In the United States, there are approximately 70 different single-use medical devices that are approved by the Food and Drug Administration (FDA) for reuse. These include everything from elastic bandages (low-risk items) to intra-vascular catheter, needles and syringes (medium-risk items) to implanted infusion pumps (high-risk items). While the general consensus is that reprocessing of single-use medical devices is safe, there are some risks associated with this practice.

The Reprocessing Procedure

For medium- and high-risk single-use items, there are a strict set of guidelines in place when it comes to how and under what circumstances reprocessing is allowed to be carried out. Take a single use intra-vascular catheter as the example, such as those used to assess the status of blood vessels or to determine the presence and severity of varicose veins or spider veins. First, the hospital or third-party reprocesser must prove that they comply with a number of requirements, such as: submitting the appropriate documents for pre-market notification/approval, registering and listing all reprocessed products, submitting adverse event reports, tracking devices whose failure could potentially have serious adverse outcomes, correcting or removing unsafe reprocessed materials from the market, and meeting manufacturing and labeling requirements. In addition, FDA approval must be obtained for each hospital and device, and regular FDA inspections should be carried out.

Pros and Cons of Reprocessing

For hospitals and clinics, the No. 1 benefit of reprocessing single-use medical devices is saving money. A single-use intra-vascular catheter can cost up to $5,000. It is also possible that products that actually can be used more than once are labelled as single use in an effort to make the manufacturers more money.

The second-biggest advantage of reusing certain devices is the positive effect on the environment. In the United States, the health care industry is currently second only to the food industry in creating waste and landfill with approximately four billion pounds of medical waste being created each year. Thus, by reprocessing certain devices, the amount of landfill could be greatly reduced.

However, there are also several risks associated with this practice. Although the FDA has approved the use of reprocessed single-use catheters, there are still some safety concerns. First, there is a risk of cross infection even in developed countries. In extremely rare cases, certain devices may be contaminated by bacterial toxins or prions, which are much harder to remove than the bacteria themselves or viruses, and if the disinfection protocol is inadequate or inappropriate, there is a risk of transmission of these. Second, depending on the disinfection protocol, there may be chemical residue left on the device. Lastly, if a device has been reused repeatedly, there is a small risk of mechanical failure or of alteration to the device material. All of these risks must be taken into consideration and weighed against the pros.

Educate Yourself

Unfortunately, not all doctors will voluntarily disclose whether or not a single-use device is utilized, so it is important to get as much information as possible from different sources before any given procedure. By knowing the potential risks and benefits involved, you can make an informed decision and learn which questions to ask your doctor or vein specialist.

While there are certainly great advantages to reprocessing single-use medical devices, this practice is associated with significant, albeit very rare, inherent risks. As a patient, you have a right to know whether or not the devices used during your procedure are reprocessed or not and a right to choose not to use reused materials if you do not feel comfortable doing so.