[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[S. 1542 Introduced in Senate (IS)]







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.

    Be it enacted by the Senate and House of Representatives 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 Amendments 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 amended by adding at the end the 
following:

``SEC. 524. REPROCESSED MEDICAL DEVICES.

    ``(a) Findings.--Congress makes the following findings:
            ``(1) The Food and Drug Administration has information 
        indicating that some reprocessed medical devices labeled for 
        single use have been associated with serious injury and that 
        reprocessed medical 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' warnings, and without a determination 
        by the Food and Drug Administration that such devices are safe 
        and effective.
            ``(3) The reprocessing of devices that are labeled 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 devices labeled for single 
        use.
            ``(5) Enforcement by the Food and Drug Administration of 
        the provisions of this Act that address the safety and 
        effectiveness of devices is the only effective way to protect 
        patients exposed to reprocessed medical devices labeled for 
        single use.
            ``(6) The United States public deserves to know that all 
        devices regulated by the Food and Drug Administration are safe 
        and effective and that the appropriate 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 Administration 
        implement all provisions of this Act that are applicable to 
        reprocessed medical devices, including device registration, 
        listing, and premarket safety controls; and
            ``(2) require the informed consent of patients prior to 
        using reprocessed class II and class III 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 establishment 
        engages in the reprocessing of such device, register with the 
        Secretary and provide all information required under section 
        510(b); and
            ``(3) for each year in which the person or establishment 
        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 reprocessing, 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.--Every person or establishment 
required to register under subsection (c) with respect to a device 
shall demonstrate to the Secretary that such reprocessed device is safe 
and effective or substantially equivalent to a device the Secretary has 
deemed safe and effective. The Secretary may exempt class I devices 
from the requirements of this subsection.
    ``(f) Informed Patient Consent and Medical Records.--
            ``(1) In general.--Every person or establishment that uses 
        a class II or class III 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 establishment 
                that uses a class II or class III 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 reprocessed the 
                        device labeled for single use and the batch or 
                        lot number of such device; and
                            ``(ii) the identity of the original 
                        manufacturer of the device.
    ``(g) Report.--Not later than 9 months after the date of enactment 
of this section, the Secretary shall submit a report to the Committee 
on Commerce of the House of Representatives and the Committee on 
Health, Education, 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 modify the MEDWATCH 
forms to facilitate reporting of information relating to reprocessed 
medical devices, including the name of a reprocessor and the number of 
times a device 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) Reprocessed medical device.--The term `reprocessed 
        medical device' means a device that--
                    ``(A) is labeled for single use, or is disposable 
                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.
            ``(2) Reprocessing.--The term `reprocessing' means a 
        procedure employed in order to produce a reprocessed medical 
        device.''.
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