United States General Accounting Office

GAO 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

GAO United States

General Accounting Office

Washington, D.C. 20548

Health, Education, and

Human Services Division

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 billion1

 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 Commerce3

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

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.

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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.

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.

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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.

Results in Brief 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

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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 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

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.

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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.

Experiences With Two

Problem Devices Gave

Rise to the Need for

Effective Tracking

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

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).

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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.

Medical Device Tracking

Provision of SMDA 90 and

FDA Enforcement

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

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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

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

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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.

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FDAMA Shifts

Responsibility for

Identifying Devices Subject

to Tracking From

Manufacturers to FDA

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 tracking12 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.

FDA’s Recall Process 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.

10S. Rep. No. 105-43, at 36, 37 (1997).

11FDAMA 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.

12FDAMA 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.

13FDA 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.

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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.)

FDA Inspections Do

Not Ensure

Manufacturers Can

Track Devices to End

Users

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

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

14Under 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)).

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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 Manual16 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

15The 1976 Medical Device Amendments mandated that FDA conduct biennial inspections of facilities

manufacturing class II and class III devices.

16The 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.

1721 C.F.R. § 820.180(c)(1998).

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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.

18Some 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.

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FDA Plans to Redirect

Inspections and Change Its

Audit Approach Toward

High-Risk Device

Manufacturers

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

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.

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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

Page 14 GAO/HEHS-98-211 Medical Device Tracking
B-280391 

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

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.)

19The manual provides guidance to field and headquarters staff on how to conduct regulatory matters,

both domestic and import.

Page 15 GAO/HEHS-98-211 Medical Device Tracking
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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.

Recalls of Tracked Devices

Were Not Completed

Within Required Time

Frames

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.)

20To 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.

Page 16 GAO/HEHS-98-211 Medical Device Tracking
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Table 1: Time Elapsed for

Manufacturers to Complete Recalls of

Tracked Devices, Fiscal Years 1994

Through 1996

Calendar days Number of recallsa 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

aFive 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

Workdays Number of 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

21To 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.

Page 17 GAO/HEHS-98-211 Medical Device Tracking
B-280391 

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.)

FDA Cites Several Possible

Factors as Contributing to

Delays

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 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

22To 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.

Page 18 GAO/HEHS-98-211 Medical Device Tracking
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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

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,

Page 19 GAO/HEHS-98-211 Medical Device Tracking
B-280391 

• 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

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,

Page 20 GAO/HEHS-98-211 Medical Device Tracking
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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.

Page 21 GAO/HEHS-98-211 Medical Device Tracking
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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.

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

Page 22 GAO/HEHS-98-211 Medical Device Tracking
Page 23 GAO/HEHS-98-211 Medical Device Tracking
Contents

Letter 1

Appendix I 

Scope and

Methodology

26

Appendix II 

Medical Devices

Subject to Tracking by

FDA

28

Appendix III 

FDA’s Medical Device

Recall Process

29

Appendix IV 

Recalls of Medical

Devices Subject to

Tracking

31

Tables Table 1: Time Elapsed for Manufacturers to Complete Recalls of

Tracked Devices, Fiscal Years 1994 Through 1996

17

Table 2: Time Elapsed for FDA to Terminate Recalls of Tracked

Devices, Fiscal Years 1994 Through 1996

17

Table II.1: Categories of Medical Devices Subject to FDA

Tracking

28

Table IV.1: Total Days Elapsed for Recalls During Fiscal Years

1994 Through 1996, by Device and Class

31

Page 24 GAO/HEHS-98-211 Medical Device Tracking
Contents

Abbreviations

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

SMDA 90 Safe Medical Devices Act of 1990

Page 25 GAO/HEHS-98-211 Medical Device Tracking
Appendix I 

Scope and Methodology

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;

23Emergency Care Research Institute, Medical Device Tracking Sourcebook, Manufacturers of Devices

Subject to Tracking Booklet, No. 3 (Aug. 1992).

24SMDA 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.

25In some cases, these recalls involved devices that were distributed both before and after August 29,

1993.

Page 26 GAO/HEHS-98-211 Medical Device Tracking
Appendix I 

Scope and Methodology

• 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.

Page 27 GAO/HEHS-98-211 Medical Device Tracking
Appendix II 

Medical Devices Subject to Tracking by FDA

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 implantable — Vascular graft prosthesis of less than 6 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

life-supporting used outside

device user facilities

— Breathing frequency monitors (apnea monitor),

including ventilatory efforts monitor

— 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

Page 28 GAO/HEHS-98-211 Medical Device Tracking
Appendix III 

FDA’s Medical Device Recall Process

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

26On 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.

Page 29 GAO/HEHS-98-211 Medical Device Tracking
Appendix III 

FDA’s Medical Device Recall Process

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.

Page 30 GAO/HEHS-98-211 Medical Device Tracking
Appendix IV 

Recalls of Medical Devices Subject to

Tracking

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

Class Recall number

Calendar days for

manufacturer

completion

Workdays for FDA

termination Total recall 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

(continued)

Page 31 GAO/HEHS-98-211 Medical Device Tracking
Appendix IV 

Recalls of Medical Devices Subject to

Tracking

Class Recall number

Calendar days for

manufacturer

completion

Workdays for FDA

termination Total recall days

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.

aAs 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.

bRecall was classified as a safety alert.

Sources: Center for Devices and Radiological Health and Office of Regulatory Affairs, FDA.

Page 32 GAO/HEHS-98-211 Medical Device Tracking
Appendix IV 

Recalls of Medical Devices Subject to

Tracking

(108337) Page 33 GAO/HEHS-98-211 Medical Device Tracking
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