Trends in medical care and technology are moving away from the obligatory hospital visit and turning to more personal therapies and home-use treatments, medical professionals said at a Food and Drug Administration seminar Monday at the University Hilton.
"We’re talking about taking medical devices beyond the bedside," Daniel Schultz, director of the Center for Devices and Radiological Health, said. "They present a lot of exciting possibilities, and we want patients to be able to use these devices as safely and effectively as possible."
Patient-use medical devices such as glucose meters, respirators and dialysis machines are coming into their own in an age when more patients are receiving out-of-office medical care, Schultz said.
Advances in medical technology are allowing for increasingly complex treatments and therapies to be performed outside of the hospital, from public defibrillators to home-use dialysis machines for patients suffering from kidney failure.
Schultz said these technologies lack a unifying identification system that can track the use, the success rate and the problems patients have in operating what can sometimes be difficult medical equipment.
"We don’t have that in medical devices," he said. "When there’s a problem with a certain medical device, it becomes very difficult to figure out what kind of device it is. What we want is better and more consistent review criteria."
Progress in the area of regulating home-use medical devices has been a slow process hindered by a lack of patient awareness, Arthur Ciarkowski, associate director of the Office of Device Evaluation for the CDRH, said.
Ciarkowski said that to empower patients requires not only a system to track use of medical devices but also clear and concise instructions so that patients can understand exactly what they are doing when operating the devices.
"Over the years we have focused on writing instructions for operating devices that can be understood by anyone with an eighth-grade level of education," he said. "But even that may be too high. The American Medical Association has done a study demonstrating that 40 percent of consumers are unable to read or comprehend medical information above the fifth-grade level."
Public Health Adviser Harriet Albersheim, also with the CDRH, said that the key to addressing this problem is simplicity.
"Labels and instructions should be composed of short sentences with relevant information grouped together in an active voice," she said. "Instead of telling users that, ‘the knob should be turned counterclockwise,’ it should read, ‘turn the knob counterclockwise.’"
Albersheim also said that consistency in language is critical.
"If you call it a knob in one sentence, don’t call it a dial later on," she said.
To accommodate a public that mostly lacks the sense of health literacy necessary to safely operate in-home health devices, CDRH is developing a compendium of knowledge on a Web site jointly maintained with Quality Systems Laboratories, who helps manufacturers meet government regulations.
"With this site, users can look up product manufacturers in alphabetical order and easily obtain information on proper product use, potential recalls, anything," Public Health Analyst Morgan Warner said. "The site will also offer users the opportunity to leave feedback about products."
The Web site is still in early stages of development, and manufacturers of medical devices will be required to submit information to the CDRH about their products within the next six months, Warner said.
The seminar continues today with more discussion about medical devices and nursing practices.
