General
EcoVue Ultrasound Gel is manufactured by HR Pharmaceuticals, Inc., a leading healthcare consumables manufacturer who also manufactures Surgilube and HR Lubricating Jelly.
No, there has never been an FDA recall on EcoVue Ultrasound Gel.
The 2021 recall of ultrasound gel manufactured in Canada by Eco-Med Pharmaceutical, Inc., is NOT related to EcoVue Ultrasound Gel or any other product of HR Pharmaceuticals, Inc.
EcoVue Ultrasound Gel is manufactured by HR Pharmaceuticals, Inc. in the United States at a cGMP compliant, ISO 13485:2016 and MDSAP certified facility under the strictest quality control/infection control guidelines, and has undergone extended usability testing and complies with USP standards for Antimicrobial Effectiveness.
EcoVue Ultrasound Gel offers two gel viscosities. Our original formula is a medium viscosity gel that can be used for a wide variety of procedures that benefit from a gel that easily glides across the procedure area yet doesn’t plow ahead of the transducer. EcoVue HV is a high viscosity gel for procedures that demand a thicker gel with more staying power.
Purchasing
EcoVue products are primarily procured through our network of national, regional and independent distributors. If you need assistance gaining access to EcoVue, please contact us. For international distribution, please contact us.
Yes, we would be more than happy to send your facility samples for trial/evaluation. Please fill out a sample request form, or contact us.
Packaging
EcoVue Ultrasound Gel has a shelf-life of 36 months from the date of manufacture across all packaging options. The expiration date can be found on the back of the package.
Once the packaging of any multi-use product has been opened, any unused portion should be discarded in accordance with internal facility guidelines on multi-use products. Single-use packets should be discarded immediately after use.
EcoVue Ultrasound Gel is available in a variety of single use packets (sterile & non-sterile) as well as several multi-use options, including an 8.5 oz. bottle, 60g tube, and our patented 8.5 oz. FlexPac®.
Single-Use Packets – The multilayer plastic used to create the packets contains a metallic layer which renders the packets unrecyclable.
Bottle – EcoVue bottles are made from LDPE plastic which carries a number 4 recycling number. Please check with your local recycling center to confirm if number 4 recyclables are accepted. Much less LDPE is recycled than HDPE, especially in the USA. If your recycling center does not accept number 4 plastics, bottles should be disposed of in the standard waste stream.
FlexPac® – The EcoVue FlexPac® lowers environmental impact through reductions in carbon emissions during production and shipping; it’s lightweight and requires less energy to manufacture and transport. The ability to evacuate all the gel from the pouch reduces gel waste by 14%, but the empty pouches should be disposed of in the standard waste stream. The multilayer plastic used to create the pouch contains a metallic layer which renders the pouch unrecyclable.
Ultrasound procedures carry different risks depending on the likelihood of exposure to bacteria, contact with body fluids and the degree of invasiveness of the procedure. Based on the Spaulding Classification and the SDMS Guidelines for Infection Prevention and Control in Sonography (May 20, 2020), the following ultrasound gel should be used for critical, semi-critical, and non-critical procedures:
| Spaulding Classification | Definition | Ultrasound Gel |
|---|---|---|
| Critical | Ultrasound gel is being used on sterile tissues, including biopsies, intraoperative, and vascular guidance | Sterile, single-use packets |
| Semi-critical | Ultrasound gel comes in contact with non-intact skin or mucous membranes but does not penetrate them | Sterile, single-use packets (preferred) or non-sterile, single-use packets |
| Non-critical | Ultrasound gel touches only intact skin and not mucous membranes | Non-sterile, single-use packets (preferred), non-sterile, multi-use gel (bottle, flexpac®, tube) |
Yes. We have found that some procedures often require more than one 20g packet of gel to complete the procedure. The 32g packet is a good option to avoid using two 20g packets and wasting gel. The 32g packet drives down cost and product waste, and thus, has been well-received in the market.
The “RX Only” indication simply means that the ultrasound gel may only be sold to a healthcare organization for use on patients. The “RX Only” symbol is short for the statement “Caution: Federal law restricts this device to sale by or on the order of a physician.”
As such, the “RX Only” only pertains to who HR Pharmaceuticals, Inc. may sell the product; it does not pertain to how the product is used within a healthcare setting and does not place any additional storage/handling requirements on healthcare facilities (like RX drugs). All ultrasound gels approved for sale by the FDA through the 510(k) process (i.e. are not Preamendment Devices) are technically “RX Only” and will either contain the symbol on the packaging or the cautionary language above in the IFU.
EcoVue Ultrasound Gel has begun the process of updating packaging to remove “RX only” and use the statement “Caution: Federal law restricts this device to sale by or on the order of a physician.”
If you have any additional questions regarding “RX Only”, please contact us.
Formula
EcoVue HV is formulated to be 35% thicker than our original EcoVue Ultrasound Gel formula. EcoVue HV is preferred for procedures that demand a thicker gel with more staying power.
EcoVue Ultrasound Gel does not contain the following ingredients:
- Methylisothiazolinone (MIT)
- Methylchloroisothiazolinone (CMIT)
- Methyldibromo glutaronitrile
- Cocamidopropyl betaine
- Isthiazolinone
- Formaldehyde
- Thimerosal
- Propylene Glycol (PG)
If there is a specific ingredient(s) you are allergic to that is not listed above, please email us at inquiries@hrpharma.com and we can inform you whether or not that ingredient is in EcoVue Ultrasound Gel.
Propylene glycol is a known cause of probe delamination and can cause minor skin irritation or allergic reactions in some individuals. By eliminating propylene glycol in our 99% natural formulation, we make our gel gentler on patients and equipment.
Yes, EcoVue Ultrasound Gel has passed MEA testing (one-cell to expanded blastocyst within 96 hrs assay), with 100% blastocyst development after exposure to our gel. The results support that EcoVue Ultrasound Gel does not exhibit embryotoxicity and will not destroy gametes and/or embryos or prevent cellular expansion or development when used with assisted reproductive technology (ART), like IVF, and will allow embryos to continue to develop.
According to the FDA, MEA is used to assess the potential for embryotoxicity of devices that have direct and/or indirect contact with gametes (i.e., sperm and oocytes) and/or embryos. A minimum of 80% blastocyst development is required to pass the MEA test.
Download Official Document
EcoVue Ultrasound Gel has been tested for sensitization, irritation and cytotoxicity, and conforms to the requirements outlined in ISO 10993-5 for cytotoxicity, and conforms to the requirements outlined in ISO 10993-10 for irritation and sensitization.
Probe Covers
Our ultrasound probe covers are used as a protective cover over medical ultrasound transducer to protect patients, users, and equipment from cross-contamination.
We currently offer four sizes of ultrasound probe covers, including 5” x 48”, 6” x 48”, 5” x 96”, and 6” x 96”. Our interoperative probe covers feature an extended length, allowing for added cable protection.
Our general purpose ultrasound probe covers are made of polyurethane, and our interoperative probe covers are made of polyurethane and polyethylene.
Yes, our probe cover kits are single-use, sterile, and ready to use. Each kit contains a sterile probe cover, EcoVue® HV Sterile 20g packet, and 2 elastic bands.
Yes, CoverAlls Probe Covers feature a 3D box end that is completely seamless, allowing for distortion-free ultrasound imaging.
The CoverAlls instructions for use can be downloaded here.
Gel Warmer
Yes, we currently offer three models of the Acclimate Gel Warmer – single-use packets, multi-use bottles, and FlexPac®. Our patented design evenly warms ultrasound gel to the desired temperature while allowing users to monitor and regulate the temperature with an LCD digital display.
Our multi-use bottle gel warmer, 289B, can accommodate (2) 8.5oz bottles.
Our single-use packet gel warmer, 289S, can accommodate approximately 14 single-use packets. The warmer has two slots, so you can mix and match the packets.
Our FlexPac® gel warmer, 289F, can accommodate (2) 250g FlexPacs®, or (1) 250g FlexPac® and 8 single-use packets, or 16 single-use packets. The warmer has two slots, so you can mix and match the packets.
By default, the Acclimate Gel Warmer is set to 100°F (37.7°C ) when turned on, and can toggle between 95°F and 105°F (35°C and 40.5°C).
Acclimate is a validated Temperature Control Unit that continuously monitors the temperature. The Control Unit eliminates the risks associated with overheating gel and ensures the product complies with the manufacturer’s Instructions For Use. Additionally, the software contained within the device has an automatic shutoff if in the extremely rare occurrence that the Control Unit fails.
EcoVue Ultrasound Gel complies with USP standards for antimicrobial effectiveness and data supports that the preservation system in EcoVue will function as intended while the gel is warmed (during a 28-day period) so long as proper storage and handling practices are maintained.
For more information, please refer to our gel warming & storage information.
EcoVue Ultrasound Gel complies with USP standards for antimicrobial effectiveness and data supports that the preservation system in EcoVue will function as intended while the gel is warmed (during a 28-day period) so long as proper storage and handling practices are maintained.
For more information, please refer to our gel warming & storage information.
At this time, the Acclimate Gel Warmer is not available in the European Union.
