Unusual Manufacturer Sterilization Recommendations

[HRJohn]

One of the 'projects' that I have assigned to me at the hospital where I work is tracking down and documenting sterilization recommendations from various manufacturers.

This has turned out to be a more complicated project than I originally thought. Many manufacturers recommend very specific parameters which don't correspond at all with standard prevac sterilization cycles.

It only gets more diversified and complicated when I get into their gravity and flash recommendations.

I thought that a good idea for a thread would be a place where we could compare notes and discoveries on these unusual parameters, and perhaps some alternatives to resetting the cycle times every time we run a load!

I will stop back by later on a start a list of the parameters I have encountered so far.

Any contributions from other members would be greatly appreciated!

-John

[HRJohn]

OK Here are a couple of parameters to get started:


Synthes faxed me their recommendations for Intruments and Implants.

Notice that the requirements are different for instruments and implants, even though we process trays that contain both in the same tray:

Implants:

10 minutes gravity @ 270-275F
4 minutes prevac @ 270-275F

Instruments:

15 minutes gravity @ 270-275F
8 minutes prevac @ 270-275F


These recommendations are to be followed, according to Synthes, unless the product insert for a particular tray gives different instructions. Synthes also makes distinctions between complex and non complex trays, so we have to make sure we are following the exact recommendation for a particular tray.


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Depuy Orthopedics changed their prevac recommendations recently, so I had the new recommendations sent to me. These instructions apply to reusable non sterile surgical instruments:

132-134C (Approx 270-274F) 8 minutes/ 20 minute dry time
134-137C (Above 274F) 5 minutes/ 20 minute dry




__________________________________________________ ___

[HRJohn]

Here's a tricky one:

Stryker Spine has some extremely cumbersome recommendations for their XIA, OPUS, DIAPASON, RPS, and RELEX HYBRID trays.

They are defaulting to the French recommendation of

18 minutes prevac exposure @ 278F!

because that is a cycle parameter which France's IC has validated to kill CJD.

I spoke with a guy at Stryker today, who tells me that new recommendations are being rolled out for lower acceptable cycle times, but they are only being changed one tray at a time, and as needed when the package inserts are updated.

I asked him if he would be willing to send me a letter confirming that lower exposure times have been validated and that our existing cycles are sufficient.

If you are doing any of these trays at your facility, it might be a good idea to contact Stryker Spine and get an update on their recommendations.

[sonny1388]

Wow, thanks for the updates. I will have to look into our Synthes sets (although we are mainly using a product from Stryker now). Here is another, although rather small one:

the Gore Suture Passer Instrument Ref #1GSP02 (we use it mostly for Lap Chole cases)
" STEAM - Using a validated gravity displacement steam sterilizer, autoclave at or above these minimum requirements:
250F (121C) for 30 minutes
270F (132C) for 15 minutes

[HRJohn]

Sonny, those items with gravity-only settings drive me nuts!

We have a similar situation with our older model Padgett Dermatome.

It is a model 'B' and you have to sterilize it for 30 minutes at 250F. Not only that, but they don't want you to exceed 18psi in the chamber.

We got rid of our ETO sterilizers last year (thank God) but now we have to find steam alternatives for several items that we used to gas.

Regarding the Dermatome, however, if you have the newer model 'S' the sterilization is easier and includes Sterrad (Hydrogen Peroxide Plasma) compatibility.

Sonny, what have you done as an overall machine setting policy as a result of these varying parameter recommendations?

[sonny1388]

Well, we are still working on it, as we have just recently (within the last 6 months) started picking up on all of the variations, but what we have done so far is to leave a "normal" setting (4min sterilize, 20min dry) on both of the autoclaves that we have in C.S. That left us with three cycles on each machine that we could designate for items with odd specifications. We have only filled two so far, but as we come across more, we will input cycles for them. It's a little confusing, but we also made out a master sheet for what items need to be run on which autoclave under which cycle. Luckily, we are a smaller hospital, I couldn't imagine trying to do the work of bigger hospitals!!

[HRJohn]

Thanks Sonny,

We've taken similar steps to what you have done. I have a 'guidelines' sheet posted by each sterilizer listing the trays which have special sterilization requirements.

I have 2 'normal' cycles: a 4 minute 270 / 25 minute dry, and a 4 minute / 45 minute dry for the heavy metal mass trays.

We have a number of trays which require 8, 9, or 10 minute prevac exposure, so I programmed in a 10 minute cycle at 270F to cover the longest exposure requirement. We use this cycle for all of our trays which need something significantly above the normal 4 minute exposure.

We have a couple other items, like our Padgett Dermatome and a W Lorenz implant tray, which call for even longer exposure times. We have to manually reset the cycle times for those trays.

I'm also thinking about changing my normal 4 minute prevac to a 5 minute prevac, because I also have a number of items with that 5 minute requirement. Does anyone have an opinion on doing that?

Are there some items, like autoclavable scopes or power equipment, whose life might be shortened by repeated 5 minute exposures? I need to look into that some more.

[HRJohn]

Here's another tricky recommendation we came across today:

EBI Spine has different requirements for their different trays.

You have to know exactly which tray/ system you have, to know the correct parameters.


-The 'Omega 21' System requires 4 minutes prevac at 270
-The 'Spinelink II' requires 8 minutes prevac at 270
-The 'EBI Assay' System requires 8 minutes prevac at 270

I think we might just put all the EBI trays onto our '10 minute prevac list' to avoid confusion the possibility of 'missing' one of these with an 8 minute requirement.

[tazmomm48]

Please check with your Synthes rep concerning strerilization times, The fax I have from Synthes is for complex and non-complex trays. Complex trays are Gravity Displacement (wrapped) 270-275F for 28 mins and Prevac (wrapped) 270-275F for 10 minutes.
Complex trays listed were:
ACLP Instrument Sets
USS Vas Instrument Sets
Pedicle Prep Sets
Clixk X Implant Sets
Large Resorbable Instrument Tray Sets
Just to list a few.

Non complex trays are 8 minutes!
This is from Matt Roybal Synthes Sterilization Specialist!

[sterilityking]

Hello,
I work for an orthopaedic company and I feel your pain in trying to get a hold on all manufacturer's sterilization instruction.

One of the reasons why it seems that manufacturer's sterilization parameter seem never to coincide with your processes is because we do not know to an extent of what our CSR customers are looking for.

I think this forum would be a great way to exchange our ideas to come to an agreement on sterilization parameters that offer safe and sterile instruments.

Recently, my company has drafted and disseminated a detailed survey to inquire about your needs and wants in regards to reprocessing our reusable devices. Unfortunately, we did not get enough responses to make a change within my company.

I would like to know if you would be willing to take the detailed survey and offer any useful information to come up with recommendations that are more user-friendly for your CSR.

If so, please leave an email address and/fax number with your name in my "Private Messages" inbox and I will be sure to get you a survey.

Thank you.

[HRJohn]

S-King,

I will try to set aside a few minutes to take your survey.

In the meantime, have you come across anyone who has compiled a comprehensive list of sterilization recommendations from different manufacturers?

Or... do you know of a better compiling method than making 5000 phone calls to manufacturers' 800 numbers, and then having half of them not return your call? :mad:

lol.

[carol1967]

Here is what I have received from the listed companies. I have faxed infor for each one. We use instruments from each of these vendors. Each sterilizer only holds 4 programed cycles. What a pain. :mad:
Carol

[HRJohn]

"Each sterilizer only holds 4 programed cycles. What a pain."


Carol,

Do you reset your machine for each different tray on this list?

We've programmed a couple of "long" cycles which can encompass the longest sterilization time required, and we use it for a variety of trays which have similar requirements.

This way, we ensure that we never go under the minimum exposure time requirement for a given tray.

Do you see any downside to doing it that way?

[chipmoore]

You have access to the FDA's public site below for 510k clearance info. Once at the site, search by the Mfg's or product name to see a list of 510k's. You can also search by Product Code of the item if known. For sterilizers, use the Product Code FLE. The word SUMMARY is a hyperlink to the actual 510k. On that document, you will find the names and direct dial phone numbers of the QA/RA person who made the submission. Call them and register your comments
Chip Moore
Getinge
Rochester, NY

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

Or... do you know of a better compiling method than making 5000 phone calls to manufacturers' 800 numbers, and then having half of them not return your call?

[sonny1388]

Carol,
In the list I see that Howmedica is listed. Is this for all of their instrumentation, as in all of the total joint pans? :eek:

[HRJohn]

Chip,

Thanks very much for that resource. That looks like it will be very helpful in tracking down the person responsible for getting us accurate recommendations

Carol, Sonny,

I had to go look up that Howmedica recommendation myself. :eek:

Fortunately, Howmedica has updated that recommendation and has now validated a 4 minute prevac cycle, across the board, for their trays

I spoke with Barry Kelly at Howmedica QA, and had him email me the new written guidelines. You can reach him at 201 831 5284 to get a written copy for your files.

[pepper]

In All My 16+ Years Of Training I Have Been Taught That Manufacturing Companies Of A Reusable Device Had To "validate Sterilization Parameters" For These Devices To Give Us Guidelines For Sterilizing Their Instrument Effectivly. Thus Ensuring Patient Safety. So My Answer Would Be Not What We As Technitions Want , But What Does Your Testing Tell Us That We Need To Sterilize At What Temp; For How Long; And With What Dry Time To Insure Patient Safety? Thank You.

[tazmomm48]

My questions is why are the companies not contacting the Sterile Processing Managers with their new perimeters when they make these changes on Ortho/Loaner trays.
I am currently researching the times Carol had posted and called Stryker/Howmedica and had them e-mail me their sterilization perimeters and I to found that it is now 4 mins and 30-90 minute dry. When they originally changed this, why were the Sterilization Depts in the millions of hospitals not notified of this. I feel notices need to be mailed to all the hospitals if you change your perimeters from 4 mins to whatever that all hospitals should be notified, or who takes the liability. When you receive new items into the hospital there is usually a sheet with cleaning and sterilization guidelines in the box with the item. Pacing cables, Volk lens etc. but this is not so when a Rep/Vendor brings in loaner trays. What is everyone elses thoughts? I have the BeliMed sterilizers and have 10 programs 3 of which are Belimed leak test, warm up cycle, and Bowie Dick cycle so that leaves me with 7 left to program to what I need but the manufactuers can not keep changing the sterilization times, validation should be done before it is first released and reprocessed or there are going to be alot of lawsuits against someone when unsterile items are delivered to an unsuspecting patient.

[HRJohn]

I feel your frustration Tazmmom.

I spend a lot of my time making phone calls to manufacturers and trying to keep up with the recommendations.

I am going to write a policy in conjunction with the OR at my hospital which will require vendors to bring current recommendations when they bring in their loaner trays

In the few cases where manufacturers have changed their recommendations, I have been told that the new recommendations would eventually be changed in the product inserts. The manufacturer did each time provide me with a letter indicating that I could make the change immediately.

The good thing was in both cases ( Stryker Spine and Howmedica ) the manufacturer was actually lowering the exposure time and bringing the recommendation more into line with our "standard" cycles.

In other words, we were still ok to sterilize at the old parameters, and they were attempting to validate their trays in more common cycles, which is to our benefit.

[Rod Brueggeman]

The answer is simple(seemingly)- there needs to be heavy pressure placed on medical device manufacturers to validate sterilization based on standard hospital cycles - not what works best for them. It would mean that they would have to do the legwork up front and maybe they would need to redesign external cases for better drying or better steam/steriliant penetration or reduce the amount of instrumentation in the sets - maybe try to keep the total weight under 30 pounds!!!!

[SHIRLEEN VANOCKER]

to all of you responding to the extended time issue; I have a book in which I keep a hard copy of all manufacturers' recommendations. I keep this in alphebetical order so staff can easily find what they need. I am more than willing to share what I have, but there is way too much to type in here. I do know that manufacturers' do not automatically inform facilities when they re-validate and make changes. For instance; Depuy was 40 minutes for sets with over 2 layers, now that has changed to 8 minutes / 20 min dry for multiple insert cases, that are metal / poly mix; all poly is 45 min sterilize time.

[Topher]

1. I recently spoke with a gentleman from Jurgan Medical and he informed me that many companies utilize independant labs for establishing validated cycle parameters. I wonder if this isn't a HUGE contributing factor to the issues we are all dealing with presently. If this is widespread, then the labs could choose any cycle they liked. They would merely need to show that it produced a sterile product. So...here's my question: Has anyone ever tried to do an in-house validation? Is it feasable and/or legal?

2. HRJohn: I had a question about using the longest cycle to encompass all "funny" items. So, is the concern that items are sterilized long enough, but no concern that the cycle is longer than recomended? What is your policy for cords, cables, and etc. that might be in sets and processed on the long cycles?

Thanks!
Topher

[Harvey Johnson]

I'd be a little nervous, legal wise, to try department validation of trays.
I have also been told the mfr's validate with some strange criteria. One tray at a time in a full size chamber, going for a longer cycle "to be safe" and not exploring if a shorter time would be as effective...etc.
But as long as we are told to follow mfr's instructions, to stay on the right side of the risk managemnt dept, that's pretty much what we have to do.

[cpdguy]

Please contact me off line. Thank you

[chipmoore]

Hello from Pelican Lake MN
Device Mfg are getting the message and are challenging commercial test labs and in-house testing protocols toward typical hospital cycle/settings. This was evident at the April AAMI meeting and more recent conversations with several orthopedic companies. It will take time and pressure (inquiries) from users can help the process.
Validating sterilization times involves lab conditions, steam supply within spec, the sterilizer working to spec and feeding up to 24 thermocouple wire inside the chamber and inside the load (s) to measure actual temperatures at tough locations. The temperature is recorded on a Yokagowa multi point recorder, later printed to show the entire cycle and temperature profiles. Difficult/complex devices may require innoculations. BI strips and CI's are also included for empty chamber and under full load conditions. All cycle validation is peformed at 1/2 the recommended cycle. This description probably is too general but essentially what's is done.
Chip Moore
Getinge
Somewhere in Western MN

[Carol Forrest]

I am trying to meet these requirements at our hospital. Does anyone have a comprehensive list that they would be willing to share reguarding sterilization times for different instrumentation? If so, Please email them to me.