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Guidelines for use of Implants
This manual is solely meant for the purpose of guidance and is no substitute for professional training and is not intended to contradict the training. Use of all our products is restricted to professional who are qualified & trained to use them. The safe and effective usage of this product largely depends on the skill of the operator. Do not use on self. Call for expert help. We are not liable for any damages due to improper or unauthorized usage or mishandling. It is buyer's responsibility to keep the products & packing away from the reach of unauthorized people, children & animals, and, dispose them off in an environment friendly way. You must keep proper record of the product to assist product recalls (if any). All disputes are subject to New Delhi Jurisdiction.
Surgical Implants act as internal aids to normal healing and cannot bear the weight of the body when the bone is incompletely healed. Surgical implants have given the surgeon a means of rigid fixation for fracture management and reconstructive surgery.
1. Selection of the Patient: During selection of patients the following factors have to be considered.
a) Immunological Intolerance: Immunological intolerance may occur in some patient. Where material sensitivity is suspected, appropriate foreign body tests should be performed.
b) Degenerative Diseases: In the case of patients suffering from degenerative diseases, this can get aggravated during implantation, and will decrease the expected life of the implant. In such cases, surgery can be considered only as a temporary relief.
c) Mental Illness: Mental illness or schizophrenia may cause patients to ignore, the limitations and precautions of the implanted material, leading to implants fracture and complication.
d) Alcohol and Drug Addiction: Patients who are addicted to alcohol and drugs may ignore during the state of stupor or during the stage of withdrawal, the necessary precautions for the use of implants. This may result in complications of implants failure.
e) Obesity: An obese patient produce abnormal stresses leading to increased load on the implant which ultimately result in failure of the implant.
f) Activity: If the patient indulges in an activity involving significant muscular strain in the implanted region, then the result could be failure of the implant.
2. Selection of the Implant: for successful implantation the selection of the proper size, shape and design of the implant is important. The size and the shape of the human bones puts limitations of size and strength of implants during fracture management and reconstructive surgery. The doctor/Orthopaedic Surgeon has to select the appropriate implant depending upon the application which should also be free from any apparent corrosion or any manufacturing defect.
3. Handling of Implants: The plate should conform to the shape of the bone, and any inequality should be adjusted by accurate shaping of the plate before it is fixed. The technique of using the screws to bend a plate to fit the bone is not recommended as the screws are instantly subjected to a strong expelling force. Hence, plate contouring should be done by the plate benders design for this purpose. Care should be taken that there are no scratches or distortions notches, sharp dents or reverse bends at the site of the screw hole. These may cause defects on surface finish and result in improper bonding.
4. Unstable: Plates even if bent and properly fixed may fatigue and break. Breakage may be due to unstable implant fixation or insufficient support. If the screw is not properly centered as it is being tightened there will be tendency for the countersink in the plate to force it to one side, thereby damaging the good threads already cut in the bone and producing a strain which will probably lead to necrosis and early loosening of the screw.
5. Implant Removal: The surgeon must take the final decision on implant removal. It is recommended that the implant used as an aid for healing should be removed once its services is over, particularly in younger and more active patients.
6. Post Operative Care: A patient must be made aware of the limitations of metallic implants and take precautions to avoid unnecessary stress to implant. No partial weight bearing or non-weight bearing device can be expected to withstand the unsupported stresses of full weight bearing or excessive muscular activity when there is an ununited fracture. Bone union is must and the patient must restrict his activities to assist in healing.
7. Second Hand Implants: Used implants which appear un-damaged may have internal and external defects. It is possible that individual stress analysis of each part fail to reveal the accumulated stress on the metals as a result of use within the body. This may lead ultimately to implant failure. Every implant must be discarded after use and should never be re-used. They should be bent & then disposed properly so that they are unfit for reuse. While disposing, ensure that the discarded implant does not pose any threat to children, stray animals & environment.
8. Incompatible Combinations: Implant components from one manufacture should not be used with those of another. Implants from each manufacture may have metal and design differences, so that use in conjunction with different device could lead to inadequate fixation or corrosion of the implant due to generation of peizo currents.
9. Packaging Disposal: The packaging material of this device if swallowed may cause choking hazards. Therefore, it should be disposed in such a way that it is out of reach of children & stray animals.
10. Sterility: For sterilized devices (by Gamma Radiation Sterilization Process as per International Standard IAEA - TECH-DOC-539, ISO-11137 94 AAMI & EN-552) if the packaging of the device is perfectly sealed & untampered, the device remains sterile for a minimum of 5 year from the date of sterility. This date is also mentioned in the sticker put on the packaging of the device & should be checked by the end user before use. In case the device is not perfectly sealed or the sterilization has expired, the device should be considered as non- Sterile & method of sterilization should be followed as given below. In case the device is supplied non-sterile, it should be sterilized before use by steam sterilization at Sterilizing Temperature- 121º C with sterilizing time of 25-30 minutes and steam pressure of 15 psi. The same has been validated.
11. Use: This device should be used by Qualified & Specialized Trained Surgeons Only.
Privacy Statement: This guide is the sole property of M/s Narang Medical Ltd. and it should not be copied / reprinted / e-media published without the written permission of its Director. Due to the continuous improvements and modifications in the instrument as per customer's requirement and our Research and Development activities, we may change some or any of its description or application without notice.