Karen Gierszewski and Sohaib Perwaiz
As we’ve discussed already
, medical device reprocessing is becoming an area of increasing interest and debate in the industry. Let’s take a look at the arguments for and against the reprocessing of medical devices in a bit more detail.
The Case For Reprocessing:
The Case Against Reprocessing:
- Environmental advantages: As expected, reprocessing can reduce waste from health care facilities by massive amounts. In fact, the health care industry is estimated to dispose of over four billion pounds of waste annually, coming in second only to the food industry in terms of waste contributions to landfills.
- Cost savings: As we mentioned before, reprocessed devices are far less expensive than the original equipment manufacturer (OEM)’s device. The cost of a reprocessed device is estimated to be about 50% of the original device, equalling substantial cost savings for facilities.
- Some industry acceptance: Again, as mentioned, big companies like Stryker and Ethicon Endo-Surgery have gotten on board with reprocessing with the acquisition of Ascent Healthcare Solutions and SterilMed, respectively. This makes it a bit easier for health care facilities to maintain their relationships with the OEMs while still using some reprocessed devices.
- Restricts R&D budgets for OEMs: With all the talk in the US about a potential innovation crisis , it’s no surprise that this topic ties in. Some people are arguing that the rising acceptance of reprocessed devices will substantially reduce revenues for OEMs, and therefore hinder their ability to invest in the development of new, innovative medical devices.
- Hard for smaller facilities to invest in: If small facilities split their purchases between OEMs and reprocessing companies, they may lose out on precious bulk discounts, potentially offsetting any savings from buying the less expensive reprocessed devices. As a result, the argument is that it’s unfair to these smaller facilities because they can’t take advantage of reprocessed devices in the same way that larger facilities can. This argument may lose some power though as group purchasing organizations (GPOs) become increasingly popular in the US —both small and large companies can take advantage of GPOs to gain bulk discounts.
- Potential safety issues: This is a big one. One of the main areas of debate around reprocessed devices is still centered on whether these devices are any less safe than a device purchased from an OEM. Some studies have found problems with reprocessed devices because of traces of human protein and hair left on the device, or even detergent residue from the cleaning process itself. Studies also discuss how the reprocessing process could potentially damage the structural integrity of the device. On the other hand, reprocessors argue that the FDA has even more stringent compliance controls and inspections for reprocessed devices, and that their devices might even be safer than OEM products. Additionally, the FDA has found that, given existing data, there is no difference in the risk between using an OEM device and a reprocessed device. This debate is ongoing.
- Patient consent: Because of the concerns mentioned above, patients might actually prefer to have OEM products used during their procedures, especially because the cost savings are generally attributed to the facility rather than the patient. So far though, the FDA has not required patient consent before the use of reprocessed devices because the products are not considered investigational or experimental.
So there you have it—4 to 3 against reprocessing. That being said, the arguments for reprocessing are not insignificant, and in reality the case for reprocessing is continuing to look stronger as more facilities adopt these products. In fact, the overall reprocessed device market is anticipated to grow steadily to reach a value of over $4.4
billion by 2016—pretty sizeable for the medical device world.
What are your thoughts on the future of reprocessing in the US? Let us know in the comments.