Y2K update
FDA planning Year 2000 audit of selected medical devices
A Healthcare InfoTech Staff Report
To ensure that electronic medical devices will not malfunction in the year 2000 due to the Y2K computer bug, FDA officials told members of a House committee last week that the agency plans to audit a sample of medical devices.
William Hubbard, acting deputy commissioner for policy at the FDA, told the Subcommittee on Health and the Environment and Oversight and Investigations a subcommittee of the House Commerce Committee that the agency is seeking funding to audit the data of 60 manufacturers that make what would be considered "high risk" devices that is, devices critical to patient health or safety if they malfunction this coming Jan. 1.
Up until now, the FDA has maintained that there is no great need to verify the information on Y2K readiness provided by device makers, and they have said, even if it were necessary, the agency does not have the resources to check all devices.
That position, however, has been challenged by the General Accounting Office (GAO; Washington). The GAO has charged that some hospitals have tested devices posted on FDA’s web site and recorded as being Y2K ready but found that they malfunctioned when dates were advanced to Jan. 1, 2000.
Testifying at the hearing, Joel Willemssen, the GAO’s point man on Y2K, said, "We continue to believe that organizations such as FDA can provide medical device users with a greater level of confidence that their equipment is Y2K compliant through independent reviews of manufacturers’ compliance test results." Willemssen said he believed the FDA’s proposed audit would satisfy his agency’s concerns.
Tom Shope, special assistant to the director of science and technology for the Center for Devices and Radiological health, emphasized that the FDA will not be testing any medical devices. Rather, he said, after identifying those high-risk device, the agency will select a sampling of companies and look closely at their manufacturing practices and procedures, similar to the process used in original device approvals.
The entire audit should be completed by the end of the summer, Shope told Healthcare InfoTech, a goal that would provide additional time for the agency to follow up if problems are found suggesting significant non-Y2K compliance.
What if those problems are found? "If we find a problem here, it means there’s a problem with our whole regulatory structure," said Shope. And he added that this, in turn, "would cause a lot of soul searing in a lot of different quarters." Specifically, he said that the identification of compliance problems would probably result in the agency using "a triage process focusing on the type of products we need to look at and figure out what we can do in the time we have left."
In written testimony provided the subcommittee, Hubbard continued to take the position that the medical device problem is not as serious as many have claimed.
Hubbard said the FDA "believes that the information received to date confirmed our original expectation that the year 2000 problems with medical devices will not be significant or widespread if facilities take appropriate actions to address this issue."
He added that "there will be specific problems that need correction; however, the current assessment is that they are much more likely to disrupt patient care rather than be of direct danger to patients."
Last week, the FDA also placed on its web site a new guidance documented titled "MDR Reporting Guidance for Date-Related Problems, Including Y2K." While outlining the guidelines for reporting "date-related medical problems," it outlines certain exemptions for "recurring date events."
The full document is available at www.fda.gov/cdrh/manualremedial.html.
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