Hydroxyapatite – CE 0434

DESCRIPTION AND ACTION FOUNDATIONS

Hydroxyapatite, Ca10(PO4)6(OH)2 is a hydrated calcium phosphate, a majority component (about 95%) of the mineral phase of human bones and teeth. It is used by the body to compound the skeleton, due to its capacity to act as a reserve of calcium and phosphorus. Owing to its chemical similarity with the mineral phase of bone tissues it becomes one of the most biocompatible materials ever known, favoring the bone growth where it is located (osteoconductive), setting up chemical bonds between it and the bone tissue (bioactive), allowing the proliferation of fibroblasts, osteoblasts and other bone cells, which do not differentiate from the bone surface indicating the high surface chemical similarity.

The hydroxyapatite allows integration of bipolar type alloys, causing water molecules and also proteins and collagen to be absorbed at the surface thus inducing tissue regeneration.

The application of Hydroxyapatite allows the bone tissue restoration through the osteoinduction process.

INDICATIONS AND PURPOSE OF USE

Hydroxyapatite based biomaterials have been largely used as bone replacement. Hydroxyapatite is a bone graft material successfully used in orthopedic, cranio-maxillofacial and odontologic surgeries. It is recommended to repair defects of the base of the skull, spinal fusion, and for orthopedicuse, it is also used for bone grafts around dental implants and hip metallic prostheses.

PRECAUTIONS, RESTRICTIONS, WARNINGS

1.    STERILE -  as long as maintained the integrity of the packaging, period of validity and storage conditions.

2.    Professional use only is the responsibility of the dentist or doctor their prior training to use this product. Only qualified professionals with expertise in surgical techniques and procedures necessary for proper use of the product should make use of Hydroxyapatite. The use of incorrect surgical techniques may cause discomfort as painful sensation, hypoesthesia, edema. The size of the particles should not be changed.

3.    PROHIBITED RESTERILIZE AND REPROCESS – If resterilized or reprocessed may occur change at the physical chemical properties and crystallinity levels of Hydroxyapatite causing foreign body reaction.

4.    PROHIBITED REUSE – If reused or used with expired validity, may cause irritation, inflammation and other adverse events, compromising the health and safety of the patient.

5.    The use of the product with surgical techniques and inadequate biosecurity conditions may damage the patient leading to unsatisfactory results.

6.    Always sterilize the tools before using them.

7.    The clinical and radiographic evaluation must be done prior to surgery, to help the correct treatment planning. Determination of bone quality and quantity, repairs and anatomical structures and analysis of neighbouring teeth.

8.    In all surgeries involving Hydroxyapatite particles must be observed proper techniques used for asepsis and antisepsis.

9.    The abuse of alcohol, tobacco, drugs, steroids or lack of proper oral hygiene can significantly impair the success of the treatment.

10.    All potential adverse effects as dehiscence, inflammation, bone loss, hemorrhage, must be previously informed to the patient.

11.    It is supplied in sterile condition and once opened should be used in aseptic conditions. Should always work with sterile fields, appropriate instruments to the procedure and in good condition in order to eliminate sources of infection and damage to the product.

12.    Hydroxyapatite should be used only for the purpose for which it is intended.

13.    If occur complications impossible to be controlled, tissue inflammation or evidence of infection is recommended the immediate removal of the material.

14.    Hydroxyapatite is provided in sterile double packaging (25 KGy gamma radiation). Provided that the package integrity is not compromised in any way, it will save the sterile product up to 3 years from the date of sterilization.

15.    There are no restrictions as to maximum amount of product that can be deployed. The amount will be determined by the professional after analyzing the size of the surgical site.

16.    The surgeon should evaluate the indication in patients who are carriers of diseases or are making use of medication that may alter the repair metabolism.

17.    The remainder of the packaging material should not be reused, reprocessed or resterilized, discard it mischaracterized as current legislation for medical waste, do not discard contaminated products in household waste.

18.    In cases of adverse effects occurring in patients, the responsible must contact immediately with the SAC Bionnovation (Customer Service) by the number 0800 707 3824 or by e-mail sac@bionnovation.com.br. The Bionnovation Biomedical Products is responsible for notifying the ANVISA (Health Surveillance Agency) about the relevant occurrences according to internal technovigilance procedure.

19.    Hydroxyapatite was developed in order to prevent that its use does not compromise the clinical condition of patients as well as their safety.

Note: we recommend that the identification stickers that come with the product be attached to the patient’s documentation: clinical record of the patient, the report delivered to the patient, product sales invoice, vendor control and control of the surgeon in charge, ensuring the complete traceability of the product.

CONTRA INDICATIONS

1.    Hydroxyapatite, as well as all the other biomaterials, should not be placed on an existing active infection or in any other degenerative disease that might affect the biomaterial’s placement.

2.    It must not be utilized in patients that are notable, under the clinical point of view, to be submitted to a medical or odonthological intervention. Such as, for example, in patients with uncompensated diabetes.

3.    Hydroxyapatite is not indicated for odontopediatric patients.

4.    It’s contraindicated for procedures different from those recommended in item "Use Indication” above.

 5.   Hydroxyapatite should not be hydrated before the use. It should be taken directly to the recipient surgical bed.

SPECIAL CONDITIONS FOR THE PRODUCT’S STORAGE AND TRANSPORTATION, CONSERVATION AND/OR HANDLING

Storage and Transportation

Store and transport the product away from direct sunlight, and from heat. (temperature between -5 and 40°C) and humidity. Keep the packaging sealed until its utilization time. Do not use it if the sterile package has been opened, or if it’s damaged, or if the sterilization validity date has expired in order to avoid possible contamination. Discard any mischaracterized product according to the applicable legislation for hospital waste, or return the damaged packages to the factory, including the device.

Conservation and Handling

In case of any alteration in the Hydroxyapatite characteristic that might have mischaracterized it, please discard it according to the applicable legislation for hospital waste, or return the damaged packages to the factory, including the device.