II

106TH CONGRESS

1ST SESSION S. 1542

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.

IN THE SENATE OF THE UNITED STATES

AUGUST 5, 1999

Mr. DURBIN introduced the following bill; which was read twice and referred

to the Committee on Health, Education, Labor, and Pensions

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.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This title may be cited as the ‘‘Reprocessed Single

5 Use Medical Device Patient Safety Amendments of 1999’’.
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1 SEC. 2. REPROCESSED MEDICAL DEVICES.

2 Subchapter A of chapter V of the Federal Food,

3 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend4 ed by adding at the end the following:

5 ‘‘SEC. 524. REPROCESSED MEDICAL DEVICES.

6 ‘‘(a) FINDINGS.—Congress makes the following find7 ings:

8 ‘‘(1) The Food and Drug Administration has

9 information indicating that some reprocessed med10 ical devices labeled for single use have been associ11 ated with serious injury and that reprocessed med12 ical devices labeled for single use have the potential

13 to cause injury.

14 ‘‘(2) Reprocessed medical devices labeled for

15 single use are being used on patients without their

16 knowledge, against original manufacturers’ warn17 ings, and without a determination by the Food and

18 Drug Administration that such devices are safe and

19 effective.

20 ‘‘(3) The reprocessing of devices that are la21 beled for single use is currently occurring without

22 premarket approval by or notification to the Food

23 and Drug Administration, such as is required for

24 certain devices under sections 510 and 515.

25 ‘‘(4) The Food and Drug Administration should

26 have the knowledge and expertise to evaluate the
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1 safety and effectiveness of reprocessed medical de2 vices labeled for single use.

3 ‘‘(5) Enforcement by the Food and Drug Ad4 ministration of the provisions of this Act that ad5 dress the safety and effectiveness of devices is the

6 only effective way to protect patients exposed to re7 processed medical devices labeled for single use.

8 ‘‘(6) The United States public deserves to know

9 that all devices regulated by the Food and Drug Ad10 ministration are safe and effective and that the ap11 propriate level of oversight is being implemented in

12 order to guarantee such safety and effectiveness.

13 ‘‘(b) PURPOSE.—The purpose of this section is to—

14 ‘‘(1) require that the Food and Drug Adminis15 tration implement all provisions of this Act that are

16 applicable to reprocessed medical devices, including

17 device registration, listing, and premarket safety

18 controls; and

19 ‘‘(2) require the informed consent of patients

20 prior to using reprocessed class II and class III

21 medical devices.

22 ‘‘(c) REGISTRATION.—Every person or establishment

23 engaged in the reprocessing of a device labeled for single

24 use shall—
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1 ‘‘(1) upon first engaging in the reprocessing of

2 such device, register with the Secretary and provide

3 all information required in accordance with section

4 510(c);

5 ‘‘(2) for each year in which the person or estab6 lishment engages in the reprocessing of such device,

7 register with the Secretary and provide all informa8 tion required under section 510(b); and

9 ‘‘(3) for each year in which the person or estab10 lishment engages in the reprocessing of such device,

11 submit to the Secretary a list of devices labeled for

12 single use that the person or establishment is re13 processing, including the names of the original

14 equipment manufacturers of such devices and the

15 specific models of such devices that are reprocessed.

16 ‘‘(d) INFORMATION.—Every person or establishment

17 engaged in the reprocessing of a device labeled for single

18 use shall, for each reprocessed medical device, provide to

19 each person or establishment that uses such reprocessed

20 medical device, information necessary for such person or

21 establishment to comply with subsection (f).

22 ‘‘(e) SAFETY AND EFFECTIVENESS.—Every person

23 or establishment required to register under subsection (c)

24 with respect to a device shall demonstrate to the Secretary

25 that such reprocessed device is safe and effective or sub-
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1 stantially equivalent to a device the Secretary has deemed

2 safe and effective. The Secretary may exempt class I de3 vices from the requirements of this subsection.

4 ‘‘(f) INFORMED PATIENT CONSENT AND MEDICAL

5 RECORDS.—

6 ‘‘(1) IN GENERAL.—Every person or establish7 ment that uses a class II or class III reprocessed

8 medical device to provide medical care to an indi9 vidual shall seek informed consent from the patient

10 for the use of such a device.

11 ‘‘(2) MEDICAL RECORDS.—

12 ‘‘(A) IN GENERAL.—Every person or es13 tablishment that uses a class II or class III re14 processed medical device to provide medical

15 care to an individual shall keep a record of such

16 use and include a note of such use in such indi17 vidual’s medical record.

18 ‘‘(B) CONTENTS.—The contents of the

19 record described in paragraph (1) shall

20 include—

21 ‘‘(i) the name and place of business of

22 the person or establishment that reproc23 essed the device labeled for single use and

24 the batch or lot number of such device;

25 and
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1 ‘‘(ii) the identity of the original manu2 facturer of the device.

3 ‘‘(g) REPORT.—Not later than 9 months after the

4 date of enactment of this section, the Secretary shall sub5 mit a report to the Committee on Commerce of the House

6 of Representatives and the Committee on Health, Edu7 cation, Labor, and Pensions of the Senate that describes

8 findings from current Food and Drug Administration

9 studies (as of the date of submission) on the safety and

10 efficacy of reprocessing of devices labeled for single use.

11 ‘‘(h) MEDWATCH.—Not later than 6 months after the

12 date of enactment of this section, the Secretary shall mod13 ify the MEDWATCH forms to facilitate reporting of infor14 mation relating to reprocessed medical devices, including

15 the name of a reprocessor and the number of times a de16 vice has been reused.

17 ‘‘(i) APPLICATION.—All other sections of this Act

18 that govern devices as defined in section 201(h) shall also

19 apply to reprocessed medical devices, if applicable.

20 ‘‘(j) DEFINITIONS.—In this section:

21 ‘‘(1) REPROCESSED MEDICAL DEVICE.—The

22 term ‘reprocessed medical device’ means a device

23 that—

24 ‘‘(A) is labeled for single use, or is dispos25 able and intended for single use; and
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1 ‘‘(B) is cleaned or sanitized after use in

2 order that such a device may be reused upon

3 another individual.

4 ‘‘(2) REPROCESSING.—The term ‘reprocessing’

5 means a procedure employed in order to produce a

6 reprocessed medical device.’’.

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