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Medical Device Reprocessing

We reproduce abstracts of a recent debate regarding use of reconditioned medical devices highlighted by "Washignton Post " under the heading , "Hospitals Save Money, But Safety Is Questioned " .

The Association of Medical Device Reprocessors counters it by giving various facts listed below and concludes by saying that .

"We are deeply disappointed that the investigation failed to compare the safety profile of reprocessed devices to that of the original equipment manufacturers. The Post missed its opportunity to provide a valuable public service, which we believe would have found that reprocessed devices are every bit as safe, if not safer than original devices.

Reprocessing saves valuable health care dollars, which hospitals can use to provide better access to care, more staff, and better technology. Reprocessing eliminates over 900 tons of medical waste per year. The nation's third-party reprocessors are committed to providing safe products at a fraction of the cost."

The Washington Post - Abstracts ( DEC. 11, 2005 )

Unlike consumer products, medical devices are often used internally and require a much higher degree of reliability. There are a number of issues that make the practice potentially problematic even though hospitals vouch for their safety and dependability.

Some possible areas where difficulties may arise are as follow:

  • Hospitals are not required to inform patients that a recondition medical device will be used in a procedure or surgery.

  • The reconditioned devices are not guaranteed by the original manufacturer.

  • Manufacturers warn against reusing of one-time medical devices and will not vouch for their safety after being reconditioned.

  • While hospitals maintain sterilization of reconditioned devices is thorough and even meticulous, the fact that they have been used before makes it impossible to guarantee the same degree of safety as an unused, sterilized, and sealed devices.

  • There are numerous reported cases of reconditioned medical devices breaking or malfunctioning during reuse with anywhere from minor to catastrophic consequences.

  • One-time -use products are approved under a different standard than multiple-use devices. The one-time-use devices are often opted for by manufacturers because they do not have to be as sturdy and the manufacturer's exposure to liability will be greatly diminished. One-time-use devices also ensure "a steady stream of replacement orders.

Hospitals see reconditioned medical devices as a significant cost-cutting measure since they regard the one-time-only "designation as a manufacturer's ploy to force them to buy more devices then they need." Thus, it is becoming more common for hospitals to ignore warnings against reuse.

Statement From the Association of Medical Device Reprocessors
( Abstracted from a report on www.complianceonline.com )

Editor's Note: The following is an updated version of a statement that previously ran on washingtonpost.com Sunday, Dec. 11 and Monday, Dec. 12.

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