You know how when you go to the doctor or dentist, hospital, or clinic, and they have to administer something…say, a shot or (heaven forbid) a surgical procedure….there is an expectation that the medical devices used on you are clean and in many cases, a disposable item. Most of us have noticed the box that says “sharps” where a nurse puts the used needle. There are many medical devices that are designated by their manufacturer and by the Food & Drug Administration (FDA) as “single use devices” that are meant to be disposed of after one use.
However, since the 1970s apparently, hospitals have been cleaning them and reusing them, with the blessing of the FDA, as a cost savings measure. Things like urethral catheters, endotracheal tubes, and cardiac angiography catheters and balloons. Why is it that an item designated by its manufacturer as a single use item can be reprocessed, i.e. washed off and repackaged, and put back to use in a medical setting?
The answer is money. A reprocessed item costs less than a new one.
The General Accounting Office (GAO) has investigated this use, and while they didn’t find much evidence of failures of reused devices, they did recommend regulation and monitoring. As far back as 2000, they expressed concerns about the reprocessing of single use devices and the need to audit facilities and companies that conduct the cleaning, sterilization and repackaging of these types of devices. Certainly some items, like those green sheets used in surgery rooms, are low on the concern-o-meter, but how about the instruments they use inside you? The orthopedic drill and saw used to perform a knee joint transplant or reconstruction of a broken bone after a horrific accident – that could have been used on someone else, and there is no telling what kind of ju-ju was in that person’s body. With historical cases of HIV having been transmitted via a dental drill, anything coming in contact with blood or bodily fluids really needs to be sparkling new before use. It just makes sense, right?
It is something that has bothered me for quite some time. When the people who make the item say it should be destroyed after one use, shouldn’t there be some consideration of that designation? Another question is whether the hospital bills your insurance or Medicare/Medicaid for a new or used item? Imagine the slush fund if they are billing for new but using reprocessed. Just think about it the next time you have to schedule some procedure, and be aware. The ick factor is high and patients have the right to know this is happening.
SINGLE-USE MEDICAL DEVICES; Little Available Evidence of Harm From Reuse, but Oversight Warranted, General Accounting Office, June 2000
Reprocessing of Single Use Devices, Food and Drug Administration website
Repositioning reprocessing: Hospitals see big potential for savings, but safety remains and issue for some; Modern Healthcare, July 6, 2013
Guideline for Disinfection & Sterilization in Healthcare Facilities, 2008; Centers for Disease Control