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)

Comments and Responses

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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)

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)

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)

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 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)

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