China3D printingNet, June 16th, researchers from the University of Queensland in Australia issued a research report requesting clarification on the use of3D printingEquipment regulations.The research team believes that as3D printingWith the maturity of the medical market and more and more products being put on the market, manufacturers and regulators need more clarity and cooperation.
Researchers at the University of Queensland are calling for closer dialogue between regulators and manufacturers. The picture is from the University of Queensland.
Medical devices in additive manufacturing
although3D printingThe emergence of medical equipment has brought innovation, speed and cost advantages to the industry, but it has undoubtedly brought challenges to regulators. These officials must determine whether the product is safe and suitable for use, and whether the new additive manufacturing product will cause different types of hazards, risks, and areas of concern.
What’s more complicated is that certain3D printingThe product is in a different development stage from other products.For example, use3D bioprintingMost of the products created are in the experimental stage, but other products that do not contain biological materials are beginning to be used in clinical settings.For example, it has been used in clinical practice3D printingOf surgical equipment, artificial limbs, hip and knee joint prostheses, implants and other medical devices, but only a few of them have been approved by the U.S. Food and Drug Administration (FDA).
In addition, products such as biomarked biodegradable stents have been used clinically for more than ten years, but they have not been converted into routine clinical applications until now. The problem is that bioprinted products are created in a research-centric environment, usually without considering product regulations, and because consumers don’t use it, they follow a different, more relaxed set of rules. As a result, consumer safety and medical product regulations are neither understood nor followed, which raises questions about how to apply the existing regulatory framework.
According to researchers, there are various opinions in the industry as to when certain aspects of biological substances containing AM will be regulated, or whether they need to be regulated at all.If you want to deal with the health sector in the near future3D printingFor products to be regulated, the personnel involved in the research and manufacturing process need to understand the challenges faced by regulatory agencies and the risk status of their products. In response to the upcoming regulatory threats, the research team advocates consistent terminology and standards in the industry, and requires AM companies to adapt to potential new processes.
3D bioprinting
It is a production technique commonly used by researchers, but it has caused confusion among regulators” alt=”
3D bioprinting
It is a production technique commonly used by researchers, but it has caused confusion among regulators.” width=”620″ height=”375″ />
3D bioprintingIt is a production technique commonly used by researchers, but it has caused confusion among regulators. Picture from Autodesk Charlie Nordstrom.
Current regulations and proposed changes
Various standards related to test methods, design, materials and processes, and terminology have been issued for additive manufacturing, but there is a lack of standards for specific health sectors. Although the law has established regulations, researchers believe that standards can explain the interpretation of the law, and reliable rules can promote the evaluation of product innovation, efficiency, performance, and safety.
The International Medical Device Regulators Forum (IMDRF) reiterated this view and recommended the introduction of new rules, which were developed through a transparent and inclusive process. According to voluntary organizations, it is important to formulate regulations not only to meet scientific or industrial purposes, but also to be aware of the needs of regulatory agencies. However, it may be difficult to coordinate these regulations, because many countries are generally unwilling to cede any sovereignty in legal matters, and supranational institutions like the European Union choose to make their own rules.
The risks associated with medical products are also important in determining their regulatory pathways. Currently, devices are classified into risk categories based on the known risks that the use of the device brings to patients.many3D printingProcesses have been used to produce medicines, and each process has different effects on its chemical and mechanical properties. Therefore, the researchers believe that stricter supervision may be postponed until the final form of production is established.In addition, with3D printingWith the increasing availability of machines, hobbyists may decide to create their own medical devices, which raises more questions about the enforceability of these risk categories.
In addition, in countries such as Australia, “customized” devices (devices for specific patients) can exempt many of the stringent testing and documentation requirements that are expected for mass production of medical devices. The purpose of introducing these exemptions is to cover special situations where commercially available mass-produced products are insufficient to meet the needs of specific patients. Nevertheless, under customized exceptions, high-risk implantable products may still bypass legislation.
The researchers concluded that additive manufacturers must understand the thinking behind the standards and work with regulatory agencies to assist them in establishing new processes. Although the regulations surrounding most non-biological medical devices do not require major reforms, there are still questions about the use of biological materials in AM and the use of the technology by potential amateurs. Regarding the role of regulators, the research team concluded that legal standards need to be revised to emphasize clarity and promote safety without inhibiting innovation.
3D printingThe widespread use of computers will encourage amateurs to3D printingMedical equipment expresses concern” alt=”Researchers on the desktop3D printingThe widespread use of computers will encourage amateurs to3D printingMedical equipment expresses concern” width=”620″ height=”447″ />
Researchers on the desktop3D printingThe widespread use of computers will encourage amateurs to3D printingMedical equipment expressed concern. The picture comes from Formlabs.
Additively manufactured medical devices
biomaterials3D printingIt may cause headaches for regulatory agencies, but this has not stopped the FDA from approving several other additive-manufactured medical products.Developed by doctors at Cleveland Clinic, a non-profit multidisciplinary academic medical center in Ohio3D printingThe patient-specific airway stent was approved by the FDA in January 2020. Silicone stents are used to keep the airway open in patients with severe respiratory disorders.
Orchestrate Orthodontic Technologies (O3D), a California dental digital solution provider, received the FDA-approved Orchestrate 3D treatment planning software system in February 2019. This software enables American dental professionals to design and produce their own orthodontic transparent aligner equipment.
Texas medical device company Osseus Fusion Systems acquired its brand Aries in August 20183D printingFDA approved the spinal implant series. These implants are designed to help surgeons relieve back pain and shorten the recovery time of the spine.
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