A Systematic Review on Research Documentation of Ocular Medical Device Focused on Perfluorocarbon Liquid (PFCL)

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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Publication

Article ID: A0501021 RA Preprint SF

Received: 28/05/2022 

Accepted: 15/11/2022

Published: 01/01/2023

DOI: 10.64307/allbiosolutionA0501021

Orthopaedic Implant Failure –An Overview

Sural Sumit

Department of Orthopaedics, Maulana Azad Medical College, New Delhi, INDIA

Abstract

Various type of implants is used in Orthopaedic surgery which are kept inside the human body for a significant period of time, sometimes permanently, in order to perform specific functions like fixation of fractures, replacement of joints and such devices are classified as Class D or high risk devices. These implants may be made of metals (pure metals like titanium or newer ones like tantalum) or metal alloys, like stainless steels (corrosion resistant low carbon 316L), cobalt chrome (used in non cemented arthroplasty), Ti-Al-Va (titanium-aluminium-vanadium) or non metals like ceramics (low friction hip arthroplasty), Polyether ether ketone (PEEK cages for spine fusion) and various types of bone cements. Implant failure may be defined as failure of the implant to produce satisfactory results due to inadequacy of the function expected of it. Failure of metal implants may be classified as plastic failure (due to plastic deformation before the yield point resulting in failure of clinical outcome); brittle failure (due to defect in manufacturing or fabrication process of the metal) and fatigue failure (due to repetitive biomechanical loading of the device). Various factors individually or in combination may be associated with implant failure. Implant related factors may result in early corrosion, bending or breaking of implant due to fault in manufacturing process. Patient related factors include unstable and comminuted fractures, non compliance regarding weight bearing after surgery or surgical site infections. Surgeon related factors may include improper selection of size or design of the implant and improper handling of metal surfaces leading to scratches and possibility of corrosion. Corrosion is found to occur at junctional area of two metals like plate and screw and breakage of implants are found at sites of holes in the implants like fenestration in femoral arthroplasty stem or holes in interlocking nails. Metal hypersensitivity reaction is found 6 times more common in failed implants. One of the major disasters was metallos is occurring in the metal on metal hips where the metal particles (haptens) released due to corrosion and wear induced a hypersensitivity response with formation of immune complexes, antibodies and inflammatory markers. Localized ALVAL (Aseptic Lymphocyte Vasculitis Associated Lesion) around these implants resulted in marked loosening and implant failure. Materiovigilance is the need of the hour and a registry needs to be maintained across centers, institutions, states and the country, since the incidence is quite low and may not occur immediately. Statutory bodies like the Bureau of Indian Standards play a vital role to ensure quality of implants meet international standards like CE and ISO. Regulatory bodies need to ensure standard quality implants are manufactured and dispensed by local or indigenous manufacturers and public awareness is important for them to select standard quality implants.   

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   

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