Quick IC tips on FDA recommendations for the Steris System 1 processor

By: December 9th, 2009 Email This Post Print This Post

By now you’ve likely heard about the Food and Drug Administration (FDA) warning urging users of the STERIS System 1 Processor (SS1) to find an alternative method. If you don’t have a replacement processor, you should take measures to find one as soon as possible.

The FDA said it “received some reports of malfunctions of the SS1 that had the potential to cause or contribute to serious injuries to patients, such as infections.” However infections are particularly difficult to trace back to the SS1, and may go unreported. The FDA has also received reports of injuries to healthcare workers, including burns from exposure to the sterilant solution.

Healthcare facilities should seek acceptable alternatives to SS1 as soon as possible, according to FDA recommendations. For now, the FDA does not “expect to take action against healthcare facilities solely because they are now using SS1s,” but facilities are required to report suspected device-related deaths, and the FDA may take enforcement action against a facility that fails to submit a report.

From a practical standpoint you are probably asking yourself, what should I do right now?

Your first step is to contact manufacturers of the devices that are disinfected in the SS1 and find out what alternate chemicals are recommended by the manufacturer. Fortunately most instruments can still be disinfected or sterilized manually using a liquid process, but as many of you know that is a much longer process. Your manufacturer will have the specifics concerning how long you should soak the instruments.

Remember, the amount of time equipment should soak depends upon both the device that is sterilized and the sterilant used. Be sure to account for both variables.

The trick is to find the accommodating chemical, notify all staff members of the change, and adjust work schedules to accommodate the extra workload. In high volume facilities this is particularly difficult, and may require additional staff members to help with the transition, but it’s imperative to maintain patient safety and sound infection prevention practices.

In the long run your facility should look into replacing the SS1 with an AER (automated reporcessor) sooner rather than later for those who are reprocessing a high volume of equipment.


By Stephen M. Kovach on December 9th, 2009 at 9:53 am

Good sound basic advice.
One additon; make sure you use a team approach and have Risk management and IC involved in the meetings.

Their are options; look at them all.

As stated above, the first step should be to contact the device manufacturer for viable alternatives.

At our facility, we recently made the switch to the new Steris product, Resert, which is a relativly quick, manual means of achieving HLD. This product is extremely safe as well.

This is also an excellent time for hospital sterilization experts to push with their administrations for other terminal means of sterilization if not currently implemented at one’s facility, e.g., Sterrad, V-Pro, ozone units, etc.

In a time of number crunching and economizing, patient safety must remain on the forefront.


Well said.

Thank you very much for your expert information.

By Vivian Butller on December 10th, 2009 at 10:19 am

Agree with all. I particularly agree with Huey statement, “Patient safety must remain on the forefront.”

Some hospitals are making quick decisions which can create increased unsafe issues, resulting in an increase cost to their institution.

Make sure you assess the devices thoroughly prior to purchasing to ensure the device can supply your needs.

Bargains are not always good.

By Hortense Powell on December 10th, 2009 at 12:58 pm

The endo units should be the ones suffering now more than anyone else. Yes I agree Patient safety should be everyones number one priority. What are the endoscopic units doing in this crisis. This reminds me of the KC wrappers we all panic.
Can we get some feed backs on what other facilities are doing other than running for bargins?

By Ann Mary Graves on December 16th, 2009 at 11:10 am

We have 3 to 6 months to make a decision. We are going to see what other devices are available and do a cost comparison. ETO and Cidex is not being considered.

By Harley D Berlant on December 18th, 2009 at 8:50 am

I agree every facility must check with the manufacturer of each and every scope. There is another issue which has yet to be brought forward. That is the material compatibility. This is why there should be a 4 step process when considering alternatives;

1-Does the diameter and length of the scope comply with the manufacturer’s approval for reprocessing?

2-Does the scope need to be high level disinfected vs. Sterilized

3-Material compatibility-Has the manufacturer of the sterilization process validated the scope in their machine and has the MFC of the scope said there are no adverse changes in the material of the scope after 100 cycles, and finally

4-What tray containers have been validated for this method of sterilization? Can we use our wrappers and trays or do we need to invest in a new tray system?

By Nancy McCarty on December 23rd, 2009 at 10:08 am

In regards to M.S. Huey’s report of switching to the Resert by Steris, did you check with the manufacturers of your equipment about this product? We were told by Wolf it is not recommended for their equipment as it is too harsh.


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