U.S. Food and Drug Administration
FDA Consumer magazine
November-December 1999
Table
of Contents
by Carol Lewis
The millennium "bug": you can't catch it, but if you're a patient or are caring for one, you may be wondering if it could affect medical products such as drugs or devices. The good news is, it appears that all industries regulated by the Food and Drug Administration--drugs, medical devices, blood products, foods, and veterinary medicines--are well prepared for the turn of the century.
Also known as the Year 2000 problem or, more commonly, the Y2K computer glitch, the "bug" is the potential inability of some computerized systems and software applications to correctly recognize or process dates after 1999. The roots of the Y2K problem began years ago in early computer programming. To reduce memory requirements, programmers used two numbers for the year--for example, "63" would mean "1963." Without modifications, those programs might recognize "00" as "1900," rather than "2000," resulting in anything from inconvenience to a serious malfunction.
FDA's Responsibility
FDA first began addressing the Y2K issue in 1996. At that time, the agency took steps to ensure that its own computers would be ready for the transition to the year 2000 by checking mission-critical systems and correcting any problems. This past June, a third party completed a thorough independent process, which verified that those systems would properly function in the year 2000 and beyond.
While many manufacturers of FDA-regulated products depend on computers, computer chips, or software for their products to function or to enable production, very few products depend critically on date-related information to function properly. FDA's normal regulatory processes, which include comprehensive manufacturing standards for drugs and devices, help assure consumers that all products are safe and available.
For example, under these standards, manufacturers of drugs and devices are responsible for ensuring that their production processes function properly and for checking their computerized processes to be sure that they will not be disrupted by any Y2K problems. To date, there is every indication that manufacturers of medical products are well prepared for the millennium and that there will be an adequate supply of safe and effective medicines and devices available to American consumers.
In June 1997, FDA began alerting regulated industry to the potential for problems with computer-controlled, date-sensitive products through a series of letters, speeches, public appearances, meetings, workshops, and guidance documents. FDA advised manufacturers of their responsibilities to make corrections--either by fixing the problems, telling their customers not to use certain products, or providing information on how the products could be modified to avoid problems. In a further effort to alleviate any potential risks associated with Y2K problems, the agency provided specific recommendations to manufacturers regarding the steps necessary to identify and address Y2K issues, and requested they put back-up plans in place to ensure that business processes would continue uninterrupted.
At the same time, the agency asked manufacturers to submit product information on biomedical equipment to help FDA uncover potential Y2K problems before they became public health concerns. To give the general public, government agencies, and the health-care and research communities one comprehensive source of publicly available information on the Y2K compliance status of medical devices and scientific laboratory equipment, FDA established a year 2000 information page on its Website (www.fda.gov). A special Federal Year 2000 Biomedical Equipment Clearinghouse database also was established, in collaboration with the Department of Veterans Affairs, in January 1998, located at www.fda.gov/cdrh/yr2000/year2000.html.
"While we've received good information and cooperation from our regulated industries, we have taken the additional step of checking that information independently," says William K. Hubbard, FDA senior associate commissioner for Policy, Planning and Legislation. Hubbard, a senior official leading FDA's Y2K effort with regard to regulated industry, adds, "We have confirmed that our industries are well prepared for the turn of the year."
To continue to raise awareness about Y2K problems, FDA is conducting educational outreach through:
In addition, FDA has established an Emergency Operations Center to assist industry and interested individuals in preparing for Y2K.
Other organizations are supporting the agency's efforts as well. In February 1999, the American Hospital Association (AHA) conducted a national survey of over 2,000 hospitals on their Y2K readiness. Although one-third admitted they might not be completely compliant, they reported that systems directly related to patient care would be.
"Our outreach efforts will be even more critical now with those few at-risk hospitals that think they could potentially have problems in their operations," says Fred Brown, AHA chairman. Brown, who is also a member of the Senior Advisor's Group to the President's Council on Year 2000 Conversion, adds, "Hospitals will be prepared because it's an issue of patient safety." AHA continues to work with FDA to ensure that hospitals obtain the information they need to achieve total Y2K compliance.
Year 2000 and Medical Devices
The vast majority of medical devices sold in the United States will not be affected by the Y2K problem, according to Thomas B. Shope, Ph.D., special assistant to the director, Office of Science and Technology in FDA's Center for Devices and Radiological Health (CDRH), "because they are not computerized or do not use dates." Only about 2,000 of the nation's approximately 13,500 medical device manufacturers make products that are the type that might be controlled by a computer and could be sensitive to Y2K problems. These include radiation therapy treatment planning systems, hemodialysis machines, some clinical laboratory systems, and some ultrasound systems.
Although most devices are regulated by CDRH, FDA's Center for Biologics Evaluation and Research (CBER) regulates blood bank software. Blood bank software is used for many different tasks within a blood bank, such as tracking donors who are deferred from donating. In January 1998, CBER posted the industry guidance document "Year 2000 Date Change for Computer Systems and Software Applications Used in the Manufacture of Blood Products" on FDA's Website. The guidance provides specific recommendations to industry for evaluating the impact of Y2K on computer and software systems used in manufacturing blood products and for assisting in evaluating problems. FDA has been in contact with the manufacturers of blood bank software and has no information to suggest that these products will not function properly in the year 2000.
Technically fixing Y2K problems, according to Shope, is fairly straightforward. But the complexity of many systems and their dependent components often makes it tedious and time-consuming to implement. Most manufacturers have already identified solutions and provided upgrades for these types of devices and have notified their customers (hospitals and other health-care facilities) of their availability.
Shope suggests users of home devices that rely on personal computers for record keeping, such as certain sophisticated glucose monitors, contact the health-care provider who prescribed or recommended the device for information on the product's Y2K status. Consumers may also contact a device's manufacturer for additional information. Most personal computers built since late 1996 are Y2K compliant, but the Federal Trade Commission says it is important to verify this.
In the same June 1997 letter sent to thousands of medical device manufacturers reminding them of their responsibilities to assess their products, FDA also recommended specific actions to ensure the continued safety and effectiveness of these devices. For previously and currently manufactured medical devices, for example, manufacturers were advised to conduct hazard and safety analyses to determine whether device performance could be affected by the date change. For future medical device premarket submissions, manufacturers of devices whose safe operation could be affected were required to demonstrate that the products could perform date recording and computations properly.
Additionally, FDA initiated a study of the Y2K readiness of potentially high-risk medical devices such as the radiation treatment planning system. A number of manufacturers were asked to undergo voluntary assessment to check their procedures and records and to validate any Y2K corrections they made. While the study had not been completed at press time, all available data indicated that these manufacturers were diligently and successfully preparing for the turn of the year.
Impact of Y2K on Pharmaceutical Operations
Consumers may have questions about the effect Y2K will have on the availability of their prescription drugs. FDA has been working closely with the pharmaceutical industry to help ensure an adequate supply of medicines.
Specifically, the agency surveyed over 4,200 domestic and foreign prescription and over-the-counter drug manufacturers, bulk drug manufacturers, distributors, repackagers, and medical gas manufacturers, as well as 1,576 licensed biologics manufacturers and registered blood establishments. In its program, FDA has focused its efforts, both in surveying and auditing, on priority firms, which are defined as sole source, orphan, and top 200 prescribed drug manufacturers and licensed biologics manufacturers of vaccines, therapeutic products, allergenic products, viral marker test kits, and large blood organizations. Approximately 97 percent of the priority drug companies and 88 percent of the priority biologics companies have responded to the survey. The results of the survey show that over 90 percent of all priority companies will have completed all necessary steps to prepare for the year 2000 by Nov. 1, 1999. The audit results to date confirm the results of the survey, and the audit activities are continuing with the goal of auditing all priority firms. FDA has checked closely with firms reporting readiness dates late in the year and will take appropriate action to help ensure continued availability of their products.
The Pharmaceutical Research Manufacturers of America (PhRMA) also conducted a survey, which indicated that Y2K preparations were under way early and that companies would spend the rest of the year continuing to check and recheck internal systems and work with external business partners to further minimize the risk of a significant Y2K systems-related failure.
"We believe that the pharmaceutical industry has taken the steps necessary to ensure that a steady supply of medicine will continue to be available prior to and immediately after the start of year 2000," says Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research. "Consumers can be sure that FDA will continue to take any action necessary to help assure that their medications will be obtainable." And Woodcock adds, "Be prudent and sensible in preparing for the year 2000. Patients should maintain their normal five- to seven-day supply of medications and essential products."
The Availability of Safe Foods
Even though many of the food processes in the United States are in some way controlled by computers, the majority of food products will not be affected by the date change. The food industry has carefully looked at the equipment used to process foods and found that it does not necessarily rely on date-sensitive microchips to help ensure product safety. In those cases where date sensitivity is an issue, such as in the labeling of foods to indicate "sell by" or "use by" dates, the food industry has made, or is in the process of making, operations meet the Y2K requirements.
FDA held a roundtable discussion on the safety and availability of foods, which was attended by representatives of the national food trade organizations, who represent the vast majority of firms that manufacture, distribute and sell food in the United States. The meeting results echoed the Y2K readiness of the food industry in general. The industry also reported that over the years, its experience with food processing and distribution problems due to natural disasters has provided them with contingency plans applicable to potential but unexpected Y2K computer-based malfunctions.
"The food supply system typically includes a 60-day inventory," says John A. Koskinen, Assistant to the President and Chair, President's Council on Year 2000 Conversion.
The council created a Food Supply Working Group, led by the U.S. Department of Agriculture, to oversee those involved in producing and distributing the nation's food supply, and to raise awareness about potential Y2K problems and possible solutions.
FDA also looked at specific foods that have significant importance to a large segment of the population. For example, infant formula manufacturers voluntarily provided FDA with written summaries of their preparations for the millennium rollover. FDA review of this information concluded that the infant formula manufacturing industry has undertaken very specific assessment, renovation, and verification activities to minimize disruption and ensure the safety and availability of its products.
What the Data Are Telling Us
FDA believes that the information received to date confirms the agency's original expectation that Y2K problems with regulated products will not be significant or widespread because manufacturers have taken appropriate actions.
"Through the hard work of many involved in this effort, including those in the agency as well as in the private sector," says FDA Commissioner Jane E. Henney, M.D., "we hope to make January 2000 simply business as usual."
Carol Lewis is a staff writer for FDA Consumer.
FDA's Center for Drug Evaluation and Research recommends the following guidelines for users of prescription drugs to follow in refilling medications and preparing for pharmacy needs as the turn of the century approaches:
--C.L.
--C.L.
FDA has Y2K information for both industry and consumers on its Website. Go to www.fda.gov/oc/y2k/ or call the hot line at 1-888-INFO-FDA (1-888-463-6332) and select option one. Other Websites with information on Y2K issues relevant to health care and public health include:
Department of Health and Human Services
www.hhs.gov/y2k/ [Note (10/25/2002): This site no longer
functions.]
Federal Trade Commission
1-888-USA-4Y2K (1-888-872-4925)
U.S. Department of Agriculture
www.usda.gov/news/y2000.htm
Centers for Disease Control and Prevention
www.cdc.gov/y2k/y2khome.htm
[Note, May 2002: URLs for Y2k information
on this site no longer function.]
Health Care Financing Administration
www.hcfa.gov/facts/fs990727.htm [Note (12/11/2003): This
site no longer functions.]
Veterans Health Administration
www.va.gov/year2000/ [Note (12/11/2003): This site no longer
functions.]
President's Council on Year 2000 Conversion
www.y2k.gov [Note (2/10/2005): This site no longer functions.]
1-888-USA-4Y2K (1-888-872-4925)
Food Marketing Institute
www.fmi.org
(202) 452-8444
American Hospital Association
www.aha.org
Publication No. (FDA) 00-1307
Questions concerning the editorial content of FDA Consumer should be directed to FDA's Office of Public Affairs.
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