Year 2000 (Y2K) Update

Statement of

William K. Hubbard
Senior Associate Commissioner for Policy, Planning, and Legislation
Food and Drug Administration

before

the Subcommittee on Oversight and Investigations
House Committee on Veterans' Affairs

October 28, 1999

INTRODUCTION

Good morning, my name is William K. Hubbard. I am the Senior Associate Commissioner for Policy, Planning and Legislation, Food and Drug Administration (FDA or the Agency). I am pleased to be here today to provide an update on the Year 2000 (Y2K) date issue as it relates to medical devices, drugs and biologics. In April of this year, I appeared before the Committee and discussed with you the need for FDA to allay the fears of the American public whether life-sustaining medical devices will function as intended and whether there will be a sufficient supply of high priority pharmaceuticals due to Y2K issues. At that time, I told you that we were optimistic that the industries were taking the necessary steps to guard against Y2K breakdowns. Now that it is October and the year 2000 draws near, I am here today to tell you about FDA's efforts to validate our optimism.

FDA stepped up its efforts to gather more information on the Y2K readiness from industry through additional surveys and audits. This additional data provides FDA with a high degree of confidence in assuring the health care community and the American public that essential medical supplies will be available; and medical devices will function as intended; and that there will be a safe and adequate supply of drugs available. The Agency's efforts to obtain additional data and the high degree of confidence we have today is a tribute to the collaborative efforts among the Federal sector, healthcare community and industry. Let me summarize for you the Agency's efforts.

Y2K STATUS OF BIOMEDICAL DEVICES

FDA has taken a number of steps to enhance the confidence of the American public that medical devices will function as intended as the year 2000 approaches. For the past two years, FDA has continued to add to its knowledge of the Y2K status of medical devices and to make this information available to healthcare facilities. In developing this high level of confidence FDA has taken a number of constructive actions to work with manufacturers and provide information to users about the Y2K compliance of medical devices.

FDA's Y2K DATABASE

An important tool for obtaining information about biomedical equipment is FDA's Federal Year 2000 Biomedical Equipment Clearinghouse database. It is available via the World Wide Web at www.accessdata.fda.gov/scripts/cdrh/year2000/cdrh/yr2000/help/y2k-search-helpme.html. While the database has proven to be useful to healthcare facilities, professionals and consumers -- receiving over 236,691 "hits" from 197,461 users over a period of 17 months -- FDA has continued to collect information from medical device manufacturers. FDA believes that approximately 2,300 of the 16,000 biomedical equipment manufacturers could produce equipment that could be affected by the Y2K problem. The vast majority of these 2,300 manufacturers have responded to FDA's requests for Y2K status information, and every effort is being made to locate the remaining companies.

SURVEYS AND ASSESSMENTS

To bolster public confidence in industry's efforts to identify and resolve Y2K problems and to assure a continued supply of needed pharmaceuticals, biologics and essential medical supplies, FDA conducted a voluntary survey of manufacturers of drugs, biologics and consumable medical devices for Y2K readiness. These surveys assessed manufacturers' preparations and plans to continue operations after January 1, 2000. FDA then audited the survey results for a sample of the firms, as well as a high proportion of high priority firms to confirm the survey reports. These surveys indicate that the regulated industries have devoted considerable efforts to Y2K preparations and we do not expect significant interruptions of necessary supplies.

POTENTIALLY HIGH RISK DEVICES (PHRDs)

Although FDA firmly believes that its normal regulatory processes provide the necessary assurances that Y2K problems with high-risk devices will be carefully addressed, FDA implemented a plan to provide additional assurance to the public and healthcare facilities about the Y2K status of medical devices. FDA addressed concerns about the adequacy of the medical device industry's actions taken to avoid serious Y2K problems by independently validating their Y2K self-assessments.

FDA developed and posted on the FDA Y2K website a list of types of potentially high risk devices (PHRDs) that are likely to be computer-controlled and that could present a significant risk of immediate harm to the patient should the devices fail to operate as expected due to a Y2K problem. The PHRDs list contains 90 types of potentially high-risk devices for which FDA has identified 803 PHRDs manufacturers. An FDA contractor contacted these 803 firms and learned that approximately 60 percent have no computerized devices.

FDA initiated a special study designated as a "Special Year 2000 Data Gathering Request" to examine the Y2K programs of a random sample of potentially high-risk device (PHRD) manufacturers. Eighty of the PHRDs manufacturers were randomly selected for an on-site assessment by an FDA contractor with extensive experience in information technology and Y2K verification and validation. The study was designed to:

• provide a high level of assurance that manufacturers have properly assessed the Y2K status of their computer-controlled medical devices;
• examine manufacturers' processes to evaluate how they assess the Y2K status of their products;
• verify that the manufacturers have developed and properly validated appropriate upgrades to correct any Y2K problems for these devices; and,
• confirm the information provided by manufacturers for the Federal Year 2000 Biomedical Equipment Clearinghouse database by examining the supporting documentation of the manufacturers.

RESULTS OF PHRDs ASSESSMENTS

As of October 15, 1999, the contractor has completed all 80 on-site reviews of records to assess the existence and adequacy of manufacturers processes and procedures implemented under a quality system. The assessments are intended to assure that potentially vulnerable devices have been adequately assessed and that upgrades are correctly implemented and appropriately tested and evaluated by the manufacturer. As part of this process, FDA is evaluating the reports as they are completed and to date has found no serious problems related to Y2K. The contractor will provide FDA with a final report of the assessments in early November. FDA will review the contractor's report and will issue a summary report in early November. FDA is confident that the evaluation of these manufacturers will demonstrate the thoroughness with which manufacturers have assessed and provided information and corrections for non-compliant products.

Now that manufacturers should have completed their assessments of Y2K compliance status and identified non-compliant devices, FDA will review this information to identify any manufacturers of PHRDs for which information is not available, or whose non-compliant products pose an actual significant risk to patient health. For firms that have declined to voluntarily participate in the PHRDs assessments, if these firms have not been inspected recently by FDA, the Agency will consider by the middle of November whether an FDA inspection of the firm should be conducted, based on the possible level of risk that the product may present. In these situations, FDA will review the steps taken by the manufacturers to notify users regarding any problems that might exist and to assure that appropriate corrections are implemented.

In any case where the action by the manufacturer has been inadequate to assure patient safety, FDA will use its statutory authorities to require corrections and publicize the situations. FDA is prepared to take action which would include public advisories to device users, suggestions to manufacturers regarding voluntary recalls, mandatory recalls or seizure of the non-compliant devices in extreme risk situations. FDA expects, however, that the situations where such actions will be required will be rare as there are many incentives in addition to possible FDA regulatory action which lead manufacturers to address any such potentially high risk situations before FDA regulatory action is needed.

PHARMACEUTICAL INDUSTRY AND Y2K COMPLIANCE

FDA also has been examining the intersection of Y2K risk mitigation and the availability and quality of certain prescription drugs. In fact, government agencies and organizations within the pharmaceutical industry supply system (including manufacturers, distributors, pharmacies, hospitals, physicians, pharmacists, insurers and others) have been working closely together to prepare for the year 2000 date change and its potential impact on the supply of pharmaceuticals.

In an effort to obtain additional data on this issue, on April 21, 1999, the FDA Commissioner, Dr. Jane E. Henney, sent a letter to the Presidents and CEOs of approximately 4,228 pharmaceutical manufacturers, which includes prescription, over-the-counter, and bulk drug manufacturers; distributors-repackagers; and, medical gas manufacturers. The letter requested their assistance in assuring FDA and the American public that their firms have addressed the Y2K problem as it affects the adequate supply of safe and effective drugs. Included with the letter was a "Y2K Assessment Survey" concerning the status of actions pharmaceutical firms have taken to address this issue and assess Y2K readiness within the pharmaceutical industry. The focus of this effort is on prescription products with emphasis on the priority firms (sole source, orphan and the top 200 prescribed products).

Survey of Pharmaceutical Manufacturers

As of October 8, 1999, 3,132 or 74.1 percent responded to the survey, including 1,053 of the 1,070 or 98 percent of the prescription drug manufacturers that were surveyed. Of the approximately 274 priority manufacturers (160 - excluding subsidiaries) which includes sole source, orphan and top 200 prescribed, 270 or 99 percent have responded. Of the firms that completed the survey, 95 percent state they will be ready for Y2K by the end of October with both the foreign and domestic firms having a similar pattern of Y2K readiness. Priority companies who indicated a later date are being contacted to determine their Y2K readiness and to make sure they are on track for meeting their goals. FDA is committed to maximizing the response rate particularly from the 274 priority manufacturers.

Pharmaceutical Audits

Many have urged that FDA take additional actions beyond the survey program that will provide independent assurance of the adequacy of manufacturers' Y2K assessments and any resulting Y2K corrections. As a result, FDA decided to have a contractor, with extensive experience in information technology and Y2K verification and validation, audit each of the 160 highest priority pharmaceutical firms, as well as a random sampling of other drug manufacturers. The surveys, by the contractor via telephone or on-site interview, were begun on July 19, 1999.

As of October 8, 1999, 88 percent of the assessments have been completed. It is important to note that to date the audit results have confirmed the findings of the survey. These results provide the basis for a clear message to reassure the American public that prescription drugs will continue to be available.

FDA and the pharmaceutical industry will continue to monitor the Y2K status and availability of pharmaceutical supplies. FDA has processes in place to address product availability and has used these procedures to help get necessary products to patients. FDA will continue to work with the health professional community, industry and patient groups regarding Y2K readiness and product availability.

BIOLOGICS INDUSTRY AND Y2K COMPLIANCE

Another section of the pharmaceutical industry produces biological drugs as well as vaccines and blood products. We took the same survey/audit approach with these manufacturers as well.

Survey of Biologics Manufacturers for Y2K Manufacturing Processes

On June 30, 1999, a survey was mailed to 1,576 licensed biologics manufacturers and registered blood establishments. Letters to the biologics trade organizations requesting their assistance in encouraging participation in the survey effort were sent on June 30, 1999. Of the responses that have been received, 92 percent report that they will be Y2K ready by the end of October.

As of October 15, 1999, we have received responses from 1,483 or 94 percent of the firms. Highest priority has been placed on 110 priority firms, which include licensed manufacturers of vaccines, therapeutics, allergenic products, viral marker test kits and major blood organizations. As of October 15, 1999, 101 or 90 percent of the high priority firms have responded.

Biologics Audits

Telephone/site visit audits of these 110 high priority firms began in late August and as of October 14, 1999, audits have been completed for 83 or 75 percent of the high priority firms. To date, we have no reports of problems regarding firms that have been audited. We also have begun audits of a random sample of the firms that are not in the high priority group. As of October 14, 1999, we have completed audits of 48 of these firms with no problems identified.

CONSUMABLE MEDICAL SUPPLY INDUSTRY AND Y2K COMPLIANCE

Survey of Manufacturers of Consumable Medical Supplies for Y2K Manufacturing and Distribution Processes

On June 18, 1999, surveys were mailed to 3,070 consumable medical supplies manufacturers (approximately 2,000 domestic, 1,000 foreign). The focus of the survey is on those manufacturers that produce essential medical devices that are used and consumed on a recurring basis during the delivery of essential healthcare services and whose availability is critical to the uninterrupted delivery of health care and patient welfare. The survey requests information on mission critical automated manufacturing and distribution systems rather than Y2K status information on specific products. A follow-up letter was sent to non-respondents on July 23, 1999. As of October 14, 1999, 2,074 responses and/or returned mail have been received with approximately 90 percent of the fully analyzed responses (1309) reporting Y2K readiness by October 31.

Consumable Medical Supplies Audits

For a sample of survey respondents, validation of survey responses by the contractor via telephone or on-site interview is being conducted. Highest priority for these assessments will be the 225 manufacturers that produce a device only manufactured by 3 or fewer firms, so called "few sources" devices, and the 57 manufacturers that are the sole source for a supply (the 57 manufacturers are included in the 225). Of the 225 "few sources" firms, 197 have responded, and of the 57 sole source firms, 48 have responded. Attention also will be focused on those manufacturers with inconsistent responses. As of October 14, 1999, approximately 58 percent of the assessments of the priority firms have been completed with no serious problems reported. Eighty-nine percent report that they will be Y2K ready by the end of November. It is important to note that the initial audit results confirm the survey results. We will continue to follow-up with those manufacturers that are not Y2K ready and whose supplies, if not available, could have a significant impact on health care delivery.

RECENT AGENCY WIDE OUTREACH EFFORTS

The FDA website, including the Federal Y2K Biomedical Equipment Clearinghouse database, provides much of the information needed by healthcare providers and consumers regarding Y2K and FDA-regulated products. For answers to questions that can not be found on the Y2K website, FDA recently established a Y2K telephone hotline which can be reached by calling FDA's main information line toll-free at 1-888-INFO-FDA or using the Y2K e-mail form on the FDA Y2K website.

FDA also has developed an extensive outreach initiative that will provide video and audio news releases, brochures and articles designed to address the concerns of the consumer and the healthcare community regarding Y2K issues. Additional FDA outreach efforts are noted in the Appendix.

CONCLUSION

In summary, Mr. Chairman, there is now extrinsic and objective evidence that drug and device manufacturers have taken the necessary steps to ensure that their products and production facilities are ready for Year 2000 conversion. Indeed, I believe that manufacturers, wholesalers, and retailers of these products should be commended for taking this issue seriously and for devoting the necessary resources to protect their customers and, ultimately, patients from Y2K related failures. For those few firms that have not taken these steps, FDA will be vigilant in following up on any reports.

FDA will continue to work with other Federal agencies, patient groups, healthcare provider associations and industry to optimize data collection and information sharing. Together we can provide the American public with the needed assurances that manufacturers will be Y2K ready. We all share a common goal of having medical devices that will function as intended and a safe and adequate drug supply available for the American public as we continue through the year-end transition.

Thank you for the opportunity to testify.

APPENDIX

Letters to Medical Device Industry

1997

• June 25, 1997, notice to all medical device manufacturers (8,322 domestic and 5,085 foreign) registered with FDA's Center for Devices and Radiological Health (CDRH) indicating that they needed to address this issue and review both embedded and non-embedded software products.

1998

• January 21, 1998, letter which was sent by DHHS to approximately 16,000 medical device and biomedical equipment manufacturers to ask them to voluntarily provide information on the Year 2000 compliance status of their products.
• June 29, 1998, targeted, follow-up letter to specific manufacturers of potentially vulnerable computerized devices.
• September 2, 1998, follow-up to the June 29, 1998, letter directed to the manufacturers of potentially computerized devices who had not responded to the previous requests.
• August 14, 1998 and September 2, 1998, letters from Dr. Bruce Burlington, then Director, CDRH, and Dr. Friedman, then Acting Commissioner of the Food and Drug Administration, to the Health Industry Manufacturers Association (HIMA) requesting that the Association take aggressive and immediate actions to encourage and assist medical device equipment manufacturers in providing information to FDA.
• Late September 1998, FDA posted on the website those manufacturers of selected product categories that are likely to include vulnerable products that had not provided a response to FDA's inquiries.

1999

• March 3, 1999, letter requesting that the 2,300 targeted biomedical equipment manufacturers carefully review the Year 2000 status information that they have provided or intended to submit, and, where necessary, provide more specific information on non-compliant products.
• March 29, 1999, letter requesting that targeted medical device manufacturers submit a complete list of individual product models that are Year 2000 compliant. Responses from 572 manufacturers have been received as of June 1, 1999.
• July 16, 1999, Public Health Notification regarding date-related computer controlled medical devices to administrators, risk managers and biomedical/clinical engineers of 67,000 hospitals and healthcare facilities. The notification urged them to develop contingency and remediation plans to avoid serious adverse events; provided information to assist them in contingency planning; provided information about the Federal Y2K Biomedical Equipment Clearinghouse website; and, encouraged them to report problems or adverse events associated with Y2K and computer-controlled devices to FDA's MedWatch Program.

Additional Outreach and Guidance

In an effort to reach the widest group of individuals, both to get information and to spread information, CDRH also has been conducting extensive outreach to the device industry and to other consumers on this issue. These efforts are as follows:

• CDRH's Division of Small Manufacturers Assistance provided an article in May 1998 entitled "Biomedical Equipment Manufacturers Urged to Share Year 2000 Information" to 12 medical device trade press contacts and to 65 U.S. and 35 foreign medical device trade associations in order to facilitate the dissemination of information to their members regarding the website database and to encourage the posting of data by manufacturers.

  The website and database were mentioned in the FDA Column of the June 3, 1998, Journal of the American Medical Association and in an article in FDA's Medical Bulletin that was sent to approximately 700,000 healthcare practitioners this past summer.

• In the spring of 1998, CDRH developed a Guidance Document on FDA's expectations of medical device manufacturers concerning the Year 2000 date problem. The guidance is available on the FDA website.
• FDA also developed an article addressed to the users of radiation treatment planning systems regarding the need to assess these systems. The article was published in the newsletters of relevant professional associations.
• Staff of CDRH have participated in numerous conferences and video teleconferences devoted to the Year 2000 problem in healthcare in order to communicate with healthcare facilities regarding the Biomedical Equipment Clearinghouse and the need to address the Year 2000 issue with devices.
• March 29, 1999, memorandum issued by the Director, Division of Emergency and Investigational Operations, Office of Regulatory Affairs (ORA), to the FDA field instructing investigators to expand the Year 2000 activities to include asking questions regarding what the firm has done to assure that the computer controlled and date-sensitive products, manufacturing processes and distribution systems are Year 2000 compliant.
• On May 17, 1999, the President's Council on Year 2000 Conversion in conjunction with the Veterans Health Administration hosted a Roundtable event. The discussion focused on those services and supply chains that are critical to the health and well-being of all Americans, and in particular the ready availability of pharmaceuticals from their manufacture to the filling of prescriptions at the drug store. The consensus of those present at the Roundtable (the brand name and generic drug manufacturers, wholesalers, and health care providers, payers, along with consumer advocates and government regulators) is that allowing patients to obtain a substantial advance (buying or stockpiling) is not necessary and may actually cause the shortage that this kind of action is trying to prevent. FDA continues to work with the pharmaceutical industry, associations, and other Federal agencies to assure a safe and adequate pharmaceutical supply.
• In a letter to providers, Health Care Financing Administration (HCFA) noted the FDA website for providers to obtain information on medical devices and Y2K compliance status information.
• FDA has participated in 18 national and regional HCFA conferences and three National Association of Rural Health Clinics regional conferences which included discussions of FDA's Y2K activities, status of the Federal Y2K Biomedical Equipment Clearinghouse, pharmaceutical supply issues and future Agency activities.
• On April 16, 1999, a Guidance for Industry and the Clinical Community on "Medical Device Reporting for Date-Related Problems Including Y2K."
• On June 7, 1999, FDA participated in a President's Council on Year 2000 Conversion Roundtable event on medical supplies.
• On August 18, 1999, FDA staff participated in a Health Resources and Services Administration (HRSA) teleconference entitled "Making Your Health Facility Y2K Compliant" directed to HRSA funded rural health clinics.
• On August 24, 1999, FDA issued a Talk Paper entitled "The Year 2000 Date Problem and Medical Devices."

Although most devices are regulated by CDRH, FDA's Center for Biologics Evaluation and Research (CBER) regulates blood bank software, which is of particular concern for potential Year 2000 problems. In January 1998, CBER posted guidance for industry entitled "A Year 2000 Date Change for Computer Systems and Software Applications Used in the Manufacture of Blood Products" on the FDA website. The guidance provided specific recommendations to assist industry in its evaluation of computer and software systems used in the manufacture of blood products and to assist in evaluating the impact of potential Year 2000 problems. CBER is aware of the status of these individual products and believes that the blood bank software will be Y2K compliant or will have a "patch" or "work-around" for the systems to ensure that the systems will work through Year 2000.