PCBA Tech - PCBA medical equipment responds to coronavirus

As we all know, the coronavirus has a growing demand for medical ventilators and other "life-sustaining" equipment. With the surge in the number of hospital visits, the supply chain of medical equipment is becoming strained ‘’

During the pandemic, the U.S. Food and Drug Administration (FDA) tried to increase the production and availability of ventilators and accessories and other breathing devices. This is the latest information on the efforts of the U.S. Food and Drug Administration, as well as some important recommendations on the management of the medical device supply chain during uncertain times.

During the COVID-19 panic, many businesses, including manufacturers, have temporarily suspended work. However, manufacturers of PCBA medical electronic equipment for the supply can still work.

As the US Food and Drug Administration pointed out, unless demand calms down, there is no choice.

"With the (production and availability) improvements of the U.S. Food and Drug Administration, medical device manufacturers can more easily make changes to existing products, such as changing suppliers or materials, to help resolve current manufacturing restrictions or supply shortages. Others Manufacturers (such as car manufacturers) can more easily repurpose production lines to help increase supply.

Maintain the lead time of PCBA medical equipment supply chain

Due to anticipated product shortages, delivery time is more important than ever.

Generally, every time a manufacturer makes a modification to a ventilator device, it triggers a pre-market review by the U.S. Food and Drug Administration. This will increase the time it takes to transport these devices to the patient's bed.

In order to reduce the regulatory burden on manufacturers, the US Food and Drug Administration now uses its discretion to decide whether to implement review requirements for certain modifications of medical devices.

The agency encourages American and international electronics manufacturers to consider seeking emergency use authorization, which will enable them to distribute ventilators in the United States. This includes US manufacturers that already manufacture medical devices but can increase production.

What is needed in the PCBA supply chain

Because they create products for life-sustaining devices, electronic medical device manufacturers are still in business, and they provide OEMs with everything they can provide as quickly as possible.

More than ever, it is vital to work with manufacturers who understand the risks and challenges of medical electronics design. The manufacturer should have:

· Design engineering team familiar with mission-critical applications

· A production facility capable of building, testing and tracking components

· Thorough understanding of ISO 13485 requirements and many years of experience

Level 3 electronics experience

PCBA electronic medical equipment belongs to IPC 3 electronic products. They are considered "mission critical", and equipment failure may endanger human life.

Cooperating with PCBA manufacturers with expertise in 3 types of projects can shorten the speed of entry and increase the possibility of designing to meet your strict safety requirements. All employees (not just some) of the contractor participating in the project should have level 3 experience.

ISO 13485 certification and other training

The ISO 13485 medical certification is a stamp that has been developed by contract manufacturers of electronic products approved as a quality management system. It ensures that the contractor produces safe, reliable and effective PCB circuit boards and components

PCB designers should receive training on all relevant standards:

· Surface mount technology and through-hole technology production: J-STD-001 and IPC-610

· Wire harness production: IPC-620

· PCB rework and repair: IPC-7711