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 an OR nurse and human being, I feel it is best to ask,"would I want this used on myself?" How about a loved one or my children?
Treating patients like family members is a great compass for making the right choice in preventing injury and infection.Surgery does not come with a practice or dress rehersal.You get one best effort.
I am also concerned with reusable sharps containers. Many of these are delivered back to facilities "wet inside" and stained. I'd like to culture some of these to see what lurks inside and is being aersosolized into the room everytime something is "dropped" in the container.

Jude Johnston (Other) at June 10, 2010 (1:22 pm)

I am also an RN (and a human) and I wouldn't require that new stainless steel instruments be used on me or my loved ones since it's clear no one could afford healthcare if we did that.

It's also clear that without looking for ways to reduce costs then fewer patients (am me or my loved ones) won't receive adequate healthcare. I'm also concerned about the environment and the impact medical waste has on it.

The real question is: "Are reprocessed medical devices safe and effective?" The FDA thinks so which is why they regulate and approve certain devices for reprocessing. If you're concerned that the FDA is wrong, then we should be concerned that new devices shouldn't be used on our loved ones since the FDA approves them for use as well.

We've been reprocessing for many years and have never had a problem. We saved hundreds of thousands of dollars and dramatically reduced our medical waste.

I'm glad to be part of making healthcare more affordable (without impacting safety or clinical outcomes) and saving the planet for future generations.

Sandy H. (Other) at June 10, 2010 (1:59 pm)

As a long term professional it is my opinion that MD concerns are due to lack of knowledge, and lack of incentive to understand. It is important to have consensus between a key surgeon, a respected infection control practitioner, and a materials management member understand and support reprocessing as a safe, efficient, cost effective, green process that meets FDA 510K requirements that original manufacturers (OEM) are required to receive. Then there must be clear policies and practices instituted in the organization for compliance and safety. Respectfully submitted, Deborah Hickman Mathis

Deborah Hickman Mathis (Director, Surgical Services/Director of Nursing) at June 10, 2010 (2:22 pm)

Have we forgot about history. Isopropl alcohol was invented in 1920 for instrument sterilization. Simply put, nearly 100 years ago we were attempting to improve infection controls. Today we manufacture "Use once and Destroy" products in order to enhance efforts for the elimination of MRSA and no socomial infections. We know what cross-contamination results can be. While it may be possible to remanufacture or re-sterilize one use products, it isn't recommended for the obvious and that is the potential for infections. Are we so pious to gamble with the lives of those who depend upon professionals to know better? Hospitals are already reluctant to release their statistics regarding their annual infection related deaths and readmissions due to nosocomial infections. Some hospitals comply with pride and have low rates of re-ads and deaths while others have horrendous records many of which are not seen or published. Are you saying that we are going to put the option of single use equipment in the hands of the already cavalier, for re-processing when their present stats regarding infection are questionable? If you are concerned about the enviroment then you should be pursuing appropriate disposal techniques and protocols leaving decisions of re-use up to the manufactures that produce products and call out the specs for them. We are all human.

Art Pichierri (Other) at June 10, 2010 (2:43 pm)

A team from our hospital...a GP, a surgeon, Materiel Mngr, two IC Mngrs and myself (CS mngr) toured two reprocessing facilities and had no question in our minds afterward about the quality and safety of the devices reprocessed there. The devices were not only cleaned, packaged and resterilized, they were disassembled, stripped down to their essential, basic parts and remanufactured. The equipment they used to visualize and sharpen drill bits and other sharps to the original specs was simply impressive.
As a society, we cannot continue to take our planet's environment for granted. Every industry must participate in conservation efforts.

Celeste E. (Administrator/Director/Manager/Owner/Exec. Officer) at June 10, 2010 (2:52 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)

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)

"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)

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)

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)]

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