Reprocessing “single-use” labeled devices has been one of the few strategies on the device cost side that have actually enabled hospitals to keep some procedures in the electrophysiology labs profitable. Instead of discarding “single-use” labeled devices after use, the hospital saves the devices and works with professional reprocessing companies to re-use the devices. Cost per catheter use, in some cases, can go down by $1,000 or more, which matters a lot in an A-Fib procedure, where device costs are more than $10,000 and CMS reimbursement less than $18,000. It is not an exaggeration that some labs have case profitability singularily due to reprocessing, which saves some labs more than $500,000 per year in the cardiology area alone.
Yes despite this, some device manufacturers have employed certain tactics, including the insertion of chips or downgrading materials to ensure some devices are used just once, and, not reprocessed — despite FDA’s issuance of a number clearances to commercial reprocessors to do so. Dr. Thording urges device manufacturers to see things from the perspective of their hospital customers:
Discovering the right balance between design quality and the need to replace products to ensure manufacturer profitability is a legitimate business. But medical device manufacturers need to become part of the solution when it comes to healthcare economics and find the right balance between profitability and utilization impact.