A systematic review on research documentation of ocular medical device focused on Perfluorocarbon Liquid (PFCL)

V.  Kalaiselvan1, Shatrunajay Shukla1, Nikita Mishra1, Subhang 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. 

References:

World Health Organization (online) (assessed Nov. 08, 2022). Available from https://www.who.int/health-topics/medical-devices#tab=tab_1.

Materiovigilance and Medical Devices (online) (assessed Nov. 08, 2022), doi.org/10.1007/978-3-319- 07653-9_21. Available from https:// link.springer.com/chapter/10.1007/ 978-3-319-07653-9_21.

Medical Device Recalls, FDA, Sep. 09, 2020. [Online] (assessed Nov. 08, 2022). Available from https:// www.fda.gov/medical-devices/medicaldevice-safety/medical-device-recalls.

Medical device World Health Organization (online) (assessed Nov. 08, 2022). Available from https://www.who.int/health-topics/medical-devices#tab=tab_1.

Medical device United States Food & Drug Administration (online) (assessed Nov. 08, 2022). Available from https://www.fda.gov/medical-devices.

Medical device European Medicines Agency Science medicines health (online) (assessed Nov. 08, 2022). Available from https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices.

Pharmaceuticals and Medical Devices Agency (online) (assessed Nov. 08, 2022). Available from https://www.pmda.go.jp/english.

Parvizi N and Woods K, Regulation of medicines and medical devices: contrasts and      similarities, J. Clin. Med · February 2014 Vol 14, No 1: 12–5. Available from https://www.researchgate.net/publication/260213443.

C. De Maria et al., “Safe innovation: On medical device legislation in Europe and Africa,” Health Policy and Technology, vol. 7, no. 2, pp. 156–165, Jun. 2018, doi: 10.1016/j.hlpt.2018.01.012.

“EUROPA - European Commission - Growth - Regulatory policy - NANDO” (online) (assessed Nov. 09, 2022). Available from https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notifiedbody.main.

A. V. Kaplan et al., “Medical Device Development: From Prototype to Regulatory Approval,” Circulation, vol. 109, no. 25, pp. 3068–3072, Jun. 2004, doi: 10.1161/01.CIR.0000134695.65733.64.

H. Randall, “Post-marketing surveillance and vigilance for medical devices: the European approach,” Drug Saf, vol. 24, no. 12, pp. 869–872, 2001, doi: 10.2165/00002018-200124120-00001.

J. Pane et al., “EU postmarket surveillance plans for medical devices,” Pharmacoepidemiol Drug Saf, vol. 28, no. 9, pp. 1155–1165, Sep. 2019, doi: 10.1002/pds.4859.

C. for D. and R. Health, “Overview of Device Regulation,” FDA, Apr. 09, 2020 (online) (assessed Nov. 09, 2022). Available from https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation.

Hubner S et al., The Evolving Landscape of Medical Device Regulation in East, Central, and Southern Africa. Glob Health Sci Pract. 2021 Mar 31;9(1):136-148. doi: 10.9745/GHSP-D-20-00578. PMID: 33764886; PMCID: PMC8087432.

Shukla S. et al., “Implementation of adverse event reporting for medical devices, India,” Bull World Health Organ, vol. 98, no. 3, pp. 206-211, Mar.2020, doi: 10.2471/BLT.19.232785.

Srivastava G. et al., “Acute intraocular toxicity caused by perfuorocarbon liquids: safety control systems of medical devices” Graefe's Archive for Clinical and Experimental Ophthalmology (2022) 260:2103–2110, doi: https://doi.org/10.1007/s00417-022-05578-w.

Kalaiselvan. V. et al, “Materiovigilance Programme of India: A scheme to assure cardiovascular devices safety surveillance,” n). Indian Heart Journal 72 (2020) 316e318, doi: https://doi.org/10.1016/j.ihj.2020.06.009.

 Kalaiselvan, et al, “Helpline facility to assist reporting of adverse drug reactions in India,” WHO South East Asia J Public Health, vol. 3, no. 2, p. 194, Jun. 2014, doi: 10.4103/2224-3151.206737.


Publication
Article ID: A0501021   RA   Preprint
Received: 28/05/2022 
Accepted: 15/11/2022
Published: 01/01/2023