What the reprocessors are going to have to do is be able to show that if they take a catheter and reprocess it six times, it still has the same shape, size and performance that it had originally, so poor Mrs. Smith doesn't have to worry if she happens to be sixth in line. Dr. Grossman refuses to use reprocessed single-use items in his practice. However, doctors who do use them, such as Bruce Lindsay, MD, associate professor of medicine at the Washington University School of Medicine in St. Louis, are also in favor of the FDA action because of concern that some hospitals or reprocessing companies may be more lax than others. But critics worry that added scrutiny will increase costs by pushing the recycling process out of the hospital and increasing use of new devices. Costs will go up.
Critics also say the rules allow too many exemptions.
Some items, available for many years and considered low-risk, are exempt from additional FDA approval if they are altered in minor ways. Under the new guidelines, the FDA allows those exemptions to cover reprocessed versions of the items as well. That is a very obvious and regrettable loophole. The AMA Council on Scientific Affairs is working on a report to be presented at the December Interim Meeting that will endorse the FDA's increased monitoring. The report also will emphasize that there is nothing wrong with using devices reprocessed within the bounds of these rules.