Episode 074 | September 18, 2023 | 38:07
Guest: Lars Thording (Innovative Health)
Published: September 18, 2023
Duration: 38:07
Description
Lars Thording and Frederik van Deurs discuss reprocessing and remanufacturing in medical technology. Reprocessed devices can significantly reduce costs for hospitals while also decreasing the environmental footprint. They cover obstacles to wider adoption and regulatory considerations.
Full transcript
About this transcript
This transcript was automatically generated and may contain inaccuracies, typos, or mistranslations. Episodes recorded before 2024 were transcribed by an on-site model and may have a higher error rate. The content reflects the original conversation to the best of our ability. For the authoritative version, please listen to the audio episode.
Hello and welcome to the Sustainable Healthcare Podcast. Today we talk about reprocessing — taking spent medical devices, taking them apart, cleaning them, and putting them back into the market so they can serve more patients.
Lars: Lars Thording, originally from Denmark, in Phoenix Arizona for 25 years. I joined the reprocessing industry in the US — almost 25-year-old industry there in terms of regulation. The FDA regulates this under the term “reprocessing”; European authorities under “remanufacturing” — same thing.
The model: companies collect single-use devices that have been used once, reprocess them at their facilities, re-sterilize, and sell back to the hospital for typically half the price. Regulated in US, Europe, Japan, Asia, New Zealand, South Africa and elsewhere — but the US is the oldest from a regulatory perspective.
Complex space because med-tech is financially interested in promoting single-use (“after one use, throw it away — I’ll sell more”). Hospitals can reduce device cost by ~50%. And there’s a substantial environmental win — published LCAs of reprocessed cardiology devices show ~50% carbon footprint of a new device.
Frederik: Can it be reprocessed more than once?
Lars: Determined by regulatory submission. My company is Innovative Health — we reprocess in cardiology. For an electrophysiology procedure for atrial fibrillation (very common, growing fast), device costs in the US can exceed $10,000. The diagnostic ultrasound catheter sells new for ~$2,500. After reprocessing, ~$1,200. We can reprocess as many times as we have proven safe to the FDA. Submission can be one-time, three-times, etc. Public domain.
The mindset that “throw it away = safer” is deep in healthcare — partly true for gloves and syringes, but a $2,500 catheter used once is different. We look at material integrity, functionality. In cardiology we don’t reuse more than three times — super conservative on patient safety.
We handle about 1,000 SKUs — really about 10 different types of devices but many brands and lengths. Math: in an atrial fibrillation procedure, you can reduce device costs by about $3,500 (from $10,000 to ~$6,500) by reprocessing what can be reprocessed. Not all devices can — some too fragile, some too complex to verify cleanliness for regulatory clearance.
Shelf life and liability: when we remanufacture, regulatory- and clinical-wise it’s treated like a new device — it’s Innovative Health’s liability. Original manufacturer is out of the picture. Device gets its own shelf life.
Physicians’ preferred items: hard to introduce sustainability initiatives that require physicians to change their preferred device. Reprocessing gets the environmental and cost savings without changing physician preferences — the Biosense Webster catheter they were trained on, reprocessed, still has all the same functionality and feel.
Of all single-use cardiology devices used, about 75% could regulatorily be reprocessed. In the US the reality is about 35-40%. Why not 75%: limit on number of reprocessings means constant new inflow is needed; resistance from med-tech sector against the practice (they lose a sale). Over time the sector will embrace this because it’s better value for hospitals and necessary for environmental footprint.
Journey of the device: we place a cart in the cardiology lab. Techs/nurses wipe down devices and put them in biohazard bags in the drawers. Our collection technologists collect them, ship to our plant — clean, test, inspect, sterilize, inspect again, package, and put in finished-goods inventory. We tell the hospital “you can now buy back five devices.” Not necessarily your own — waiting two weeks for your own is unacceptable. FDA clearance means the reprocessed device is substantially equivalent to the new device and involves no added patient risk. 46 FDA clearances cover our 1,000 SKUs — one clearance covers a brand or a group of equivalent brands.
On LCAs: hospitals are under so much pressure to demonstrate footprint — sustainability coordinators have gray hair because they can’t get numbers from suppliers. I’m not going to do 1,000 LCAs. We use the Fraunhofer LCA on a Vanguard reprocessed EP catheter — new is ~2 lb CO2 equivalent more than reprocessed. Assume the same applies across our other devices; assume transport, cleaning chemicals, inventory time are similar. A lot of assumptions, but always clear about it. Got to start somewhere.
Healthcare-pathway perspective beats product-by-product LCAs alone — and design choices upstream (which plastic) matter too.
Summary: reprocessing has huge potential. 1-3 times typically. Lifecycle analysis is early — assumptions required. Device journey: surgical procedure → reprocessing facility → cleaned, tested, cleaned again → sold back. ~50% cost saving and ~2 lb CO2 saved per device.
Thank you Lars. Thanks for listening — please subscribe and share.