The re-use of single-use medical devices has again attracted the attention of the popular media, this time the Wall Street Journal.
The article quotes a study of devices manufactured by Medtronic. The study found that new devices were of excellent quality but “a majority of reprocessed devices had corroded parts and traces of human hair and protein, bringing into question the effectiveness of the reprocessing efforts.”
This stands in stark contrast to the comments from Kenneth Kizer, MD, MPH who stated “single-use labeling is a real scam for a lot of devices, and by not using reprocessed devices where possible it is wasteful and not environmentally responsive, since these items have to be disposed of as biomedical waste.” Dr. Kizer continues: “The reuse of medical devices that are labeled for single-use only is a well-established and safe practice regulated by the FDA and utilized by most of the top-ranked hospitals in the country.”
This is only partly true. The FDA strictly regulates the original device. The FDA has some oversight for reprocessing but it was only 2002 that the FDA required these devices to be marked as reprocessed. Safety has yet to be definitively determined. Top hospitals re-use to save money, not to improve care. After all what patient would say his/her care is improved by implanting “corroded parts and traces of human hair and protein” into him/her? Some hospitals may be concerned about waste material but only because they pay to haul it away.
For now the safest thing for patients is to insist on disclosure of the use of reprocessed devices. If reprocessed devices are to be used ask about cost differences to you the patient. Do not hesitate to insist on new devices- especially if there’s no cost difference and now demonstrable equality of quality.
It’s your health. Take it seriously and take care.