By David Jensen, MasterControl
Many medical device manufacturing businesses are busily exploring how to reduce the soaring costs of health care without putting the quality of care or patient safety at risk. One of the ways the industry is contributing is by repurposing single-use devices (SUDs).
Historically, devices designed to be used once had a short-lived life cycle. After a device served its purpose, it was simply discarded and replaced with a new one. Purchasing new SUDs drove up the cost of health care — it also added to the collection of discarded devices piling up in landfills. Now, by employing good manufacturing practices (GMPs) for medical devices, SUDs can be cleaned, sterilized, and restored to their original condition. Therefore, these devices can, and should, be reused.
Driven by a mission to “profoundly change the medical device industry, using innovative methods and compliant processes,” medical device remanufacturer Northeast Scientific, with the help of medical device manufacturing software, is making SUDs usable again. However, medical device manufacturing is accompanied by an exponential amount of paperwork, given that each device has a device history record (DHR). Managing all the necessary documentation for the many devices Northeast Scientific remanufactured was complex and prone to errors.
Using a modern manufacturing execution system like MasterControl Manufacturing Excellence means there are no more lost or damaged documents, no more waiting for documentation to be completed, and no more searching through filing cabinets and boxes to find a record and scan it for an audit.