Holding Manufacturers Accountable for Their IFUs

By Nancy Chobin, RN, AAS, ACSP, CSPM, CRER

Q: If an end user finds that the manufacturer instructions for use (IFUs) are vague and not detailed enough and there is not an update/ revision available, can this be reported via the Food and Drug Administration (FDA) Medwatch program, so that the manufacturers can update their IFUs so that they are comprehendible? Or is there another means by which to handle this? If the IFUs aren't clear and the manufacturer cannot provide more clarification immediately for a reprocessable item, do you halt the process and take the item out of use until you can get clarification on the care/cleaning/sterilization IFU?

A: The sophistication of medical/surgical procedures has resulted in new generation of instruments and medical devices. These devices can vary in size, weight, complexity and immersibility. In addition, they can vary in cleaning, disinfecting and sterilization processes.
The Joint Commission (2014) addressed improperly sterilized or high-level disinfected (HLD) equipment in Quick Safety Issue 2. Three years later, improperly sterilized or HLD equipment continues to be a frequently scored noncompliant standard - Infection Control (IC) 02.02.01. “The Joint Commission encourages leadership to carefully oversee these processes and ensure that staff is properly trained and has the resources needed to adequately perform these critical functions.” 

The Joint Commission Standard IC.02.02.01 requires organizations to reduce the risk of infections associated with medical equipment, devices and supplies. This standard is applicable to Joint Commission-accredited hospitals (HAP), critical access hospitals (CAH), ambulatory (AHC), and office-based surgery (OBS) facilities. Of these, the most vulnerable locations for lapses in sterilization or HLD of equipment are 1) Ambulatory care sites (including office-based surgery facilities) and 2) decentralized locations in hospitals, even though the data shows higher noncompliance rates for critical-access hospitals and hospitals.

The Joint Commission standard IC.02.02.01 states that, "The [organization] reduces the risk of infections associated with medical equipment, devices, and supplies.) was one of the top requirements cited most frequently as 'not compliant' during surveys and reviews of ambulatory care facilities, hospitals and office-based surgery practices for the first half of 2016."

The non-compliance rates (2016):
- For ambulatory care, this standard was the most challenging requirement, with 49 percent non-compliance.
- For hospitals, it was the second most challenging, with 59 percent non-compliance.
- For critical-access hospitals, it was tied for the most challenging, with 73 percent non-compliance.
- For office-based surgery practices, it was the second most challenging, with 53 percent non-compliance .

So, what are the consequences? The consequences of failed processes can result in one or more of the following:
- Placing patients at risk for contamination
- Causing potential outbreaks
- Potential loss of Joint Commission accreditation
- Potential loss of Centers for Medicare and Medicaid Services (CMS) deeming status
- Bad publicity, lost business and a damaged reputation
- Litigation

The Joint Commission has found that from 2013 to 2016, immediate threat to life (ITL) declarations directly related to improperly sterilized or HLD equipment increased significantly. In 2016, 74 percent of all immediate threat to life declarations were related to improperly sterilized or HLD equipment.
What helpful resources exist? AAMI has a document, AAMI TIR-12, “Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers." This document was originally published in 2005 and was updated in 2010; it is currently being updated again. While not a national standard, this document does address all the design considerations to make sure products can be safely and effectively reprocessed in healthcare facilities.

In this document, it states that, Medical device manufacturers are responsible for providing clear written instructions on handling, cleaning, disinfection, testing, packaging, sterilization and aeration. The manufacturers must also test to validate their claims and instructions they provide. In addition, healthcare personnel need to verify manufacturers’ data and instructions, and have resources to follow them through”.

Your facility should have a policy, supported by administration, that:
- devices will not be purchased unless the IFU has been reviewed and that the IFU can be duplicated, exactly as written, at your facility.
- ensures all instructions followed correctly by staff

For new devices, an in-service should be scheduled with the device manufacturer’s representative. The in-service should be on-site, include hands-on training, a return demonstration and competency verification for each staff member. You should also inquire if the company has any instructional videos, manuals or poster to enhance staff education.

Understand that without IFUs, the device may not be cleaned, packaged, disinfected or sterilized correctly. This can result in a processing failure which is inexcusable. Your facility assumes full responsibility for the safety and efficacy of the device. Also, when not following IFUs, you are using a product off-label.

Regarding your specific question, when IFUs are not clear or do not reflect current standards or regulations (e.g., OSHA), first contact the device manufacturer directly. Speak with the manufacturer's technical service department, not customer service. The technical service department has all the information on how the device was tested. Ask this department to clarify the information. Second, the Food and Drug Administration wants end users to report these problems on the FDA’s Medwatch 3500 form, which is on the FDA webpage at: www.fda.gov. or at: http://www.fda.gov/Safety/MedWatch/default.htm.

The only way the FDA can take action against a manufacturer is to get the information from end users. The FDA is also asking manufacturers to consider human factors when developing their IFUs so the information is specific and accurate for the end user. If the device manufacturer cannot provide you with comprehendible IFUs, the device should not be processed. You may need support from your institution's risk management and infection prevention departments with this.

To ensure you can comply with the IFUs, ask questions when considering the purchase of a new device. The best practice is to obtain the IFU before the device is purchased. Why would any facility purchase a device when they did not have the equipment or sterilization cycles to effectively process it? The FDA cannot make a manufacturer update their IFU; however, if complaints are received from end users, the FDA will contact the manufacturer and take appropriate action which may include updating their IFU.

In summary, healthcare facility personnel perform cleaning, disinfection and sterilization of various medical and surgical devices and instruments. To process them safely, compliance with IFUs is required. If IFUs are received that are not clear or do not comply with current standards, the device should not be processed in the best interest of patient safety.

Nancy Chobin, RN, AAS, ACSP, CSPM, CRER, is a sterile processing consultant and educator.


ANSI/AAMI: ST79:2017. “Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities.”

AAMI TIR 12 -Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers, 2010

Basics of Sterile Processing, 6th Edition. Sterile Processing University, LLC. Lebanon, N.J.