Steris Machines Shut Down

openheartmary · Dec 8, 2009

I just got off work at 5:30. Didn't hear a word about this all day! It is going to create a nightmare where I work!

SandraCVRN · Dec 8, 2009

They told us this AM...not good

lindaloo51 · Dec 9, 2009

We are still using Steris. The FDA letter states that facilities may continue to use the Steris units while evaluating their needs. There are NO reports of patient injuries or infections with the use of the Steris unit. Read the information and the questions and answers on the FDA site and the Steris response on their web site.

By the way some of the reports they are concerned about are staff "burns" from the sterillant (am I the only one who has gotten a burn from an autoclave? They aren't restricting them) and a malfunction that could have caused an infection. (I had an autoclave cycle fail last month because of a steam failure)

Some how, I get the feeling that FDA is dragging its feet evaluating the information and applications that they have.

mcmike55 · Dec 27, 2009

I don't have the actual documents in front of me, but I saw some info coming down the chute on this in early summer I think.

The FDA says Steris made modifications to the System 1 after it got approval. As I understand this, the modifications, in the opinion of the FDA, required another application of some sort. More paperwork I guess.

Long story short, the FDA got fed up with Steris and filed this recall, I guess. This includes units made back into the 80's I think.

We are still using our Steris, but are in the process of figuring out a good substitute. Initially, we thought the recall did not include our "ancent" unit, but recently discovered it did.

We've got a Sterad for most of our stuff that can's handle high temps, but it will not due scopes, etc, that have a long narrow channel. It's my understanding that they now have something out, similar to Sterad, that will do the job.

The run time looks to be around 30 minutes, which is about what our Steris is.

The search continues.......

Mike

grandmab · Jan 1, 2010

The original Steris 1 is still acceptable however, this is completely outdated and most facilities have upgraded to the most recent version of that unit which is the one on recall by the FDA. Our particular facility uses the Steris 4-5 times a day every day because we have no other allternative. Our corporate office is allowing us to continue to use them until they can be replaced.

Being from a rural hospital though, our budget is not allowing for us to purchase the Sterad unit just yet and it appears that we will have to go back to the Cidex or OPA process. We have a limited number of cameras none of which can be autoclaved. Needless to say this will make for some pretty stressful times and turnover times will be unreal.

$fracturenurse$ · Jan 2, 2010

We are still using Steris. The FDA letter states that facilities may continue to use the Steris units while evaluating their needs. There are NO reports of patient injuries or infections with the use of the Steris unit. Read the information and the questions and answers on the FDA site and the Steris response on their web site.
By the way some of the reports they are concerned about are staff "burns" from the sterillant (am I the only one who has gotten a burn from an autoclave? They aren't restricting them) and a malfunction that could have caused an infection. (I had an autoclave cycle fail last month because of a steam failure)
Some how, I get the feeling that FDA is dragging its feet evaluating the information and applications that they have.

We are still using them too. You can go to the Steris website and read the letter from the FDA. You can still use them, but you are supposed to be showing that you are working toward an alternative.

SRNA4U, BSN, DNP, RN, CRNA · Jan 2, 2010

In the Air Force, we were told to continue using Steris and not to resort to buying new equipment. The report from FDA did not cite any patient safety or infection control issues. We are just going to wait it out.