INTRODUCTION
Good morning, my name is William Hubbard. I am the Acting
Deputy Commissioner for
Policy, Food and Drug Administration (FDA or the Agency). I am pleased to be here today to
provide information on the Year 2000 date issue as it relates to medical devices and
pharmaceuticals. FDA has taken a number of constructive actions to work with manufacturers
and provide information to users about medical device Year 2000 compliance.
FDA promotes and protects public health by helping to ensure that medical devices are
safe and effective. The Center for Devices and Radiological Health (CDRH) is the component
of FDA that has responsibility for regulating medical devices. CDRH helps carry out the
Agencys mission by evaluating new products to determine if they can be marketed;
assuring quality control in manufacture through inspection and compliance activities;
monitoring adverse events in already marketed products; and taking action, when necessary,
to prevent injury or death. A device manufacturer must comply with all applicable
requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act, including, but not
limited to, establishment registration and device listing, premarket review, use of good
manufacturing practices, and reporting adverse events.
WHAT IS A MEDICAL DEVICE?
According to the definition in the FD&C Act, a "device" is:
an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent,
or other similar or related article, including any component, part or accessory, which is
intended for use in the diagnosis of disease or other conditions, or in the cure,
mitigation, treatment, or prevention of disease, in man or other animals, or intended to
affect the structure or any function of the body and which does not achieve its primary
intended purposes through chemical action and which is not dependent upon being
metabolized for the achievement of its primary intended purposes.
As this definition suggests, many different types of products are properly regulated as
medical devices. Medical devices include over 100,000 products in more than 1,700
categories. The products regulated by FDA as medical devices range from simple everyday
articles, such as thermometers, tongue depressors, and heating pads, to the more complex
devices, such as pacemakers, intrauterine devices, diagnostic imaging devices, and kidney
dialysis machines.
Any computer software which meets the legal definition of a medical device is within
the scope of the law and must comply with applicable FDA regulations. Medical devices
which use computers or software can take several forms including: products containing
embedded microchips which are part, or components, of the devices; devices employing
non-embedded software which is used with, or to control, the devices or to record data
from the devices; or individual software programs that use or process patient data to
reach a diagnosis, aid in therapy, or track donors and products.
A. Embedded Computer Software
Computer software frequently is embedded as a "component" of devices, i.e.,
software contained on a microchip to control device operation. Examples of such common,
important devices are pacemakers, infusion pumps and ventilators. The majority of these
products will not be affected by the Year 2000 problem since almost none of them require
knowledge of the current date to operate safely and effectively. For example, pacemakers do
not use the current date in their operation.
B. Non-embedded Computer Software
Non-embedded software is intended to be operated on a separate computer, often a
personal computer or work station. Such software devices may be used to control or enhance
the operation of another device or devices and, further, may use the two-digit year
format. It is possible that non-embedded software devices may rely on date information for
proper operation and might be affected by the Year 2000 date change if not designed
appropriately.
An example of non-embedded software is a computer program used to plan radiation
therapy treatments delivered using radioactive isotopes as the radiation source
(teletherapy or brachytherapy). These treatments possibly could be affected if the
computer program that calculates the radiation dose parameters uses only a two-digit year
representation. The calculation of the length of time since the source was last calibrated
could be in error and thus lead to an incorrect treatment prescription.
Other examples of uses of non-embedded software devices include: conversion of
pacemaker telemetry data; conversion, transmission, or storage of medical images;
automated analysis and interpretation of ECG data; programming or control of rate response
for a cardiac pacemaker; perfusion calculations for cardiopulmonary bypass; and
calculation of bone fracture risk from bone densitometry data. Since there is a chance
that the two-digit format may affect the performance of these software devices, FDA
believes that the Year 2000 risk requires that healthcare facilities take steps to
identify and mitigate such problems through proactively working with manufacturers.
FDA EFFORTS TO ADDRESS YEAR 2000 ISSUE
Year 2000 Database
In order to give the general public, government agencies, and the healthcare and
research communities one comprehensive source of publicly available information on the
Year 2000 compliance status of biomedical equipment, the Federal Year 2000 Biomedical
Equipment ClearingHouse database was established in March 1998 and is available to
facilities via the World Wide Web. The Biomedical Equipment ClearingHouse provides Year
2000 product status information in five categories including: products that are Year 2000
compliant; products that do not use a date; products that have a date related problem;
products whose status is provided on the manufacturers website; and identification
of manufacturers for
whom no information is available (nonrespondents to FDA requests).
The Biomedical Equipment ClearingHouse database is being maintained by FDA on its World
Wide Web site at the request of the Interagency Biomedical Equipment Working Group. This
Working Group was organized early in 1997 under the Subcommittee on the Year 2000 of the
Chief Information Officers Councils. The database can be found on the Internet at: www.fda.gov/cdrh/yr2000/. Manufacturers
also may submit a World Wide Web link to their own website, if they so choose, where the
requested information is provided to the public.
FDA and the Department of Veterans Affairs (DVA) have worked in partnership to develop
a single data clearingHouse for biomedical equipment Year 2000 status information. DVA, as
a purchaser of medical devices, collected information from its vendors as to the
compliance status of the medical devices used in its facilities. This data, along with
data from the Department of Defense, has been provided to FDA and following confirmation
by FDA, has been added to the clearingHouse database. Both FDA and DVA are working with
private sector associates, mostly professional associations and organizations such as the
American Medical Association, the American Hospital Association, the Joint Commission on
Accreditation of Healthcare Organizations, the Health Industry Manufacturers Association
(HIMA), the Medical Device Manufacturers Association (MDMA), and the National Electrical
Manufacturers Association (NEMA) that provide advice and assistance as requested.
RECENT LETTERS TO MANUFACTURES
A. March 29, 1999 Letter on Year 2000 Compliant Products
Biomedical equipment users have expressed the need for specific information on all Year
2000 vulnerable products that are compliant and have urged the establishment of a single,
comprehensive source for this information. On March 29, 1999, FDA issued a letter
requesting that medical device manufacturers submit a complete list of individual product
models that are Year 2000 compliant to the FDA-operated Federal Year 2000 Biomedical
Equipment ClearingHouse. Many biomedical equipment users have told FDA that a single
statement that all of a manufacturers products are Year 2000 compliant does not meet
their need to have affirmatively identified specific compliant equipment. Once information
on compliant products is received from medical device manufacturers it will be made
available, with improved search tools, as part of the Biomedical Equipment ClearingHouse.
This database of Year 2000 compliant products is intended to provide information on
products that biomedical equipment users might consider to be vulnerable to date-related
problems because these products could utilize software, a computer or microprocessor
control. Accurate Year 2000 status information on these products is critical to these
users as they evaluate their product inventory and plan any needed remedial actions.
B. March 29, 1999 Letter on Interim Inspectional Policy
Regarding Y2K Issues.
On March 29, 1999, the Director, Division of Emergency and Investigational Operations,
Office of Regulatory Affairs (ORA), issued a memorandum to the FDA field instructing
investigators to raise the awareness of potential Year 2000 problems to firms during FDA
inspections. In this letter, ORA expanded the Year 2000 activities to include asking
questions regarding what the firm has done to assure themselves that their computer
controlled/date sensitive products, manufacturing processes and distribution systems are
Year 2000 compliant, and to include information on this subject in their Establishment
Inspection Reports when relevant. In addition, if the investigators encounter serious
problems or concerns, or find the firm is not taking appropriate steps to avoid serious
Year 2000 problems, this information must be reported to appropriate District and Center
personnel.
C. January 13 and March 3, 1999 Letters on Non-Compliant
Products
On January 13, 1999, FDA issued a letter to device manufacturers announcing FDAs
intent to expand the product information maintained on the FDA-operated Federal Year 2000
Biomedical Equipment ClearingHouse and requested the continued cooperation of biomedical
equipment manufacturers in this effort. The letter requesting this information was issued
on March 3, 1999. In this letter FDA indicated that in some of the manufacturer responses
to the earlier requests the information on the FDA website was not sufficiently detailed
to adequately assist facilities in assessing the impact of non-compliant products. FDA
requested that 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.
Previous Letters to Manufacturers
A. June 25, 1997 Notification to Manufacturers
In light of the review of the impact of the Year 2000 on some medical device computer
systems and software applications, FDA has been actively alerting the medical device
industry through a series of letters to medical device manufacturers for approximately two
years. The first alert letter was sent on June 5, 1997, to all CDRH registered
medical device manufacturers (8,322 domestic and 5,085 foreign) indicating that
manufacturers needed to address this issue and review both embedded and non-embedded
software products. FDA reminded manufacturers that, in addition to potentially affecting
the functioning of some devices, the two-digit year format also could affect
computer-controlled design, production, or quality control processes. FDA requested that
manufacturers review the software used in medical devices to determine if there is any
risk.
Device manufacturers who identify products that have a date-related problem are
required to take appropriate action to remedy the problem. An example of appropriate
action in some instances would be notification to device purchasers so that their devices
can be appropriately modified before the year 2000.
B. January 21, 1998 Request for Information
In a letter dated January 21, 1998, Department of Health and Human Services (DHHS)
Deputy Secretary Kevin Thurm asked approximately 16,000 medical device and biomedical
equipment manufacturers to voluntarily provide information on the Year 2000 compliance
status of their products. Included in the mailing were all FDA registered manufacturers
without respect to the specific kind of device produced, even though FDA estimates that
only approximately 2,000 manufacturers make products listed in the categories which
include computerized products potentially sensitive to Year 2000 problems. Approximately
3,000 of the manufacturers included in the mailing are not regulated by FDA; for example,
scientific instrument manufacturers. The letter detailed instructions on ways to submit
the data requested and explained that to be Year 2000 compliant products must function as
intended regardless of the date. Manufacturers also were given the opportunity to certify
that their products are not affected, if that is the case, or certify that none of their
products use computers or date information.
C. Targeted Follow-up with Manufacturers of Computerized
Devices
On June 29, 1998, FDA issued a targeted, follow-up letter to specific manufacturers of
computerized devices urging them to respond to our January 21 request to submit product
data. This list was derived from the names of those firms which have registered as
manufacturers of devices in the categories where Year 2000 vulnerability is likely.
Then on September 2, 1998, FDA issued a follow-up to the June 29, 1998 letter, directed to the manufacturers of potentially computerized devices
who had not responded to the previous requests to specific manufacturers for information
on the Year 2000 status of their devices. In the letter, FDA requested that the
manufacturers respond to FDA within two weeks with the Year 2000 compliance status of
their devices, or at least indicate that a complete response was being developed.
On August 14, 1998, Dr. Bruce Burlington, then Director, CDRH, and on September 2,
1998, Dr. Friedman, then Acting
Commissioner of the Food and Drug Administration, issued
letters to HIMA requesting that HIMA take aggressive and immediate actions to encourage
and assist medical device equipment manufacturers in providing information to FDA about
the Year 2000 compliance status of their products.
In late September 1998, FDA decided that it would be useful to provide an indication of
whether a particular manufacturer of computerized devices potentially susceptible to Year
2000 concerns has or has not provided information on Year 2000 compliance. To that end,
FDA posted on the website those manufacturers of selected product categories which are
likely to include vulnerable products that had not provided a response to FDAs
inquiries. FDA will continue to work with manufacturers to obtain this data and report to
Congress on the status of these Year 2000 requests.
ADDITIONAL OUTREACH AND GUIDANCE
In addition to the website and the letters, CDRH has been conducting extensive outreach
to the device industry and to other consumers on this issue. CDRHs Division of Small
Manufacturers Assistance provided an article 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 FDAs 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 FDAs expectations of
medical device manufacturers concerning the Year 2000 date problem. The guidance is
available on the FDA website. The guidance was published in the Federal Register on
June 24 for greater dissemination. The guidance re-emphasizes the provisions in existing
regulations that require manufacturers to address any date problems which may present a
significant risk to public health.
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.
Although most devices are regulated by CDRH, FDAs 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
"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.
PHARMACEUTICAL INDUSTRY
In order to raise the awareness of the pharmaceutical industry to the Year 2000 issue,
Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research, sent a letter
dated October 14, 1998, to trade organizations requesting assistance in relaying
FDAs expectations regarding the Year 2000 problem as it affects the pharmaceutical
industry. FDA believes that the potential impact of the Year 2000 on pharmaceutical
safety, efficacy, and availability merits special attention. The Year 2000 issue can cause
a variety of problems in how dates are expressed or computed that could adversely affect
automated drug process controls. Of special concern are manufacturing processes, which if
disrupted by Year 2000 issues could result in shortages of needed pharmaceuticals.
On February 22, 1999, FDA participated in "Y2K Preparedness Pharmaceuticals
and Biotech A Joint Government/Industry Forum." The objective of this meeting
was to raise awareness and help further preparedness for successfully managing Year 2000
related issues. The pharmaceutical industry is expected to address the problem as a high
priority, to thoroughly assess and test their computer systems and develop appropriate
contingency plans. FDA also has been meeting with trade organizations and associations to
further communicate the Agencys expectations regarding the industrys Year 2000
efforts.
In addition, the Agency also has been meeting internally to discuss additional
potential initiatives to assess the industrys Year 2000 compliance status to avoid
disruptions in the drug supply. These internal discussions have focused on how to address
the compliance of manufacturers of single-source and foreign bulk product suppliers, and
also possible collection of data to assess Year 2000 readiness and contingency plans. Also
discussed have been communication initiatives to inform the public, healthcare providers,
associations, etc., that there will be a safe and adequate supply of drugs as we enter the
year 2000.
Once our internal deliberations are concluded, we will be happy to provide the
Committee with specific details.
WHAT IS THE DATA TELLING US THUS FAR?
As indicated above, FDA believes that approximately 2,000 manufacturers may produce
equipment that may be affected by the Year 2000 problem. As of March 30, 1999, FDA has
entered a total of 4,305 responses from the 16,000 manufacturers originally contacted. The
data from all of these manufacturers who have responded have been entered into the
database on the FDA website. These numbers change daily as data are entered, corrected or
even removed at the request of manufacturers. Of the 4,305 manufacturers who have
responded, 3,153 have reported that their products do not use date-related data or are
compliant. Six hundred seventy-three manufacturers have reported one or more products with
date-related problems. Four hundred manufacturers have provided World Wide Web links
(URLs) to data provided on their own manufacturer-operated websites. There are a few
submissions in which the data were incomplete or unclear in some manner. FDA is
communicating with these manufacturers to obtain clarification before entering the
information into the database. FDA will continue to post additional responses as they are
received.
In reviewing the data received from the manufacturers so far, FDA sees no indication of
widespread problems which will place patients at risk, if and only if the solutions being
developed and offered by manufacturers are implemented as they have indicated. Of course,
FDA can not make assurances about manufacturers who have not reported product status. FDA
believes that the information received to date confirms 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. There will be specific problems
which 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. Nonetheless, such
disruption could be serious and the potential for it to happen certainly merits rigorous
attention to the problem.
One indication of FDAs belief that Year 2000 problems are not significant or
widespread has been borne out by DVA in their testimony and responses to questions before
the House Committee on Veterans Affairs, Subcommittee on Oversight and
Investigations. The DVA indicated that they had received answers from manufacturers on all
of the critical care device components and they expected to be ready for Year 2000.
Legal Authority
FDAs Quality System Regulation (QSR) (21 CFR 820) places on manufacturers an
ongoing responsibility to take corrective and preventive actions that may include recall
for problems with current production. Devices automated with computer software are subject
to all requirements of Title 21, Code of Federal Regulations (CFR), Part 820,
unless expressly exempted by regulation. The regulation puts in place a system whereby
manufacturers must incorporate a set of procedures and processes in their design and
manufacturing activities to assure that products being manufactured are safe, effective
finished products. The QSR regulation does not require the submission of any reports to
FDA, however, it does require firms to maintain internal procedures and documentation of
corrective and preventive actions (21 CFR 820.100).
The Removals and Corrections Regulation (21 CFR 806) requires manufacturers to submit
reports to FDA. In order to be reportable, a Year 2000 problem must pose a "risk to
health" as defined in section 806.2(j). Many of the problems reported in the
Biomedical Equipment database or on manufacturers Year 2000 Web pages concern date
recording or display problems that are readily apparent to the user and are unlikely to
pose a risk to health. In the Year 2000 context, a decision to correct a problem may occur
long before the correction itself is actually announced to customers. Once the decision
for action is made, however, and if the action is to correct a risk to health, then the
firm has 10 working days to notify the Agency through a report of correction or removal. A
firm that previously notified FDA about a removal or correction through a Medical Device
Report (under 21 CFR 803) does not have to submit an additional report under 21 CFR 806.
FDA will continue to emphasize to manufacturers the importance of reporting on the Year
2000 compliance status of their products and take additional steps to boost the response
rate. Healthcare facilities need information from all manufacturers to properly prepare
and plan for any actions they need to take to assure their devices needing corrections or
updates receive these well before the Year 2000.
CONCLUSION
Thank you for the opportunity to update you about the issue of the Year 2000 and
medical devices. Let me assure you that FDA takes this issue very seriously and is
committed to a scientifically sound regulatory environment which will help provide
Americans with the best medical care. In the public interest, FDAs commitment must
be coupled with a reciprocal industry commitment: that medical device firms will meet high
standards in the design, manufacture, and evaluation of their products. FDA recognizes
that this can only be attained through a collaborative effort -- between government and
industry -- grounded in mutual respect and responsibility. The protections afforded the
American consumer, and the benefits provided the medical device industry, cannot be
underestimated.
FDA will continue to provide any assistance it can to address specific problems that
any other agency, such as the DVA, identifies. FDA also is working with other agencies,
patient groups, medical associations and industry to optimize data collection and
information sharing. FDA will continue urging manufacturers to ensure the continued safety
and effectiveness of their medical devices by ensuring that their devices can perform date
recording and computations that will be unaffected by the Year 2000 date change.
Thank you for the opportunity to testify.