Single-use devices (SUD) and instruments may offer the benefit of using a new tool for each procedure, but a study published in the Journal of Medical Devices found inconsistent quality and higher rate of defects for these items.
To learn more about this study, Surgical Products connected with study author Dr. Terrence Loftus.
What prompted this study?
Loftus: Banner Health uses Clinical Consensus Groups to help guide clinical practice development for the system. I was the co-lead for the Surgery Clinical Consensus Group when the topic of reprocessing was brought to this group for their input. There was a great deal of passionate debate around the topic with surgeons both for and against reprocessing. We couldn’t get the group to arrive at a consensus. Finally, one of the surgeons asked if it was possible to pull data on this. It took a while to find out where this data was stored. When I did find it, it was stored in two different databases in Supply Chain Services and not in our Quality Department as we assumed. I was also working with our VP of Supply Chain Services at the time, developing a Value Analysis Program, so I was able to access the data and analyze it.
What were you expecting to find?
Loftus: I thought there would be one of two answers. Many of the surgeons believed, at the time, that reprocessed devices (RP) would have a greater defect rate compared to the original equipment manufacturer devices (OEM). There was a great deal of support for this perception so this was our number one expectation. The other belief, which was supported by the reprocessing representatives, was that the defect rates would be equivalent, so this was the other possible expectation.
How did this compare to what you found?
Loftus: What no one expected was that the OEM devices would have a defect rate that was 4.9 times greater than the RP devices.
How important is this gap in quality?
Loftus: The defect rate for OEM was on average, 2 percent. The defect rate for RP was on average, 0.41 percent. The gap between the two is about 1.5 percent, however the perception of the defect rates is the opposite of the results in this study. The most important lesson to learn from this is, when in doubt, check the data. It was amazing how confident people were in their perception without having any data to support it. When we tested this, we wanted to understand how these devices performed under real world conditions.
For the purposes of this study, “defective” was defined as any time a member of the surgical team (surgeon, scrub tech, first assistant, or circulating nurse) determined that the bipolar and ultrasound diathermy device was not functioning in a manner consistent with the devices intended purpose. This takes it out of the laboratory testing environment and into the operating room environment where it really counts. The other thing to remember is that this defect rate is most likely a result of how the product is tested before it is packaged and shipped to the hospital. Batch testing is the accepted, and FDA approved, methodology. RP devices are all tested prior to shipping. It may be that the gap of 1.5 percent is explained by the manner in which each device is tested. If all OEM devices were tested in a similar manner, then we could see equivalent outcomes. This would, no doubt, raise the cost of producing the OEM devices. Since RP devices are roughly half the cost of OEM devices, this would still shift the value buy to RP devices. The other thing to keep in mind is that OEM devices are the supply chain for RP devices. OEM devices found to be defective are pulled out of that supply chain, therefore decreasing the likelihood of passing on a defective product into the RP product line. Either way, we are still going to need to use OEM devices if we are to use RP devices.
How will your findings impact how you approach future device selection?
Loftus: I think this study demonstrates that many of our fears regarding RP equipment, especially when performed by qualified companies, are not supported by testing under real world conditions. We will need to be more open to using RP equipment.
Loftus is a former medical director of surgical services and clinical resources at Banner Health. He is currently president of Loftus Health, a healthcare consulting company. He has no other relevant disclosures.
