May / June 2009

Human Factors

Home Medical Equipment Rentals
and Instructions for Use

By William A. Hyman, ScD, PE

Home use of medical equipment continues to grow, including both equipment expressly designed for the lay user and equipment adopted for home use but where the layman may not be the original intended user. Some of this equipment is rented to the home user directly and some through the insurer. Because of the increase in home use, there has been increasing attention to the design of this equipment with respect to its usability by non-professional users. This attention typically focuses on the user interface, with the goal of making it less complex, more intuitive, and more clearly labeled, therefore enhancing effective use and reducing "use error." The term "use error" is preferred to "user error" because the former identifies only what happened while the latter implies blame. In this regard, the principles of human factors, or human factors engineering, assert that the identification of potential errors and their mitigation is a design problem, and that design must therefore seek to eliminate errors, and warn against them only when the adverse situation cannot be reasonably designed out. Good design for home use might also include making a device more "décor friendly."

In addition to the actual design of the equipment, all medical devices must have "adequate directions for use" based on good design and marketing practices, legal expectations, and Food and Drug Administration (FDA) regulations (2003, April 4). The FDA has addressed the writing of instructions aimed at the lay user (1993) as well as for medical professional (2003, August 28). In this regard, the FDA definition of adequate directions for use for over-the-counter devices is "directions under which the layman can use a device safely and for the purposes for which it is intended." The instructions for use (IFU) must also include frequency and duration of administration and preparation for use such as any adjustments to be made. It is also common and necessary for IFUs to include a variety of warnings about unsafe practices, as well as contraindications for use of the device, adverse reactions and inherent hazards. In addition, IFUs will typically include contact information for the manufacturer as well as warranty information. The IFU may also have troubleshooting guides and other information that can be helpful to the end user. Devices for professional use have separate labeling requirements. The situation for prescribed, home-use devices is more complex in that the prescription requirement implies that a professional intermediary is required, yet the patient or their caregivers are the actual end users. Many such devices include distinct professional and end user IFUs. There are also devices for which the FDA provides specific labeling requirements (e.g. devices containing latex) or guidance documents (e.g. laboratory test kits).

Joint Commission Standards
In addition to FDA requirements for manufacturers, The Joint Commission (n.d.) addresses Patient Equipment Management in its homecare accreditations standards. While not specifically requiring the provision of IFUs, doing so is certainly consistent with EC.6.30: The organization plans for effective selection, delivery, set-up, and maintenance of equipment and supplies provided to patients; EC.6.40: The organization appropriately delivers medical equipment provided to patients; and EC.6.50: Medical equipment provided to patients is set up appropriately in the patient's home. A relevant performance element under EC.6.30 is the CMS Quality Standard: The supplier implements an equipment and item management program that promotes the safe use of equipment and items and minimizes safety risks and hazards both for its staff and for beneficiaries. Under EC.6.50 is found CMS Quality Standard: The supplier provides all items that are necessary to operate the equipment or item. Appropriate instructions must logically be included here.

Rental and Loaner Device IFUs
When a medical device is purchased new, the IFU and all other paperwork can be expected to be packaged in the box with the device, and therefore it will reach the end user in most cases. Rental and loaner devices may present a more challenging situation in that the IFU document may become separated from the product and not be provided to the end user by the actual supplier. This may be as a matter of policy and practice, or it may be by omission. Policy or practice may arise because only one IFU was originally received from the manufacturer with each item, and it has been retained (or lost) by the rental supplier. Even if the IFU was once provided to the end users, there may be a problem with recovering the IFU when the rental equipment is returned. Thus the supplier would have to continually or frequently replace the IFU. However these realities cannot offset the fundamental safety principle and good practice that dictates that the manufacturer's IFU must be provided to the end user if they are to have access to all of the information that the manufacturer determined was part of the "adequate directions for use."

Instead of providing the actual IFU, some rental suppliers have chosen to prepare their own simplified version, or to rely on verbal instructions upon delivery. In either case, these abbreviated instructions tend to be limited to the fundamental how-to-operate aspects of the device and not include the complete warning and caution information contained in the original IFU. For example, how to move the side rails on a bed up and down is certainly valuable and necessary information, but providing just these instructions does not include the information on entrapment or fall hazards that may exist in the design and be addressed (whether adequately or inadequately) by the manufacturer's instructions. Furthermore verbal instructions, even if acknowledged by the responsible party in the home, may or may not be really understood, or if initially understood, may not be remembered or effectively transferred to other caregivers. In addition, delivery personnel may not be well enough trained to adequately provide clear and complete verbal instructions. Availability of the manufacturer's written instructions may also demonstrate discrepancies between what the user was told, or thinks they were told, and what the instructions say. This can be a good stimulus for seeking clarification and preventing harm.

Another unacceptable excuse for not providing the actual IFU might be that IFU is "too complicated" for the end user and that therefore simplified instructions are better. If in fact the IFU is too complicated, then might the device also be too complicated for that user? In addition, this judgment puts the rental supplier in the position of substituting their assessment of appropriate directions for use for those of the manufacturer. This is a perilous exercise. While safe and effective use is the primary goal, post-incident risk management also suggests that failing to provide an IFU that contained warnings relevant to an adverse event that has already occurred will be challenging to explain and justify. If it is felt necessary to provide supplemental abbreviated instructions, they should include the instruction to "Read and understand the manufacturer's Instructions for Use." In some cases, home health providers may be in a position to supplement and reinforce instructions, and to identify safety concerns in the home, but only if they are themselves thoroughly familiar with the relevant IFUs.

The IFU for a device designed for home use will also typically include a consumer contact telephone number so that the end user can communicate directly with the manufacturer as well as with their medical professionals and the rental supplier. This access to the manufacturer can provide added, and perhaps more detailed, support with respect to the user's questions. The warranty information will initially not be relevant to a rented device, but can become important if the device transfers from rental to ownership as a result of the amount of rent paid over a period of time. Depending on the clarity of the communications from the supplier, the consumer may or may not understand that they have become the owner of the equipment, nor what portion of the original warranty period, if any, is being transferred to them. In the worst example of this transfer situation, the new owner may not know they have in fact become the owner until the next time they contact the rental supplier with a problem. At that point they may be told that they now own the device, and that the warranty has expired.

It should be clear that home users of medical devices need clear and complete written instructions on the safe and effective use of their home medical devices. A primary source for this information is the IFU provided by the manufacturer of the device, and there is no rational or compelling reason or excuse for this IFU not to be provided to the end user of rental equipment. The end consumer also needs clear written information on whom to contact with questions on use and on the commercial aspects of their transaction including conversion from rental to ownership and warranty status. In addition to being fundamentally logical, the simple concept of users needing the IFU is consistent with elements of the FDA's guide for home users, which includes "Read your patient education information," "Keep Instructions for Use close to your device," and "Read your instructions for taking care of your device and follow them" (FDA, 1993).

References

FDA. (2003, April 4). Device advice, labeling requirements. Available at http://www.fda.gov/cdrh/devadvice/33.html. (Accessed September 1, 2008.)

FDA. (2003, August 28). Home healthcare medical devices: A checklist. Available at http://www.fda.gov/cdrh/cdrhhhc/brochure-checklist.html. (Accessed September 1, 2008.)

FDA. (1993, August). Write it right: Recommendations for developing user instruction manuals for medical devices used in home health care. Available at http://www.fda.gov/cdrh/dsma/897.pdf. (Accessed September 1, 2008.)

The Joint Commission. Home medical equipment supplement. Available at http://www.jointcommission.org/AccreditationPrograms/HomeCare/hme_supplement.htm. (Accessed September 2, 2008.)