Healthcare is increasingly moving from institutional to domestic settings. According to the National Home and Hospice Care Survey, approximately 1,459,900 patients received home health care in 2007, up from 1,355,300 in 2000. We expect these numbers to continue rising as Baby Boomers age and people with chronic conditions requiring daily care live longer.

This shift in care poses unique challenges to the medical device industry. As the healthcare system grows more complex and as patients take on a greater share of their care responsibilities, caregivers and patients alike must have easy access to the information they need for safe and effective use of user-friendly products via simple-to-understand labeling and support networks for information sharing.

FDA initiative

The U.S. Food & Drug Administration, recognizing that growing numbers of sophisticated medical devices are migrating into the home setting, is strengthening its efforts to promote best practices in product and labeling design for medical devices used in the home, often by people with no formal medical training. As part of its Medical Device Home Use Initiative, the agency this summer launched a 10-month pilot program . Under the program, manufacturers of home-use devices may voluntarily submit their labeling for posting on a central website repository. The repository will provide a central location for home care patients and caregivers to access important information about the safe use of their devices.

This portal can be a valuable learning tool for everybody involved — a one-stop-shop for useful information about our products as well as a laboratory for innovating best practices in product and labeling design. In addition, this repository is an example of how FDA and industry can work collaboratively to accomplish the mutual goal of improved patient safety. As part of this initiative, FDA can provide the industry with information that continually improves labeling and design practices — and industry members can contribute valuable knowledge and experience in understanding and anticipating patient needs.

Leveraging industry knowledge

The medical device industry has already invested heavily in product and labeling design. At KCI, for example, a sizeable percentage of our research and development staff specialize in user-centered design, and all of our products that have received 510(k) clearance for home use have undergone extensive scrutiny to ensure they are appropriately designed for use in the home by patients and caregivers who often may not have a clinical background.

As part of this scrutiny, manufacturers and designers continually ask questions that are relevant to improving home use safety:

• Who are the patient-users and what are their environments of use? What are their needs, wants, concerns, limitations, and distractions?

• How do we promote elegant design that makes our devices as intuitive to use as possible?

• How do we harness design to minimize user hassle and frustration, which in turn may improve user compliance with manufacturer recommendations for safe use and clinical outcomes?

• How do we create designs that minimize impact on patients' lives?

• How do we design our products to anticipate the wear and tear that can result from home use, especially for our most portable units?

• How do we simplify instruction without missing important details?

• Where possible, how can we minimize opportunities for user, error?

• Finally, how can we harness technology to enable patients to maximize their experience with our products and rapidly communicate with us if problems arise?

These questions have led to important lessons that may help FDA in its quest for product and labeling design best practices for home use:

• Where possible, keep user interfaces simple to make devices less intimidating and to reduce margin for error.

• Provide patients with enough information to be confident in the status of the device and the result of their actions. However, recognize that too much information causes uncertainty and confusion.

• Make instructions easy to read and actionable. Couple simple instructions with powerful graphics to drive home important messages.

• Offer instruction in multiple languages and strategically incorporate clear images, standard symbols, and graphics into devices and labeling to minimize translational issues.

• Where appropriate, develop e-labeling, which allows for a high level of interactivity — a proven learning tool.

• Put all products through extensive testing and scrutiny. KCI's process includes Highly Accelerated Life Testing (HALT), which subjects products to, among other things, high levels of shaking and vibration to ensure strength and durability.

• Simulate real-world product testing. We put products through several rounds of iterative testing with representative patient-users.

• Finally, recognize that no amount of design and instruction can replace the role of robust patient support. KCI trains almost 50,000 clinicians annually on usage of V.A.C. Therapy (for wounds) and provides a 24/7 phone support line where patients can access both technical representatives and staff clinicians.