Single-Use Medical Device Reprocessing Is Being Regulated By Several Governments Around the World to Ensure Safety of Devices or Reuse

Single-Use Medical Device Reprocessing

Across Europe and North America, hospitals are adopting single-use medical device reprocessing programs to reduce costs, minimize environmental impact and improve sustainability. Reprocessing devices saves health facilities hundreds of millions of dollars a year, according to the Association of Medical Device Reprocessors.

Reprocessing is the disinfection, cleaning, remanufacturing and sterilization of single-use medical devices that have been used or discarded yet, are still in working order. This process is a highly regulated industry and the reprocessors must comply with strict quality control and sterilization specifications to ensure that the reprocessed devices are safe for reuse. The reprocessing process involves collecting used devices from hospitals in collection boxes, which are then labelled with unique identification codes to allow tracking throughout the entire process. The collection boxes are then transported to the reprocessing facility, where the devices undergo a rigorous inspection to determine their suitability for reuse and whether or not they require additional cleaning or disinfection.

According to Coherent Market Insights the Single-Use Medical Device Reprocessing Market Industry Insights, Trends, Outlook, and Opportunity Analysis, 2022-2028.

These steps are repeated for all reprocessed devices, ensuring that the highest standards of cleanliness and safety are maintained. Moreover, reprocessed devices are sterilized in accordance with the relevant European and the U.S. regulatory requirements. Depending on the type of device, reprocessed devices are classified as Class I or Class II; Class 1 devices include low-risk, non-invasive products such as sequential compression sleeves and tourniquet cuffs. Classes II includes medium-risk devices such as pulse oximeter sensors and ultrasound catheters, and most laparoscopic equipment including scalpels, forceps and graspers.

The U.K. MHRA also regulates single-use medical device reprocessing, and in June 2016 it issued new guidelines on the practice. Among other things, the UK guidelines state that third-party reprocessors should have a clear understanding of the characteristics of the device and should be able to demonstrate that the reprocessed device meets all of the relevant requirements under the relevant device directive, including the CE mark. In June 2022, The Association of Medical Device Reprocessors announced “Global Regulatory Standards for ‘Single-Use’ Medical Device Reprocessing and Remanufacturing” the first roadmap for helping Notified Bodies, regulatory authorities, Ministries of Health, of medical devices, in order to offer these benefits for health systems and hospitals globally.