Medications and medical devices prescribed to patients for at-home use typically include instructions for use (IFU), or directions for proper usage. According to the Food and Drug Administration (FDA), IFUs are critical "to help ensure that patients receive clear, concise information that is easily understood for the safe and effective use" of medical products at home. They are legally required in order for a product to be sold and are accompanied by warnings that any deviation from the IFUs may result in safety issues, malfunctioning equipment, or a voided warranty.
Patients are expected to adhere to strict at-home product IFUs. Likewise, clinical users in healthcare settings have a responsibility to read and follow the IFUs of any equipment they come into contact with throughout their day. It may be time-consuming for healthcare staff to read up on multiple IFUs, but this practice can avoid annoyances like equipment glitches and prevent tragedies like fatal outcomes.
Ultimately, when healthcare staff familiarize themselves with IFUs, they lay the groundwork to enhance patient safety and ensure both proper function and top-quality performance among all of a facility's clinical devices.
Exploring the Components of an IFU
As with consumer products, the law requires all medical equipment, devices, and accessories sold for clinical use to include appropriate labeling—including an IFU.
Under the Code of Federal Regulations Title 21, IFUs should feature:
- The intended use of the device
- How to set up the device
- How to use the device
- Handling and storage information
- How and when to perform tests on the device
- Maintenance instructions and schedule
- Troubleshooting guide
- Disposal instructions
- Parts and accessories compatibility
- Safety guidelines, such as:
- Risks of use
- Who should not use the device
- Cleaning instructions, such as:
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- Which chemicals are safe to use
- How to disassemble and reassemble the device
- Which parts should not be cleaned and how to dispose of them
- How to repackage the device for future use
Understanding the Importance of IFUs
Medical Error Reduction and Prevention reports that in-hospital medical errors affect close to 400,000 patients every year. The report provides two examples of medical errors:
- Administering medication to a patient who has a known allergy or not labeling a laboratory specimen that is then given to the wrong patient.
- Failing to strap a patient into a wheelchair or not stabilizing a gurney prior to patient transfer.
The first example points to issues with staff neglecting to pay close enough attention to the task at hand while the latter is an indicator of staff not following a product's IFU. This could stem from inadequate training; however, it's each staff member's responsibility to familiarize themselves with IFUs rather than rely on others to deliver this information to them.
As healthcare institutions introduce more advanced and complex equipment to their staff, the potential for user or use error will increase. Use error, as defined by the FDA, is when a device has a different result than expected, but the device itself has not malfunctioned. When it comes to high-grade medical machinery and clinical accessories, patient safety and outcomes are at stake. Every result must be as accurate as possible—simply having a machine not malfunction is not good enough.
A staff consisting of individuals who follow a manufacturer's IFUs can ensure that critical healthcare products function as intended.
Assigning Stakeholders' Responsibilities
Every stakeholder has a role to play to ensure that a clinical device's instructions for use are accurate, tested, followed, accessible, and evaluated—and within each role, they all carry their own unique responsibilities.
Manufacturers
Manufacturers design, develop, test, manufacture, package, and label medical devices and equipment. According to the World Health Organization (WHO), it is the responsibility of the manufacturer to conjecture all the ways in which the end-user might interface with their product.
Anticipating human use (and possible error) guides how they develop their product's IFUs, including safeguards, warnings, risk labeling, and appropriate training. Manufacturers should also include information on which accessories and supplies are safe to use in tandem with the product in order to deliver the best performance.
Vendors
A medical device vendor markets and sells the product and will provide support, service, and training for its customers. A vendor should also follow up on customer complaints and report any labeling or use issues to the FDA.
Healthcare Facilities
The hospital or healthcare facility should ensure that its staff, the end user, is familiar with the device and adheres to its IFUs. This responsibility includes setting up policies and procedures for staff to review IFUs and making these documents as accessible as possible.
According to Infection Control Today, sterile processing departments (SPDs) and materials managers within healthcare facilities are responsible for something a bit more nuanced: complying with IFUs to protect patients from unsafe reprocessed devices. SPDs verify that the IFUs' recommended cleaning and sterilizing processes have been followed as directed.
Meanwhile, materials managers play an essential role in acquiring the chemicals that assure cleanings follow the manufacturer's protocols. New designs for devices increasingly feature materials that are safer for patients, though the wrong cleaner can degrade these materials, such as the device's coating, thereby causing safety issues, breakage, failure, or imprecise data output. Materials managers are a key part of guaranteeing that does not happen.
End Users
Unit managers, clinicians, nurses, and other hospital staff are the end users of many medical devices. Unit managers and nurses must be familiar with the equipment and devices they operate, even if they plan to only use it once. Staff must not become complacent when using a new device or as they shift from one device to another. Each clinical device is unique and requires specific handling as defined by their IFUs.
Ideally, facilities will place IFUs near their partnered device or in a digital library that every staff member can access. Managers can work to make sure that IFUs are easily accessible on their floor and are reviewed periodically by their team. End users should be able to locate the IFUs as well as demonstrate their proper execution. Scheduling manufacturer-led training may help staff become familiar with IFUs in a hands-on way.
Following IFUs Lays a Path to Better Care
As the US healthcare system shifts from fee-for-service models to a value-based care reimbursement model, as laid out by the US Centers for Medicare & Medicaid Services, healthcare settings must refocus on preserving resources and providing the best patient care. Adherence to IFUs can help accomplish both of these goals at once.
