Perhaps Covid-19 has become the biggest challenge to humanity. It disrupted all events and forced people worldwide to go inside and maintain social distancing. The challenge requires rapid production and delivery of test kits, personal protective equipment, respirators, and ventilators, among others.
The dangers of failing to perform medical device performance tests.
It is where the danger is that companies will forgo standard medical device testing practices to meet demand in half the time. Because it is necessary to ensure a rapid response to infection by testing more people, doing so without the proper tested equipment can backfire. Therefore, those manufacturing such devices or kits must suspend and follow established test protocols during development and delivery.
Medical device manufacturers must quickly confront the pandemic and respond to the changing situation. The need now is to develop strategies that take advantage of exemptions, permits, protocols, innovations, and communications to deliver goods. The whole strategy should be based on risk and consider the need for permits and exemptions.
Despite the easing of evidence, the FDA will conduct a risk-benefit analysis to determine whether it is worth releasing the device on the market. Also, during a pandemic-like situation such as that caused by Covid-19, the government may ask non-medical manufacturers to get involved and increase the production of basic at home rapid covid test kits. However, these manufacturers must not lose sight of quality, performance, and safety standards.
As the pandemic forced the world to practice social distancing and self-isolation, this could be a problem for medical device manufacturers. For example, this will significantly impact the conduct of clinical trials, as patients may not be able to travel, or the number of tests may be smaller than needed for effective analysis. In addition, testing protocols may change if medical device testing experts visit patients at home or use telemedicine.
Social distancing can be detrimental to test teams working remotely. With limited or no access to collaboration tools, typical processes that were previously running may become unresponsive. Let’s understand some cases as described below:
- If the team is more interested in documenting things on paper, travel restrictions can make it difficult to get physical signatures.
- In the absence of a centralized communications network, messages and documents will take a long time to reach the intended recipients. In addition, rework can move things forward in the event of any slip and cause delays.
- Outdated systems can prevent fast, safe and reliable testing of healthcare software. In other words, manufacturers and testers will not be able to work together effectively to maintain an adequate level of security.
During the challenging times of Covid-19, medical device manufacturers must adapt to innovative ways to use exemptions and permits. However, quality and safety aspects should not be undermined, as only quality kits can handle a disaster and hopefully mitigate the effects.