[Congressional Record (Bound Edition), Volume 145 (1999), Part 19]
[Extensions of Remarks]
[Page 26913]
[From the U.S. Government Publishing Office, www.gpo.gov]



                     A CONSUMER PROTECTION PROPOSAL

                                 ______
                                 

                            HON. FRED UPTON

                              of michigan

                    in the house of representatives

                       Tuesday, October 26, 1999

  Mr. UPTON. Mr. Speaker, I rise today to join my colleague and friend, 
Rep. Anna Eshoo, in introducing important consumer protection 
legislation. This legislation addresses the safety of medical devices 
which are designed to be used once but which are reprocessed for 
further use.
  In correspondence to Rep. Eshoo, the Food and Drug Administration 
(FDA) ``agrees that the reuse of disposable medical devices and devices 
labeled for a single use is a very important public health issue.'' The 
agency further indicates that cleaning and sterilizing these devices 
can be very difficult and that material properties and device 
performance can be affected by resterilization. Yet single use device 
reprocessors, which may be companies specializing in this practice or 
hospitals or other health care facilities, are unregulated. They are 
not required to register with the FDA or to provide convincing evidence 
that the processes they use are appropriate and that the reprocessed 
devices are safe and effective.
  Our legislation would correct this loophole in the Federal Food, 
Drug, and Cosmetic Act by requiring single use device reprocessors to 
register with the FDA and to demonstrate the safety and effectiveness 
of reprocessed devices. The bill will also require device users to 
obtain informed patient consent for the use of the device and establish 
a system whereby the safety and effectiveness of the devices when 
actually used in patient care may be tracked.
  I urge my colleagues to join me supporting this important consumer 
protection measure.

                          ____________________