Update on Steris System 1 Teleconference Call with the FDA Today

FDA held a teleconference today at 1pm ET regarding the current issue with the Steris System 1 Processor used by many hospitals and endoscopy centers.  See yesterdays posting at InCo and Associates to view the recent letter sent to healthcare providers from the FDA.

If you are having problems coming up with an alternative call 808-282-5738 and we will help you come up with a solution.

The moderator for the teleconference call today was Theres A Toigo RPh, MBA from the office of Special Health Issues at the FDA.  The speaker was Timothy A. Ulatowski the Director, Office of Compliance from the Center for Devices and Radiological Health (CDRH).  You may listen to the call until January 6, 2010 by calling toll-free 866-421-5878.  For international callers call 1-203-369-0811.

The conference call began today at 1:12 PM EST.  More than 1000 people registered for todays calls.  The Q&A document will be updated on the FDA website.  There will be a transcript from this call on the FDA website in about a week.  FDA has posted three major documents that facilities should obtain fromt he FDA website related to the need to change product and/or the need to notifiy patients.

Early next week the FDA will issue more information to assist healthcare providers to come up with alternatives.  FDA notified Steris that they made change to the SS1 that could alter the safety of the Steris System 1.  These changes caused the system to not be FDA approved.  Steris stopped selling the Steris System 1.  There is a question on whether they notified the facilities of this issue.  Steris was supposed to be working with clients to transition to an approved product.  FDA has found that Steris was not doing this. FDA cannot assure that the Steris System 1 is safe to use for users or assure that the system is providing sterilization/disinfected.

The FDA notice applies to all Steris System 1 Processors, all models, all machines.  The FDA is asking for voluntary compliance with coming up with alternatives for patient safety.  This should be done immediatly.   FDA expects some facilities will continue using the Steris systems until they can come up with an alternative and provide proper staff training.  Do not interrupt providing diagnotic testing on patients.  FDA believes healthcare facilities should be able to come up with an alternation with the next 3 to 6 months.  FDA wants to be told of any obsticules to comply with this transition so they can assist individual healthcare facilities and healthcare associations.  This is not an opened timeline the FDA expects all facilities to transition to a safe alternative.

In the meantime it is important that all facilities utilize the biologicals required for the Steris System 1 Processor to assure everything is processed as well as possible.  But there is no assurance that this system is processing the instrutments safely for use on patients.

FDA encourages facilities to asked the alternative companies to show them the FDA approval letter and ask them if they have made any alterations to the system/product since they received the FDA approval.

FDA will post additional information early next week that list approved products that can be used as alteratives.  The FDA will assist healthcare facilities to come up with an alternative.

Many items are placed in the Steris System 1.  Identify what you are processing and check the manufacturers label on how each item is to be processed and decide what product(s) you will need to purchase for each item.  If the manufacturers label is not clear facilities are asked to call the manufacturer for assistance.  If the manufacturer cannot assist you call the FDA for assistance.

At this point this is not a recall of the Steris System 1.  The FDA is asking healthcare facilities to voluntarily comply with this transition and is giving healthcare facilities 3-6 months to transition.

How to communication with patients who have questions.  Check the FDA Q&A section.  There is no need to contact patients who have already been treated.

InCo and Associates Note:

It is important that if facilities are going to manual cleaning until an alternative is found that all employees should be trained extensively and monitored for following all procedures to prevent transmission of infections to multiple patients and/or the build up of biofilm on the instrutments which would lead to the disposal of the instrutments.  Manual cleaning is not the best option.

Back to Conference Call:

For physicians who do endoscopies the FDA does not recommend the interruption of performing procedures but to go to alternatives as soon as possible.

Is there compensation from Steris to healthcare facilities?  The FDA does not know and cannot respond to this question.

Important weblinks: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm191585.htm



Questions can also be directed to Candace McManus, DrPH by email at candace.mcmanus@fda.hhs.gov or by telephone message at 1-877-260-3731