Healthcare Industry News:  Association of Medical Device Reprocessors 

Devices

 News Release - August 8, 2006

Associated Press Stories on Reprocessing Recklessly Mislead Readers

Response from the Association of Medical Device Reprocessors

WASHINGTON, Aug. 8 (HSMN NewsFeed) -- Recent reports by the Associated Press (AP) on medical device reprocessing, "Recycling Medical Devices Raises Concerns" (July 30 and 31, 2006) and "Patient Advocates Urge NJ to Limit Medical Device Recycling" (August 1, 2006), contain patently false and misleading information. In a tremendous disservice to readers, AP reporter Linda Johnson misinformed readers as to the true safety record of commercial medical device reprocessing.
  • The AP reported that, since early 2004, FDA has "received 13 reports of patient deaths" from the use of reprocessed medical devices. Contrary to Ms. Johnson's report, FDA's own database for the same time period reveals ZERO patient deaths attributed to reprocessed devices. FDA's database of medical device adverse events is freely available via the Internet for anyone to search for him/herself (link provided below).

  • Significantly, the AP also failed to inform readers that, for the same time period, January 1, 2004 to the present, FDA's adverse event database contains over 6,500 reports of patient deaths associated with original (unreprocessed) devices! In light of the fact that unreprocessed (original) equipment must be used if reprocessed equipment is not, it is irresponsible for the AP to report that there are alleged safety problems associated with using reprocessed equipment but fail to put this information in context by describing the safety record of original equipment.

  • FDA-regulated, third-party reprocessors in the U.S. have reprocessed over 40 million devices with no evidence, from any source, of an increased risk to patient safety. Reprocessors' safety record is every bit as good as, if not better than, the safety record of the original equipment manufacturers (OEMs). AMDR made its members' safety record (link provided below) available to the AP reporter, and yet this information was omitted from the story. Readers have a right to know these facts.

  • The AP story attempts to instill panic in readers through the use of an outdated, irrelevant example. The tragic incident of Sean Van Duyn's injury from the use of a defective breathing tube is a blatant attempt to inflame readers' emotions, but has nothing to do with FDA-regulated device reprocessing in the U.S. today. Our understanding is that the incident, nearly 6 years old, involved in-hospital cleaning and sterilization, and occurred at a time when, unlike commercial reprocessors, hospitals that cleaned and sterilized "single use" devices in-house were not subject to FDA regulation. The Van Duyn case is outdated as an example of the alleged risks associated with the reuse of "single use" devices because hospitals that perform their own reprocessing have since been subject to the full range of FDA medical device manufacturer requirements (since 2002). Moreover, today, the vast majority of reprocessing of "single use" devices in the U.S. is done by third-party companies, which have always been stringently regulated by FDA. Further, "single use" tracheal tubes like those used on Sean Van Duyn are not reprocessed by third-party reprocessors in the U.S. Despite being provided with this information, the AP failed to include it. Ms. Johnson's tarring of the commercial reprocessing industry by indiscriminate use of a dated example of harm caused by inadequate procedures at one hospital is inaccurate, misleading and unfairly damaging to an industry with a stellar safety record.

  • The AP failed to report that the "single use" label is used at the manufacturer's discretion, often as a way to sell more devices, and that the designation of a device as "single use" is not an FDA requirement. Indeed, "single use" does not always mean that a device is not suitable for reprocessing, as evidenced by the fact that some OEMs now reprocess their own "single use" devices, and some have changed the labels on certain "reusable" devices to "single use" without significantly changing the devices. We shared all of this information with the AP, and yet none of these facts were included in the final story.

  • Ms. Johnson's second story on reprocessing, "Patient Advocates Urge NJ to Limit Medical Device Recycling" (August 1, 2006) falsely implied that reprocessed "single use" devices may put patients at risk of contracting Creutzfeldt-Jakob Disease. In fact, AMDR's search of FDA's publicly available database shows that no reprocessors reprocess any neurological devices, or any devices that potentially pose a risk of CJD transmission. AMDR provided this information to Ms. Johnson days before her story ran, and yet the article failed to mention this fact. Indeed, the article omitted any statement, at all, from the reprocessing industry.

  • Obtaining informed consent from patients for the use of reprocessed "single use" devices does nothing to increase patient safety nor does it provide patients with any meaningful information about the actual risks and benefits of the medical procedures they are about to undergo. Reprocessed devices are as safe and effective as original equipment, and there is no evidence that the use of reprocessed devices increases the risks associated with a medical procedure. Reprocessed devices are legally marketable devices that are subject to stringent regulation by FDA. These regulations compel reprocessors to comply with all of the requirements applicable to original devices, including premarket clearance and approval requirements, along with some additional requirements applicable only to reprocessors. These are not investigational or experimental devices. It is not good or standard medical practice to obtain informed consent to use legally marketed medical devices, and there is no legal, medical or ethical basis for imposing a requirement to seek informed consent for the use of reprocessed devices but not for the use of original devices.
AMDR Demands that the AP Retract False and Misleading Statements and Issue Certain Clarifications Regarding Reprocessed Medical Devices

By failing to check its facts and by reporting clearly erroneous information, the AP has violated the public's trust. AMDR demands that the AP issue a retraction and correction to all media outlets that received the original story. The public counts on the AP to deliver the facts, and to correct itself when erroneous information is presented as fact.

The AP retraction and clarification should inform the public that:
  1. FDA's own database reports zero patient deaths attributed to reprocessed devices since January 1, 2004. To give fair perspective, the AP should also report that FDA's adverse event database contains over 6,500 reports of patient deaths associated with original (unreprocessed) devices in the same time period.

  2. The Van Duyn example cited in the original AP story was misleading to readers as it has no relevance to FDA-regulated device reprocessing in the U.S. today. The AP should also inform readers that no third-party firms in the U.S. today reprocess tracheal tubes.

  3. The second AP article, which focused on the alleged risk of CJD transmission by use of reprocessed devices, was misleading and irrelevant because no reprocessors in the U.S. today reprocess any neurological devices, or those that potentially pose a risk of CJD transmission.

  4. The AP articles failed to inform readers that the "single use" label often serves as a marketing tool, and is not a designation required by FDA.

  5. The AP should clarify that a patient's informed consent is typically only obtained prior to procedures that may pose an increased risk to the patient, that there is no evidence suggesting that reprocessed devices increases a patient's risk, and that there is no medical, legal, or ethical basis to require informed consent for the use of reprocessed devices.
Reprocessing in the U.S. is safe, FDA-regulated, environmentally responsible, and helps to contain spiraling health care costs. The AP missed an opportunity to provide a valuable public service. Had the AP's story been based on the facts, it would have shown that reprocessed devices are every bit as safe, if not safer, than original devices. Readers have a right to accurate, unbiased reporting, and AMDR therefore demands that the AP retract its misstatements, and provide readers with factual information about medical device reprocessing.

* FDA's MAUDE Database
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM

* AMDR's Adverse Event Spreadsheet
http://www.amdr.org/documents/AMDRMDRSpreadsheet.pdf

* FDA's Listing database
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/listing.cfm

* AMDR's Device Listing
Spreadsheet
http://www.amdr.org/documents/ReprocessedDevicesMasterListingSortedByNumber.pdf

* AMDR's Web site
http://www.amdr.org


Source: Association of Medical Device Reprocessors

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