Medical Devices: FDA Can Improve Oversight of Tracking and Recall Systems
(Letter Report, 09/24/98, GAO/HEHS-98-211).
Pursuant to a congressional request, GAO provided information on whether
the Food and Drug Administration (FDA) is providing adequate oversight
of the tracking systems of high-risk device manufacturers and whether
recalls of devices are executed promptly, focusing on whether: (1) FDA
ensures that manufacturers operate tracking systems that are capable of
tracking devices through the distribution chain to end users; and (2)
device manufacturers and FDA are executing recalls of tracked devices in
a timely manner.
GAO noted that: (1) there are several weaknesses in FDA's approach for
determining whether device manufacturers are operating tracking systems
capable of quickly locating and removing defective devices from the
market and notifying patients who use them; (2) FDA's inspections of the
tracking systems do not include independent audits that could verify the
completeness and accuracy of data in the systems; (3) instead, the
inspections focus on reviews of the manufacturers' written standard
operating procedures for tracking; (4) further, although the good
manufactured product standard require FDA to inspect manufacturers of
tracked devices at least once every 2 years, only about one-half of the
238 manufacturers subject to tracking were inspected during fiscal year
(FY) 1996 and FY 1997; (5) FDA attributed its limited inspection
activity to a reduction in field resources; (6) FDA has also not acted
to ensure that device tracking continues when establishments go out of
business, merge, or are acquired by other entities; (7) FDA officials
told GAO they are are planning to revise their inspection program to
include an audit plan to better assess manufacturers' compliance with
the tracking requirements and redirect FDA's compliance priorities
toward high-risk devices, such as implant devices; (8) the details for
most of these plans, however, have not yet been determined; (9) in GAO's
analysis of FDA's recall data, manufacturers and FDA have not acted in a
timely manner to correct and remove defective devices from the market;
(10) less than one-third of the 54 recalls initiated from FY 1994
through FY 1996 were completed by manufacturers within 6 months, as
specified in FDA guidelines; (11) FDA has also had problems terminating
device recalls in a timely manner; (12) less than one-half of the 49
recalls reported completed by manufacturers were reviewed and terminated
by FDA within the 90-workday standard established by the agency; and
(13) FDA officials have identified several factors that may contribute
to delays in completing recalls, but an in-depth review of the recall
procedures used by manufacturers and FDA has not been conducted.
--------------------------- Indexing Terms -----------------------------
REPORTNUM: HEHS-98-211
TITLE: Medical Devices: FDA Can Improve Oversight of Tracking and
Recall Systems
DATE: 09/24/98
SUBJECT: Product recalls
Product safety
Consumer protection
Medical equipment
Prosthetic devices
Manufacturing industry
Monitoring
Management information systems
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Cover
================================================================ COVER
Report to the Subcommittee on Oversight and Investigations, Committee
on Commerce, House of Representatives
September 1998
MEDICAL DEVICES - FDA CAN IMPROVE
OVERSIGHT OF TRACKING AND RECALL
SYSTEMS
GAO/HEHS-98-211
Medical Device Tracking
(108337)
Abbreviations
=============================================================== ABBREV
CDRH - Center for Devices and Radiological Health
ECRI - Emergency Care Research Institute
FDA - Food and Drug Administration
FDAMA - Food and Drug Administration Modernization Act
GMP - good manufacturing practice
HIMA - Health Industry Manufacturers Association
MDMA - Medical Device Manufacturers Association
NEMA - National Electrical Manufacturers Association
SMDA90 - Safe Medical Devices Act of 1990
Letter
=============================================================== LETTER
B-280391
September 24, 1998
The Honorable Joe Barton
Chairman, Subcommittee on Oversight
and Investigations
Committee on Commerce
House of Representatives
Dear Mr. Chairman:
The Food and Drug Administration (FDA) is responsible for reviewing,
approving, and monitoring medical devices to ensure that they are
safe and effective for human use. In 1997, about $49 billion\1 was
spent in the United States on more than 65,000 different types of
medical devices made by almost 12,000 manufacturers.\2 These devices
are used by health care professionals every day to diagnose, treat,
or prevent illness in millions of Americans. Among these devices are
ones that FDA characterizes as critical--such as heart valves,
pacemakers, and other permanently implantable devices--because they
are used to sustain or support life.
In 1990, a report by the House Committee on Energy and Commerce\3
expressed concern that FDA and device manufacturers were unable to
track critical medical devices from the manufacturer to the ultimate
user--the patient--in the event that manufacturers had to recall
potentially dangerous or defective devices. To address this concern,
the Congress enacted the Safe Medical Devices Act of 1990 (SMDA 90),
which requires manufacturers of certain critical devices to establish
and maintain systems capable of tracing these devices through the
manufacturing and distribution networks to patients.\4 Under FDA
regulations implementing the act, manufacturers were responsible for
determining whether the devices they made were subject to these
provisions.
To assist manufacturers in identifying the devices that were subject
to tracking, FDA's regulation provided a list of 26 categories of
devices that the agency regarded as subject to tracking.\5 The list
included permanently implanted devices, such as heart valves and
pacemakers, or life-sustaining or life-supporting devices, such as
ventilators, apnea monitors, and defibrillators that are used outside
of device user facilities. FDA ensures compliance with the tracking
requirements through good manufacturing practice (GMP) inspections of
device manufacturers' facilities.\6 FDA also oversees manufacturers'
efforts to recall problem medical devices to ensure that unsafe and
ineffective medical devices are promptly removed from the market.
Recently, the Food and Drug Administration Modernization Act of 1997
(FDAMA) revised the tracking requirement.\7 Under FDAMA, FDA, rather
than the manufacturers, is now required to specifically identify the
devices subject to tracking and notify manufacturers of such devices
that they must adopt a tracking system. Devices that are not
identified for tracking are exempt until FDA issues an order to the
contrary. FDAMA did not alter the purpose of device tracking
described in SMDA 90 or the requirements it imposed on manufacturers
of tracked devices to establish and maintain tracking systems capable
of locating the devices; rather, it removed the uncertainty as to
which devices were or were not subject to tracking.
During fiscal years 1994 through 1997, FDA received about 163,800
reports of death, serious injury, or device malfunction that were
related to devices subject to tracking. FDA expects to receive a
high volume of reports on tracked devices because these devices often
serve large patient populations, have a large share of the device
marketplace, and can pose a significant risk to patient health. Yet
little is known about whether FDA is providing adequate oversight of
the tracking systems of high-risk device manufacturers and whether
recalls of devices are executed promptly. For these reasons, you
asked us to determine whether (1) FDA ensures that manufacturers
operate tracking systems that are capable of tracking devices through
the distribution chain to end users and (2) device manufacturers and
FDA are executing recalls of tracked devices in a timely manner.
To address these questions, we met with officials from FDA's Center
for Devices and Radiological Health (CDRH) and Office of Regulatory
Affairs who oversee the implementation of the medical device tracking
regulation to discuss the agency's efforts to carry out provisions of
the tracking regulation and the methods used to inspect the tracking
systems of manufacturers and recall tracked devices. We also
reviewed FDA data on GMP inspections of manufacturers subject to
tracking to determine how frequently FDA inspected their tracking
systems and the amount of time manufacturers and FDA required to
conduct recalls of tracked devices to determine if recalls were being
executed in a timely manner. Appendix I provides a more detailed
description of our scope and methodology. Our work was conducted
from July 1997 through August 1998 in accordance with generally
accepted government auditing standards.
--------------------
\1 Health Industry Manufacturers Association, U.S. Medical
Technology Industry Fact Sheet,
http://www.himanet.com/about/medtechfactsheet.html (cited July 14,
1998).
\2 Medical Economics, Medical Device Register 1997, Volume 1,
http://www.bookzone/indexed/10000913.html (cited July 17, 1998).
\3 This committee is now known as the House Committee on Commerce.
\4 Section 3(b)(1) of SMDA 90 (21 U.S.C. 360i(e)) added the tracking
requirement.
\5 The medical device tracking regulation became effective on August
29, 1993. FDA has identified about 300 device manufacturers and
distributors subject to the tracking regulation, which represents
about 7 percent of the 4,440 device manufacturers and distributors
who have registered with the agency, in accordance with the Federal
Food, Drug, and Cosmetic Act.
\6 GMP requirements are set forth in FDA's Quality System Regulation
(21 C.F.R. � 820 (1998)). The requirements contain quality
assurance practices in the manufacture, packaging, storage, and
installation of all finished medical devices, with the goal of
preventing the distribution of unsafe or ineffective medical devices.
\7 P. L. 105-115, � 211.
RESULTS IN BRIEF
------------------------------------------------------------ Letter :1
There are several weaknesses in FDA's approach for determining
whether device manufacturers are operating tracking systems capable
of quickly locating and removing defective devices from the market
and notifying patients who use them. These weaknesses threaten the
agency's ability to adequately protect the public.
First, FDA's inspections of the tracking systems do not include
independent audits that could verify the completeness and accuracy of
data in the systems. Instead, the inspections focus on reviews of
the manufacturers' written standard operating procedures for
tracking. Further, although GMP standards require FDA to inspect
manufacturers of tracked devices at least once every 2 years, only
about one-half of the 238 manufacturers subject to tracking were
inspected during fiscal years 1996 and 1997. FDA attributed its
limited inspection activity to a reduction in field resources. FDA
has also not acted to ensure that device tracking continues when
establishments go out of business, merge, or are acquired by other
entities. FDA officials told us they are planning to revise their
inspection program to include an audit plan to better assess
manufacturers' compliance with the tracking requirements and redirect
FDA's compliance priorities toward high-risk devices, such as implant
devices. The details for most of these plans, however, have not yet
been determined.
We also found, in our analysis of FDA's recall data, that
manufacturers and FDA have not acted in a timely manner to correct
and remove defective devices from the market. Less than one-third of
the 54 recalls initiated from fiscal year 1994 through fiscal year
1996 were completed by manufacturers within 6 months, as specified in
FDA guidelines. FDA has also had problems terminating device recalls
in a timely manner. Less than one-half of the 49 recalls reported
completed by manufacturers were reviewed and terminated by FDA within
the 90-workday standard established by the agency. FDA officials
have identified several factors that may contribute to delays in
completing recalls, but an in-depth review of the recall procedures
used by manufacturers and FDA has not been conducted.
Our report contains several recommendations to the Commissioner of
FDA to improve FDA's ability to monitor manufacturers' compliance
with the medical device tracking regulation and conduct recalls of
tracked devices in a timely manner.
BACKGROUND
------------------------------------------------------------ Letter :2
FDA categorizes medical devices in one of three classifications based
on the degree of potential risk and control needed to reasonably
ensure their safety and effectiveness. Class I, or "low risk,"
devices are subject to minimum regulation and include such items as
tongue depressors, elastic bandages, and bed pans. Class II, or
"medium risk," devices include syringes, hearing aids, resuscitators,
and electrocardiograph machines and are subject to more scrutiny than
class I devices. Most medical devices designated as class I or class
II reach the market through FDA's premarket notification--or
510(k)--process.\8
Class III, or "high risk," devices are the most rigidly controlled
and include devices such as heart valves, pacemakers, and
defibrillators. These devices are life-supporting or
life-sustaining, or are substantially important in preventing the
impairment of human life, or present a potentially unreasonable risk
of illness or injury. Class III devices are subject to FDA's
premarket approval process, which requires the manufacturer to
present evidence, often including extensive clinical data, that there
is a reasonable assurance that the device is safe and effective
before placing it on the market.
To help ensure the safety of medical devices, the Federal Food, Drug,
and Cosmetic Act was amended in 1976 to expand FDA's responsibility
for regulating medical devices in the United States. However,
studies prepared by our office, the former Office of Technology
Assessment, and the Office of Inspector General of the Department of
Health and Human Services, as well as congressional investigations
and hearings led the Congress to conclude that the 1976 amendments
were inadequate to protect the public from dangerous and defective
medical devices. Among its concerns, the Congress concluded that
FDA's ability to ensure the removal of dangerous or defective
devices, such as heart valves and other life-sustaining devices, from
the market was hampered because manufacturers did not have adequate
systems for tracking patients with these high-risk devices.
--------------------
\8 Premarket notification is commonly called "510(k)" in reference to
section 510(k) of the Federal Food, Drug, and Cosmetic Act. Under
this section, FDA may grant clearance for the marketing of devices if
it determines that they are substantially equivalent to certain
devices on the market. Once FDA has made that determination, a
manufacturer can begin to market the new device.
EXPERIENCES WITH TWO PROBLEM
DEVICES GAVE RISE TO THE
NEED FOR EFFECTIVE TRACKING
---------------------------------------------------------- Letter :2.1
The efforts of two medical device manufacturers--Shiley, Inc., and
Vitek, Inc.--to notify product recipients of potential product
defects highlight the need for effective medical device tracking
systems.
Shortly after passage of the 1976 Medical Device Amendments, Shiley
applied for and received approval to market its Bjork-Shiley
artificial heart valve under FDA procedures--which were under
development and would not be finalized for another decade. According
to a congressional study, between 1979 and 1986, an estimated 40,000
people in the United States received the valve.\9 During this period,
the struts that held the mechanical valves in place fractured,
leading to death in an estimated two out of three cases where strut
failures occurred. Despite a redesign, strut fractures persisted,
and Shiley was forced to recall all of its devices and cease
production in November 1986. According to the congressional study,
Shiley had reported a total of 389 fractures related to one of its
valves and 248 deaths, as of January 1990.
In December 1990, Shiley voluntarily undertook an effort to locate
and inform approximately 23,000 recipients about one of its
artificial heart valves that was subject to life-threatening
fractures. Although Shiley reported distributing patient
registration cards to hospitals to obtain recipients' names when
valves were implanted, less than 50 percent of the cards were
reportedly returned. As a result, efforts to locate patients--which
also included letters and telephone calls to physicians and
announcements in print media--confirmed the locations of only about
14,000 of the 23,000 (61 percent) heart valve recipients, as of
November 1991.
There were similar difficulties in locating patients who had received
a jaw implant device manufactured by Vitek. The device contained
layers of teflon or proplast--or various combinations of these
materials--which Vitek argued were substantially equivalent to a
product on the market prior to the 1976 amendments. Following FDA
approval, the devices were reportedly prone to break apart, fragment,
and function improperly. FDA estimated that more than 26,000 of the
devices were distributed between 1973 and 1988. However, Vitek did
not know how many devices were actually implanted because it was not
required to and did not maintain records of patients who had received
an implant. FDA officials reported that apart from the devices
recovered through seizures executed in October 1990, it was unable to
determine the number of devices that were in distribution or
implanted in patients because the devices were manufactured in sets
of two, which could be split between patients.
Following Vitek's declared bankruptcy in June 1990 and the bankruptcy
trustee's refusal to notify recipients of Vitek's implant device, FDA
established and funded a patient notification program, which it
estimates cost about $41,000. In September 1991, as part of its
patient notification program, FDA notified physicians and hospitals
on Vitek's consignee list and requested that they advise patients
about the problems associated with the Vitek implants and treatment
options. FDA also conducted an extensive media campaign, which
included a video news release and various press releases and forums
targeted to health organizations and professionals. In addition, the
Medic Alert Foundation, a nonprofit organization, established a
registration program for Vitek proplast implant patients at FDA's
request. For an enrollment fee, patients in the registry received
updated information about Vitek implants, symptoms and treatments
available after the implant was removed, and other devices that could
possibly serve patients better. Through the program, FDA could, if
needed, locate patients and their doctors. However, in mid-1994,
Medic Alert informed FDA that it was no longer financially feasible
to operate the program. In November 1994, FDA issued letters to
about 5,000 patients to inform them that the notification program was
closing and that patients could receive updated information through
various organizations.
--------------------
\9 See The Bjork-Shiley Heart Valve: Earn As You Learn, Subcommittee
on Oversight and Investigations, House Committee on Energy and
Commerce, 101st Cong., at 1 (Comm. Print, 1990).
MEDICAL DEVICE TRACKING
PROVISION OF SMDA 90 AND FDA
ENFORCEMENT
---------------------------------------------------------- Letter :2.2
The medical device tracking provision, enacted in November 1990 as
part of SMDA 90, was intended to improve manufacturers' ability to
track patients with high-risk medical devices and to ensure that FDA
and manufacturers could quickly remove dangerous or defective devices
from the market. The provision defines high-risk devices as those
that are permanently implantable and would likely have serious
adverse health consequences were the device to fail or those that are
life sustaining or life supporting and are used outside the
device-user facility. The Secretary of Health and Human Services may
also designate any other device as high risk. All manufacturers of
such devices must adopt a method of device tracking.
CDRH's Office of Compliance has primary responsibility for
implementing and enforcing the requirements of the device tracking
regulation. These responsibilities include providing agency field
staff with guidance on inspecting manufacturers for compliance with
the regulation during GMP inspections and monitoring corrections and
removals of device products from the market. The Office of
Compliance is also responsible for reviewing and approving exemptions
and variances from one or more parts of the tracking regulation,
filed by a manufacturer, importer, or distributor seeking relief.
In addition, FDA's Office of Regulatory Affairs and FDA's 21 district
offices within the United States and Puerto Rico are responsible for
all FDA inspections, which include inspections of medical devices.
District office staff conduct on-site GMP inspections for all
FDA-regulated facilities and monitor the efforts of recalling
manufacturers to ensure that defective or dangerous devices are
corrected or removed from the market.
FDA'S MEDICAL DEVICE
TRACKING REGULATION
---------------------------------------------------------- Letter :2.3
In August 1993, FDA issued a medical device tracking regulation that
implemented the new tracking requirement of SMDA 90. Under the
regulation, manufacturers must adopt a method of tracking that
enables them to quickly provide FDA information on the location of
the device and patients using them to facilitate efficient and
effective mandatory recalls or notifications. Manufacturers
generally use one of two basic approaches. The first approach
registers the patient at the time of implant and uses a periodic
follow-up mechanism--such as post card, letter, or phone call--to
update names and addresses. The second approach uses a health care
professional, usually a physician, who stays in contact with the
patient to update his or her location.
While no specific method of tracking is required, under the
regulation, manufacturers are required to follow three key tracking
requirements:
-- First, manufacturers are required to develop written standard
operating procedures for implementing a tracking method to
generate the required information on devices and patients. The
operating procedures must include data collection and recording
procedures that include documentation on the reasons for missing
required tracking data, a method for recording all modifications
to the tracking system--including changes to the data format,
file maintenance, and recording system--and a quality assurance
procedure to ensure that the operating procedures are working
effectively. The manufacturer's quality assurance program must
provide for audits of the tracking system based on a
statistically relevant sampling of the manufacturer's tracking
data. For the first 3 years of tracking a device, manufacturers
are required to perform the audits in 6-month intervals;
thereafter, the tracking systems must be audited annually.
These audits must check both the functioning of the tracking
system and the accuracy of the data in the system.
-- Second, manufacturers are required to establish and maintain
certain data in their tracking systems. For device products
that have not yet been distributed to a patient, the
manufacturer must obtain and keep current the name, address, and
telephone number of the distributor holding the device, as well
as the location of the device. For tracked devices distributed
to a patient, the manufacturer must obtain and maintain
information on the identity and current location of the patient
and other information on the device product, such as the lot,
batch, model, or serial number, and the attending physician's
name, address, and telephone number.
-- Finally, upon request by FDA, manufacturers must be able to
quickly report device and patient location information. Within
3 workdays of FDA's request, manufacturers must report the
location of tracked devices that have not yet been distributed
to patients as well as provide information about the
distributor. For devices distributed to patients, manufacturers
must report the locations of devices and patients within 10
workdays of FDA's request.
The tracking regulation also states that manufacturers have the
responsibility of determining the devices subject to tracking and to
initiate tracking. To provide guidance to manufacturers, FDA listed
26 categories of devices in the regulation that it regards as subject
to tracking and has focused enforcement efforts on manufacturers of
such devices. (See app. II for the 26 device categories.)
Distributors of devices--which may include user facilities,
physicians, and pharmacies--also have reporting and recordkeeping
responsibilities under the device tracking regulation. Distributors
must collect, maintain, and report back to the manufacturer current
information on the locations of tracked devices and patients who use
them.
FDAMA SHIFTS RESPONSIBILITY
FOR IDENTIFYING DEVICES
SUBJECT TO TRACKING FROM
MANUFACTURERS TO FDA
---------------------------------------------------------- Letter :2.4
Following concerns that SMDA 90 provisions did not provide
manufacturers with clear guidance on which devices were subject to
tracking,\10 the medical device tracking provision was revised in
FDAMA.\11 Under FDAMA, FDA--not manufacturers--is required to
determine whether certain devices are subject to tracking\12 and to
issue orders to manufacturers requiring them to adopt a tracking
system for these devices. Devices not identified are exempt from the
tracking requirement until FDA issues an order to the contrary.
FDA has taken several actions to implement the changes mandated by
FDAMA. In February 1998, FDA issued orders to manufacturers of
devices in categories designated for tracking under SMDA 90
provisions, requiring them to continue their tracking systems while
FDA considered reducing the number of devices subject to tracking.
In March 1998, FDA announced in a Federal Register notice the
availability of guidance on manufacturers' responsibilities for
medical device tracking under FDAMA and requested comments from the
public on factors FDA should consider in deciding whether some device
categories should no longer be subject to tracking. FDA is currently
reviewing these comments and plans to publish a notice in the Federal
Register with a revised list of device categories subject to
tracking.
--------------------
\10 S. Rep. No. 105-43, at 36, 37 (1997).
\11 FDAMA also amended various provisions of the Federal Food, Drug,
and Cosmetic Act related to both premarket review processes and
postmarket reporting and created new authority by which FDA can
increase the opportunity for achieving some degree of harmonization
of requirements for regulating devices through the recognition of
national and international consensus standards.
\12 FDAMA stipulates that FDA may require tracking for class II or
class III devices, if the failure of the device would be reasonably
likely to have serious adverse health consequences or the device is
intended to be implanted in the human body for more than 1 year or is
a life-sustaining or life-supporting device used outside a device
user facility.
FDA'S RECALL PROCESS
---------------------------------------------------------- Letter :2.5
If a medical device exhibits a problem after it is marketed, one
remedial action available to the manufacturer of the device and FDA
is to recall the product.\13 In these cases, manufacturers must
develop a strategy for implementing recalls and take appropriate
action to protect the public health, including effectiveness checks
to ensure that users of devices have been notified of the recall.
FDA reviews and approves recall strategies and assigns one of three
recall classifications--class I, II, or III--to indicate the relative
degree of health hazard of the product being recalled. For a class I
recall, FDA has determined that the use of or exposure to the product
could cause serious health consequences or death. Class II recalls
are designated for situations where FDA has determined that the use
of or exposure to the product could cause temporary or medically
reversible adverse health consequences and the probability of serious
health consequences is remote. Class III recalls are reserved for
situations that involve minor component malfunction repairs and
labeling changes where use of or exposure to the product is not
believed likely to cause adverse health consequences.
FDA also monitors the progress of recalls and audits a sample of
completed recalls to verify that the recalling manufacturer has
properly removed defective devices from the market. As a goal, FDA
expects manufacturers to complete recalls within 6 months of
initiation and requires FDA staff to conduct audits and terminate
recalls in not more than 90 workdays after the manufacturer reports
the recall completed. (For more details of FDA's recall process, see
app. III.)
--------------------
\13 FDA defines a recall as a manufacturer's removal or correction of
a marketed product that the FDA considers to be in violation of the
laws it administers and against which the agency would initiate legal
action, such as seizure. FDA also uses the word to denote field
repairs, hazard warnings, and the correction of labeling or
promotional material.
FDA INSPECTIONS DO NOT ENSURE
MANUFACTURERS CAN TRACK DEVICES
TO END USERS
------------------------------------------------------------ Letter :3
FDA's approach to ensuring that device manufacturers are operating
tracking systems capable of tracing devices from distribution to end
users has several limitations, such as a failure to include audits of
the tracking systems in its inspections and infrequent inspections.
To address these problems, CDRH's Office of Compliance is considering
initiatives that are intended to strengthen its oversight of
manufacturers' tracking systems, but the details of most of these
initiatives have not yet been developed. Moreover, FDA has not taken
steps to ensure that tracking continues when manufacturers
responsible for tracking go out of business, merge, or are acquired
by others.
SCOPE AND FREQUENCY OF FDA
INSPECTIONS OF DEVICE
TRACKING SYSTEMS IS LIMITED
---------------------------------------------------------- Letter :3.1
FDA on-site inspections of device manufacturers' facilities are
intended to ensure compliance with the requirements of the GMP
regulation, the medical device reporting regulation,\14 and the
medical device tracking regulation. Manufacturers of class II or
class III devices, such as those subject to tracking, are to receive
inspections at least once every 2 years.\15 Although these
inspections represent a key element of FDA's oversight of device
tracking, we found that both the scope and frequency of the
inspections are limited.
FDA's Compliance Program Guidance Manual\16 requires investigators to
determine whether manufacturers are complying with the device
tracking regulation by reviewing their written standard operating
procedures for tracking during GMP inspections. If the manufacturer
does not have a tracking system, the investigator is required to cite
the violation on the agency's list of inspection observations,
commonly referred to as FDA form 483. This form is presented to and
discussed with the manufacturer's management at the conclusion of the
inspection. The investigator also prepares an establishment
inspection report, which summarizes the manufacturer's operations and
any conditions observed during the inspection that may violate
federal statutes. FDA's guidance manual also requires investigators
to document in the report whether the manufacturer makes any of the
devices subject to tracking, and if so, whether it is meeting its
tracking obligations.
However, in making assessments of manufacturers' compliance with the
tracking regulation, FDA does not require inspectors to conduct
independent audits of the tracking systems to ensure that the systems
are working. Moreover, inspectors are directed not to review
manufacturers' quality assurance audit reports that evaluate the
functioning and accuracy of data in the tracking systems. Reviewing
these reports or conducting independent audits of manufacturers'
tracking systems would assist FDA investigators in assessing whether
manufacturers are operating tracking systems capable of quickly
identifying the locations of devices and patients that use them. FDA
can use its existing regulatory authority to require manufacturers to
certify that they are, in fact, conducting required audits.\17
However, a senior FDA official told us that this requirement has
never been used and is not included in FDA's guidance manual.
FDA officials explained that its current inspection strategy for
assessing compliance with the tracking requirements is intended to
educate and encourage compliance among manufacturers before actually
enforcing the provisions of the regulation. The officials also
explained that due to a written policy established as part of the GMP
regulation in 1978, FDA inspectors are precluded from reviewing or
copying manufacturers' records and reports that result from audits
performed in accordance with a written quality assurance program at
any regulated entity.\18 FDA officials also told us that the medical
device industry has resisted the agency's access to the audits
because they fear the audits would yield incriminating information
that FDA could use against them. According to FDA officials, this
belief may cause manufacturers to be less than candid and thorough in
their audits if the audits were subject to FDA inspection. As such,
FDA adopted the policy to encourage manufacturers to conduct
self-audits that are unbiased and meaningful. Nevertheless, the
agency has not conducted its own audits of the tracking systems.
In addition, FDA's inspections of manufacturers' tracking systems
have not been conducted at least once every 2 years, as required by
GMP standards. Our analysis of FDA data shows that FDA conducted GMP
inspections in 137 (58 percent) of the 238 reportedly active
establishments subject to tracking during fiscal years 1996 and 1997.
In addition, during fiscal years 1994 and 1995, FDA conducted GMP
inspections in only 91 (45 percent) of the 202 reportedly active
manufacturers subject to tracking.
FDA officials told us that reductions in field staff resources used
to conduct inspections has made it difficult for FDA to meet the GMP
biennial inspection requirement. According to FDA officials, the
number of investigators available to inspect all FDA-regulated
facilities--including manufacturers of foods, drugs, biologics,
veterinary medicine, and medical devices--has declined since 1993.
They noted for example that investigators assigned specifically to
cover the approximately 4,400 device manufacturing establishments
nationwide declined from 34 in fiscal year 1994 to 28 in fiscal year
1997, while the scope of GMP inspections has increased to include
compliance programs for the medical device reporting regulation and
medical device tracking regulation.
--------------------
\14 Under the medical device reporting regulation, manufacturers,
medical device user facilities, and distributors are required to
report to FDA whenever they become aware of information that
reasonably suggests that one of their devices may have caused or
contributed to a death or serious injury. Manufacturers and
distributors must also report certain types of device malfunctions
(21 C.F.R. �� 803, 804 (1998)).
\15 The 1976 Medical Device Amendments mandated that FDA conduct
biennial inspections of facilities manufacturing class II and class
III devices.
\16 The manual provides FDA field staff with instructions on the
enforcement of the requirements of the GMP regulation, medical device
tracking regulation, and the medical device tracking regulation.
\17 21 C.F.R. � 820.180(c)(1998).
\18 Some manufacturers within FDA-regulated industries establish
quality assurance units to perform functions independently from the
manufacturing or quality control organization. These units may
routinely audit and critically review processes and procedures (for
example, data collection, manufacturing practices, and quality
control processes) to determine whether established protocols have
been followed.
FDA PLANS TO REDIRECT
INSPECTIONS AND CHANGE ITS
AUDIT APPROACH TOWARD
HIGH-RISK DEVICE
MANUFACTURERS
---------------------------------------------------------- Letter :3.2
FDA officials acknowledged that changes are needed to better assess
compliance with the medical device tracking regulation and improve
its oversight of manufacturers subject to tracking. For example, FDA
has included in its fiscal year 1999 performance plan a risk-based
inspection plan that will require FDA to identify and prioritize
device areas of concern to focus resources on the highest priorities.
Inspection activities would be prioritized based on several factors,
including reports of problems with medical devices, earlier
inspections, and devices associated with higher risk. FDA officials
told us that many of the devices designated for tracking, such as
cardiovascular implants, would likely receive priority attention
because of the relative high risk associated with their use. The
risk-based plan is expected to be presented to FDA's Medical Device
Field Committee, which is responsible for reviewing and approving
significant changes to on-site inspections before they can be
included in FDA's compliance program.
To improve FDA's assessment of manufacturer compliance with tracking
requirements, officials of the Office of Compliance told us they are
considering separating GMP inspections of manufacturing and
distribution processes from records inspections--which typically
include reviews of manufacturer compliance with medical device
reporting and tracking requirements under SMDA 90--thereby allowing
inspectors more time to review manufacturer compliance with
recordkeeping requirements. In addition, the Office of Compliance
also plans to develop an audit plan that will require FDA inspectors
to independently verify the adequacy of manufacturers' standard
operating procedures for tracking and determine whether the
procedures are being followed. However, at the time of our review,
FDA did not have a draft of the planned changes available for review
and had not established a time frame for presenting these changes to
FDA's Medical Device Field Committee for approval.
FDA DOES NOT KNOW WHETHER
TRACKING CONTINUES WHEN
MANUFACTURERS FAIL OR MERGE
---------------------------------------------------------- Letter :3.3
Maintaining accurate and complete tracking records when a
manufacturer goes out of business, merges, or is acquired by another
manufacturing establishment is critical to ensuring that devices can
be traced from distribution to end users if a recall becomes
necessary. However, FDA has not acted to ensure that tracking
continues in these situations. Several options are available to FDA
for covering the costs of operating a tracking system when a
manufacturer goes out of business. Requiring manufacturers to notify
FDA when mergers and acquisitions take place could also help FDA
ensure that device tracking systems continue.
The device tracking regulation requires a manufacturer that goes out
of business to advise FDA at the time it notifies any government
agency, court, or supplier and provide FDA with a complete set of its
tracking records and information. Our review of FDA's registry of
device manufacturers shows that 47--or 16 percent--of the 285
establishments subject to tracking were classified by the agency as
either tentatively (21 establishments) or permanently (26
establishments) out of business, as of May 1997, and that some
manufactured high-risk devices, such as heart valves, pacemakers,
ventilators, defibrillators, and apnea monitors. However, none of
the manufacturers that were reportedly closed for business has
provided FDA with tracking records. FDA officials believe it is
possible that several of the manufacturers may have merged or been
acquired. In such instances, the tracking regulation requires the
acquiring establishment to continue the tracking obligations of the
failed one. However, the device tracking regulation does not require
the establishment acquiring the rights to manufacture the device to
notify FDA when these transactions take place. As a result, FDA
officials could not determine the number of manufacturers that were
involved in mergers or acquisitions or whether any of them had
assumed the tracking responsibilities of establishments involved in
these transactions.
FDA officials told us they have no plans to recover the tracking
records of any failed establishments and operate a tracking system
itself. In FDA's view, absent a public health emergency with a
tracked device, the agency would not be able to justify cuts in other
programs to carry out a tracking program, which is largely the
responsibility of a manufacturer. Further, officials said they have
no basis to determine how much it would cost to operate any of the
failed establishment's tracking systems because the variables, such
as the number of devices distributed by the manufacturers and used by
patients, are unknown. Thus, no valid cost estimates could be made
by FDA.
While we recognize that FDA would likely incur additional costs to
operate the tracking system of a failed establishment, without
reliable tracking data, FDA may have serious difficulties promptly
recalling and notifying patients if a public health emergency were to
occur. To pay the cost of maintaining the tracking systems of failed
establishments, FDA could seek legislative authority to require
manufacturers of tracked devices to provide some form of financial
assurance to FDA that would demonstrate their commitment to meet
their tracking obligations. Alternatively, FDA could encourage
patients and health providers that use tracked devices of defunct
establishments to pay a fee to establish and maintain a registry of
the current locations of patients and devices, as was done in the
case of the Vitek jaw implants. FDA could also consider shifting
resources from other programs or request additional funding from the
Congress for the operation of a tracking program.
A senior FDA official said the agency could attempt to obtain the
tracking records of failed establishments. This, at a minimum, would
provide FDA with information on the last known locations of devices
and patients in the event a recall and notification became necessary.
To locate the records would likely require FDA investigators to visit
the last known address of the manufacturer to confirm its closure,
the local post office to determine whether a forwarding address was
provided, or government agencies or courts that may have received
notification of the manufacturer's closing. For manufacturers
involved in mergers and acquisitions, FDA could include a requirement
in the medical device tracking regulation that an establishment that
has acquired the right to manufacture another manufacturer's tracked
device must notify FDA that it has assumed the tracking duties of the
former establishment. This would provide FDA with greater assurance
that tracking of critical devices is being continued when mergers and
acquisitions have taken place.
RECALLS OF TRACKED DEVICES HAVE
NOT BEEN EXPEDITIOUS
------------------------------------------------------------ Letter :4
Medical device recalls are an important remedial action that
manufacturers and FDA can take to protect the public from unsafe and
ineffective device products. According to FDA, delays in the
identification and removal of potentially hazardous devices from the
market can increase the chances of inadvertent misuse of devices and
risk to public health. To encourage expeditious recalls, FDA
requires that manufacturers complete recalls within 6 months from the
date of initiation. In addition, FDA, through its Regulatory
Procedures Manual,\19 requires district offices to review and audit
the recall effort and submit a report to headquarters that summarizes
the results of the recall and recommends approval to terminate the
recall not more than 90 workdays after the recall is completed.
These reports provide FDA with assurance that recalling manufacturers
have taken prompt and appropriate actions to resolve problems with
devices and assists FDA in identifying trends and evaluating new
problem areas in manufacturing and processing. (See app. III for
additional detail on FDA's recall process.)
However, our review of recalls of defective tracked devices initiated
by manufacturers and monitored by FDA shows that most were not
completed within the required time frames. The number of devices
subject to recall and type of correction or modification required
were among possible factors cited by FDA officials as contributing to
delays in manufacturers completing recalls; late submissions of
summary recall reports due to other work priorities in district
offices were believed to have contributed to delays in FDA
terminating the recalls. At this writing, FDA has not conducted a
comprehensive review of its recall procedures and recall performance
to determine how to improve the timeliness of recalls.
--------------------
\19 The manual provides guidance to field and headquarters staff on
how to conduct regulatory matters, both domestic and import.
RECALLS OF TRACKED DEVICES
WERE NOT COMPLETED WITHIN
REQUIRED TIME FRAMES
---------------------------------------------------------- Letter :4.1
From FDA's recall records and computer databases, we identified 54
recalls of tracked devices, all of which were voluntarily initiated
by 35 manufacturers, during fiscal years 1994 through 1996. Three of
the 54 recalls were designated by FDA as class I recalls--where FDA
had determined that use of or exposure to the device could have
serious adverse health consequences; 43 were class II recalls--where
FDA determined that use of or exposure to the device could cause
adverse health consequences that are reversible or the probability of
adverse health consequences is remote; and 7 were class III
recalls--where FDA determined that use of or exposure to the device
would likely not cause adverse health consequences. The remaining
recall was a safety alert.
As of January 1998, 49 (90 percent) of the 54 recalls of tracked
devices had been completed; however, only 15 (31 percent) of these 49
recalls had been completed within FDA's 6-month guideline.
Thirty-four (69 percent) of the 49 completed recalls took longer than
6 months to complete, including 17 (35 percent) that took between 6
months to 1 year to complete. Seventeen other recalls (34 percent)
took more than 1 year to complete, including 4 class II recalls that
took more than 2 years. For example, a class II recall of
ventilators took 919 calendar days to complete. In addition, we
found that five class II recalls were still ongoing as of January 16,
1998, even though four of the recalls were started in 1996 and one
started in 1995. Recall completions ranged from 12 calendar days to
1,044 calendar days, with a median of 226 calendar days.\20 (See
table 1.)
Table 1
Time Elapsed for Manufacturers to
Complete Recalls of Tracked Devices,
Fiscal Years 1994 Through 1996
Number of
Calendar days recalls\a Percent
------------------------------ ------------ ------------
180 days or less 15 31
181 to 361 days 17 35
361 to 540 days 7 14
541 days or more 10 20
Total 49 100
----------------------------------------------------------
\a Five recalls initiated by manufacturers were still ongoing as of
the date of our review, January 16, 1998.
FDA also did not terminate recalls of tracked devices in a timely
manner. Of the 49 recalls that were reported completed by
manufacturers, less than one-half were terminated by FDA within its
90-workday standard. As of January 16, 1998, FDA had approved 36 (73
percent) of the 49 recalls for termination; 13 recalls (27 percent)
were still awaiting termination by FDA, which included two class I
recalls of a ventilator and a pacemaker that were completed by the
manufacturers in August 1995 and August 1997, respectively. For the
36 recalls terminated by FDA, 24 (67 percent) were reviewed and
terminated by FDA within 90 workdays. For 12 completed recalls (33
percent), FDA took more than 90 workdays, including 2 class II
recalls of ventilators and defibrillators that required about 1 year
or more for termination. (See table 2.)
Table 2
Time Elapsed for FDA to Terminate
Recalls of Tracked Devices, Fiscal Years
1994 Through 1996
Number of
Workdays recalls Percent
------------------------------ ------------ ------------
90 days or less 24 67
91 to 180 days 4 11
181 to 260 days 5 14
261 days or more 3 8
==========================================================
Total 36 100
----------------------------------------------------------
Note: Thirteen completed recalls by manufacturers had not been
terminated by FDA as of the date of our review, January 16, 1998.
FDA time to terminate the 36 recalls ranged from 1 day to as many as
390 workdays, with a median of 45 workdays.\21 Total recall time for
device manufacturers and FDA ranged from 20 days to 786 days, with a
median of 333 combined calendar days and workdays.\22 Total recall
time for one class I recall of a defibrillator was 529 days. (App.
IV shows for each recall, the number of calendar days elapsed for
manufacturers to complete the recall, the number of workdays elapsed
for FDA to terminate the recall, and the total time elapsed.)
--------------------
\20 To measure the time elapsed for completed recalls, we calculated
the number of calendar days from the date the manufacturer reported
the start of the recall to the date it reported the recall completed.
\21 To determine the number of workdays FDA took to terminate
recalls, we calculated workdays elapsed from the date manufacturers
considered recalls completed to the date FDA approved each recall for
termination.
\22 To measure total recall time, we added the number of calendar
days spent by manufacturers to complete recalls and the number of
workdays FDA took to terminate the recalls.
FDA CITES SEVERAL POSSIBLE
FACTORS AS CONTRIBUTING TO
DELAYS
---------------------------------------------------------- Letter :4.2
It was beyond the scope of this study to identify the underlying
reasons for delays in completing recalls of tracked devices.
However, we discussed our analysis of the recalls with officials in
FDA's Office of Regulatory Affairs who are responsible for recalls.
Although these officials did not conduct an in-depth review of the
recalls, they told us that the length of time manufacturers generally
took to complete recalls can vary due to factors such as the amount
and type of recall correction or modification required, the amount of
product subject to recall or correction, the number of notifications
needed to obtain responses from consignees, and inadequate attention
some manufacturers give to recalls. The officials also explained
that while district offices are often slow in submitting the summary
reports to FDA for closure due to higher-priority work, such as
conducting comprehensive GMP inspections, district offices are
monitoring the progress of recalls and completing audit checks to
verify the effectiveness of recalls.
FDA reported that it is taking a number of actions to complete and
close all outstanding recalls initiated during 1994 through 1996, as
quickly as possible. These include instructing district offices to
complete and close out all outstanding recalls by the end of fiscal
year 1998 and updating the recall database with current information
on the status of all recalls.
CONCLUSIONS
------------------------------------------------------------ Letter :5
FDA's approach to inspecting medical device tracking systems provides
little assurance that manufacturers can track devices through the
chain of distribution to patients within a short period of time.
Without conducting inspections once every 2 years that include audits
of the tracking systems to verify the reliability of data in them,
FDA cannot be certain manufacturers are operating systems that will
work when recalls are necessary. FDA's initiatives for improving
oversight of high-risk manufacturers appear to be a step in the right
direction. However, it is unclear whether these initiatives will
provide FDA with adequate oversight of manufacturers subject to
tracking, given the workload and size of FDA's inspection force
available to conduct inspections in device establishments. Still,
FDA may be able to increase its oversight presence, if as expected,
FDA reduces the number of device categories subject to tracking under
FDAMA, focuses its inspection priorities on high-risk devices, and
separates GMP inspections from record inspections.
In addition, because FDA has not acted to recover the tracking
records of failed establishments and is unaware of manufacturers
involved in mergers or acquisitions, the agency has no assurance that
the tracking obligations of such manufacturers are being continued.
While we recognize that device tracking is the responsibility of
manufacturers, FDA, as the protector of public health, must have a
method of continuing the tracking obligations of manufacturers when
they go out of business or the agency will likely have serious
problems executing prompt and effective recalls--as was the case with
Vitek's jaw implants. FDA can explore a number of options for
funding tracking systems for failed establishments to ensure public
safety, including seeking necessary legislation. Requiring
manufacturers to notify FDA when they merge or acquire the rights to
manufacture another establishment's product would also better fulfill
the goals of tracking and protect public health.
Finally, because recalls of tracked devices have been executed slowly
by manufacturers and FDA, the agency has less assurance that
dangerous or defective devices under recall are promptly and
appropriately removed from the market and less information available
to analyze trends in device problems. Timely completion and
termination of recalls provide FDA with greater assurance that
defective devices are corrected and removed promptly and effectively
and with more information to analyze and resolve device problems.
FDA actions to address these problems are encouraging. Nevertheless,
FDA's efforts to improve the timeliness of recalls could benefit from
evaluating the reasons why manufacturers and FDA frequently require
extensive amounts of time to complete and terminate device recalls.
RECOMMENDATIONS TO THE
COMMISSIONER OF THE FOOD AND
DRUG ADMINISTRATION
------------------------------------------------------------ Letter :6
To improve FDA's ability to monitor manufacturer compliance with the
medical device tracking regulation and conduct recalls of tracked
devices in a timely manner, we recommend that the Commissioner of FDA
-- develop and implement a plan to verify the completeness and
accuracy of data in the tracking systems of device manufacturers
to ensure that the systems can trace devices through the chain
of distribution to end users,
-- take steps to recover the medical device tracking records of
manufacturers that have failed and have not provided such
information to FDA and report to the Congress on the results of
its assessment of options for covering the costs of operating a
device tracking system for failed establishments,
-- revise the medical device tracking regulation to require an
establishment that acquires the right to manufacture another
establishment's tracked device either through merger or
acquisition to immediately notify FDA that it has assumed the
tracking obligations of the former establishment, and
-- examine the reasons for delays in completing recalls of tracked
devices and develop and implement strategies for improving the
timeliness of recalls.
AGENCY AND INDUSTRY COMMENTS
AND OUR RESPONSE
------------------------------------------------------------ Letter :7
We obtained comments on a draft of this report from FDA and three
trade associations that represent the medical device industry--Health
Industry Manufacturers Association (HIMA), Medical Device
Manufacturers Association (MDMA), and the National Electrical
Manufacturers Association (NEMA). In general, FDA agreed with the
findings and some of the recommendations in our report and said they
had begun acting on them. While NEMA agreed with our findings and
recommendations, HIMA and MDMA were concerned that implementing our
recommendations would place undue burdens on manufacturers without
improving the agency's oversight of device tracking or benefiting
public health.
FDA agreed that manufacturers should maintain accurate and complete
data in tracking systems and indicated that it was revising its
inspection approach to verify that manufacturers have adequate
procedures in place to comply with medical device tracking
requirements. However, FDA does not plan to verify the data in the
tracking systems as we recommended because it believes the agency
should focus on ensuring that manufacturers have tracking systems in
place. While we agree that determining whether manufacturers have
appropriate tracking procedures in place is an important element of
an FDA inspection, limiting inspections in this way does not provide
FDA with assurance that the data in the tracking system are accurate
and complete.
HIMA and MDMA were concerned about the methods FDA may use to
implement our recommendation to verify tracking system data and the
cost of these efforts. HIMA believes it is unnecessary for FDA to
conduct independent audits of tracking systems because such audits
would duplicate those already performed by the manufacturers. They
noted that, if necessary, FDA is authorized to require manufacturers
to certify that they are, in fact, conducting required audits. MDMA
indicated that we had not linked weaknesses in FDA's oversight of
tracking systems with an adverse impact on public health. They also
believed that in order to independently verify tracking system data,
FDA would need to conduct "mock recalls" that would require
manufacturers to generate reports of the location of all devices in
distribution with hypothetical malfunctions. MDMA believes such an
effort would be costly and provide little benefit to FDA and the
public.
In our view, FDA needs to develop an approach to verify the data in
manufacturers' tracking systems. However, the industry's comments
are not without merit and should be considered by FDA as it weighs
the costs and benefits of different approaches for addressing this
issue. We agree with HIMA that requiring FDA inspectors to conduct
independent audits of tracking systems could duplicate manufacturers'
own internal audits and would likely result in some additional costs
to FDA and manufacturers. Nevertheless, it may be one way FDA can
verify the tracking data without having access to the internal audit
reports. HIMA also correctly notes that FDA is authorized to require
manufacturers to certify that they are conducting required audits of
tracking system. We have revised our report to include certification
as an option FDA could use to verify tracking system data. While our
report does not link weaknesses in FDA's oversight of device tracking
with adverse health events, as noted by MDMA, we do not believe FDA
should await a public health emergency before taking action to ensure
that device tracking systems are capable of tracing devices to end
users. We disagree with MDMA that FDA would need to conduct mock
recalls to independently verify the tracking data. Indeed, such an
approach would be costly and inefficient and may be outside of FDA's
authority. Although we are not prescribing a specific method of
verification for FDA, the agency could select a random sample of
tracking system data and contact end users of devices to confirm
their locations. Such an approach would likely take less time and
resources to complete than the mock recalls suggested by MDMA.
HIMA and MDMA also disagreed with our recommendation that FDA examine
options for requiring manufacturers of tracked devices to provide
financial assurance to offset the costs FDA may incur in maintaining
a tracking program for failed establishments. HIMA said that such a
requirement would be costly and difficult to implement. MDMA
indicated that while it supports FDA's efforts to ensure compliance
with these regulations, the cost should be borne by the taxpayers who
benefit from the tracking of medical devices, rather than the
manufacturers.
While it may be costly to operate the tracking systems of failed
establishments, these systems must be maintained so that end users
can be promptly notified of serious device problems that warrant
corrective action. However, as HIMA and MDMA point out, there may be
ways to cover the cost of this activity other than requiring
manufacturers to provide financial assurance. In our view, FDA needs
to evaluate approaches for resolving this problem, including who
should be responsible for maintaining the tracking records and who
should pay the cost of this activity. FDA should report its findings
to the Congress, and, if necessary, seek authority from the Congress
to implement a solution. We have modified the report and
recommendation to address this issue.
HIMA believes it would be better to measure the effectiveness of a
recall based on a manufacturer's success in identifying and
contacting a device's end users or patients where notification was
required. While we agree with HIMA that the ability of a tracking
system to locate end users provides a valuable measure of recall
success, we believe that the timeliness of recalls is also important.
A key goal of tracking is to ensure that defective or dangerous
devices can be corrected or removed from the market within a short
period of time. Thus, in our view, FDA's timeliness guidelines for
completing and terminating recalls are valuable indicators for
measuring recall performance.
---------------------------------------------------------- Letter :7.1
As agreed with your office, unless you publicly announce its contents
earlier, we plan no further distribution of this report until 30 days
from the date of this letter. At that time, we will send copies of
this report to other congressional committees and members with an
interest in this matter, and we will make this report available to
others upon request. If you or your staff have any questions about
this report, please call me at (202) 512-7119 or John Hansen at (202)
512-7105. Other major contributors to this report are Darryl Joyce,
Julian Klazkin, and Claude Hayeck.
Sincerely yours,
Bernice Steinhardt
Director, Health Services Quality
and Public Health Issues
SCOPE AND METHODOLOGY
=========================================================== Appendix I
We conducted our study of FDA's implementation of the provisions of
the medical device tracking requirements of the Safe Medical Devices
Act of 1990 at FDA's Office of Compliance within the Center for
Devices of Radiological Health (CDRH) and the Office of Regulatory
Affairs. In addition to reviewing the laws, regulations, and
literature relevant to medical device tracking, we met with officials
of CDRH and the Office of Regulatory Affairs to discuss the agency's
efforts to implement the tracking regulation and policies and
procedures used to inspect manufacturers' tracking systems and recall
tracked devices. From a list of about 150 manufacturers subject to
tracking provided to us by the Emergency Care Research Institute
(ECRI), a nonprofit health research agency,\23 we judgmentally
selected and interviewed representatives of 10 manufacturers to
discuss the methods they used to track devices, which included
pacemakers, heart valves, defibrillators, ventilators, apnea
monitors, and jaw implants. We also analyzed FDA statistics on the
number of GMP inspections conducted in establishments that were
subject to tracking during fiscal years 1994 through 1997. We
reviewed a list of manufacturers registered with FDA to identify the
number of active and inactive establishments that were subject to
tracking as of May 1997.
To identify recalls of medical devices that were subject to tracking
during fiscal years 1994 through 1996, we reviewed a list of recalls
of tracked devices known to FDA.\24 To supplement this list, we
obtained a list of recalls of tracked devices covering the same
period from ECRI because it maintains an automated database that
collects information from manufacturers, FDA weekly enforcement
reports, and scientific literature on devices subject to recalls.
With CDRH staff, we reviewed a total of 135 recalls from these two
sources and identified 54 recalls of devices that were subject to
tracking. Included in our analysis were recalls of devices
distributed on or after August 29, 1993, the effective date of the
medical device tracking regulation.\25 We excluded recalls for at
least one of the following reasons:
-- date of distribution of the device could not be determined;
-- device was not subject to the tracking regulation;
-- date of distribution of the device occurred prior to the
effective date of tracking;
-- device was granted an exemption from tracking by FDA;
-- recall commenced in 1997, which was beyond the scope of our
study; or
-- recall involved devices distributed outside the United States,
which are not subject to tracking.
To determine the amount of time manufacturers and FDA took to
complete recalls of tracked devices, we analyzed data in recall
records and FDA's recall database maintained by CDRH and the Office
of Regulatory Affairs on the dispositions of 54 recalls of tracked
devices that were initiated by manufacturers during fiscal years 1994
through 1996. From documentation in the recall records and
databases, we calculated the number of calendar days manufacturers
took to complete each of the 54 recalls and compared the results
against FDA's instructions to manufacturers to complete recalls
within 6 months of initiation. Calendar days were used because we
wanted to measure the time elapsed for manufacturers to remove
devices subject to recall from the market. The number of workdays
FDA took to review and approve recalls for termination was compared
to FDA's requirement that recalls be terminated in not more than 90
workdays after manufacturers reported recalls completed. Next, to
measure total recall time, we added the number of calendar days spent
by manufacturers to complete recalls to the number of workdays FDA
took to terminate the recalls. We did not independently verify the
information contained in the recall databases or evaluate the
internal controls of the computer systems.
--------------------
\23 Emergency Care Research Institute, Medical Device Tracking
Sourcebook, Manufacturers of Devices Subject to Tracking Booklet, No.
3 (Aug. 1992).
\24 SMDA 90 expanded FDA's authority to require manufacturers to
report recalls to FDA. However, FDA did not issue a final rule
establishing procedures for manufacturers to report corrections and
removals until May 1997. Therefore, some corrective actions taken by
manufacturers that would be classified as recalls by FDA may have
been unknown to FDA.
\25 In some cases, these recalls involved devices that were
distributed both before and after August 29, 1993.
MEDICAL DEVICES SUBJECT TO
TRACKING BY FDA
========================================================== Appendix II
FDA's medical device tracking regulation, effective August 29, 1993,
required manufacturers to use the criteria established in SMDA 90 to
determine the devices that meet the criteria for tracking and to
initiate tracking. To illustrate and provide guidance to
manufacturers, FDA listed 26 categories of devices in the regulation
that it regarded as subject to tracking.
Table II.1
Categories of Medical Devices Subject to
FDA Tracking
Device type Device categories
---------------------- ----------------------------------------------
Permanently --Vascular graft prosthesis of less than 6
implantable millimeters in diameter
--Vascular graft prosthesis of 6 millimeters
and greater in diameter
--Total temporomandibular joint prosthesis
--Glenoid fossa prosthesis
--Mandibular condyle prosthesis
--Interarticular disc prosthesis
(interpositional implant)
--Ventricular bypass (assist) device
--Implantable pacemaker pulse generator
--Cardiovascular permanent pacemaker
electrode
--Annuloplasty ring
--Replacement heart valve
--Automatic implantable cardioverter/
defibrillator
--Tracheal prosthesis
--Implanted cerebellar stimulator
--Implanted diaphragmatic/phrenic nerve
stimulator
--Implantable infusion pump
Life-sustaining or --Breathing frequency monitors (apnea
life-supporting used monitor), including ventilatory efforts
outside device user monitor
facilities --Continuous ventilator
--DC-defibrillator and paddles
Other --Penile inflatable implant
--Silicone inflatable breast prosthesis
--Silicone gel-filled breast prosthesis
--Testicular prosthesis, silicone gel-filled
--Silicone gel-filled chin prosthesis
--Silicone gel-filled angel chik reflux valve
--Infusion pumps
----------------------------------------------------------------------
FDA'S MEDICAL DEVICE RECALL
PROCESS
========================================================= Appendix III
A recall is a voluntary action by a manufacturer to remove a medical
device from the market or to correct a problem with a medical device
to protect the public from products that present a risk of injury,
gross deception, or are otherwise defective. Under SMDA 90, FDA can
require manufacturers to report to the agency any corrections and
removals of problem devices from the market and order recalls of
defective and dangerous devices.\26
However, in practice, with the exception of urgent situations, the
majority of recalls are initiated voluntarily by manufacturers with
FDA oversight.
FDA assigns one of three classifications--class I, class II, and
class III--to indicate the relative degree of risk the recalled
product presents to public health. For a class I recall, FDA has
determined that the use of or exposure to the product could cause
serious health consequences or death. Class II is designated for
situations where FDA has determined that the use of or exposure to
the product could cause temporary or medically reversible adverse
health consequences and the probability of serious health
consequences is remote. A class III recall is reserved for
situations where use of or exposure to the product is considered not
likely to cause adverse health consequences.
To initiate a recall of a product from the market, manufacturers
develop and submit a recall strategy report to FDA that includes
information on the reason for the correction or removal of the
device, an assessment of the health hazard associated with the
device, and volume of product in distribution. The recall strategy
also includes provisions for effectiveness checks to ensure that
users of devices have been notified of the recall and taken
appropriate action to protect the public health. In general, class I
recalls require a check with 100 percent of the device users that
received notice of the recall and class II recalls require checks of
80 percent of device users. No checks are required for class III
recalls because there is no public health risk involved. FDA
guidelines instruct manufacturers to complete recalls within 6 months
from the date of initiation of the recall. FDA reviews and
recommends changes, if any, to the proposed recall strategy; advises
the manufacturer of the assigned recall classification; and places
the recall in its weekly enforcement report.
At least once a month, FDA district offices monitoring recalls
receive recall status reports from manufacturers that provide updates
on the progress of recalls. Status reports on class I and some class
II recalls are forwarded to FDA headquarters for review. Upon
completion of the recall, the district offices conduct audit checks
to confirm that the recalling manufacturer has properly corrected or
removed devices from the market, in accordance with the recall
strategy. Audit checks, which generally range from 2 to 10 percent
of the total number of device users notified of the recall notice,
are always performed on class I recalls and are usually conducted on
class II recalls. After the monitoring district has determined that
the recall was effective at notifying device users and appropriate
action has been taken, a recall termination recommendation and
summary of recall report is prepared by the district and forwarded to
FDA headquarters for termination approval. This report provides FDA
headquarters with documentation that reasonable and appropriate
actions have been taken by the manufacturer to correct or remove the
defective device product from the market. FDA requires from the time
a manufacturer considers the recall completed to FDA's recall
termination approval should not exceed 90 days. Both the Office of
Compliance and Office of Regulatory Affairs maintain separate
automated computer databases that track the processing of recalls.
--------------------
\26 On May 19, 1997, FDA issued a final regulation establishing
procedures that require manufacturers, importers, and distributors to
promptly report to FDA any corrections or removals of a device
undertaken to reduce a risk to health.
RECALLS OF MEDICAL DEVICES SUBJECT
TO TRACKING
========================================================== Appendix IV
Table IV.1 shows our analysis of the days elapsed for manufacturers
and FDA to complete and terminate recalls of tracked devices that
were initiated during fiscal years 1994 through 1996.
Table IV.1
Total Days Elapsed for Recalls During
Fiscal Years 1994 Through 1996, by
Device and Class
Calendar days
for manufacturer Workdays for Total recall
Class Recall number completion FDA termination days
-------- ---------------------------- ---------------- --------------- --------------
Annuloplasty ring
-----------------------------------------------------------------------------------------
II Z-1394-4 62 1 63
Monitor (apnea detector, ventilatory effort)
-----------------------------------------------------------------------------------------
II Z-891-4 379 14 393
II Z-1387/1390-4 573 45 618
DC-defibrillator, low energy (including paddles)
-----------------------------------------------------------------------------------------
I Z-299/300-4 313 216 529
II Z-1215-6 15 5 20
II Z-005/006-6 211 185 396
II Z-1433-4 190 24 214
II Z-968/969-4 210 339 549
II Z-037-7 159 26 185
II Z-979/980-4 595 4 599
II Z-550-5 54 138 192
II Z-1097/1098-5 224 204 428
Defibrillator, automatic implantable cardioverter
-----------------------------------------------------------------------------------------
II Z-053-7 115 197 312
Pump, infusion, elastomeric
-----------------------------------------------------------------------------------------
II Z-573/591-5 612 38 650
II Z-1368/1369-4 313 60 373
Pump, infusion
-----------------------------------------------------------------------------------------
II Z-072-5 249 17 266
II Z-008-5 343 10 353
II Z-247-4 58 56 114
II Z-842-5 129 80 209
II Z-147-7 219 \a \a
II Z-034/035-7 363 \a \a
III Z-348-7 226 355 581
Pump, infusion, implanted, programmable
-----------------------------------------------------------------------------------------
II Z-152/156-7 159 \a \a
Pulse generator, pacemaker, implantable
-----------------------------------------------------------------------------------------
II Z-1099/1102-4 44 94 138
II Z-720-4 12 10 22
II Z-954/955-5 243 \a \a
III Z-319/320-5 37 41 78
III Z-321-5 416 54 470
III Z-322-5 428 12 440
III Z-482-6 134 176 310
\b N-952/064-4 328 57 385
Electrode, pacemaker, permanent
-----------------------------------------------------------------------------------------
I Z-209/211-5 299 \a \a
Vascular graft of 6 mm and greater diameter
-----------------------------------------------------------------------------------------
II Z-853-5 204 43 247
II Z-511/515-5 397 2 399
Prosthesis, breast, inflatable, internal, saline
-----------------------------------------------------------------------------------------
II Z-017/018-6 204 46 250
Prosthesis, penis, inflatable
-----------------------------------------------------------------------------------------
III Z-163/164-5 74 73 147
Ventilator, continuous (respirator)
-----------------------------------------------------------------------------------------
I Z-935-6 469 \a \a
II Z-1375/1377-4 22 22 44
II Z-817-5 212 192 404
II Z-830-4 396 390 786
II Z-264/266-5 627 10 637
II Z-144-5 213 151 364
II Z-571-6 633 \a \a
II Z-496-5 912 \a \a
II Z-454-5 919 \a \a
II Z-041/044-5 782 \a \a
II Z-831-4 1,044 \a \a
II Z-593-5 562 \a \a
II Z-769/760-6 176 \a \a
-----------------------------------------------------------------------------------------
Note: The table includes recalls for products whose distribution
dates occurred both before and after August 29, 1993.
\a As of January 16, 1998, FDA had not received a summary recall
recommendation report from the district office and, therefore, had
not approved the recall for termination.
\b Recall was classified as a safety alert.
Sources: Center for Devices and Radiological Health and Office of
Regulatory Affairs, FDA.
*** End of document. ***