New research from Coherent Market Insights has found that single-use medical device reprocessing is gaining in popularity as it helps to reduce hospital waste and allows for major cost savings.
Growth
For instance, US healthcare provider Kaiser Permanente reportedly saves $11 million per annum by reprocessing certain single-use devices. Non-profit environmental group Practice Green Health, is quoted as saying that single-use medical device reprocessing prevented the entry of 10,000 tonnes of medical waste into the waste stream from 1997–2007, via the re-processing of an estimated 50 million devices.
Coherent’s research states that hospitals potentially stand to reduce the cost associated with medical devices by 50%.
However the findings report that the Asia Pacific, Europe and South America regions have historically been lacking in regulatory standards, which is a restraining factor for the growth of the reprocessing market.
The European Union is looking to address the matter, however, and the upcoming European medical device regulations (MDR) set out the minimum requirements for the reprocessing of single-use medical devices. According to a fact sheet issued by the European Union, under the new rules reprocessing may only take place when authorised under national law and in accordance with the provisions of the medical devices regulation.
When reprocessing is allowed, the entity that wants to reprocess the device must assume the same obligations as a manufacturer. However, a different regime is applied in the case of reprocessing by health institutions and by third parties on the request of health institutions.