Reprocessed vs. New Single-Use Devices

The FDA says reprocessed single-use devices are safe, but some surgeons have concerns. What do you think?

Started by: Irene Tsikitas (Other) at June 10, 2010 (12:15 pm)

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As the President of a distribution company Crestpoint Management, we only sell top quality instruments and disposables. Last year we took on a Japanese ophthalmic blade line""MANI. My wife, the CEO of Crestpoint and I have been in the field of ophthalmology for 70 years collectively. We have both been surprised and shocked to have world renowned ophthalmologist tell us how durable our single use knives are. One OR tech from the south told me they reused one knife 20 times! Each knife packaging is clearly marked with the international symbol for single use. Another OR supervisor, with whom I have known for many years, ask for MANI samples. I asked if she reused and her reply was "of course not"! I asked if she would call with the results from her surgeons. She did call and told me the blades are great we did 28 cases with just four blades""two blades on each tray! That is 14 times for each blade. Most patients would be outraged to find out they had a single use item reused on them. With ophthalmic blades the surgeons that reuse know when to through them out, because they no longer cut. And at the same time possibility form an incision that will not heal as well. Why would an ophthalmic surgeon risk contamination for a blade that only cost $8.00? Will unannounced audits stop this? Loosing ones license to operate is penny wise pound foolish. CMS knows this is going on, and when I talked to them, they told me it is not only in ophthalmology.
Henry M. Mitchell

Henry M. Mitchell (Other) at September 3, 2010 (10:12 am)

Reprocessing should become the norm. The medical industry has become an enoumous waster of natural resources. How many of us would through out dishes after every meal, they can be safely cleaned and resues. Many of the items we use every day in our facilities can be safely reprocessed and used again. When items are reporcessed they are inspected and reinspected, in fact there are times when I see poor products that are single use items. this is not a time in history to turn our noses up at something that will be safe, save money and our environment.

Chris Rosenthal (Director, Surgical Services / Director of Nursing) at August 13, 2010 (2:26 pm)

I have seen the monetary reward with reprocessed items, although I will say that there are alot of surgeons (ortho) that have consistenly remarked that reprocessed shaver blades are dull for the most part.

James N. (OR Manager/Supervisor) at June 14, 2010 (12:35 pm)

So let's look at this in a responsible manner as it really isn't the hospital against the supplier. If the product can be purchased at a fair price and reprocessed for a fair price, which would be less then buying a new disposable product, it may be best to reprocess. However if it cannot be adequately cleaned in a timely manner for a reasonable cost then the disposable may make sense. Every item should be evaluated in that manner and the process would justify the decision. It may have to be re-evaluated annually as disposable and reprocessing costs are probably moving in opposite directions with disposables going down and the labor involved with reprocessing rising.
Also disposable doesn't need to mean "throw away". It actually should mean returned for a rebate or credit off the next purchase and recycled by the original manufacturer and made into new disposables. That is what I see the responsible companies promoting.
I hope to see some comments on this interpretation of reprocessing vs disposables.

Don Marcello (Other) at June 13, 2010 (3:07 pm)

Why healthcare costs are spiraling out of control is probably a topic for another discussion; Monopolistic behavior of big device and pharma companies, conflict of interest resulting from cozy doctor/vendor relationships, underpayment by Medicare, growing numbers of uninsured receiving medical care for free, little competition for insurers, government regulations favoring certain companies or services, frivolous lawsuits

Back on topic... Reprocessing exists because the healthcare industry needs to reduce costs or be forced to make very unpleasant decisions like layoffs, reducing services, increasing patient to nurse ratios, etc. No doubt reprocessing will decrease the device makers"™ profit margins. This competition is good and will have a net savings for consumers. (Just like you see with computers and TVs.) We should keep reprocessing until the device makers reduce their prices low enough to not make it worth the effort.

Sandy H. (Other) at June 11, 2010 (3:58 pm)

Providers, have observed the reprocessing industry develope and add cost to the healtcare system because of our inability to force price controls on the disposible vendors. For quality care reasons it would seem best to use disposables only once. The problem leading to the development of the reprocessing industry is that the vendor industry has been allowed establish high prices and increase prices on an annual basis without constraint. A $1000 retail single use disposible may cost one facility $900 and another only $500. Vendors have not looked at healthcare as a global industry, rather they have compartmentalized us into healthcare sectors, thus the large range in cost for differet providers based on the supply and demand. Supply & demand does not necessarily work in the healthcare. Reprocessing may have a negative long-term effect the cost of disposibles. If reprocessing becomes widespread, facilities will purchase fewer new disposibles from the vendor. As the volume of sales decreases, the vendor will be forced to increase the price of the new product, thus a vicious cycle. Over time there will be no advantage since you can't reprocess the same device forever. Had the vendor provided a product at a reasonable cost to begin with, there would be no need for the reprocessing industry. Most likely ASCs will continue to be taken advantage of by the disposible instrument and orthopedic implant vendors. Computer prices have fallen significantly over time, but the cost of screws, other implants, and single use disposible items continue to increase year after year. Why? Perhaps it is time for government oversight of medical device and implant manufacturing in an effort to control cost. It may be the only way that cost & quality can be controlled. Over time the US Healthcare industry would likely benefit significantly. Oh sure, the CEOs of the major vendor companies would need to downsize their yachts and summer homes but they would survive. In reality it is not the providers (ASCs, Hospitals, Physicians) who are responsible for the high cost of healthcare. Rather it is the unconstrained vendor & pharmaceutical industry that is driving up the cost of healthcare.

Steven Gunderson (Administrator/Director/Manager/Owner/Exec. Officer) at June 11, 2010 (12:15 pm) [last edited on June 11, 2010 (12:16 pm)]

I really am amazed at how ill informed everyone is about products in general. Did you know that when you have an accident in your automobile that your parts that are replaced are not of the same quality as factory new. Is NEW REALLY NEW? Have you ever gone to these facilities and inspected them? I at first was skeptical about reprocessing until we started using them. When we have had issues with new products the manufacturer is very distant and difficult to work with. When we have issues with reprocessed items they are easy to contact & work with and fast to get closure.

Paul Justice (Other) at June 11, 2010 (8:06 am)

"Use once and destroy" is a great for the device manufactures and those hospitals (and patients) with unlimited resources. You are correct in suggesting the "use once and destroy" approach MAY reduce infections however that logic would lead to throwing away sheets after one use...throwing away surgical instruments after one use...throwing away rigid endoscopes after one use... There is no evidence at all that reprocessed devices increase infection rates. Just like there's no evidence reusing sheets (when cleaned correctly) increases infection rates either.

True the FDA isn't infallible but it seems odd to pick and choose which approvals we agree with based on what the manufacturer recommends. My guess is that Ethicon like us to buy more of their products and will suggest we continue to do so rather than reprocess - even if the FDA says it's safe.

On the topic of fair billing, we charge by the procedure being done not by what tools are used during the case. If a case goes long we don't charge more. Conversely, if we do it quickly, we don't give a refund. The patient is paying for a service. If we get real fast and get the price down on the tools we use, then we should decrease our price. That's the way businesses work. No moral issue with that.

Sandy H. (Other) at June 10, 2010 (5:19 pm)

What patient is going to get the unused sterile item. I disagree because every patient should get the same standard of care.

kathy street (Other) at June 10, 2010 (3:11 pm)

Lets remember that the FDA is not infallible. I believe this is a moral question. The first time a product is used and the patient gets charged. Then we process the product, reuse, and recharge at the same rate as a brand new item. Would you pay the same price for a used item as you would for a brand new one? Would/should we be passing along the discount to the patient? Isn't this a deceptive practice? Should we be telling patients that we will be using a reprocessed item? Call me a cynic, but I believe we are using this practice to pad our bottom line and are jumping on the "green" bandwagon to justify our practices.

barbara m. (Other) at June 10, 2010 (3:08 pm)

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