Manufacturer's Instructions for Use: Keeping Your Facility Compliant

Over the past several years, we have seen increased attention paid to compliance with manufacturer’s instructions for use (IFU). Compliance with IFU — a term often used interchangeably with directions for use (DFU) — is essential to better ensuring patient safety and infection prevention.

The Food and Drug Administration (FDA), Centers for Medicare & Medicaid Services (CMS), accreditation agencies, such as The Joint Commission, Accreditation Association for Ambulatory Health Care (AAAHC), and national associations, including the Association for the Advancement of Medical Instrumentation (AAMI), have all placed greater emphasis on organizations strictly adhering to IFU when reprocessing medical devices. When undergoing survey, healthcare facilities and their staff are closely scrutinized for compliance.

In late 2016, the 21st Century Cures Act was signed into law. It requires the FDA to publish, in the Federal Register, a notice listing those reusable device types that must include validated IFU and validation data regarding cleaning, disinfection and sterilization in their 510(k) submissions. Manufacturers of reusable medical devices are responsible for labeling that bears adequate DFUs, including instructions on preparing a device for use.

Updating IFU remains the responsibility of manufacturers. The FDA provides guidance to manufacturers for the "complex activities involved in crafting and validating reprocessing instructions that ensure that the device can be used safely and for the purpose for which it is intended."

With technology evolving and more complex medical devices being developed, reprocessing is becoming a greater challenge. The more complex the device, the more difficult it is to clean, disinfect and sterilize.

Preventing Infections: Filling in Knowledge Gaps

The key to appropriate and safe reprocessing is a joint effort between manufacturers, healthcare facilities, infection prevention staff and most, importantly, central processing personnel. It's important to note that the emphasis on IFU — and requirements surrounding them — extends beyond the central processing department and perioperative environment. It also applies to general medical equipment that requires cleaning and low-level disinfection, such as IV pumps, point-of-care devices (e.g., glucose and INR testing meters), blood pressure cuffs, electronic thermometers and environmental surfaces. Furthermore, it includes those products used to clean and disinfect devices and equipment, which often display IFU with an imprinted label on their containers.

Facilities are required to provide staff members with easy access to IFU. Surveyors may ask staff specific questions about cleaning, disinfection and sterilization and will often request to see individual IFU. Surveyors are also interested in a facility's process for ensuring easy access to IFU for all employees involved with medical devices and equipment.

IFU can be provided via several methods, including the following:

  • Leaflet or pamphlet accompanying the product

  • User manuals, depending on the type of product (hard copies and/or online)

  • Imprinted on the product (e.g. surface cleaning agents, enzymatic detergents)

  • Resources on the company's website

  • Online companies that specialize in obtaining IFU and storing them for easy access by subscribers

The Infection Control Consulting Services (ICCS) team suggests several steps facilities and staff can take to ensure IFU are readily available and strictly adhered to. Compliance with abiding by IFU includes the following multidisciplinary work:

  • Manufacturers are responsible for providing easy-to-follow, explicit instructions for cleaning, disinfecting and sterilizing (if applicable to the product) medical devices, items and equipment to every customer.

  • End users should locate IFU and place them in an easily accessible location for all involved parties to access and use.

  • End users should follow the step-by-step IFU with no diversion.

  • End users should reach out to manufacturers if IFU are missing, unclear or ambiguous.

  • End users should ensure that all personnel responsible for reprocessing or cleaning/disinfection are familiar with the location of IFU and the processes for undertaking the tasks described in the instructions.

The ICCS team frequently encounters staff members who are unaware that instructions may be printed directly on a container. This can include, for example, surface disinfectant wipes for low-level disinfection and enzymatic detergent products used for cleaning instruments and items in central processing. During onsite visits, ICCS team members spend time with the staff, assisting with accessing and following IFU.

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