reprocessing Archives - Medical Design Sourcing

Medline doubles size of Oregon medical device reprocessing plant

The ReNewal medical device reprocessing plant in Redmond, Oregon [Image courtesy of Medline]

Medline announced today that it expanded a facility for its ReNewal medical device reprocessing program.

Northfield, Illinois-based Medline — the fourth largest medical device company in the world, according to Medical Design & Outsourcing’s 2023 Big 100 — said it expanded the Redmond, Oregon, plant by nearly 52,000 square feet.

The expansion doubled the facility’s size and capacity to reprocess medical devices that Medline says would otherwise end up in a landfill.

The Medline ReNewal program has reprocessed nearly 15 million devices since 2014. The reprocessing helped to divert more than 10 million pounds of waste from landfills. In 2022 alone, the company reprocessed 2.3 million medical devices, equating to reducing approximately 1.1 million pounds of waste.

Medline ReNewal Presid…

Medical device reprocessing design tips from Cardinal Health’s Sustainable Technologies

Medical device reprocessing includes mechanical, chemical and/or electrical processes. [Photo courtesy of Cardinal Health Sustainable Technologies]

Medical device reprocessing is a key focus for Cardinal Health’s Sustainable Technologies business, which collects and cleans single-use devices for safe re-use under FDA standards.

Reprocessed devices keep medical waste out of landfills while offering significantly lower costs than brand-new products for hospitals and other healthcare customers, according to the Association of Medical Device Reprocessors.

Meg McClanahan, chair of the Association of Medical Device Reprocessors Board and global portfolio director for Cardinal Health’s Sustainable Technologies business, offered some advice for designing medical devices for reprocessing.

Previously: Cardinal Health expands single-use device reprocessing facility

What advice can Cardinal He…

FDA hits Olympus with warning letters after factory inspections

The FDA today released warning letters against Olympus Medical Systems Corp. and Olympus Corp. subsidiary Aizu Olympus following inspections of their endoscope and reprocessor manufacturing facilities.

The warning letters allege medical device reporting (MDR) and quality system violations at the manufacturing operations.

An Olympus representative told Medical Design & Outsourcing that the medtech manufacturer would issue a public response as soon as today.

FDA issued the first letter to Aizu Olympus President and CEO Yasuo Takeuchi on Nov. 2, 2022, following a July 5-8 inspection. The warning letter covers the company’s endoscope and automated reprocessing equipment manufacturing operations in Aizuwakamatsu, Fukushima, Japan.

FDA issued the second letter to Olympus Medical Systems President Tomohisa Sakurai on Dec. 12, 2022, following a Sept. 6-9 inspection. That warning letter covers the company’s gastrointestinal and surgical end…

FDA hits Olympus with warning letters after factory inspections

The FDA today released warning letters against Olympus Medical Systems Corp. and Olympus Corp. subsidiary Aizu Olympus following inspections of their endoscope and reprocessor manufacturing facilities.

The warning letters allege medical device reporting (MDR) and quality system violations at the manufacturing operations.

“Olympus’ highest priority is providing patients and users with safe and effective medical devices that comply with all applicable legal and regulatory requirements,” the company said in a statement to Medical Design & Outsourcing. “For that reason, we are committed to working together with FDA to address concerns.”

FDA issued the first letter to Aizu Olympus President and CEO Yasuo Takeuchi on Nov. 2, 2022, following a July 5–8 inspection. The warning letter covers the company’s endoscope and automated reprocessing equipment manufacturing operations in Aizuwakamatsu, Fukushima, Japan.

FDA issued …

Cardinal Health expands single-use device reprocessing facility

Cardinal Health’s Sustainable Technologies facility in Riverview, Florida [Photo courtesy of Cardinal Health]

Cardinal Health (NYSE:CAH) recently opened its expanded Sustainable Technologies facility in Riverview, Florida.

The facility is now twice as large as before, at 100,000 square feet, said Dublin, Ohio-based Cardinal Health.

The medical device manufacturer and distributor launched Sustainable Technologies in 2015 to collect, reprocess and recycle single-use devices in the U.S. Sustainable Technologies now works with more than 3,000 U.S. hospitals and ambulatory service centers, Cardinal Health said.

The FDA allows single-use devices to be used more than once if reprocessors can show the reprocessed devices are substantially equivalent to the original device. Many single-use devices can be recycled when they can not be reprocessed.

NEED TO KNOW: Ramping up manufacturing for sing…