At Parker, product quality and reliability by adhering to the strictest quality control/infection control guidelines with each and every line. Furthermore, Parkers’ commitment to quality is nowhere more evident than ever in the flagship, Aquasonic 100 Ultrasound Transmission Gel.
In response to inquiries made regarding possible microbial contamination, the following information is provided:
Parker Laboratories products meet the USP criteria for Antimicrobial Preservative Effectiveness.
Studies performed on Aquasonic 100 Ultrasound Transmission Gel show that the product remains free from microbial growth for more than five years from date of manufacture.
During the course of a 28-day study, samples of Aquasonic 100 were stored both at room temperature, and at 36 – 38°C to simulate conditions in a Thermasonic® Gel Warmer.
Samples under both conditions met the USP criteria for preservative effectiveness. As long as a bottle that has been opened is stored properly and not contaminated during use, the gel is expected to maintain its original shelf life.
Since there is no effective way to determine whether an opened bottle of gel has been contaminated general guidelines are that gel should be marked to expire 28 days after opening. Using a warmer for the gel does not impact the expiration time.
Parker Laboratories stringent quality assurance procedures include the following:
- Environmental monitoring program routinely tests several areas of the manufacturing and production areas for microbial contamination, including manufacturing and packaging equipment.
- Microbial testing is performed monthly on the process water used to make all Parker products and results have shown no presence of bacteria at all points of use.
- Sanitization of entire process water system is performed quarterly.
- Continuous monitoring of water quality provides real-time indication of any system malfunction.
- Microbial testing is done on all Parker products during the routine stability program every six months throughout the life of the product. There have been no indications of microbial growth.
- Quarterly pathogen testing on Aquasonic 100 demonstrates product is free from pathogens when manufactured.
What this means for you is simple…
The quality and reliability you expect from Aquasonic 100 and Parker Laboratories is as strong and unwavering today as ever.
If the gel shows no microbial growth after opening, as long as it is not contaminated, and it can be used for it’s shelf life, why are hospitals discarding it after 28 days of opening? Thank you, Susan
Hi,
My nephew has an eye condition that requires him to only use preservative free products. As he frequently needs ultrasound of his eyes, I am looking to get preservative free ultrasound gel. Do you provide this? Or if not, could you please let me know if there is anywhere else I could try.
Thank you very much,
Suzanne
I have two questions, if this gel is only good for 28 days, how can you possibly have a 5 liter, refillable product. 2) in your literature on the gels and warmer you state 3 months if placed in a warmer. How are you notifying your clients that they must dispose of this gel 28 days after opening the container whether warmed or not.
Ginger, Thank you for your inquiry. The 5 liter size is not refillable. It does however come with a .25 liter bottle that can be filled from the 5 liter.
Regarding the warmer/28 days. The 28 day expiration is from time of opening of the gel regardless of warming or not. As far as the 3 months in the warmer this may be incorrect information (where did you see this?). Current advice is that warming does not effect expiration. Does that answer your question?
Brian,
I recognize that the 5 liter is to refill the.25 liter bottle, my question is according to the “new” 28 day expiration, you would have to dispose of that 5 liter container after twenty eight days.
Second the 3 months is in your companies description for products in warmers.
We went by this information when writing our hospital policy and now that your new 28 day statement has been mad, 1) we have to change policy, 2) we have to re-educate staff. Remember your product is not only used by education trained in ultrasound but by physician and nurses for various other procedures. 3) This information needs to be shared LOUDLY across the country, because most people do not have any idea of this “new manufacturer guideline”
Brian/Staff,
We just had a mock JCAHO inspection this morning (no warning to me). There were 2 items that they found, 1 was were we using the 5-litre container (no we don’t) and the 2nd about tracking the time of using the bottles in warmers and when the bottles would expire. I noted the blog entry above but where can I obtain that for download to use for our records? I’d prefer that the downloaded entry uses your official logo and a date on it if possible.
Thanks for the information!
-Grae
I too would like to know if the 5 liter bottle should be disposed of after 28 days? Or does this only apply to the .25 liter?
I also am very confused by this new guideline. In the statement above, it says that studies show that “the product remains free from microbial growth for more that five years from the date of manufacture”. It further states, “since there is no effective way to determine whether an opened bottle of get has been contaminated general guidelines are that get should be marked to expire 28 days after opening”. My questions are:
1. Why 28 days? What magic is there in those 28 days? If a bottle is contaminated, it should be discarded immediately, not used for 28 more days. If it is not contaminated, it should be good until the manufacturer exp date.
2. The bottles are not “sealed” when we get them, so technically they should be marked to expire in 28 days as soon at they are filled.
3. This is not a sterile product. Why treated is as one?
4. Where can I find the studies that show that patients have been harmed by using this gel longer that 28 days after “opening” them (again, there is no seal so they are “opened” from the time they are filled)
Deborah, For the most accurate information please contact the manufacturer Parker Labs directly and speak with the QC department.
The 28 day guideline is because the study was only done for 28 days. I cannot locate the specific study info as this was written some time ago.
The manufacturers advice to us is that as long as the gel is not contamination it is good until the original expiration date.
I do not know of any studies showing “harm”. Again the study was only conducted for 28 days.
This information may also be helpful (page 194 refers specifically to gel):
Infection Control in the Sonography Department
So the 5 liter container must be discarded 28 days after opening? I don’t see my department ever using a 5 liter container in 28 days, so basically it seems like I should never purchase a 5 liter container of gel. . .
Sounds to me the benchmark of 28 days was arrived at based on the time period of their internal study. The question is if had been done for 6 months then it would have still be acceptable?
Perhaps the Manufacturer can do a longer study before making us all jump through hoops?? Brian, can we ask for them to retract their recommendation until that is done?
1. Should the pre-filled bottles of ultrasound gel be labeled with an opened date and a 28-day use-by expiration date?
2. Should refillable bottles not be used?