For the past year, federal authorities have expressed concern about slow progress by medical device manufacturers in reporting the Year 2000 compliance of their products. In September 1998 testimony to Congress, for example, the General Accounting Office's expert on Year 2000 issues warned that the Food and Drug Administration has made "limited progress" in determining the "compliance status of biomedical equipment."
The FDA has advised manufacturers that "[u]nder the Quality Systems Regulation, device manufacturers must evaluate their entire line of medical equipment and software, not just currently produced or supported products, to identify and assess problems that could result from inaccurate date representation." (CRDH, Guidance for Industry (May 15, 1998)). Both the FDA and the Department of Health and Human Services have issued letters to medical equipment manufacturers discussing legal responsibilities and requesting information about the Year 2000 compliance of medical devices.
The FDA has established a website for the posting of information about Year 2000 compliance by medical devices. On January 13, 1999, the FDA wrote biomedical equipment manufacturers requesting "more detailed identification of non-compliant products" as well as "compliant product information." The FDA is also posting information on the website concerning companies for which "no Y2K status information is available."
On December 29, 1998, the FDA issued an "FDA Medical Device Malfunction Advisory." This advisory warned hospitals, emergency medical services and health care practitioners that FDA had commenced investigations of alleged computer date problems in fifteen medical devices. The FDA indicated that computer date problems had been verified in two devices, a defibrillator and a patient monitor, and that more than forty thousand of these products had been sold. The FDA indicated that the computer date problems would not "present an immediate risk to the patient," but did "present a potential for confusion and incorrect records."
Regulators will continue to seek disclosure of Year 2000 compliance information about medical devices this year. Companies not able to certify their Year 2000 compliance status will be barred from selling products to U.S. governmental agencies and could have their products classified as "adulterated" and, thus, subject to FDA seizure or injunction. Moreover, companies that fail to provide accurate notice to purchasers regarding potential Year 2000 problems, may significantly increase their potential legal exposure if any patients are injured as a result of noncompliant products.
Pharmaceutical and biologics companies face different types of Year 2000 problems in that computers control the manufacturing, quality control testing equipment, environmental monitoring and temperature/air control equipment in production facilities. These companies, like device manufacturers, must have documentation in their Good Manufacturing Practice (GMP) files indicating that all such computers have been inspected and certified as Year 2000 compliant. The FDA Center for Biologic Evaluation and Research (CBER) has issued guidance to blood banks on Year 2000 compliance. This CBER guidance is instructive for all life science product manufacturers as to FDA's policies and the type of GMP documentation required.
Increasingly, FDA inspections of drug, device and biologic manufacturers include an assessment by the FDA inspectors as to whether a plan exists for achieving Year 2000 compliance, and how the company is progressing in its Year 2000 compliance efforts. Failure to have a plan and/or to make reasonable progress in its implementation will be characterized as a GMP violation. Biomedical product and scientific equipment companies must devote sufficient resources to address Year 2000 issues.
Life science companies, like all companies with potential Year 2000 issues, must also carefully consider the provisions of the Year 2000 Information and Readiness Disclosure Act signed into law on October 19, 1998. This Act strengthens the legal protections available to companies that exchange information about Year 2000 readiness, disclose information about product compliance, or establish websites to provide public notice of this information. Because the Act also contains significant ambiguities, limitations and disclosure requirements, however, life science companies should obtain a clear understanding of the Act's provisions in order to maximize its application to public statements and disclosures about Year 2000 compliance.