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Verify that the syringe is properly positioned into the infuser as instructed in the pump user manual. The syringe should be parallel to the infuser with the syringe flanges properly engaged and seen in the safety check window.

Verify that the components are properly connected. The BD 60 ml syringe (model no. 309653) is properly connected to the flow rate control infusion set and is correctly connected to the patient needle set.

Check the flow rate control infusion set to make sure flow is not being blocked. For infusets, make sure that the side clamp is not blocking the flow. For the Versarate or VersaRate Plus, make sure that the dial is not in the 'OFF' position.

Verify the correct flow rate control infusion set and patient needle set is being used. If using Infuset, confirm appropriate item code and patient needle set combination is being used. If using VersaRate or VersaRate Plus to control the flow rate turn the dial to a lower number to reduce the flow rate. Consult appropriate flow rate calculator to estimate expected flow rates by visiting www.versarate.com

If the syringe 'pops out' of the infuser when inner drive is closed/screwed in, it is an indication that the syringe was not properly positioned in the infuser. Unscrew the inner drive and properly position the syringe following the instructions for use.

Verify the flow rate control infusion set is appropriately closed. If using infuset, verify that the side clamp on the Infuset is fully closed. If using VersaRate or VersaRate Plus flow rate controllers, verify that the dial is turned all the way to the 'OFF' position.

Verify the correct flow rate control infusion set and patient needle set combination is being used. Note: Storage of the Infuset with the slide clamp engaged for an extended period of time may temporarily deform the tubing and decrease the flow rate. If using Infuset, confirm appropriate item code and patient needle set combination is being used, and that the Infuset or specified administration set is not kinked in any way. If using VersaRate or VersaRate Plus to control the flow rate, turn the dial to a higher number to increase the flow rate. Consult the appropriate flow rate calculator to estimate expected flow rates by visting www.versarate.com

Insertion and removal techniques are important factors that determine patient experience. If a needle is not inserted perpendicularly, the force required to insert the needle increases. Based on user feedback, it was noted that a 30° angle needle requires double the force to insert compared to a needle that is inserted at a 90° degree angle.

EMED has conducted various penetration force test with regional and global needle manufacturers. In these studies Soft-Glide® needles have been shown to require the least amount of penetration force when compared to other needle sets (including needles from the global leader BD). A new special test was conducted in August of 2017 to further update the data from previous tests. The results are shown in MM-057 under “Average Penetration Force During Insertion”.

EMED has selected its needle design parameters to optimize the patient experience. Its triple angular bevel aligns with the specific design characterized in ISO 7864:1993. EMED’s Soft-Glide® needles have the lowest penetration force of the SUB-Q alternatives.

Needle sharpness is affected by the choice of the best materials, needle design, and manufacturing processes.

Needle manufacturers have long debated about their respective needles. Generally, needle sharpness depends on multiple factors including needle design, gauge, wall thickness, materials and quality of manufacture.

Needles that do not have coating properties may create a dimple effect which could increase the patient’s perception of pain as well as the actual penetration force. Adverse skin site reactions during therapy are the result of various factors. Lowering friction during needle insertion helps reduce tissue damage. That tissue damage can result in site adverse reactions such as redness, swelling and itching.

We have utilized protocols similar to those of the industry leaders to draw conclusions relative to the sharpness of the needles. The test protocol is based on ISO 7864:1993 and other Industry standards such as ASTM F3014-14.

In addition to the penetration force, which is the most objective measure of patient comfort, patients feel a subjective experience relative to the puncture of the needle through the skin. The coating used in Soft-Glide® needles reduces friction of the needle not only during the puncture as well as during the sliding of the needle through the skin and when removing the needles after an infusion.

A standard method to measure penetration force is to utilize a vertical single axis machine to insert a needle into a membrane under repeatable conditions. The membrane should have characteristics similar to the skin of a patient. A precise digital force gauge is used to measure the penetration force dynamically and plot the results.

As a measure of quality control, EMED tests needles on an ongoing basis to correlate production batches with baseline penetration data.

The bevel of a needle is an important element that influences needle performance. Needle bevels are determined by the type, tip, length and number of bevels in a needle.

Industry leaders such as Terumo and BD have long debated about the sharpness of their respective needles and have chosen to measure needle penetration force as the means to establish an objective basis for comparison. Specific protocols have been established to measure needle penetration force.

Stainless Steel is generally accepted as the best material to manufacture needles.

No, all FDA-cleared infusion systems indicated for the subcutaneous infusion of immunoglobulins specify only the BD model 309653 syringe.

EMED is continually working to adapt with market changes and provide our customers with optimal clinical solutions. Please contact EMED Customer Service for additional updates at 916.932.0071.

As the market continues to increase prescriptions for patients over 50ml, it is recommended that patients repeat the initial set up process referenced in the user manual. Patients can also refer to their health care provider for additional direction.

Yes, EMED has received and analyzed BD’s August 2019 notices. Bench testing to verify accuracy and precision of our SCIg60 Infusion System remains unchanged after the update to the model 309653 syringe scale. Research and Development activities are underway to build long term solutions, including exploring opportunities for alternative compatible syringes. EMED is reaching out to distributors, partners, and key opinion leaders to ensure standard of care for the SCIg therapy is not compromised and patient needs are met. Please contact EMED Customer Service for additional updates at 916.932.0071.

The flow rates of the SCIg60 Infusion System with the BD model 309653 syringe remain within the expected tolerance range. Flow rate calculators and information provided in the SCIg60 Infusion System User Manual are still valid. Laboratory testing verifies that the SCIg60 Infusion System can accommodate both the 50 ml and 60 ml syringes as there was no modifications to volume, form, fit or function of the BD model 309653.

Yes, BD model 309653 is still compatible with the SCIg60 Infusion system. Per the letter provided by BD dated August 26, 2019, there are no changes to device form, fit, function or raw material composition, and therefore , the new 50 ml BD® Syringe will maintain compatibility with any ancillary devices currently being used for either preparation or administration of medications (e.g., syringe pumps, robotic filling equipment, etc.).

Being labeled and sold as a “50 ml” syringe Change impacts the graded scale marking only - the scale marking printed on the syringe will not extent beyond 50 ml. The physical internal volume will remain the same as it has been for years. The design, dimensions, and raw materials will remain the same.