Reprocessing

Definition

The disinfection, cleaning, remanufacturing, testing, packaging and labeling, and sterilization among other steps, of a used, (or, in some cases, a device opened from its original packaging but unused), medical device to be put in service again.(8) 

Reprocessing medical devices and personal protective equipment (PPE) involves the proper cleaning and disinfection of the product, so it can be reused. Medical devices or PPE that require reprocessing, include: respirators, scalpels, IVDs, surgical forceps, endoscopes, and stethoscopes. Reprocessing is conducted in the following procedure: point-of-use processing, thorough cleaning, and then disinfection or sterilization depending on the contact-type of the device.(5) Disinfection or sterilization can be conducted with moist heat/steam, EO, H2O2 and O3, or with dry heat.(5) 

 

Reprocessing times must be specified on the label, or a provided method allowing the user to identify when a device exceeds its use based on user performance testing, visual inspection, or a built-in design feature.(5) The EU/MDR states that single-use devices for reprocessing must have validation for the number of cycles the device can withstand.(7) Without proper reprocessing, medical devices can retain chemical or biological components from one patient or area to another. Biological components can occasionally lead to Healthcare-Associated Infections (HAIs).(2) It is of the utmost importance that the reprocessing of medical devices is conducted in a thorough manner. 

Medical device reprocessing is important to device manufacturers and users of the device alike. According to the Association of Medical Device Reprocessors (AMDR), hospitals in the United States, Canada, and Europe saved $471 million by using AMDR-member reprocessors in 2018. Along with the financial benefits there are direct environmental benefits. It is estimated that 15,889,741 pounds (7,093 tons) of medical waste were kept from landfills in 2018.(3) In the United States, devices released for reprocessing are regulated heavily by the FDA to ensure they contain the proper instructions for use. MicroBio Consulting stays up to date on these regulations and can provide important knowledge about regional and global regulations. 

Medical devices are commonly reprocessed in a hospital setting both in the United States and in other countries around the world. Manufacturers can conduct reprocessing testing in house, or through an external test lab. Some local test labs that conduct reprocessing testing include Nelson Labs, Steris Labs, and Pacific Biolabs. Regarding reprocessing of “single-use” medical devices and their global regulations, more information can be found here: http://www.amdr.org/wp-content/uploads/2014/06/International-Regulation-of-Medical-Device-Reprocessing_2014-update-06.14.pdf 

The regulations surrounding medical device reprocessing vary by country regarding labeling, sterility testing required, etc. Manufacturers must validate the cleaning and sterilization processes through a “worst-case” scenario regarding the level of soil on the device.(4) These processes may be conducted with automated equipment or manually, but the process must be validated, nonetheless.(5) Per Pacific Biolabs, the FDA is currently recommending six full disinfection cycles for reprocessing validation.(6) Our team works directly with test labs to coordinate these studies for medical device manufacturers to ensure their cleaning and sterilization processes are sufficient with the goal of protecting patient safety. Overall, medical device reprocessing validation is important in reducing healthcare waste, saving hospitals money, and ensuring patient safety. 

Resources referenced:

  1. https://www.merriam-webster.com/dictionary/reprocess 

  2. https://www.fda.gov/medical-devices/products-and-medical-procedures/reprocessing-reusable-medical-devices 

  3. http://amdr.org/reprocessing-by-the-numbers/ 

  4. https://www.fda.gov/media/80265/download 

  5. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff 

  6. https://pacificbiolabs.com/new-fda-reusable-device-rules 

  7. REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

  8. https://en.wikipedia.org/wiki/Single_use_medical_device_reprocessing