In the present time of Covid-19 induced pandemic, the medical devices testing approach should be adapted 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 become the biggest challenge to hit humankind after the Second World War. It has thrown every activity out of gear and forced people around the world to go indoors and maintain social distancing. The immediate challenge is to flatten the curve with more testing followed by quarantining the Covid-19 patients. The challenge requires quick manufacturing and delivery of testing kits, Personal Protection Equipment (PPE), respirators, and ventilators, among others. To defeat the immediate enemy, 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 reserves 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 a rapid response 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 pause 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 conducting performance testing on medical devices. A faulty testing kit, PPE, or ventilator can wreak havoc if it does not raise an alarm when there is a positive case or vice-versa. The entire response of the medical fraternity in combating the pandemic would depend on the knowledge that such pieces of equipment are functioning and meeting the expected parameters.
Leveraging authorizations and exemptions
The need of the hour is to build strategies that leverage exemptions, authorizations, protocols, innovations, and communication tools to deliver the goods. The medical device manufactures should be quick to confront the pandemic and respond to the evolving situation. The entire strategy should be risk-based and take into consideration the need for obtaining authorizations and exemptions. For example, in the USA, there is a provision where the federal or central governments can authorize manufacturers to scale up the production of devices to address the pandemic. Known as the Emergency Use Authorization or EUA, the provision can empower manufacturers to shore up production and deliver medical devices quickly to the market. During such times even the FDA can expedite its premarket review and be a facilitator in the larger scheme of things. Since the current market demand is mainly for PPE, ventilators, respirators, and diagnostic test kits, it is better 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. Notwithstanding 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 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 track of by such manufacturers in terms of quality, performance, and safety. For example, non-medical manufacturers like automotive and industrial ones may 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 evaluate the biological parameters of medical devices
- ISO 80601 for medical equipment such as respirators and ventilators
What about international exemptions?
The scourge of Covid-19 has led to a lot of flux in the international markets as far as medical devices are concerned. Rules related to medical device testing seemed to have been relaxed to meet the rising demand. So, should you be 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 ponder are as follows:
- Singapore to do away with the need for registrations for certain devices, namely, PPE, surgical masks, thermometers, and particulate respirators.
- Australia has exempted devices from registration that are needed for the diagnosis, monitoring, prevention, and treatment of Covid-19.
- China to facilitate the registration for PPE should they meet the standards prevalent in the USA, the EU, or Japan.
Prepare against pandemic related disruptions
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 impact on conducting clinical trials because patients will not be able to travel or there might be a smaller number of trials 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 may get delayed due to such restrictions.
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 documenting things on paper, the travel restrictions 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 way of a quick, secure, and reliable healthcare software testing. In other words, manufacturers and testers will not be able to collaborate effectively in upholding appropriate security levels.
In the challenging times of Covid-19, the manufacturers of medical devices should adapt to innovative ways in leveraging the exemptions and authorizations. The need 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 confronted and hopefully mitigated.
For additional information on Covid-19 please refer to the CDC website.