V. Kalaiselvan1, Shatrunajay Shukla1, Nikita Mishra1, Shubhang Arora2, Yash Kumar Vimal3, Rajeev Singh Raghuvanshi1
1 Indian Pharmacopoeia Commission, Ministry of
Health & Family Welfare, Government of India, Ghaziabad, India.
2 Yashoda Super Specialty Hospital, Ghaziabad,
India.
3 Delhi Institute of Pharmaceutical Sciences and Research (DIPSAR) University, DPSRU, New Delhi, India.
Abstract
Medical devices are using worldwide and has a good annual consumption on ocular medical devices. Medical devices are being used in healthcare domain for diagnosis, monitoring, prevention and treatment of an array of diseases. The use of medical devices benefits the patients immensely, but they also carry significant risk potential. Recently, countries like- Spain, Holland, France, Italy, Middle East, Switzerland and Chile have reported several cases of acute retinal toxicity due to perfluorocarbon liquids (PFCL), especially perfluoro-octane (PFO). These reported cases cause a panic situation among healthcare practitioners such as doctors, nurses, technicians, biomedical engineers and medical device stakeholders. So, regulation & scientific publications of these medical devices across globe are the need of an hour. Method: Global regulation on PFCL were thoroughly studied and analysed. The web of science-based search was performed on scientific publications available worldwide. Conclusion: This paper reviews the global regulation & scientific publications on PFCL and provides an idea about the need of further improvement.
Keywords: Medical device, regulation, PFCL toxicity, adverse event.
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