How to produce usable medical parts via AM

You would like to help in coronavirus times, by designing and printing medical equipment or parts via AM? Let Sirris be your guide and inform you about what to do and how to do it correctly! 

In the fight against coronavirus Covid-19, there is a very high need for high-quality protective equipment, medical equipment and replacement parts. To anticipate those needs, right at the start of the pandemic, many enthusiastic people started designing and printing parts via AM, ranging from face protection to respiration valves. While the enthusiasm and dedication are very heartening, a lot of the produced parts are in the end not usable. Often this is due to the lack of knowledge and confusion about what someone is allowed to do and what not. Therefore, we would like to guide and inform the man with a plan, so no effort is wasted.

1. Think before you print

  • Is there a real need for this part?
    Don’t just start designing and printing parts because you think you see a potential need. Several initiatives were set up to match supply and demand.
  • Perform a full-functional analysis
    Communicate with the end user to clearly understand the need and requirements.
    You can think of the medical purpose and performance, required post-treatments, operating conditions, mechanical and dimensional requirements, certain standards that need to be followed, …
  • Do some preliminary research
    Thanks to the Internet we have the possibility to scan very quickly to find out if someone else has already had a similar idea. If so, try to learn from this. Maybe the design and production settings can be shared. This could make things much easier.

2. Legislation and regulations

Even if the parts are produced for free, you can be responsible in case something goes wrong. 

Depending on the intended use of your manufactured part, it may be qualified as a medical device or accessory, according to the definitions set out in the medical device legislation. If this is the case, the following harmonised standard may be used:
ISO 13485:2016 - requirements for a comprehensive quality management system for the design and manufacture of medical devices

Concerning the production of mouthguards and personal protection materials in Belgium, the most relevant standards are published for free: https://www.nbn.be/nl/nieuwsberichten/gratis-normen-voor-mondmaskers

Some of the important standards: 

ISO 10993: Biological evaluation of medical devices
ISO 10993-1: Evaluation and testing within a risk management process
ISO 10993-5: Cytotoxicity
ISO 10993-10: Irritation & sensitization
10993-11: Systemic toxicity
EN 14683: Medical face masks - Requirements and test methods 

FAGG information on directives for medical devices: https://www.famhp.be

3. Production conditions 

Printing material

You should be aware that your regularly used bright coloured, non-iso-certified filament, might not be safe to use for all kinds of applications. Therefore, we would advise you to use a material with ISO certification. PET-G is one of the most frequently used materials for those kind of applications. Try to avoid using coloured filaments, as the additives used, such as colorants can cause irritation. Polymers containing butadiene or styrene contain the risk of leaching out. 

Production environment

The production process should occur in a sufficiently clean environment. Furthermore, traceability and biocompatibility must be taken into account throughout the entire manufacturing process or should be guaranteed at the end of it.

Post-processing

Depending on the production technology and the final use of the part, post-processing might be needed. For powder technologies we want to ensure that all excess powder particles are removed. For FDM technologies on the other hand, a smoothened surface might be needed. Last but not least, sterilization or disinfection of the parts is often required. Disinfection could be done with ethanol or Isopropanol.
For sterilization both low- and high-temperature processes could be used. Steam sterilization can easily reach up to 135 °C, which might be problematic for most 3D printing materials. For those parts, low temperature processes as for example 'hydrogen peroxide gas sterilization' can be an alternative.

Try to take into account those requirements as soon as possible, because not every production technology or material might be suitable. 

Note: we try to give you some tips and tricks when working on C19-related design projects. Unfortunately, we are unable to guarantee the accuracy of all provided data… 

If you have any specific technical questions to help you in your AM related C19 challenge, please contact us.