Covid-19 has perhaps end up being the greatest challenge hitting humankind after world war ii. It’s tossed every activity from gear and compelled people all over the world to visit inside and keep social distancing. The immediate challenge would be to flatten the bend with increased testing adopted by quarantining the Covid-19 patients. The task requires quick manufacturing and delivery of testing kits, Personal Protection Equipment (PPE), respirators, and ventilators, amongst others. To defeat the immediate enemy, the novel Coronavirus, the healthcare sector requires a large infusion of the aforementioned-pointed out kits while increasing the size of testing. Because the world was without enough reserves for such equipment, there’s an abrupt requirement to scale their manufacturing to satisfy the demand.
This is when there’s some risk of companies flouting standard medical device testing practices to satisfy the demand in double-quick time. As there’s a necessity to provide an immediate reaction to the contagion by testing in greater figures, doing this without correct tested equipment could be counterproductive. So, professionals manufacturing such devices or kits have to stop and stick to the established testing protocols within the development and delivery pipeline. During such occasions, quality matters greater than other things. Let’s comprehend the risks of not performing performance testing on medical devices. A faulty testing package, PPE, or ventilator can wreak havoc if it doesn’t raise a security when there’s an optimistic situation or vice-versa. The whole response from the medical fraternity in combating the pandemic depends around the understanding that such items are functioning and meeting the expected parameters.
Leveraging authorizations and exemptions
The necessity of the hour would be to build strategies that leverage exemptions, authorizations, protocols, innovations, and communication tools to provide the products. The medical device manufactures ought to be quick to confront the pandemic and react to the evolving situation. The whole strategy ought to be risk-based and consider the requirement for acquiring authorizations and exemptions. For instance, in the united states, there’s a provision in which the federal or central governments can authorize manufacturers to scale up producing devices to deal with the pandemic. Referred to as Emergency Use Authorization or EUA, the supply can empower manufacturers to shore up production and deliver medical devices rapidly towards the market. During such occasions the Food and drug administration can expedite its premarket review and become a company within the bigger plan of products. Because the market demand is principally for PPE, ventilators, respirators, and diagnostic test kits, it is best to leverage a EUA to scale your manufacturing process.
However, the EUA doesn’t give any manufacturer a carte blanche to prevent medical device testing. Rather, devices must meet a particular standard requiring less evidence. Notwithstanding the comfort in supplying evidence, the Food and drug administration would conduct a danger-benefit analysis to determine when the system is worth authorizing to achieve the marketplace. Further, throughout a pandemic like situation like the one driven by Covid-19, the federal government can ask non-medical manufacturers to get involved with the act while increasing producing essential medical kits. The factors nevertheless shouldn’t be lost tabs on by such manufacturers when it comes to quality, performance, and safety. For instance, non-medical brands like automotive and industrial ones could get into manufacturing of medical equipment by submission with certain regulatory protocols as pointed out below.
• IEC 60601 for medical electrical equipment
• IEC 62304 for that SDLC of medical devices
• ISO 10993 to judge the biological parameters of medical devices
• ISO 80601 for medical equipment for example respirators and ventilators
How about worldwide exemptions?
The scourge of Covid-19 has brought to numerous flux within the worldwide markets so far as medical products are concerned. Rules associated with medical device testing appeared to possess been relaxed to satisfy the increasing demand. So, for anyone who is selling real estate or manufacturer of medical devices, time would be to leverage the exemptions and scale up production or delivery of these devices. A few of the important exemptions for that medical devices testing specialists to ponder are listed below:
• Singapore to eliminate the requirement for registrations for several devices, namely, PPE, surgical masks, thermometers, and particulate respirators.
• Australia has exempted devices from registration that are required for that diagnosis, monitoring, prevention, and management of Covid-19.
• China to facilitate the registration for PPE whenever they satisfy the standards prevalent in the united states, the EU, or Japan.
Prepare against pandemic related disruptions
Because the pandemic has brought the planet to rehearse social distancing and quarantining, it could be challenging for that medical device manufacturers. For instance, there will be a significant effect on performing numerous studies because patients won’t be able to visit or there can be a smaller sized quantity of trials than otherwise required for effective analysis. Also, test protocols may change with medical device testing experts visiting homes of patients or using telemedicine. Further, the IRB review and approval could get delayed because of such limitations.
Social distancing can enjoy havoc using the testing teams working remotely. With less or no use of collaboration tools, typical processes adopted earlier might become unresponsive. Let’s understand a couple of instances as described below:
• If they is much more into documenting things in writing, the travel limitations can hamper the entire process of acquiring physical signatures.
• In the lack of a centralized communication network, messages and documents can get delayed to achieve the best recipients. Also, for just about any slippage, the rework can push things further and cause delays.
• Legacy systems may come when it comes to a fast, secure, and reliable healthcare software testing. Quite simply, manufacturers and testers won’t be able to collaborate effectively in upholding appropriate security levels.
Conclusion
Within the challenging occasions of Covid-19, the makers of medical devices should adjust to innovative ways in leveraging the exemptions and authorizations. The necessity of the hour would be to arrest multiplication from the pandemic by manufacturing Covid-19 related medical devices in huge figures. However, by doing this , the standard and safety aspect shouldn’t be undermined because it is just with quality kits the scourge could be faced and hopefully mitigated.