Winds of Change: Bad Science Loses in the Court of Public Opinion

Medtronic picked the wrong fight and the company is not exactly popular for it. Back in 2020, a comparative study of new and reprocessed LigaSure™ vessel sealing devices (from Medtronic) was published in Surgical Endoscopy. The study looked at the existence of organic material inside the vessel sealing devices. 64 new devices from Medtronic were compared with 64 reprocessed devices (from Stryker Sustainability Solutions, which holds an FDA clearance to reprocess the Medtronic LigaSure™). The results were as follows:

• 96% of the reprocessed devices failed at least 1 in 4 tests that checked for organic material while 100% of new devices passed the test 100% of the time
• 48% of the reprocessed devices passed a visual test while 100% of the new devices passed
• Under optical microscopy, 100% of the new devices passed, while 0% of the reprocessed devices passed.
• Etc. – you can see all the horrible results in the article – or on Medtronic’s website.

Truly damning results – for Stryker as well as for the entire reprocessing industry and anybody else that believes that an FDA clearance has any value at all.

However, under more careful inspection, it turns out that the Stryker team lost this game not because they didn’t play well, but because both the umpire and all the balls were provided by the opposing team. Under these circumstances, it isn’t hard to win: Not only was the study funded by Medtronic, the alleged soiled devices were not supplied by the users of the devices, but instead were procured, tested, and supplied to the study authors by Medtronic. And they failed to disclose this. Sponsorship of the study by an interested party and questionable chain of custody of research objects – and the failure to disclose both - call into question the research integrity of the study. Failure to disclose the chain of custody for any product evaluated in a study, especially one purporting to show product soiling, is especially troubling. Later, the journal published a clarification, but as usual, admitting the crime after you have been caught doesn’t do much for you.

Failure to disclose the chain of custody for any product evaluated in a study, especially one purporting to show product soiling, is especially troubling.

That was 4 years ago. However, it looks like Medtronic has “reprocessed” their bad science, and recently, we have been able to see the company’s assault on reprocessing directly on Medtronic’s website, under the heading “We won't compromise on patient safety”. On the site, you can watch a video that shows the horrible results from the 2020 study, there is a clinical summary (with the same content), and the results are repeated again. Medtronic finishes its tirade with this statement: “There are significant differences between original equipment manufacturer (OEM) LigaSure™ devices and third-party reprocessed vessel sealing devices. Learn how to quickly identify inauthenticity — because if it’s not LigaSure™ technology from Medtronic, it’s not LigaSure™ technology”. Given that Medtronic is a large, recognized corporation undoubtedly with lawyers scrutinizing every statement – I must take this seriously. FDA’s 510(k) clearance process is specifically designed to determine whether two devices are “substantially equivalent”. Stryker has (and had) a 510(k) clearance to reprocess the LigaSure™, because they had provided data that demonstrated that the reprocessed device was substantially equivalent to the new device. Medtronic’s statement must mean they don’t accept FDA’s ability to make this determination AND that they believe FDA allows contaminated devices to be used in patients. I sure hope (and believe) we can have more confidence in FDA than that. And yes, Medtronic, a reprocessed LigaSure™ is still “LigaSure™ technology”. It’s just re-used LigaSure™ technology. Sorry.

The website’s closing statement’ “Say no to reprocessing: Sustainability without compromise” takes the prize. Elsewhere, on Medtronic’s recycling pages, the company states that “[…] we do look for opportunities to refurbish and reprocess select products to give them a second life when appropriate”. Say no – but say yes? Which is it? This website also says one of 5 new stewardship targets is to “Integrate circularity and eco-design criteria into the New Product Development process” – which is contradicted every day by the much more real-life launch of more single-use products as well as the present efforts to hamper reprocessing and reuse and multiple instances of anti-reprocessing warfare in the past.

Say no – but say yes? Which is it?

I don’t actually believe anybody in healthcare is impressed with bad science, greenwashing, and adolescent attacks, and I sincerely doubt that this is helpful for Medtronic – the corporation or the salesperson. In fact, a LinkedIn post about the website by a Medtronic rep backfired and really became a demonstration of how embedded the practice of single-use device reprocessing is among clinicians, environmentalists, and healthcare thought leaders. The times are gone where you could stir up fear, doubt and uncertainty among folks by showing “dirty pictures” of reprocessed devices. People in healthcare know that single-use device reprocessing is safe, and they know it is an important cost containment and sustainability strategy. Bad science and bad behavior fortunately lose in the court of public opinion (in this case, LinkedIn). The LinkedIn post (and its many comments) has since disappeared.

If Medtronic truly wanted a comparative study of its vessel sealing devices – reprocessed vs. new, it would be a whole lot more relevant and interesting if it included both parties (or an independent third party), so that partial interests could be eliminated from the study and results could be considered valid. At Innovative Health, we have always been supportive of comparative studies. We have even invited manufacturers to join us in studies that compare new devices to reprocessed. Interestingly, the invitations have never been answered. I would encourage Stryker to invite Medtronic to do a REAL comparative study, even if chances are slim they will get a response.