IPC issues safety alerts on medical devices including Cranial Perforator, Orthopedic drill
New Delhi: The Indian Pharmacopoeia Commission has issued a safety alert on certain medical devices, including Cranial Perforator, Orthopedic drill, and ocular devices, and directed the stakeholders that all suspected adverse events related to these medical devices be reported in medical device adverse event reporting form.
Through a release on Medical Device Adverse Event Monitoring issuing safety alert, National Coordinator Centre- Materiovigilance Programme of India (NCC-MvPI), IPC has directed, "If these devices are being used at your hospital. Kindly report all the suspected adverse events in medical device adverse event reporting form after the use of these devices to NCC-MvPI,/PC via e-mail: shatrunjay.ipc@gov.in"
This was based on various reports received by NCC-MvPI, IPC on significant adverse events associated with medical devices.
As per the issued safety alert, "NCC- MvPI, IPC has observed a certain 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."
Cranial perforators are drills that are used to create a small hole in a patient's skull which allows neurosurgeons to operate on the brain. According to the IPC safety notice, a drill bit broke during operation while using Stryker Corporation's Cranial perforator, resulting in a severe patient outcome.
S. No | Suspected Device Details | Event Details | |
Device Name | Manufacturer | ||
1 | Cranial Perforator | Stryker Corporation | Drill bit breakage during use leading to serious patient outcome. |
Further, the safety alert added, "NCC- MvPI, IPC has observed a certain 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."
S. No | Suspected Device Details | Event Details | |
Device Name | Manufacturer | ||
1 | Orthopedic drill | Manman Manufacturing Company Private Limited, Maharashtra | Drill bit breakage during use leading to serious patient outcome. |
Furthermore, NCC-MvPI, IPC has indicated that Perfluorocarbon Liquid/Per Fluoro Octane (e.g. Bio octane, Ala octa), Heavy Silicone Oils, and intraocular membrane staining dye, among others, are suspected to cause serious adverse outcomes in patients, as discussed in the table below:
S. No. | Device Name | Suspected Device Details Use | Suspected adverse event following the | |
1 | Perfluorocarbon | Used in vitreoretinal surgery as they have the ability to displace aqueous humor from the retinal surface, maintaining the adhesion between retina and retinal pigment epithelium. The major applications are as follows: . Post-operative tamponade in vitreoretinal surgery . Relocating and fixing the detached retina . Displacing the sub-retinal and sub-choroidal to fluid anteriorly . Revealing proliferative vitreous retinopathy (PVR) for further maneuvers . Protecting the macula from exposure to chemicals with potential toxicity . Assisting the removal of foreign body. . Retinal detachment with severe proliferative vitreoretinopathy . Giant tear, diabetic retinopathy (DR) . Retinopathy of prematurity (ROP) . Posterior dislocated crystalline and intraocular lenses | . . . . . . . . . | |
Liquid | ||||
2 | Heavy Silicone | |||
Oils | ||||
Acute blindness | ||||
Moderate intraocular | ||||
inflammatory | ||||
reactions | ||||
Retinal necrosis | ||||
Retinal vascular | ||||
occlusion | ||||
Optic nerve atrophy | ||||
Ratinal atrophy | ||||
Subretinal fibrosis | ||||
Proliferative | ||||
vitreoretinopathy | ||||
Pthysis | ||||
3 | lntraocular | Used to stain living tissues or cells for identifying | ||
membrane | ocular tissues and visualizing intraocular | |||
staining dye | tissues during vitreoretinal surgery | |||
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To access the official release, click on the link below-
