Medical Device Link.

Originally Published MDDI January 2002

USER MANUALS

Medical Device User Manuals: Shifting toward Computerization

Will manufacturers digitize their medical device user manuals as readily as they've digitized other aspects of their operations?

Michael E. Wiklund

Consider the challenges facing technical communicators (i.e., technical writers) who design and produce medical device user manuals: First, their work must address the needs of an especially diverse audience, starting with caregivers and extending to trainers, biomedical engineers, sales personnel, government regulators, and many others. Because of its broad potential audience, the typical medical device user manual must be several documents in one. Second, technical communicators often have only limited resources and time to produce high-quality manuals as their companies speed products to market. Third, a user manual's primary audience—arguably the nurses, physicians, and technicians who deliver direct care to patients—tend to prefer engaging in hands-on training over reading user manuals. The popularity of the hands-on approach creates a perception of user manuals as perfunctory—a perception that could take the wind out of any technical writer's sails.

As computer technology grows ever more ubiquitous, a popular trend toward computerizing learning tools is cause for new excitement among technical communicators and allied professionals alike. As more caregivers gain computer access, the practicality of their viewing instructions on a medical device's computer display, on the Web, or on an interactive CD-ROM, for example, will increase. Such technological progress will enable content developers to think beyond the printed page and embrace alternative delivery mechanisms that may be more compatible with a particular user's learning style. In addition to the benefits it might afford users, computerization will assist manufacturers in updating content as readily as they install new versions of software into devices. As a result of this emerging multimedia approach, the hard-copy medical device user manual is swiftly evolving toward a system of both print and electronic components.

Since some institutions and individuals will embrace computer-based learning more readily than others, device manufacturers will be challenged to make their transition to a systems approach easy and comfortable. Manufacturers will also have to prove to FDA and other certifying bodies that a multimodal approach to documentation will help ensure the proper and safe use of devices. It appears certain, however, that dynamic, interactive user manuals viewed on computer displays will be a desirable adjunct to paper-based documents, and the cost savings associated with computerization are likely to make it imperative.

CURRENT PRACTICE

As mentioned earlier, caregivers usually prefer to determine how devices work through hands-on experimentation or by being tutored by another person. Spending hours reading a user manual hardly suits their need to get things done under the pressure of a critical-care environment. Most device end-users would rather sit through a 30-minute in-service session to learn a device's essential functions and then rely on intuition or the experts from biomedical engineering to solve any technical problems that arise. End-users' preference for interactive, person-to-person instruction makes them a challenging audience for the people who develop conventional user manuals that lack an interactive element.

Nevertheless, FDA requires device manufacturers to supplement their products with printed manuals. The applicable law (21 CFR 801 and 809) considers user manuals to be an extension of a device's labeling that clarifies its proper and safe use.

As a result, some manufacturers view user manual writing as a regulatory mandate rather than a facet of product design excellence. They reason, Why invest so much time and money into producing a high-quality user manual when we know that few people read them? In fact, medical device salespeople frequently encounter customers—the chair of a hospital's device selection committee, for example—who insist on judging a product based on how easy it is to use without any training, assistance, or referrals to the user manual.

THE NEGATIVE REINFORCEMENT LOOP

Unfortunately, when a manufacturer views the user manual as merely an obligatory measure to meet regulations in the United States and other countries, this "peg in the hole" mentality establishes a negative reinforcement loop. These manufacturers are less inclined to invest heavily in product documentation because, presumably, nobody is reading the manuals. Caregivers who then try to solve a problem by checking one of these manuals discover that the manuals are not particularly helpful and not worth consulting again, thus reinforcing the manufacturer's perception that no one reads the manuals. This unfortunate cycle causes considerable waste of user-manual development effort, and it renders manual production, distribution, storage, and final disposal incrementally less efficient.

Meanwhile, companies that choose to invest substantially in producing excellent user manuals should be commended. Ultimately, there will always be caregivers who prefer to read a manual; as a courtesy to those individuals, manufacturers should produce good ones. Europeans, in fact, are generally regarded as avid manual readers in contrast to their American counterparts. Moreover, user manuals have confirmed value to biomedical engineers and staff educators who often use manufacturers' manuals as a starting point for developing their own in-house training materials. So, good user manuals are helpful to some, even if the primary beneficiary is not an end-user.

Unfortunately, most people would be unable to cite a company known to produce extraordinary user manuals. Because excellent documentation is not generally perceived as a competitive advantage, good user manuals do not receive special recognition. More likely, companies that produce high-quality user manuals are better known for producing products that are customer oriented and that feature good user interface designs, and for offering outstanding customer service.

On the other hand, the shift toward computerization may garner a new visibility for user manuals and the people who produce them. Recognizing the downstream cost savings and the potential to use high-quality learning tools to their competitive advantage, companies may be driven to make greater up-front investments in educational resources than they do now.

According to Brian French, a nurse who serves as the professional development coordinator at Massachusetts General Hospital (Boston), his institution expects computer-based learning to play a significant role in nurse education within the next three to five years. The new technology will augment current in-service training programs. "An institution likes ours," French says, "needs to address staff training needs on a 24/7/365 basis. Computer-based learning tools will be particularly important to us because we can make them continuously available. Printed materials will serve as a backup to the computer." French represents a large teaching hospital with more than 800 beds and a staff of about 15,000 employees, including more than 2500 registered nurses. Surprisingly, his institution faces the same challenges many smaller hospitals do in terms of providing staff with access to computers and the Internet. "Current technology and space are designed to meet the clinical needs of patients, our first priority. The new challenge is to increase the number of computers and the amount of design space to meet the learning needs of staff at the bedside, while maintaining our ability to meet patient-care needs. But computerization is coming and we will have no choice but to adapt our facilities accordingly."

PAPER MANUALS VERSUS ELECTRONIC VERSIONS

In light of the computerization trend, will paper-based user manuals become as archaic as the typewriter? It is starting to look that way, despite paper documents' portability and their survival through power outages and operating system crashes. It's likely that they will always have a permanent quick-reference and backup role. And because of different learning styles, there will always be individuals who prefer to read a user manual over taking other learning approaches.

Still, little evidence exists to suggest that the majority of caregivers will dedicate more time to reading manuals, the quality of the documents notwithstanding. Busy caregivers have little time or inclination to search for guidebooks; in their parlance, they need solutions "stat" and at the point of care. User manuals are rarely within easy reach during a crisis.

Debra Wagner, a technical writer with GE Medical Systems Information Technologies (Milwaukee) shares the view that while computerization is inevitable, traditional paper manuals will always have a role in instruction. Wagner's company, which produces a range of high-technology devices, including cardiographs and patient monitors, expects computers to revolutionize the way medical device manufacturers support customer training efforts. "We pay close attention to the voice of the customer," she says. "Right now, our customers are seeking customized resources they can use to build their own training programs. Every institution has its own way of doing things, so a flexible approach is best. At GE, we are looking toward delivering content through many electronic means, including over the Web. In doing so, we will move toward a new paradigm involving the establishment of a generic-content warehouse that can be used by people responsible for training, marketing, and sales." Still, Wagner recognizes that employees have different learning styles and that some prefer hard copy to pixels. Therefore, GE Medical Systems expects to continue making content available in many formats, including traditional hard copy. She points out that hospitals are "loaded with lots of high-tech equipment. But there is currently a relatively low percentage of people who are comfortable with accessing information over the Web. Of course, this is changing quickly."

Peg Rickard, manager of information design and human factors at Datex-Ohmeda (Madison, WI), a manufacturer of anesthesia delivery systems and monitoring products, also sees the need for a hybrid approach to producing learning tools. She reports that her company has conducted studies on how people learn to use Datex-Ohmeda products. "As you would expect, most people prefer being shown how to use the devices by one of our people or the people we train," Rickard says. "But there are still a substantial number of individuals who do read the user manual." She adds, "Our surveys show that as many as 50% of our customers read some portion of the user manual, though not necessarily cover to cover. These people tend to be the over-forty crowd: those who did not grow up using computers and who may find them intimidating. We need to address their preference for hard copy, even though it would be less expensive to put the materials on a CD-ROM."

Rickard adds, "Looking ahead, we have to be prepared to serve the needs of the younger generation, which has grown up on computers and will expect to access our training materials by computer."

She expects that medical devices, such as patient monitors with laptop computer–sized displays, will be their own conduit for educational content. But, she points out, "Built-in help systems have their limitations. Obviously, on-line resources are not going to help you troubleshoot a patient monitor that has a malfunctioning display. You will always need to include with the product some sort of quick reference card or troubleshooting guide."

THE HYBRID STRATEGY

Plotting the future of her information design efforts, Rickard envisions a hybrid strategy: taking a systems approach to address the variety of customer learning styles and infrastructural constraints. She says, "To address the needs of one group of customers at the sake of another would be a missed opportunity." For now, her company plans to produce educational materials in various formats. Datex-Ohmeda will continue to deliver paper-based user manuals along with CD-ROMs containing the same basic document in electronic form. Looking ahead, the company envisions delivering content over the Internet and opening the door to new methods of content organization.

GE's Wagner has similar expectations for her company over the next few years. She says, "The kinds of Web-based content delivery systems that we are pilot testing today should be mainstream within the next five years. However, we are likely to continue to provide critical product information, as well as the content necessary to fulfill regulatory requirements, in hard-copy form."

As the nature of product documentation changes, so will the nature of the teams developing the material. Today, GE Medical Systems Information Technologies maintains a group of five writers to support its clinical systems development work. However, in the near future the company expects the work to involve additional people with database management and Web development expertise, while the writers continue to focus on producing high-quality content.

Massachusetts General Hospital's French anticipates that the movement of manufacturers to computerize their education materials may outpace customers' demand and their ability to accommodate the change. He expects the cost savings realized with Web-based delivery, as opposed to those of printing and shipping documents, will be the driving factor that leads manufacturers to computerize. For this reason, he advocates that manufacturers adopt a hybrid approach during the transition and let the market dictate the pace of change.

THE BENEFITS OF COMPUTERIZATION

The medical device industry's movement toward computerization of user manuals parallels similar movements in the medical industry as a whole. Paper is disappearing all over the hospital with the advent of information networks and the related software applications. Caregivers have already been participating in distance-learning sessions associated with building their clinical and reporting skills.

Fortunately, many vendors are prepared to help those medical device developers who lack the expertise or time to develop their own on-line resources. These vendors claim that computer-based learning tools offer the following benefits over the more-traditional forms of printed manuals and in-service training sessions:

• Greater knowledge retention on the part of the learner.
• Reduced learning time.
• Fewer disruptions to normal hospital operations.
• Ease of documenting participation.
• Around-the-clock access to quality education.
• Reduced costs.
• Simplified updating of content.

Despite the alleged benefits of computerization, getting busy caregivers to actually sit down in front of computers and realize these benefits might still pose a challenge, especially because in-service sessions often include social interaction, which computer-based training activities do not necessarily provide. That is a challenge for administrators to address with infrastructural improvements and other motivational efforts. The ultimate payoff should reflect a greater ability of staff to operate devices safely and effectively.

THE REGULATORY PERSPECTIVE

Patricia A. Kingsley, deputy director of CDRH's Division of Postmarket Surveillance and coauthor of Write It Right: Recommendations for Developing User Instruction Manuals for Medical Devices Used in Home Health Care, acknowledges that "written documents are not the professional caregiver's preferred source of guidance." As a registered nurse with more than two decades of clinical experience, she has observed that nurses strongly prefer being shown how to use a medical device rather than reading about it. And CDRH research supports this observation. Nonetheless, one of her major initiatives at FDA following her move to the agency was to improve the quality of instruction manuals written for professional caregivers and laypersons buying a medical device over the counter.

About the professional users, she says, "They tend to read the user manual if a device has reported problems or when they have an unusual patient who may require the caregiver to use a device's more complicated features." Kingsley also mentions the legal role that manuals fill: "The manual serves as a legal document that offers manufacturers liability protection by informing users of the risks and benefits associated with a device, and by describing its proper uses," she says.

Kingsley also cites the anecdotal evidence that nurses, who are the primary users of most medical devices, are looking for more convenient forms of guidance than paper documents provide. In fact, Kingsley says, she is "very excited" about the potential of computer-based learning. "I think it is suitable for sophisticated users as well as laypersons who are unable to read English." She adds, "The agency has been discussing, both internally and with industry, the topic of computer-based learning and other electronic means of educating users." Many within FDA anticipate a future in which end-users learn how to operate a device by means of computer-based learning tools in addition to other resources.

So how can device manufacturers pursue innovative solutions to user training while FDA continues to uphold the existing paradigm of requiring printed manuals that demonstrate the safe and effective operation of devices? Kingsley advises manufacturers to work with FDA in a partnership to "explore innovative options." More specifically, she says that manufacturers "should work with FDA's policy people to discuss new conceptual approaches. If a manufacturer has a specific solution in mind, then it should work directly with the appropriate division of the Office of Device Evaluation [ODE]. Tell the office what you have in mind. See what options ODE will consider. The agency is moving cautiously because it needs more data on the effect of these new labeling approaches on users' ability to operate the devices safely and effectively. Have research available to support your idea so FDA can be assured that the proposed learning tools will ensure the safe and effective operation of the given device."

Kingsley's remarks suggest an open door to nontraditional approaches to user-oriented documentation at FDA. But she expects the agency to assume a reactive posture, and she notes that "industry groups such as AdvaMed need to suggest the agenda. FDA could go in many directions but would prefer to let industry tell us where it wants to go with labeling requirements. This type of industry-led brainstorming is how we originally got involved in looking at standard symbols for use on medical devices."

CONCLUSION

Hospitals taking a paperless approach to patient medical histories, patient billing, vital-signs recording, and laboratory test reporting seem to represent the future of medical information management. But does the future leave room for the paper-based user manuals that have traditionally been shipped along with medical devices? Will hard copy remain a regulatory requirement? The emerging computerization trend in nearly all industries will leave little room for paper. Even professional airline pilots are turning away from paper documents and toward electronic forms of critical checklists, operating manuals, and maps. Still, the concept of the electronic book has been slow to catch on with consumers who have already embraced personal organizers, such as the ubiquitous Palm Pilot. So one cannot be sure about the pace or completeness of the shift away from paper user manuals to electronic formats.

While computerization is already happening to a meaningful degree (industry insiders expect the shift to occur within the next three to five years), some expect that critical information about the operation of a medical device will still be provided in printed form for years to come. To accommodate both possibilities, medical device manufacturers will undoubtedly benefit from producing a core set of content that can assume either print or electronic form to match a customer's preference. Meanwhile, manufacturers should continue to explore innovative solutions and work closely with regulators to determine the viability of their potential solutions.

BIBLIOGRAPHY

CDRH Web site, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/topicindex/topindx.

Blue Book Guidance on Labeling, http://www.fda.gov/cdrh/g91-1.html.

1997 Draft Labeling Guidance, http://www.fda.gov/cdrh/ode/labeling.html.

Patient Labeling Guidance, http://www.fda.gov/cdrh/ohip/guidance/1128.html.

Michael Wiklund is a vice president at the American Institutes for Research, and he manages the consulting firm's human factors and usability testing services.

Illustration by Larry Limnidis/Getty Images.

Copyright ©2002 Medical Device & Diagnostic Industry