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Safety and sustainability in medical device manufacturing

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We observe the growing need for safe and sustainable manufacturing practices in the area of medical devices. As Medtech engineers and designers responsible for Medical Technology development, we should also think about how our innovations impact the patient’s safety and the global environment.

Manufacturer’s Field Safety Notices

I’m sure you’ve heard about spectacular mishaps in the engineering field, which resulted in dangerous car or plane malfunctions, weird driving behavior in tight corners, or engine breakdowns in the air. Usually, we’ve seen massive recalls or plane groundings. 

The medical field can have a serious impact on people’s lives, so it is also highly regulated. The purpose of nearly all medical devices is to heal people, which means most of them to interfere with their bodies and mental health. Medical device manufacturers must respect certain safety rules. 

That’s why field safety notices (FSNs) should be an integral piece of every manufacturer’s quality policy. FSNs are safety communications sent out by medical device manufacturers or their representatives in relation to actions that may be necessary for relation to their medical device that is on the market. 

We can also distinguish a Field Safety Corrective Action: (FSCA). This is a corrective action recommended by the manufacturer to use the medical device in a safe way to reduce potential risk and protect the patient’s / user’s health. What can we expect in such a document:

  • Spare part replacement information
  • New instruction for use
  • Software updates may affect device operations.

On the other hand, there is a recall. It is a type of FSN where a manufacturer has to withdraw the defective medical device from the market due to a defect that cannot be resolved by corrective action and can put patients at high risk. 

Common principles for sustainability

Imagine that during the pandemic, it was estimated by Cambridge Design Partnership that over two billion plastic Covid-19 tests have been provided in the UK alone. With most tests being single-use and non-recyclable, as well as packaged within the plastic, the leftover refuse is typically incinerated or sent to a landfill. While this is true, medical device manufacturers must find a way to reconcile a reduction in waste and disposables with the need for healthcare workers and patient safety. Processes revision to be more compatible with environmental protection is now the need that should be addressed to bring energy efficiency and increased productivity. Despite plastic waste and other harmful materials, gas emissions also come to play.

According to the No harm Global report, the global health care climate footprint is equivalent to the annual greenhouse gas emissions from 514 coal-fired power plants. It shows the scale, isn’t it?

What we can do to make medical devices more eco-friendly:

Utilize greener materials

About 90% of medical device waste consists of single-use, disposable products or components. Efforts to reduce the volume of disposable components are constrained by the need to maintain safety standards. However, despite searching for multiple-use solutions, some plastics can be less harmful than others. PVC, for example, can be recycled many times without losing its key properties. Research is also expanding around renewable polyethylene (PR) and polyethylene terephthalate (PET), as these materials are easily recycled.

Sustainable manufacturing

Energy efficiency and ensuring that all on-site energy comes from clean, renewable sources. That’s for the start. As a second step, I would suggest reducing water consumption, optimizing logistics, and using fewer polluting chemicals. Reducing consumption is an attractive goal. We are seeing a continuous increase in the price of natural resources, so this is also a response to cost efficiency while reducing the carbon footprint. 

Design that drives sustainability

If this approach is taken, medical product designers need to understand how their ideas make an impact on the environment. As a result, an already difficult task gets even more complicated. Worth to undertake that challenge. Existing design procedures should be revised to include a thorough assessment of energy efficiency, environmental impact, material use and recycling, and their impact at each stage, including methods of transportation and end-of-life disposal.

Medical device standards

ISO 13485 is a stand-alone Quality Management System standard derived from the internationally recognized and accepted ISO 9000 series of quality management standards.

ISO 13485 was written to support medical device development companies in developing quality management systems that establish and maintain the effectiveness of their processes. The standard ensures the consistent design, development, manufacture, installation, and delivery of medical devices that are safe for their intended purpose.

ISO 13485 benefits:

  • Increased competitive advantage
  • Greater access to global markets
  • Increased efficiency – Identifying how to review and improve your organization’s processes
  • Safety – demonstrating that the medical devices you produce are safer and more effective
  • Savings – increasing efficiency, reducing costs, and monitoring supply chain performance
  • Compliance with market requirements. Meeting regulatory requirements and customer expectations.

Clashing medical device design and engineering with sustainability and medical regulations build pressure on Medtech developers and manufacturers. It’s not an easy task to reconcile all areas mentioned. However, if we agree that sustainable changes can’t all be made overnight, postponing them wouldn’t help either. A better understanding of factors like the microbiology, chemistry, and material science of a device during the design process can be a key to delivering a more eco-friendly Medtech product.


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