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Q: What is the definition of a closed-system drug transfer device?
A: NIOSH and ASHP both 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.”
Q: Is there any other product that has been proven as a closed system?
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.
Q: How many clinical studies have been published on PhaSeal?
A: PhaSeal has 10 peer-reviewed, independent studies currently available and over 10 years experience in the safe handling of hazardous drugs. Ask your local Territory Manager for copies of these clinical documents.
Q: What is the difference between PhaSeal and filtered/vented chemo pins?
A: PhaSeal is a closed-system drug transfer device that uses double membranes to ensure dry connections, an expansion chamber to capture aerosols and vapors, and a needle-safe 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 air to pass in and out of the filter/vent. Additionally, chemo pins have only a needleless port which may prevent retrieving all of the drug from its vial.
Q: How long will it take a pharmacist or technician to learn how to use PhaSeal and return to the rate of preparation they were at before they started?
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 you’re staff has adapted to the new system. For additional instructions and training, please contact your local Territory Manager, Clinical Support Manager, or call 1-866-487-9250.
Q: Can we use the Assembly Fixture and cap the vials outside the BSC?
A: The local pharmacy should make a decision from a hygienic point of view. This should be determined by individual regulations.
Q: How many times can the membranes be punctured?
A: All membranes can be punctured up to 10 times.
Q: Can vials with the PhaSeal Protector attached be stored in the refrigerator?
A: Yes, just ensure that the protective membranes reach room temp before use. Additionally, if an IV bag with an Infusion Adapter has been refrigerated, you must allow both to warm up to room temperature prior to use, in order to maximize holding power.
Q: Can bags with the Infusion Adapter spiked into them be stored in the refrigerator?
A: Yes, just ensure that the Infusion Adaptor and IV bag are brought to room temperature. Please note: All bags that have been stored in the refrigerator have less holding power due to the temperature change (expansion/contraction).
Q: Will the use of PhaSeal extend the stability of the drug?
A: No, please follow package insert for each drug you use.
Q: For drugs that require a filter, can I use PhaSeal to maintain a closed system?
A: Yes, only if the filter is inline and not vented to the outside for administration. When filtering, only use filters inline and not vented to the outside. Please contact your local Territory Manager, Clinical Support Manager, or call 1-866-487-9250.
Q: What is the protector spike made of?
A: Stainless steel
Q: Can you use PhaSeal with drugs that come in ampules?
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.
Q: Does the Injector fit onto a 1 ml (TB) syringe?
A: The Injector Luer Lock fits onto all luer lock syringes.
Q: How can I reconstitute a 2 GM vial of Cytoxan with 100 ml of liquid?
A: Seal the vial with a Protector 50. If you are reconstituting manually, 50 ml can be pushed into the vial, remove the air from the expansion chamber and then add another 50 ml. Please contact your local Territory Manager, Clinical Support Manager, or call 1-866-487-9250.
Q: How do I get rid of air bubbles in the syringe?
A: In general, to avoid clogging the filter in the expansion chamber the system should always be pressurized with the syringe vertically above vial and the end of the needle 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. When you then aspirate the last third of the volume this will rinse the filter and maintain satisfactory performance of the expansion chamber.
Q: What IV tubing’s are compatible with the PhaSeal Infusion Adaptor?
A: All lines that fit regular infusion bags will fit the Infusion Adapter.
NOTE: A non-vented IV set should be used together with the C70 or C100 Infusion Adapter. If a vented set is used, make sure that the air inlet is closed throughout the infusion procedure.
Q: When using PhaSeal, does the pharmacy still have to spike and prime the lines for nursing?
A: NIOSH suggests that pharmacy personnel should prime the IV tubing and syringes. PhaSeal’s Infusion Adapter 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. This may save valuable time for both nursing and pharmacy.
Q: Can I check for blood return when performing an IV push with PhaSeal?
A: Yes, when the Injector is connected to the patient’s IV line, pull back on the plunger of the syringe and blood return should become visible.
Q: What amount of time can the Connector safely stay on the patient’s IV line?
A: When the connector 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 is a permanently fastened, designated, dry connection port for handling hazardous drugs. Please continue to follow your hospital’s policy for changing IV lines.
Q: Can I attach the Connector Luer Lock to tubing with rubber ports at the Y-site?
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 will fit all luer lock connections.
Q: What does OSHA say about PhaSeal and needle safety?
A: PhaSeal’s needle safe design has met all OSHA safety requirements for approval.
Q: How can I prevent needle exposure?
A: While keeping your hands on the white pieces, lock the Injector and Syringe Assembly to PhaSeal Connector ports by pushing in and twisting to the right. Slightly lift safety latch and engage needle. Inject drug with one hand on the Injector/Connector and one hand on the syringe. Pull back Injector and Syringe Assembly until safety latch “clicks” into a locked, flat position. Disengage Injector and Syringe Assembly.
Q: How do I dispose of PhaSeal products?
A: All PhaSeal components should never be disconnected from vial, syringe or bag in order to maintain a closed system in your waste disposal. It should be disposed of as one unit.
Q: How do I disinfect the membranes of PhaSeal products?
A: PhaSeal products come in sterilized packages. Membranes can be cleaned with either alcohol or chlorhexidin. When using alcohol, use either large cotton square swabs or ChloraPrep. Please follow your hospital’s policy for disinfecting or cleaning products.
Q: Do I still need to double glove?
A: Please follow OSHA recommendations for proper PPE.
Q: Can PhaSeal be used on drugs where the package insert states “do not use filter”?
A: Yes, the PhaSeal products available on the US market do not contain inline filters.
Q: What is the gauge of the Injector Luer Lock needle?
A: 18G
Q: Can the Injector needle damage any needleless ports?
A: No, the needle ends inside the Connector Luer Lock, thus protecting the port.
Q: What is the volume in a PhaSeal Infusion Adapter C100?
A: The volume in Infusion Adapter, C100, is 0.16 ml.
Q: What type of material makes up the expansion chamber in the Protector?
A: There are two layers of plastic material – Polyamide (PA) and Polypropylene (PP)
Q: Is PhaSeal latex free?
A: Yes, all components in the PhaSeal system are latex free.
Q: Do any of the PhaSeal components contain PVC?
A: All products are PVC free except C80 Y-Site Connector. It has a DEHP –free PVC tubing.
Q: What are the membranes made of?
A: Thermo Plastic Elastomer (TPE)
Q: How are the PhaSeal components packaged?
A: All products are individually sterilized and packaged in case quantities.
Q: Does your company provide a competency test?
A: Yes, please contact your local PhaSeal Territory Manager, Clinical Support Manager, or call 1-866-487-9250.
Q: Is there an existing patent on PhaSeal?
A: Yes.
Q: Do any of the PhaSeal components contain silicone?
A: No, all components, including the tubing and membranes, are completely silicone free.
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