FDA Issue Green Light to Sterilize N95 Respirators


As supply chains are thrown into question due to the knock-on effects of the COVID-19 pandemic, manufacturers are ambling into unknown territory. For some, a crisis management plan amounts to suspending normal production and instead shifting production lines by redesigning products and services—all in the hopes of staying afloat while also providing security and safety for the workforce.

But it isn’t easy. Even as the U.S. Food and Drug Administration (FDA) has eased some requirements, non-medical manufacturers repurposing to building ventilators, respirators and other life-saving equipment must demonstrate they can achieve levels required for medical device manufacturing in such areas as supply chain traceability, factory cleanliness, personnel training and records documentation. 

Global safety company UL (Underwriters Laboratories) receives dozens of calls from Fortune 500 companies eager to pivot, said Deborah Jennings-Conner, UL’s director of Global Life & Health Sciences Regulatory & Testing Assurance. While those with strong quality management systems in place will have the easiest transition, plants still need to address critical issues to qualify as manufacturers of non-medical equipment and supplies, she said.

In this Q&A, Jennings-Conner shares insights on the factory retooling process and quality control measures, as well as what’s at stake as manufacturers consider retooling.

Machine Design: What standard operating procedures do manufacturers need to adhere to?

Deborah Jennings-Conner: For medical devices there are strict quality manufacturing requirements. The FDA, under their quality system regulation for the U.S., says that you need to follow good manufacturing practices. And a lot of that has to do with making sure that you have the right procedures and processes in place for all the staff that are working in the factory.

The bottom line is that they’re confident that the product is produced exactly in the manner in which it’s been approved by the FDA for market access. So, it affects not only the manufacturing plant, but things such as procurement. You can’t easily switch out components because a different component is on the shelf—you need to choose original equipment. For medical production the requirements are quite rigorous for training of staff and making sure they know to follow the correct standard operating procedures.

Deborah Jennings-ConnerMD: Given the constraints, how can they speed up the process?  

DJC: The FDA is putting out quite a bit of guidance for emergency use (Emergency Use Authorizations). In some cases, manufacturers may not fully comply with all the requirements. So, if you’re looking at a factory, it may mean that they do not need to meet every part of the ISO or quality requirements. There may be some things that we can help fast-track, if it’s actually designing a product that they might not have had in their factory before.

The FDA guidance makes provision for processes and procedures that are not exactly in keeping with what they look for in long-term use. They may allow some easier pathways; for instance, a device might need to come with instructions that are only for use within a timeframe, but after that it might need to be removed from the market.

Let me give an example: We’re hearing about mobile hospitals that might set up wash stations outside the hospital. But products are still going to need to meet a level of essential performance. The FDA will not allow substandard products in the market.

MD: Consider specialized parts and access to medical-grade textiles. How does this affect standards?

DJC: Yes, this is important. In a factory, as I mentioned, you can’t interchange components. Take as an example, a switch. The design control is very strict and we need to make sure that you can get the parts that were originally designed or the approved alternatives. Right now, plants can’t readily get the supply they would normally get from China. It’s important to work within the framework of the procurement process and make sure that it’s fully traceable and also track changes in manufacturing through change orders. 

It’s extremely important; once a medical device gets in the field and there are adverse events, it will ultimately need to get reported to the FDA. So, if you’re going to set up a new factory, maintaining that control is important. 

MD: This raises another concern: counterfeit goods. Can you speak to that?

DJC: From the UL standpoint, we have a whole group that deals with anti-counterfeiting. We do have a certification process, and sometimes you’ll see our marks—the UL with the circle—on the products. We try our best to make sure the products getting into the U.S. with our mark are not counterfeit. In some cases, they may have holographic labels or other things that make it harder to counterfeit.

We work a lot with customs to ensure authenticity and our teams work with law enforcement to remove products bearing counterfeit UL marks. But one thing we are hearing is that customers are having trouble sourcing components from other countries. It might be due to delay in flight, or the factories aren’t open. And I’ve noticed they are trying to source more components from within the U.S. because they couldn’t get them, which hopefully mitigates opportunity for counterfeiting.

MD: We’re observing several automakers retooling and preparing to produce medical devices quickly. While they are collaborating with the medical community, there is still curiosity about how quickly they can get this set up and still uphold quality standards we associate with medical devices. Can you speak to quality management in these situations?

DJC: We’ve been talking about that as well. We do have an automotive division here at UL, which is a new division. And there are specific ISO and quality management standards for automotive. The automotive industry is used to the supplier controls; they’re used to not changing components without changing notices and the proper rigor that’s required to make sure the car that’s manufactured is as it was originally designed, and for safety reasons as well.

People who work in factories will know how to work in a strict quality management system. For other industries it might be a bigger leap. However, when you look at medical standards, ISO 13485, I call it ISO 9001 on steroids because it’s the basic quality standard of all the extra support for medical devices. Similarly, automotive IATF 16949 has a basis in ISO 9001. (See “Common Standards Related to the Automotive Industry” below). 

MD: What is UL’s role in this process?

DJC: It depends on the types of products that are being manufactured. But there are many queries about working in clean environments—for manufacturing ventilators, for instance. And we get queries on proper sterilization of medical products. A lot of the [COVID-19] test kits that are coming out now come in sterilized blister packs. So, if a manufacturer wants to try to move into that realm, it could be challenging for them to break into that space. Sterilization is a pretty complex process when it comes to compliance for manufacturers. We can help navigate that.

With regard to retooling in general, it’s important to note that UL has been around for 126 years. We have more than 1,000 field engineers in 200 locations around the globe and we are in 40 countries. This is where we can provide some value. Right now, we visit about 65,000 manufacturing sites around the world. So, we are doing over 650,000 inspections. UL has a large-enough footprint to really help out. 

We’re maintaining a list of every country where we have people, what we can or can’t do, whether we can travel or not. We’ve also put in place quite a few measures. Everybody has video cameras, right? We can witness what’s going on in the factory. And we’ve been given a lot of leeway to be able to do that and still make sure that we meet our requirements for compliance. We can help out the customer and physically not be there. 

Common Standards Related to the Automotive Industry

IATF 16949Developed by the International Automotive Task Force (IATF), the standard is based on ISO 9001, and emphasizes process-oriented quality management that provides continual improvement and defect prevention, as well as reduction of waste in the supply chain. Companies partnering with the automotive industry are required to be certified to this standard.

ISO 9001: IATF 16949 works in combination with the comprehensive quality management standard, ISO 9001 certification, which provides a framework for managing an organization by demonstrating credentials such as customer satisfaction, operations effectiveness, legal compliance and risk management.

ISO 14001As the principal international standard for environmental management systems (EMS), ISO 14001 provides guidance for managing and controlling environmental impact and economic sustainability.

ISO 45001: The Occupational Health and Safety certification is prudent for companies committed to improving employee safety, reducing workplace risks and creating safe working conditions. ISO 45001 builds on the success of earlier international standards in this area, including the International Labour Organization’s ILO-OSH Guidelines on occupational health and safety systems.



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