The Drugs Controller General of India (DCGI) has issued safety alerts on medical devices related to orthopaedic, neurosurgery and eye related disorders and has asked all the stakeholders to report the suspected adverse events (SAEs) related to the same urgently.
As per the safety alerts issued by the DCGI, if these devices are being used at any hospital, they have to report all the suspected adverse events in medical device adverse event reporting (MDAER) form following use of these devices to the National Coordination Centre (NCC) -the Materiovigilance Programme of India (MvPI), IPC via e-mail at [email protected]
NCC-MvPI at IPC has observed a number of reports of cranial perforator manufactured by “Stryker Corporation” indicating device breakage during its use. The device is suspected to cause serious adverse outcomes to the patient.
It has also observed a number of reports of orthopaedic drill manufactured by Manman manufacturing company private limited, Maharashtra indicating device breakage during its use. The device is suspected to cause serious adverse outcomes to the patient.
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Besides this, Perfluorocarbon Liquid/Per Fluoro Octane (e.g. Bio octane, Ala ocata), heavy silicone oils and intraocular membrane staining dye are suspected to cause serious adverse outcomes to the patient.
Perfluorocarbon Liquid is used in vitreoretinal surgery as they have the liquid ability to displace aqueous humor from the retinal surface, maintaining the adhesion of Heavy Silicone between retina and retinal pigment epithelium.
The major applications of Perfluorocarbon Liquid/Per Fluoro Octane (e.g. Bio octane, Ala ocata) and heavy silicone oils are post-operative tamponade in vitreoretinal surgery, retinal necrosis revealing proliferative vitreous retinopathy (PVR) for further maneuvers, displacing the sub-retinal and sub-choroidal reactions to fluid anteriorly, protecting the macula from exposure to chemicals with potential toxicity, retinal detachment with severe proliferative vitreoretinopathy, assisting the removal of foreign body, giant tear, diabetic retinopathy (DR), posterior dislocated crystalline and intraocular lenses and retinopathy of prematurity (ROP).
Intraocular membrane staining dye is used to stain living tissues or cells for identifying ocular tissues and visualizing intraocular tissues during vitreoretinal surgery.
Some of the major serious adverse events associated with these products are acute blindness, pthysis, retinal vascular occlusion, optic nerve atrophy, retinal atrophy, proliferative vitreoretinopathy, subretinal fibrosis and moderate intraocular inflammatory reactions.
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