Greedy Trial Lawyer
Fraud On Surgical Patients - Hospitals Are Re-Using Medical Devices
Category: Torts For Our Time
If an auto mechanic repaired your 2004 Explorer with used parts without telling you, would the word fraud come to mind? How would you feel if a hospital used reconditioned, used medical devices during your surgery or, worse, implanted them in your body, without your consent? I would feel used. And, I would believe a jury of my peers would feel the fraudulent use of such devices would justify both compensatory and punitive damages, especially when the used part failed.
The Washington Post details the growing practice of reconditioning and using medical devices despite manufacturer warnings and reports of serious consequences to patients. The excellent article states, in part:
Hospital cost-cutting may outweigh safetyReprocessing of one-time use devices gains popularity despite warnings
A growing number of U.S. hospitals, including at least eight in the Washington area, are saving money by reusing medical devices designated for one-time use, ignoring the warnings of manufacturers, which will not vouch for the safety of their reconditioned products.
Hospitals are not required to tell patients that reconditioned devices will be used in surgery -- surgeons themselves often do not know. The Food and Drug Administration regulates the practice, and many hospital administrators say reusing single-use devices is not only cost effective but also poses no threat to patients because the instruments are cleaned with such care that they are as good as new.
But single-use devices have malfunctioned during reuse, federal records and interviews show. In one instance, an electrode from a catheter broke off in a patient's heart. In another, a patient's eyeball was impaled. And an infant who for months gagged and retched on a resterilized tracheal tube now can take food only from a tube attached to his stomach.
The Washington Post examined thousands of pages of documents, including FDA records, court filings and internal company reports, and was able to document dozens of cases of patient injuries and device malfunctions after single-use devices were reused over the past decade.In one case in March 1998, cardiologist Peter Karpawich removed from a child's body a single-use catheter, which was handed to a nurse. The device tip appeared to be twisted, and the shaft at one end of the catheter had separated from its bonding. After investigating, manufacturer Boston Scientific Corp. told the FDA that the problems were "likely due to aggressive disinfecting and cleaning between uses."
While hospitals reprocess in-house, they are increasingly sending their used devices to outside companies to clean and resterilize. The three biggest U.S. reprocessors, which dominate the industry, declined to disclose the hospitals they serve but said they have 3,370 accounts. There are about 4,800 U.S. hospitals, according to the American Hospital Association. Last year, the big three reprocessors said they refurbished about 4.6 million single-use devices, which were used in medical procedures involving almost every part of the body.
Device makers say the single-use tag is not just a label. "Single-use devices typically contain difficult-to-access areas that create barriers to cleaning and permit blood, tissue or other bodily fluids to contaminate the reprocessed device, allowing potential transmission of viral and bacterial infections," said Stephen J. Ubl, president and chief executive of the Advanced Medical Technology Association, which represents device makers worldwide.
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