Originally Published MDDI April 2001
Inside MD&DI
A Reality Check for Device ManufacturersRobert Drummond
In this month's special in vitro diagnostics supplement ("Regulating the Point of Care: The IVD Connectivity Industry Consortium"), Alan Reder outlines the efforts of a group of point-of-care (POC) device manufacturers—the Connectivity Industry Consortium (CIC)—to develop a connectivity standard for the POC industry. What's noteworthy about the consortium is not only that a number of competing companies have come together for the task, but that the manufacturers have included a group of healthcare providers—end-users of their products—to help develop the standards.
"We are there to make sure that whatever standards are developed remain real-life standards," says James Nichols, PhD, chair of the CIC's provider review committee (PRC). The committee's task is to see to it that end-user requirements make up the basis of the proposed standards.
With POC devices, "real-life" usability requires manufacturers to expand their understanding of human factors engineering. The challenge for POC manufacturers has more to do with data management than it does simple ergonomics, explains Nichols, who is also the director of clinical chemistry at Bay State Medical Center (Springfield, MA). "Manufacturers have expertise in the technology—the test itself—but they don't have expertise in data management."
By establishing the PRC, Nichols explains, the CIC has forced manufacturers to recognize this problem. "Manufacturers were each developing custom, proprietary data-management systems," he says, which rendered the devices incompatible with each other. And the providers—mostly laboratory personnel—weren't happy with the results. "We didn't want to buy what [the manufacturers] were coming up with, because it wasn't able to link with all the other things we were doing."
Ellis Jacobs, a member of the PRC and the director of stat laboratories and point-of-care testing at the Mount Sinai Hospital (New York, NY), says that data management goes hand in hand with the quality assurance requirements of end-users—something that traditionally has not been high on manufacturers' list of priorities. "Every manufacturer has to adhere to ISO 9000 or GMPs," Jacobs says. "So in theory, the concept [of quality control] is not alien to them. But manufacturers can't always appreciate how quality has to be managed in a clinical laboratory."
This is where the PRC comes in. It has insisted that manufacturers eliminate proprietary solutions and come together to standardize the communications of POC devices. The CIC is providing the forum, and the PRC will ensure that manufacturers follow through.
"We're the reality check for manufacturers," Jacobs says. "We set the priorities for functionality." The PRC gave initial input into the proposed standards, and it will have the final say before the proposals move to the voting stage. "We're there to say, 'Does this proposal make sense? Does it do what we need it to do?'" If the PRC deems a proposal insufficient from the users' viewpoint, the document will go back to the technical group for further work.
A side benefit of the PRC is that it has informed manufacturers of issues they might not otherwise have learned about. For example, if data are not being managed properly at the point of care, tests might not be recorded correctly on patients' medical charts. According to Jacobs, this has two impacts: the first is obvious—it impairs a doctor's ability to provide the proper patient care. The second impact involves reimbursement, an all-too-familiar topic to device manufacturers. "From a laboratory financial perspective, there can be reimbursement for a lot of POC tests," Jacobs says. "But if those tests are not properly charted or recorded, the institution loses any chance of reimbursement."
"The role of the PRC is to ensure that the end product is useful and viable and that it meets the needs of end-users," says Jacobs. Presumably, this is the goal of every device manufacturer; by involving end-users in the standards-making process, the CIC has ensured that, at least in the POC diagnostics industry, manufacturers will not lose sight of their objective.
Robert Drummond is managing editor of MD&DI.
Copyright ©2001 Medical Device & Diagnostic Industry
