PRP - Intended Use
Safe and rapid preparation of autologous platelet-rich plasma (PRP) from a small sample of blood at the patient point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics.
- PRP should be applied to the same patient from whom the blood was drawn.
- Storage of tubes containing blood at or below 0°C may result in tube breakage.
- Storage of tubes above 40°C may damage the gel stability.
- Do not remove conventional rubber stoppers by rolling with a thumb. Remove stoppers with a twist and pull motion.
- Do not use tubes if foreign matter is present.
- All liquid preservatives and anticoagulants are clear. Do not use tubes after their expiration date.
- Do not re-sterilize and do not attempt to clean this product.
- Do not use products if pouch is damaged.
- Use prepared platelet concentrate material within 4 hours after drawing blood from patient.
- Practice Universal Precautions. Process all procedures under controlled environment, use gloves, gowns, eye protection, other personal protective equipment and engineering controls to protect from blood splatter, blood leakage and potential exposure to blood-borne pathogens.
- All glass has the potential for breakage. Examine all glass for potential damage in transit before use and take precautionary measures during handling.
- Handle all biologic samples and blood collection “sharps” (lancets, needles, luer adapters, and blood collection sets) according to the policies and procedures of your facility. Obtain appropriate medical attention in the event of any exposure to biologic samples (for example, through a puncture injury) since they may transmit viral hepatitis, HIV (AIDS), or other infectious diseases. Utilize any built-in used needle protector, if the blood collection device provides one. Estar Technologies Ltd. does not recommend reshielding used needles.
- Discard all blood collection “sharps” in biohazard containers approved for their disposal.
- Transferring a sample from a syringe to a tube is not recommended. Additional manipulation of sharps increases the potential for needlestick injury, in addition, depressing syringe plunger during transfer can create a positive pressure, forcefully displacing the stopper and sample and causing a potential blood exposure. Using a syringe for blood transfer may also cause over or underfilling of tubes, resulting in an incorrect blood-to-additive ratio and potentially incorrect analytic results. Tubes with draw volume smaller than the apparent indicated dimensions may not be filled to their stated volume when filled from a syringe. The laboratory should be consulted regarding the use of these samples.
- Underfilling of tubes will result in an incorrect blood-to-additive ratio and may lead to incorrect analytic results or poor product performance.
Possible Side Effects
- Damage to blood vessels, hematoma, infection and/or irritation.
- Temporary or permanent nerve damage that may result in pain or numbness.
- As with any injection-based treatment, infection is a slight possibility.
FDA Clearance: 510(k) number: BK110035