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Showing posts with label Medical Device Toxicity. Show all posts
Showing posts with label Medical Device Toxicity. Show all posts

Overview of Materiovigilance program of Govt. of INDIA

V. Kalaiselvan 

Indian Pharmacopoeia Commission, Government of India (Ministry of Health & Family Welfare), INDIA

Abstract

The Materiovigilance programme of India (MvPI), launched by the Ministry of Health & Family Welfare, Government of India; the Indian Pharmacopoeia Commission (IPC)mandated with the responsibilities to coordinate as National Coordination Centre (NCC). The MvPI aims to collect, collate and analyze the adverse events associated with the use of medical devices and communicate the safety outcomes to healthcare professionals and Central Drugs Standard Control Organization (CDSCO). The IPC as NCC plays a crucial role in establishing the programme by recognizing Medical Devices Adverse Events monitoring centres (as a dynamic process), providing training to the stakeholders, effectively coordinating with CDSCO and state drug control authorities for effective implementation of MvPI. The culture of suspected adverse events of medical devices reporting among the healthcare providers in India is increasing year by year. The reported adverse events are regularly analyzed and findings have been communicated to the stakeholders. The IPC is committed to promote the MvPI starting from primary health care. Also IPC is working towards establishing a network of academic and research institutes as well to understand the devices related issues through research based approach. 

Publication
Article ID: O0401019 (Suppl 1)   RA  Preprint
Received: 08/06/2022 
Accepted: 08/07/2022
Published: 08/08/2022

How to cite this paper 

Suitability of ISO standards for medical device toxicity measurement

Girish K. Srivastava,

IOBA, Universidad de Valladolid, Valladolid, Spain

Abstract

ISO standards are applied at global level for quality assurance of medical devices. More specifically, ISO 16672 is used for ophthalmic implants and ocular endotamponades, and ISO 10993 for biological evaluation of medical devices. Recently, several clinical cases of perfluorocarbon liquid (PFCL), which are used in vitreo-retinal surgery, are reported from Chile, Spain, Switzerland, Holland, France, Italy, the Middle East and South America which has raised the questions on suitability of ISO standards for cytotoxicity measurement of PFCL. The investigation showed that ISO recommended extract indirect and agarose overlay method failed to detect the cytotoxicity of CE-marked PFCL samples, however a new direct method had detected the cytotoxicity of same samples confirming that clinical cases were due to PFCL toxicity. Therefore, this is very crucial to consider specific device-type situation for cytotoxicity test during applying the ISO standards for quality assurance. The PFCL is non-soluble and highly volatile substance. Similarly, intraocular gases, PFCL and silicon oils are completely different products and they may need different ISO standards for their quality measurement. 

Publication
Article ID: O0401019 (Suppl 1)   RA  Preprint
Received: 08/06/2022 
Accepted: 08/07/2022
Published: 08/08/2022

How to cite this paper