The hospital has developed policies and medical devices procedures governing the procurement and usage of implantable prosthesis. Relevant, sufficient and scientific data before selection. International guidelines – FDA (US) or National guidelines – Drugs & Cosmetics Act notification October 2005 can be referred for criteria for approval of the particular product.
- Hospital uses only those implants which are approved by the PTC.
- Final approval is done after in consultation with respective doctors.
- All the approved implants are listed in the approved formulary.
- These implants are of different types, manufactured by different companies.
- The implants to be used in particular patient are selected by the concerned surgeon in discussion with the patients and family after explaining the benefits and side effects of the same.
- All purchases of the implants and devices follow the purchase policies of the pharmacy
- The commonly used implants can be kept in hospital stores.
- The doctors concerned can give the list of implants required
- Orders can be placed through the stores for commonly used prosthesis.
- Selection of implantable prosthesis will be based on scientific criteria and internationally recognized approvals.
Criteria for selection will include:
- Technology, safety, effectiveness and clinical uses of devices.
- Current national and international policy and regulation regarding the same.
- Medical profession’s opinion.
- The regulatory status of the device, both nationally and internationally.
- Medical literature review
- Economic Issues
- Almost all the implants used are readily available in the hospital
- Some specific implants need to be ordered before surgery
- Order for the implants are given to the purchase and stores in-charge by the OT in-charge after consulting with the surgeon
- The identification and traceability of each implants used is maintained by pasting the respective bar coded identification stickers in the OT register and respective patient case sheets.
- It is important to write both the serial number and stick the bar code stickers in the register and case sheet so that the serial numbers are available even if the barcode stickers become illegible in future.
- In case of a recall notice, the recall procedure will be followed
Patient and his / her family are counselled for the usage of implantable prosthesis and medical device including precautions, if any, by the treating doctor. The brochure of the implant/ device is available is shared with the patient and family.
Complete identification and traceability with respect to batch and serial number of implantable prosthesis are maintained and recorded in the patient’s case sheet.