[Congressional Record (Bound Edition), Volume 145 (1999), Part 19]
[Extensions of Remarks]
[Page 26904]
[From the U.S. Government Publishing Office, www.gpo.gov]


[[Page 26904]]

REPROCESSED SINGLE USE MEDICAL DEVICE PATIENT SAFETY AMENDMENTS OF 1999

                                 ______
                                 

                           HON. ANNA G. ESHOO

                             of california

                    in the house of representatives

                       Tuesday, October 26, 1999

  Ms. ESHOO. Mr. Speaker, I rise to express my grave concerns about the 
practice of reprocessing and reusing single-use medical devices. There 
have been several recent media reports of medical devices intended for 
one use only being cleaned and used again on a different patient. 
Delicate devices, such as balloon catheters and biopsy forceps, are 
being reused on patients and causing infection and injuries.
  It's estimated that as many as one in every three hospitals are 
reprocessing and reusing medical devices intended for single-use only. 
They are doing it without the consent of the patient and they are 
charging Medicare and the Federal Government the full price of a new 
device.
  This practice is both deceptive and dangerous. Unsterile, brittle 
devices are injuring patients. A recent article in U.S. News & World 
Report told of a 50-year old woman who needed surgery when two 
reprocessed catheters broke during a brain scan. Premature babies have 
suffered infections from unsterile sutures. A biopsy patient was 
contaminated with hepatitis B from reused biopsy forceps.
  Mr. Speaker, FDA clearly has the authority to regulate the practice 
of reusing medical devices yet it has failed to do so. Representative 
Upton and I are introducing legislation today to ensure FDA regulation 
so that patients are protected. Our bill, the Reprocessed Single Use 
Medical Device Patient Safety Act of 1999, will require reprocessed 
medical devices to undergo pre-market approval for safety and 
effectiveness. The bill will also require hospitals to get a patient's 
informed consent before reusing a single-use medical device on them. 
Finally, the bill will require hospitals to monitor and report any 
injuries or infections that occur as a result of using a reprocessed 
medical device.
  I understand the fiscal constraints hospitals are under. Managed 
health care has cut their payments so drastically that they feel 
pressured to cut costs wherever possible. However, we can't continue 
putting patients at risk in order to save a few dollars. We must put 
patients before profits. I urge my colleagues' support for the 
Reprocessed Single Use Medical Device Patient Safety Act of 1999.

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