I
106TH CONGRESS
1ST SESSION
H. R. 3148
To amend the Federal Food, Drug, and Cosmetic Act to require any person
who reprocesses a medical device to comply with certain safety require-
ments, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
OCTOBER 26, 1999
Ms. ESHOO (for herself and Mr. UPTON) introduced the following bill; which
was referred to the Committee on Commerce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to
require any person who reprocesses a medical device
to comply with certain safety requirements, and for other
purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This title may be cited as the ‘‘Reprocessed Single
Use Medical Device Patient Safety Act of 1999’’.
SEC. 2. REPROCESSED MEDICAL DEVICES.
Subchapter A of chapter V of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
ed by adding at the end the following:
‘‘SEC. 524. REPROCESSED MEDICAL DEVICES.
‘‘(a) FINDINGS.—Congress makes the following find-
ings:
‘‘(1) The Food and Drug Administration has
information indicating that some reprocessed med-
ical devices labeled for single use have been associ-
ated with serious injury and that reprocessed med-
ical devices labeled for single use have the potential
to cause injury.
‘‘(2) Reprocessed medical devices labeled for
single use are being used on patients without their
knowledge, against original manufacturers’ warn-
ings, and without a determination by the Food and
Drug Administration that such devices are safe and
effective.
‘‘(3) The reprocessing of devices that are la-
beled for single use is currently occurring without
premarket approval by or notification to the Food
and Drug Administration, such as is required for
certain devices under sections 510 and 515.
‘‘(4) The Food and Drug Administration should
have the knowledge and expertise to evaluate the
safety and effectiveness of reprocessed medical de-
vices labeled for single use.
‘‘(5) Enforcement by the Food and Drug Ad-
ministration of the provisions of this Act that ad-
dress the safety and effectiveness of devices is the
only effective way to protect patients exposed to re-
processed medical devices labeled for single use.
‘‘(6) The United States public deserves to know
that all devices regulated by the Food and Drug Ad-
ministration are safe and effective and that the ap-
propriate level of oversight is being implemented in
order to guarantee such safety and effectiveness.
‘‘(b) PURPOSE.—The purpose of this section is to—
‘‘(1) require that the Food and Drug Adminis-
tration implement and enforce all provisions of this
Act that are applicable to reprocessed medical de-
vices, including device registration, listing, and pre-
market safety controls; and
‘‘(2) require the informed consent of patients
prior to using reprocessed class II, class III, and
critical class I medical devices.
‘‘(c) REGISTRATION.—Every person or establishment
engaged in the reprocessing of a device labeled for single
use shall—
‘‘(1) upon first engaging in the reprocessing of
such device, register with the Secretary and provide
all information required in accordance with section
510(c);
‘‘(2) for each year in which the person or estab-
lishment engages in the reprocessing of such device,
register with the Secretary and provide all informa-
tion required under section 510(b); and
‘‘(3) for each year in which the person or estab-
lishment engages in the reprocessing of such device,
submit to the Secretary a list of devices labeled for
single use that the person or establishment is re-
processing, including the names of the original
equipment manufacturers of such devices and the
specific models of such devices that are reprocessed.
‘‘(d) INFORMATION.—Every person or establishment
engaged in the reprocessing of a device labeled for single
use shall, for each reprocessed medical device, provide to
each person or establishment that uses such reprocessed
medical device, information necessary for such person or
establishment to comply with subsection (f).
‘‘(e) SAFETY AND EFFECTIVENESS.—Not later than
6 months after the date of enactment of this section, every
person or establishment required to register under sub-
section (c) with respect to a device shall, before intro-
ducing into interstate commerce a reprocessed medical de-
vice labeled for single use, meet the requirements of sec-
tions 510(k) and 515 to demonstrate to the Secretary that
such reprocessed device is safe and effective or substan-
tially equivalent to a device the Secretary has deemed safe
and effective.
‘‘(f) INFORMED PATIENT CONSENT AND MEDICAL
RECORDS.—
‘‘(1) IN GENERAL.—Every person or establish-
ment that uses a class II, class III, or critical class
I reprocessed medical device to provide medical care
to an individual shall seek informed consent from
the patient for the use of such a device.
‘‘(2) MEDICAL RECORDS.—
‘‘(A) IN GENERAL.—Every person or es-
tablishment that uses a class II, class III, or
critical class I reprocessed medical device to
provide medical care to an individual shall keep
a record of such use and include a note of such
use in such individual’s medical record.
‘‘(B) CONTENTS.—The contents of the
record 
described 
in 
paragraph 
(1) 
shall
include—
‘‘(i) the name and place of business of
the person or establishment that reproc-
essed the device labeled for single use and
the batch or lot number of such device;
and
‘‘(ii) the identity of the original manu-
facturer of the device.
‘‘(g) REPORT.—Not later than 9 months after the
date of enactment of this section, the Secretary shall sub-
mit a report to the Committee on Commerce of the House
of Representatives and the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate that describes
findings from current Food and Drug Administration
studies (as of the date of submission) on the safety and
efficacy of reprocessing of devices labeled for single use.
‘‘(h) MEDWATCH.—Not later than 6 months after the
date of enactment of this section, the Secretary shall mod-
ify the MEDWATCH forms to facilitate reporting of infor-
mation relating to reprocessed medical devices, including
the name of a reprocessor and the number of times a de-
vice has been reused.
‘‘(i) APPLICATION.—All other sections of this Act
that govern devices as defined in section 201(h) shall also
apply to reprocessed medical devices, if applicable.
‘‘(j) DEFINITIONS.—In this section:
‘‘(1) CRITICAL CLASS I MEDICAL DEVICE.—The
term ‘critical class I medical device’ means a device
that may break the mucosal boundary, may be intro-
duced in the bloodstream, or may be introduced into
other than normally sterile areas of the body.
‘‘(2) REPROCESSED
MEDICAL
DEVICE.—The
term ‘reprocessed medical device’ means a device
that—
‘‘(A) is labeled for single use, or is dispos-
able and intended for single use; and
‘‘(B) is cleaned or sanitized after use in
order that such a device may be reused upon
another individual.
‘‘(3) REPROCESSING.—The term ‘reprocessing’
means a procedure employed in order to produce a
reprocessed medical device.’’.
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