In our time of Covid-19 activated pandemic, the medical devices testing approach should be modified to the changed reality. Manufacturers should take advantage of the exemptions and authorizations to mass produce medical devices without sacrificing quality.

Covid-19 has arguably get to be the biggest challenge hitting humankind after the Second World War. It has thrown every activity out of gear and forced people around the world to go inside your home and look after social distancing. The immediate challenge is to flatten the blackberry curve with an increase of testing accompanied by quarantining the Covid-19 patients. Task requires quick manufacturing and delivery of testing kits, Personal Protection Equipment (PPE), respirators, and ventilators, among others. To defeat the immediate adversary, the novel Coronavirus, the healthcare sector needs a large infusion of the above-mentioned kits and increase the scale of testing. Since the world did not have enough supplies for such equipment, there is a sudden requirement to scale their manufacturing to meet the demand.

This is where there is a danger of companies flouting standard medical device testing practices to meet the demand in double-quick time. As there is a need to deliver an instant respond to the contagion by testing in greater numbers, doing so without proper tested equipment can be counterproductive. So, professionals manufacturing such devices or kits need to temporarily stop and follow the established testing protocols in the development and delivery pipeline. During such times, quality matters more than anything else. Let us understand the dangers of not doing performance testing on medical devices. A flawed testing kit, PPE, or ventilator can wreak mayhem if it does not raise an alarm when there is a confident case or vice-versa. The entire response of the medical fraternity in combating the pandemic would depend on the knowledge that such parts are functioning and meeting the expected guidelines.

Profiting authorizations and exemptions

The requirement of the hour is to build strategies that leverage exemptions, authorizations, protocols, innovations, and communication tools to provide materials. The medical device manufactures should be quick to deal with the pandemic and respond to the growing situation. The entire strategy should be risk-based and take into consideration the requirement for obtaining authorizations and exemptions.

For example, in america, there is a provision where the federal or central governments can authorize manufacturers to scale in the production of devices to treat the pandemic. Known as the Emergency Use Consent or EUA, the provision can encourage manufacturers to shore up production and deliver medical devices quickly to the market. medical exam room chairs During such times even the FDA can expedite its premarket review and grow a facilitator in the larger scheme of things. Since the niche demand is for PPE, ventilators, respirators, and diagnostic test kits, it is best to leverage a EUA to scale up your manufacturing process.

However, the EUA does not give any manufacturer a carte blanche to avoid medical device testing. Instead, devices ought to meet a certain standard requiring less evidence. Despite the relaxation in providing evidence, the FDA would conduct a risk-benefit analysis to ascertain if the device is worth authorizing to reach the market. Further, during a pandemic like situation such as the one driven by Covid-19, the costa rica government can ask non-medical manufacturers to get into the act and increase the production of essential medical kits. The standards nonetheless should not be lost on top of by such manufacturers in terms of quality, performance, and safety. For example, non-medical manufacturers like auto and industrial ones could get into manufacturing of medical equipment by complying with certain regulatory protocols as mentioned below.

IEC 60601 for medical electrical equipment
IEC 62304 for the SDLC of medical devices
ISO 10993 to gauge the neurological guidelines of medical devices
ISO 80601 for medical equipment such as respirators and ventilators
Think about international exemptions?

The scourge of Covid-19 has led to several flux in the international markets as far as medical devices are concerned. Rules related to medical device testing appeared to have been relaxed to meet the rising demand. So, if you’re a seller or manufacturer of medical devices, the time is to leverage the exemptions and scale up production or delivery of such devices. Some of the important exemptions for the medical devices testing specialists to consider are as follows:

Singapore to do away with the requirement for registrations for certain devices, that is, PPE, precise masks, thermometers, and particulate respirators.
Australia has exempted devices from registration that are needed for the analysis, monitoring, prevention, and treatment of Covid-19.
China to facilitate the registration for PPE if he or she fulfill the standards prevalent in america, the EUROPEAN, or The japanese.
Prepare against pandemic related interferences

Since the pandemic has led the world to practice social distancing and quarantining, it might come as a challenge for the medical device manufacturers. For example, there would be a significant affect doing clinical studies because patients will not be able to travel or there can be a smaller number of studies than otherwise needed 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 due to such constraints.

Social distancing can play havoc with the testing teams working remotely. With less or no access to collaboration tools, typical processes followed earlier might become unresponsive. Let us understand a few instances as explained below:

If the team is more into saving things in writing, the travel constraints can hamper the process of obtaining physical signatures.
In the absence of a centralized communication network, messages and documents will get delayed to reach the right recipients. Also, for any slippage, the rework can push things further and cause delays.
Legacy systems can come in the form of a quick, secure, and reliable healthcare software testing. In other words, manufacturers and testers will not be able to team up effectively in upholding appropriate security levels.
Conclusion

In the challenging times of Covid-19, the manufacturers of medical devices should adjust to innovative ways in profiting the exemptions and authorizations. The requirement of the hour is to arrest the spread of the pandemic by manufacturing Covid-19 related medical devices in humongous numbers. However, in doing so, the quality and safety aspect should not be undermined as it is only with quality kits the scourge can be experienced and hopefully mitigated.