The entire world population is suffering the pangs of the Coronavirus disease. World Health Organization stated COVID-19 as a pandemic. It recapitulated the voice for countries to establish necessary steps and increase the response towards reducing, detect, and treat transmission to save an individual’s life. As per the observation by MoHFW, i.e., Ministry of Health & Family Welfare, 29435 total COVID-19 cases include 111 foreign nationals, which has been reported in 32 union territories and states. Amongst these, there are 6868 that are discharged or cured, 934 deaths of novel Coronavirus disease, and one who has migrated.
India is currently conducting a trial to cure coronavirus with plasma therapy. If successful outcomes are noticed, millions of lives could be saved. Doctors are instructed to conduct clinical trials of plasma enrichment method to treat all patients suffering from Coronavirus. Sources have revealed that many COVID-19 patients have improved a lot with plasma therapy, who were admitted to hospitals in the last week of March and the beginning of April. Many of them are known to be discharged within a few days of recovery.
Plasma Therapy and related reports
Convalescent Plasma Therapy is an exploratory method for patients with COVID-19. In this treatment procedure, plasma is transfused into the Coronavirus patient from the person already recovered from the virus. The treatment makes use of antibodies from the convalesced patient’s blood to treat and improve the other patient in critical condition.
The first patient in India who recovered the deadly Coronavirus is a 49 years aged man who was supervised plasma therapy in Saket’s Max Hospital, and this therapy has brought positive outcomes. The patient is now taken off from ventilation, as the hospital declared on Monday.
Required benchmarks for plasma therapy clinics
It is evident that there is a strong requirement of certain global benchmarks for ascertaining the reliability of plasma therapy clinics. 2 of them are explained below:-
- ISO 18250 is an ISO Certification standard, which is for the Aphaeresis set of tubing may consist but are not restricted to those for utilizing therapeutic collection, plasma collection, and blood collection.
- The international quality structure standards for all medical devices are ISO 13485 and ISO 13488. ISO Certification 13485 comprises all of the constituents of ISO 9001 and a collection of least additional need for the medical devices.
Role of ISO Certification in case of the Plasma Therapy Clinic
The ISO certification alone is structured to become the latest international standard for medical devices. The regulatory requirements for a standard system may cover the facilities, control, and methods utilized by manufacturers in the labeling, manufacture, design, packaging, storage, servicing, and installation of medical devices.
- The ISO certification 13485, i.e., the standard illustrates the requirement of standard management structure to fulfill consumer requirements and also permits the incorporation of relevant regulatory prerequisites within an institution’s standard management system. Know more about ISO 13485.
- Similarly, the ISO certification 18250 denotes the need to intercept misconnections or minimize its occurrence to a reasonable level linking the reservoir connectors utilized in distinct applications.
With that, it is strongly hoped that the plasma therapy technique effectively works to cure the Coronavirus infection.