Frequently Asked Questions
A: The National Institute for Occupational Safety and Health (NIOSH), the American Society of Health-System Pharmacists (ASHP) and the International Society of Oncology Pharmacy Practitioners (ISOPP) define a closed-system drug transfer device as “a device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system.” ISOPP further stipulates that such a device must be “leakproof and airtight.”
A: No, PhaSeal is the only product that is clinically proven to effectively minimize hazardous drug release into your environment. This includes both surface contamination and human uptake.
A: PhaSeal is backed by 19 independent, peer-reviewed, published studies and 15+ years of experience in the safe handling of hazardous drugs. Ask your local Territory Manager for copies of these documents.
A: Yes, when aspirating the last few mL, it is possible to retract the Injector Luer Lock cannula in order to minimize the residual drug volume in the vial.
A: PhaSeal is a closed-system drug transfer device (CSTD) that uses Double Membranes to ensure dry connections, an Expansion Chamber to capture aerosols and vapors and an intuitive design that allows you to retrieve all of the drug from the vial during the sealed transfer process. This unique design effectively minimizes hazardous drug release into your environment.
Chemo pins are open and allow aerosols and/or vapors to pass in and out of the filter/vent. Additionally, chemo pins have only a fixed spike, which may prevent retrieving all of the drug from its vial.
A: With any new procedure, time to adjust is necessary. The initial use of PhaSeal may increase preparation time, depending on the amount of chemo preparations your particular institution is doing. However, the same rate of preparation is proven to return quickly once your staff has adapted to the new system. For additional instructions and training, please contact your local Territory Manager, Clinical Support Manager or call 866-487-9250.
A: The local pharmacy should make a decision from a hygienic point of view. This should be determined by individual regulations.
A: All membranes can be punctured up to 10 times.
A: Yes. Store the vial with the Protector in an upright position and allow it to reach room temperature before use. Make sure to refer to the instructions of the drug manufacturer.
A: Yes, IV bags spiked with the Infusion Adapter (C100) may be refrigerated. They should be brought to room temperature before being transported or hung for infusion to ensure maximum holding power of the Infusion Adapter (C100).
A: No, please follow package insert for each drug you use.
A: Yes, only if the filter is inline and not vented to the outside for administration. Please contact your local Territory Manager, Clinical Support Manager or call 866-487-9250.
A: Stainless steel.
A: No, ampules are rare, open, cannot be resealed and do not have a rubber stopper. The PhaSeal System is a closed system for the safe handling of hazardous drugs.
A: The Injector fits onto all luer lock syringes.
A: Seal the vial with a Protector 50 (P50). If you are reconstituting manually, push 50 mL of liquid into the vial, remove the air from the Expansion Chamber and then add another 50 mL. For the complete procedure of reconstituting 2 grams of Cytoxan, please contact your local Territory Manager, Clinical Support Manager or call 866-487-9250.
A: In general, to avoid clogging the filter in the Expansion Chamber, the System should always be pressurized with the syringe vertically above the vial and the end of the cannula in the air space above the fluid. Try to aspirate liquid back into the syringe with as little air as possible. The slower you aspirate, the fewer air bubbles will be created. Small bubbles can be pushed back; the whole assembly must first be inverted so that the vial is vertically above the syringe.
If you prefer working fast and need to push air bubbles back into the vial, we recommend that you push them back when you have aspirated two-thirds of the desired volume into the syringe. Aspirating the last third of the volume will rinse the filter and maintain satisfactory performance of the Expansion Chamber.
A: All lines that fit regular infusion bags will fit the Infusion Adapter (C100).
NOTE: A non-vented IV set should be used with the Infusion Adapter (C100). If a vented set is used, make sure that the air inlet is closed throughout the infusion procedure.
A: NIOSH suggests that “pharmacy personnel prime the IV tubing and syringes.” (NIOSH Alert, 2004) PhaSeal’s Infusion Adapter (C100) provides a dry connection for spiking the administration set into the IV bag. Its unique adaptability allows nurses the opportunity to select the tubing they need to spike into the bag.
A: Yes, when the Injector Luer Lock is connected to the patient’s IV line, pull back on the plunger of the syringe and blood return should become visible.
A: When the Connector Luer Lock is attached to the patient’s IV line, it becomes a permanent part of the IV line and should only be removed when the IV line is removed. PhaSeal’s Y-Site Connector (C80) is a permanently fastened, designated dry connection port for handling hazardous drugs. Please continue to follow your hospital’s policy for changing IV lines.
A: Yes, but the rubber port at the Y-site must be converted to a luer lock with an access pin. The Connector Luer Lock (C35) will fit all luer lock connections.
A: PhaSeal’s needle-safe design meets all OSHA safety requirements.
A: All PhaSeal components should never be disconnected from the vial, syringe or bag in order to maintain a closed system in your waste disposal. It should be disposed of as one unit.
A: PhaSeal products come in sterilized packages. Membranes can be cleaned with either 70% Isopropyl Alcohol (IPA) or chlorhexidine. When using either product, use large, cotton square swabs or swab sticks. Please follow your hospital’s policy and procedure for disinfecting or cleaning products.
A: Please follow OSHA recommendations for proper PPE.
A: Yes. Some pumps may need a modified set-up with some sizes of syringes. Contact your local Territory Manager, Clinical Support Manager or call 866-487-9250.
A: Yes, the PhaSeal products available to the US market do not contain inline filters.
A: 0.04 mL.
A: No, the cannula ends inside the Connector Luer Lock, thus protecting the port. For additional instructions and training, please contact your local Territory Manager, Clinical Support Manager or call 866-487-9250.
A: The volume in the Infusion Adapter (C100) is 0.16 mL.
A: There are two layers of plastic material – Polyamide (PA) and Polypropylene (PP).
A: Yes, all components in the PhaSeal System are latex-free.
A: All products are PVC-free except the Y-Site Connector (C80) and Secondary Set with Drip Chamber (C60), which has PVC, DEHP-free tubing.
A: Thermoplastic Elastomer (TPE).
A: Yes, the Injector Luer Lock (N35) has a medical grade silicone seal which does not come in direct contact with the drug during normal use. Silicone is a frequently used material in disposable three-part syringes, which have a silicone seal or are sprayed with medical grade silicone oil for lubrication.
A: All products are individually sterilized and packaged in case quantities.
A: Carmel Pharma provides a competency checklist that can be customized per individual facility. Please contact your local Territory Manager, Clinical Support Manager or call 866-487-9250.
A: Yes, PhaSeal is protected by a number of patents.
A: All products in the PhaSeal System are sterilized using ethylene oxide except for the Syringe Tray (M15), Infusion Clamp (M20) and Infusion Clamp (M25), which are non-sterile.