SUDHA HOSPITALS Document SH-HAP-NABH- 26
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NABH Ref MOM.10 (b)
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IMPLANTABLE PROSTHESIS Number
1.0 Purpose:
To provide guidelines for selection and usage of implantable prosthesis.
To ensure patient safety when implantable devices are used.
2.0 Scope:
The following departments are using the implantable prosthesis in SUDHA Hospital
Ophthalmology
General surgery
Orthopaedic surgery
Neuro surgery
Urology
3.0 Responsible person:
Consultant, Chief operating officer Pharmacy incharge.
4.0 Policy:
All the prosthesis used in SUDHA Hospital is approved by Drugs and cosmetics act
notification October 2005 & FDA approved.
Implants are procured only from the approved list of vendors.
The selection of implantable prosthesis is based on the scientific criteria, and it is decided by
the Pharmacy and therapeutic committee.
All the used implant details are documented in the HIS in pharmacy stores.
The Short Expiry products are not acceptable at the time of procurement.
Introduction of any new implants or vendors, it has to be approved by the Purchase
committee.
Consultant doctors are choosing the implant from US-FDA approved company. We are using
companies such as
Hitech
Zimmer
Lotus surgicals
Medzone surgical
SM medicare
Bio Med
SUDHA HOSPITALS Document SH-HAP-NABH- 26
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NABH Ref MOM.10 (b)
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IMPLANTABLE PROSTHESIS Number
Smith and nephew
Depuy
Exactech
Minor cases implants stored in the pharmacy. Other major case implants such as
(Ortho Cases) will be delivered company representative. After the surgery the remaining implants will
be handed over to the company representative.
The patient and the family members are counselled about the usage of implants and patient will be
educated about the symptoms of the drug that is being used.
Batch number and the serial number of the implant will be mention in the patient’s medical record, master
log book and discharge summary.
List of implantable prosthesis
1. Mesh
1. VP Shunt
2. Urinary Stent
3. Total knee replacement implant
4. Total hip replacement implant
5. Pedicle screws
6. ORIF implants
7. ACL implants
SUDHA HOSPITALS Document SH-HAP-NABH- 26
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NABH Ref MOM.10 (b)
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1.0 Purpose:
To develop guidelines and implement the procedure for medical equipment and medical device
related adverse events and compliance hazard notices on recalls.
2.0 Scope:
Applicable to all the clinical and diagnostic services those who handle medical equipment and
medical devices.
1.0 Responsible person:
Consultant surgeon , Nursing supervisor, Staff nurse, pharmacy incharge.
3.0 Definitions:
Recall - means any action taken by its manufacturer or authorised agent or supplier to remove the
medical device from the market or to retrieve the medical device from any person to whom it has been
supplied, because the medical device,
a) is hazardous to health; or
b) Fails to conform to any claim made by its manufacturer relating to its quality, safety or
efficacy; or
c) Does not meet the requirements of the Act and these rules;
4.0 Policy:
1. Hospital follows the guidelines given in the Gazette of India GSR 78(E) 2017.Medical
device rules 2017 for recall of medical devices.
2. Recall of medical device is done under the following circumstances
All medical equipment, devices are procured from the authorised or licensed vendors.
When there is any problem identified by a manufacturer or authorised agent, sold or
distributed medical devices which is likely to pose risk to the patient during its use or
unsafe for patient use. Under such conditions, Manufacturer or authorised agent shall
immediately initiate procedure to recall or withdraw the medical device.
Safety communication alert is given by a manufacture or authorised agent to the
hospital authorities regarding the safety issues
SUDHA HOSPITALS Document SH-HAP-NABH- 26
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NABH Ref MOM.10 (b)
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Problems faced by use of demonstration of medical devices. Adverse event form is
raised for notification
Following details are documented in the adverse event reporting form for medical
equipment, device- name of the equipment or device, back ground, Reason for recall,
immediate action to be taken by user, contact details.
5.0 Procedure:
5.1 Role of manufacture authorised agent:
On receipt of the adverse event report. Manufacturer replace the medical equipment if needed.
Recalled within 24 hours adverse event coming to the notice of licence holder
Analysis of adverse device effects and any history of modification or recall.
Risk management
1. Summary of the risk analysis, including identification of residual risks.
2. Result of the risk assessment.
3. Anticipated risks, contra-indications, warnings, etc. for the investigational medical device.
Role of pharmacy:
Implantable products are stored in low quantity and based on reorder level.
If any damages in the product is found, it is return to the supplier, it will be replaced with new
one.
Recall or return the product for when the procedure is cancelled, postponed or unfit to patient.
