A surprising and unexpected secondary crisis brought on by the impact of the current COVID-19 pandemic is the nation-wide shortage of medical devices and personal protective equipment (PPE). An all-hands-on-deck approach has been asked of manufacturers and engineers across the country to design, develop and manufacture solutions as quickly as possible to keep up with the heavy demand for life-saving products. Clinicians and medical workers have turned to 3D printers to mitigate the shortage; however, products made using this technology face many technical and legal hurdles before they can be considered safe to use to address the shortage.

Many places with 3D printing capabilities have been effective in this effort. For example, Rice University was able to have their 3D-printed face shields quality-tested and approved within a short timeframe because all members of the development team were able to operate as a coherent team, constantly present and available. Many projects are delayed or deferred by pandemic isolation and lack this effective management and chains of communication. However, there remains a threat: poor quality control and a lack of quality assurance.

Without proper quality control on essential PPE safety equipment, there can be severe consequences. There is a growing list of complaints regarding imported foreign medical devices, PPE and testing kits. These complaints from Governments from several countries have come from Spain, the Czech Republic, Turkey, and Australia, among others. For one example, the Netherlands asked to return 600,000 face masks purchased from China which turned out to have inadequate filters and were poorly fitted. In some cases, receiving poor quality medical products has cost governments millions of dollars.

There are concerns within the U.S. as well as many rely on the products supplied by these manufacturers. Chinese State Council reported on March 12th that authorities seized more than 80 million counterfeit or faulty masks and 370,000 defective or fake disinfectants and other anti-coronavirus products in the prior month alone.

The volume of products entering the market means it has become difficult to determine which are truly FDA approved and which are not.

A good place to start to ensure safety for all products is to adhere to a standard process. For example, in Michigan, many distilleries have morphed into hand sanitizer manufactures following the CDC guidelines on what is required to safely create and distribute hand sanitizers. There are also Maker spaces, such as Make: Projects, that discuss experiences and researched information. For example, there is a test, where if you can blow out a candle flame through your mask, that mask is deemed ineffective.

Overcoming Manufacturing Hurdles

COVID-19 presents crucial challenges to all health service units, including hospitals, mobile hospitals, ambulances, and other health care stations. Life-saving supplies should be in the critical supply chain to make sure that the frontline professionals are supported with essential equipment such as PPE kits including facemask, face shields, gloves, and any other protective component. Other sophisticated medical devices are also needed, including ICU-ventilators, and supporting controls systems.

The rapid ramp up of production volumes of these crucial supplies adds risks. The principal hurdles are assurance of (A) product quality and (B) product reliability for the service.

The role of the engineering community is especially important here. The manufacturing processes for all medical products should adhere to a strict Quality Management Standards (QMS) that has been reviewed, assessed, and approved by quality engineers and design engineers.

According to researchers of Quality Management at Beihang University, the missing part of the emergency manufacturing processes in most developing countries, such as China, Indonesia and others, are mistakes within the management of reliability and quality standards under urgent situations, such as the pandemic. This leads to component manufacturing and product assembly failing to achieve the intended design objectives and purpose.

It is exceedingly difficult to conduct inspections at the frontlines in these emergency circumstances. This means that the burden of quality and reliability assurances must be completed at the manufacturing and supply side, i.e. prior to product shipment.

Rehashed from Harvard University on a course in quality assurance, here are some recommendations for makers, quality manufacturers and suppliers for the urgent production of medical equipment should follow several guidelines:

1. Adapt and implement swift but focused quality management standards.
2. At each step of the design and manufacturing process, there must be a check-off point for quality assurance.
3. Engineers should develop quick quality flow charts for manufacturing and assembly line technicians.
4. On-the-spot training should be available for the engineers, assemblers, machinists, technicians and workers on the Quality Management Standards.
5. Implement strict quality engineering inspections for adherence to regulations and specifications and product reliability, which must be done prior to shipment.

Each step of the process is recommended to be documented, and all product testing should fall onto the manufacturers—not the medical facilities or the front-line workers.