New Sterilization Recommendation for Synthes Power Drive

[ebenezer]

All users attention.
The minimum exposure time in prevacuum sterilizer has been changed to 24 minutes for Synthes Power Drive. Check with synthes.

[Harvey Johnson]

Are you sure someone is not confusing vacuum and gravity?
The latest instructions I could find on line indicate 8 min vacuum and 22 min gravity.
I can't imagine the parameters would change that drastically.....
Here is the site: http: products.synthes.com/prod_support/Product%20Support%20Materials/Charts/SUSA/SUCHTPwdrBatdrJ2970C.pdf

[Sno]

I recieved paperwork in the mail unfortunately I havent gotten to read it full length. I guess I should in the morning. Thanks for the update- will read it!

[ebenezer]

The new sterilization parameters for Synthes Power Drive is available in the following link.
I received also a letter from synthes about this new sterilization parameter.

http://products.synthes.com/prod_support/Product%20Support%20Materials/User%20Guides%20and%20Manuals/SUSA/SUMANPowerDriveJ2971F.pdf

[Harvey Johnson]

Tanks for the link, ebenezer, very informative.
To me it looks like another company throwing darts at a board to decide cycle times to cover their posterior in place of actual real world testing.
Yes, it is a very large and dense tray, but to come out with the same 24 minute exposure times wrapped or unwrapped flash makes me very suspicious.......
(and what method of verification are we supposed to use that is approved to validate parameters have been met for a 24 minute exposure cycle?)

[chipmoore]

Regarding Synthes, They have been working over the last few years to validate their cycles to more realistic hospital times/temps and re-designing packaging for improved sterilization. This is per discussions w/ them at AAMI. The publication date on the referenced document is year 2000, so there might be a more current one. Worth asking.
Chip Moore
Somewhere in Western MN

[Sno]

24 min. exposure time.. Wow that is long and very inconvenient for the staff to have to manually change the cycles and what other equipment are we supposed to run at the same time. The only small sterilizer we have in our department is so ancient it is 250C gravity machine.

[Harvey Johnson]

I still suspect for most companies who throw out these instructions it's CYA time and smoke and mirrors are taking the place of actual real world testing.
My question remains unanswered.......
What method of verification are we supposed to use that is approved to validate parameters have been met for a 24 minute exposure cycle?
Maybe companies who come up with these incredible times should be required to supply a verification / validation method also.

[jrc]

I agree with soup on this. It sounds as if Synthes is just trying to limit their liability without any consideration for how this affects their customers. The makers of the indicators have a BI that shows lethality at 2 minutes, but the instrument maker says we have to run a 24-minute cycle. How can we make sure the instruments are sterile if we aren't testing the last 22 minutes of the cycle? Where did Synthes come up with this recommendation of 24 minutes? Did they perform studies in which they took dirty instruments and found that at 24 minutes they finally killed the bugs in them?

There is another thing that irritates me, as well. The sterilizer manufacturers validate their units for 16 lb. trays. The instrument manufacturers who sit on the AAMI committees would not go below 25 lbs. as the maximum weight. How can we know that a 25 lb. tray is getting sterilized? Why can't the two groups agree on one standard?

Forgive this rant, but I am very frustrated that the manufacturers of sterilizers, instruments, and indicators cannot come together and devise a system that allows for us, the users and processors, to know we have a sterile product coming out of our autoclaves (within reasonable certainty).

[cpdguy]

My views might not be popular but I do want to share them on this topic; of extended cycles and being active and making changes to practice.

The user still has the most power and influence . I say this in being an x user and now sitting in the same church as every body but in a different pew.

To make a change you / we must all be involved. The first step is being active. In this topic; each person should join AAMI . It does not cost much. Then as a user join these different committees. You wil get all the updates and know what is going on;and be able to make comments and voice your concerns. You do not have to attend the meetings ; it is nice. I was a member for a few years and never went to a meeting. I was a CS manager and submitted my comments and they made a difference( you do not have to be a manger or supervisor, technicains anybody can join). Going to the meetings is nice , as we all know the interaction both inside and outside the meeting is worth its weight in gold. But I could not afford to go as a CS manager but I wanted my view points heard in a positive way and I did that by joining; spending the time to research the topics and give my views and comments on the topics I felt strong about.

I want to share this one example back in the days( the 90's) when the flash document was up for review. Anne Cofiell was on AAMI and some standards were being suggested to be changed which were not in the best interest of the patient and staff. She shared those views and why these certain changes should not be accepted. Our State CS group got over 100 CS professionals to sign a a letter to AAMI expressing our concern on the changes; i know other CS groups did the same thing. All of us together were able to get better wording in that document; those changes were not accepted and new and better wording was used. I saw the power of the user at that time and joined AAMI. We can make a difference;please join AAMi to make a difference.

Next on the manufacture and the sterilization times. At the bottom of the letter their is a name. Call that person. Let them know in a positive way your frustration. Ask them to explain why the change and what they are doing to make the cycle more in line with "actual practice"; be proactive. maybe they have a user group you can be part of to offer feedback,ask. Maybe you can even do testing for them at your hospital. Be part of the solution. I have always found that helpful in calling companies when I was working in CS. Being proactive helps; also the knowledge in asking is so valuable. Ihave learned so much by just calling up the person and asking why,in a positive way.

Next now with one professional group, now is the time for the CS profession to start setting our Central Service Standards and Recommended practices.

This is and should be priority for all of us.

AORN does a great job in setting the way for Perioperative Standards and Recommendations. APIC,SGNA all do the same for their profession.We are now in a position to do the same for our discipline; it is needed.

This can only take place when the active members want it. This takes time and lots of volunteers and time;but can be done; and should be done; and soon.

Now wanting and getting it done as stated takes everybody to be more active and involved. Studies show that volounteering is down. we see it at our state and local groups;many of the same people working hard.

I understand the need to vent and the frustration not only with this topic of extended cycles but other issues. This forumn is a great way to do this.

we all need to channel this into action and change in a positive way for the patient and the staff.

So, thank you all for letting me vent and voice my concerns. remember we all can a make a difference; we just have to want to and then move and use or talents to make the move to make the change. That is the hard part.

[Sno]

I wanted to mention that these new cycles did not include the Battery Power Line system. Originally I thought that was included and even talked to Synthes about the times. My rep called and said that the Battery Power line was not included- So why they sent me the notices.. I have no clue! But luckily we escaped the 24 min. cycle!

[chipmoore]

Further to Sno's post, the customer notice sent applies to only the power drive unit PN 530.100.

Chip Moore
Somewhere in Western MN

[chipmoore]

(and what method of verification are we supposed to use that is approved to validate parameters have been met for a 24 minute exposure cycle?)

Perfect example for the Class 6 Emulator PCD.
Chip Moore
Somewhere in Western MN

[Harvey Johnson]

So, in that class 6 are cycle specific, which company wil be first to market the 24 minute exposure emulator pcd ?

[wcj]

I have a question about the 24 min exposure time. Can all the other surgical sets be run for this length of time? What about linen, power cords, rigid containers(hard plastic)? Is there any type of equipment, that is normally steamed, that cannot be run for this length of time? All I've ever heard of is the 4 minute "minimum" exposure time, is there a maximum time? Thanks for the help.