAMI), Centers for Medicare & Medicaid Services (CMS), Association of perioperative Registered Nurses (AORN), and The Joint Commission all have guidance sharing the importance of IFU adherence. The FDA places the primary responsibility for developing and validating methods for effective reprocessing of a reusable medical device on the manufacturer of the device. AAMI ST79 7.3 states, The device manufacturer’s current written IFU should be accessible, reviewed, and followed. If there are no specific written IFU in the labeling, then the manufacturer should be contacted and requested to provide a documented method of cleaning.”1

“If manufacturers’ instructions are not followed, then the outcome of the sterilizer cycle is guesswork, and the ASC’s practices should be cited as a violation of 42 CFR 416.51(a).”We risk patient safety, place our facility name at risk, and risk failing an accreditation survey through The Joint Commission.

User feedback
Users state that some IFUs are quite lengthy. IFU length can vary greatly, depending upon the complexity of the device and its intended use. As an example, some endoscope manufacturer IFUs may consist of more than 200 pages. Considering the need for quick turnover and the time that it takes to properly read, some instructions might appear overwhelming to the user.

Some IFUs are difficult to follow and contain vague instructions. Similarly, users say that it would be helpful if all IFUs had the same standardized format. We read “if applicable,” and this language causes confusion. Medical device manufacturers are responsible for providing clear written instructions.

User concern
Some users ask what IFU stands for? Some staff members may not be aware of what an IFU is, where to locate them within their facility, or they haven’t received an opportunity to review them. It is important that staff are provided access and training with their IFUs.

We may find that after purchasing a device, staff are unable to follow the directions due to systems, equipment, or the allotted time to effectively clean and sterilize the device. The importance of reviewing a manufacturer’s IFU prior to trialing or purchasing a device is paramount. AAMI ST79 Section 7.1 states, “Facilities should ensure their sterile processing department can accommodate the directions based upon their current systems, equipment, and supplies in place.”3

Some users gather instructions from the internet. It is important to note that IFUs are updated periodically from the manufacturer.  An IFU gathered from the internet could place our patients at risk, as they may not be the manufacturer’s most current instructions. We should always contact the manufacturer directly or use a reputable platform such as OneSource to receive the most current instructions.4

Even after following the IFUs, a complex device or design flaw is an issue. In a study performed by the FDA, although the hospital had followed the IFU provided by the manufacturer, they “…ran the 350 suction tips through the manufacturer’s recommended cleaning and disinfection processes and reexamined them. All but seven of the suction tips still contained debris.”5

Are staff feeling rushed? The old adage “to err is human” is absolutely valid in reading and understanding IFUs and the quick turnover of devices; therefore, we all have a role in communicating staff consideration of human factors to the manufacturer prior to writing their IFUs.6

In an effort to recognize facilities’ concerns on manufacturer IFUs, the FDA has communicated guidance on human factors and the six criteria for reprocessing instructions.7  The FDA asks manufactures to “…consider the following recommendations regarding human factors in developing your reprocessing instructions.” Some examples of IFU recommendations entail the following:

  1. “We recommend that you develop consistent reprocessing instructions across each of your product lines. Labeling that provides consistent methods and terminology, and utilizes the same document layout for all devices of a type, may help improve the user’s comprehension and adherence to the instructions.”
  2. You should address any known post-market human factors issues known to exist for reprocessing your device or similar devices. Examples of human factors issues include, but are not limited to, actions requiring substantial dexterity or strength, good visual acuity, or familiarity with uncommon practices.
  3. For devices that are subject to design controls under 21 CFR 820.30, you should validate your reprocessing instructions to ensure that users will be able to successfully understand and follow them.”

Joint Commission surveyors have been known, rightly so, to ask who is the newest employee in the department, walk up to that employee, and ask how they clean a device. If the employee states he or she follows the IFU, the surveyor might ask the employee to pull the IFU and follow along during the cleaning and sterilization processes to ensure compliance. Until all manufacturers’ IFUs are modified to reflect the recommended criteria, we are all accountable: both the manufacturer and the users of the device. According to the FDA, “If a healthcare facility sterilizes a product used on a patient without having or following the validated and written IFUs, they become the manufacturer who is subject to the FDA rules and regulations.”8

Patient safety depends on us all.

Bibliography

  1. AAMI ST79
  2. https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/downloads/SCLetter09_55.pdf
  3. AAMI ST79
  4. https://www.onesourcedocs.com/?onesource_session=86baab261f1ae9e6a2d57bf34244e221
  5. https://www.publicintegrity.org/2012/02/22/8207/filthy-surgical-instruments-hidden-threat-americas-operating-rooms
  6. https://www.mddionline.com/when-reprocessing-devices-human-factors-matters
  7. https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM253010.pdf
  8. http://www.biosealnet.com/2018/04/wait-should-we-really-be-processing-these-a-closer-look-at-properly-processing-put-ups/

 

 

 

 

 

Sara Freiberg, CST, CBSPDT, CER, has more than 15 years experience working as a certified surgical technologist, with five of those years spent traveling to various operating rooms across the U.S. Following Sara’s time in the clinical arena, she worked as a surgical technology didactic and lab instructor at Rasmussen College. Sara holds bachelor degrees in science and business and marketing, which led to her work with various medical device companies as a clinical specialist, product manager, and clinical training manager. She has experience working on quality and regulatory teams, monitoring patient-adverse events, and postmarket surveillance activities.

Sara currently works for Northfield Medical as a clinical education manager where she provides education which is based on current manufacturer and regulatory guidelines regarding various healthcare topics for SPD, OR, and GI staff. Training entails the care and handling of medical devices to ensure patient safety, as well as targeted education addressing departmental cost concerns. Her passion is working with SPD, OR, and GI departments; providing assessments; and sharing best practices with respect to patient and staff safety, surgical instruments, and medical devices. Sara is a voting member of the AAMI ST/WG84, ST91 flexible endoscope committee, and she has developed several CEU presentations approved through CBSPD, CBRN, NCCT, and IAHCSMM. Sara also authors a biweekly healthcare article for Ultra Clean Systems.

Sara is currently studying for the Certification Infection Control (CIC) exam through APIC.

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