This article will take you through the requirements of the laser marking machines for the medical industry and all that you need to know.
The medical industry is ever-evolving and rapidly growing. With pandemics like Covid-19, there has been a sharp increase in the production of certain medical products like ventilators, face masks, etc. In order to keep up with the pace of the demand, the medical industry is revving up.
However, with the increase in production, there is also an increase in demand for marking solutions for newly made products. The medical industry is now looking towards laser marking solutions for the medical industry in order to resolve its issue of demand shortage.
Which Medical Products Require Laser Marking?
When it comes to the medical industry there are always very strict regulations on every part of the manufacturing process. This includes tight regulation of the manufacturing process where the entire process is monitored for quality assurance.
Subsequently, when it comes to the marking of medical products, certain regulations apply that need to be catered. But before looking at the regulations, we need to take a look at the main products that can be laser marked in the medical industry:
- Surgical equipment like surgical scissors, scalpels, etc.
- Body implants like bone screws, ligaments, biological nuts, prosthetics, etc.
- Plastics and pipes, tubes, and other non-metallic hoses for delivery of fluids to and from the body.
- Plastic implants are like the pacemaker.
- Electronic devices like hemodialysis machines, blood pressure meters, diabetic check meters, etc.
- Packaging materials like cardboard, polythene bags, transparent bags, etc.
Need of Laser Engraving Solutions during Covid-19
With the rapid increase in the number of Covid-19 cases around the world, the demand for protective equipment and other respiratory disease-related products has increased. As a result, the medical product manufacturing industry is revving up its business to meet the increased demands.
According to the WHO, there is an acute shortage of PPEs that have worsened the situation in many countries. In order to keep up with the pace of increase in demand, different vendors are coming up with solutions to mark the high rate of produced PPEs.
For instance, you can see how GloryStar is offering laser marking machines for PPEs marking. You can see a demonstration video here to get a better idea of the pace of marking, accuracy, and quality available.
Similarly, there are many other lasers marking machine vendors that are producing different marking machines for the Covid-19 pandemic.
We can ensure you that you can increase your rate of PPE marking by almost 1.5 times in the same period by using Laser Marking solutions for the medical industry. But before we move on, we need to focus on the rules and regulations that apply to the medical industry in general.
Rules and Regulations of Laser Marking Solutions in the Medical Industry
Since the medical industry is highly sensitive, there are stringent regulations in place to ensure the safety of the patients.
UDI Marking Scheme
The Unique Device Identification (UDI) is a series of Alpha-numeric characters that are internationally accepted to code and identify devices. This ensures that there are unambiguous marking standards in the market. For medical products in the USA, the Food and Drug Authority (FDA) has published the regulation for establishing the UDI system.
Regulation 21 USC 321(h)
defines the devices that have a requirement of marking under the UDI system. According to the article, the medical products are divided into three main parts; The low-risk products like masks, gloves, etc, are categorized as Class 1 devices. Whereas, the Class 3 devices include complex medical products like pacemakers, dialysis machines, knee prosthetics, etc.
These products are classified as high-risk parts and any mistake on the part of marking or otherwise could prove to be fatal. Class 2 products are moderate-level products that usually include surgical tools and moderate-risk metal products.
Subsequently, according to the class of the medical product, it can either be direct part marked. Otherwise, the product can be indirectly marked via package labeling.
Class 2 devices, which are surgical devices, need to be direct part marked. Further details about the categories of medical products can be found on the e-CFR site.
As per 21 CFR 801.40
The UDI on medical devices must fulfill two criteria:
1- Machine-readable code (Linear Barcode or 2 D data matrix) (AIDC)
2.-Human readable plain text. (HRI)
The UDI characters must follow ISO/IEC 15459 -2, -4, -6 standards. Furthermore, the marking designs of AIDC should conform to ISO/IEC 16022 and their quality conforms to ISO/IEC 15415, 15416, and TR 29158.
Furthermore, the UDI code must contain two parts. i.e. the Device Identifier and the Production identifier. A good example of the DI and PI are shown below:
Challenges of the Direct Part Marking under UDI
The major challenge that medical products are made of titanium/steel is that they have to regularly undergo a sterilization process. As a result, over time, the readability of the marking is affected and it becomes difficult to read what is written on the item.
Other main challenges include low contact marking, misaligned markings, markings that are too close to the edge and hence not readable, etc.
As a result, the laser marking solution becomes the marking solution of the choice for UDI marking. This is also advised by the GS1 preference guidelines.
According to a whitepaper on the subject by FOBA:
There is much more to marking medical devices than just complying with regulations. Whether manufacturers have to comply with global standards and apply all ID marks reliably with repeat accuracy or whether they have to ensure product quality – all medical products have to be marked properly in the first place.
To ensure correct part identification, absolutely traceable marks are indispensable. Laser marking is the ideal method to create these marks and at the same time offers an increase in production efficiency and a decrease in costly product scrap. Thus, the marking of medical products has multiple dimensions and requirements that need to be fulfilled.
Why Use Laser Marking Machines for Medicinal Products?
There are certain advantages of using laser marking solutions for the medical product:
- Clear Readability
Laser marking machines for the medical industry offer a very legible marking. This is extremely important in recognizing the part for surgical procedures.
Moreover, the computer readability of the mark is also very clear. Thus, it becomes easier for the product to pass the UDI criteria.
- Resistant to erosion
Erosion of the upper surface of the medical equipment is a common thing with time. However, laser markings on the medical equipment have full immunity to the erosion that might take place over time.
- Resistant to sterilization
Furthermore, sterilization is a very frequent process for surgical equipment. Most of the other marking techniques like ink or dot peen fail to perform well against frequent sterilization. However, laser marking technology is the best and is unaffected by the sterilization process.
- Passivation Resistant
Passivation is the process of chemical treatment of stainless steel to sterilize it. Since a lot of the surgical equipment is made from stainless steel, it has to constantly undergo the process. Laser marking provides the best resistance to passivation on surgical equipment.
- Marking Size is exact
Laser marking has a precision of +/-.01mm. (depending on the type of machine and laser). Thus, laser marking machines provide the best accuracy of marking. Subsequently, the markings are of the exact size as required.
Does not change the chemical composition of the device
Another major advantage of using the laser marking scheme is that it does not change the chemical composition of the equipment. As a result, it is safe to use laser marking technology as compared to chemical etching or ink marking.
Summing up, laser marking technology has an edge over all the other marking techniques available for the medical industry. Moreover, the precision, speed, and efficiency of the laser marking machines are much higher as compared to any other form of marking.
Most Common Laser Marking Machine for Medical Products in the Market?
Fiber Laser Marking Machine M1000
FOBA’s M1000 is a state-of-the-art laser marking machine that has a very wide range of applications in the medical industry. The main features of the laser marking machine include:
- Programmable Z-axis
- Electric Lift door
- Vision systems IMP and Point & Shoot
- Mobile worktable (optional)
- Exhaust system
- Accuracy package
- Wide and easily opening the door for comfortable operation while you laser marks your medical products.
- The machine complies with EU safety standards and safety regulations
- For accommodation of larger components, the laser is adjustable along the left, right, front and rear axis
- It is an air-cooled system that offers accessibility and comfortable handling
Fiber Laser Marking Machine M2000
FOBA’s M2000 is another amazing laser marking machine that can be implemented in the medical industry. The main specs of the laser marking machine are as follows:
- Advanced manually loaded laser marking workstations
- Programmable Z-axis
- Electric lift door (ideal for direct part marking of medical products)
- The rotating high-throughput R models provide with automated two-position rotary table. This is perfect for marking all kinds of serial parts including medical implants and surgical equipment
- The laser marking machine provides high efficiency and process reliability. The end-products are of high quality and the markings are very clear and legible
- The air-cooled laser system is compact and gives an efficient output compared to the size and power input
MECCO’s Enclosure Laser Marking machine for Medical Industry
MECCO is another major brand that is providing laser marking machines for the medical industry. The main aspects of the marking machine are as follows:
- 160mm lens
- Manual or programmable Z-axis adjustment
- Air-cooled laser marking system
- Operated by 110/220 VAC
- Compact footprint for desktop operation
- option for an internal single-board computer
- Class 1 laser safe
- Laser safe viewing windows
- Safety interlocks to make the marking process fool-proof
HeatSign’s Laser Marking Solution
One of the rapidly becoming popular names in the laser marking industry is the HeatSign. You can get laser marking solutions for all industries from HeatSign’s team of experts.
OurR&D team has worked day and night to chalk out a few laser marking machines that work best for the medical industry. Furthermore, it has also been kept in view that the UDI and other regulations have been considered. Thus, laser marking machines are adapted to the regulations and will provide high-quality results.
HeatSign provides laser marking solutions in various categories. Here is a brief summary of the laser marking machines that you can choose for the medical industry:
- Fiber Laser Models
Among the state-of-the-art laser marking solutions, we have a wide variety of fiber laser marking solutions for the medical industry. The HS-FL 10/20/30/50 models provide great flexibility to the users.
The greatest advantage of the fiber laser is the high precision and the wide range of materials that you can mark with it. You can view the complete list of laser marking options for the medical industry here.
- CO2 Laser Models
The CO2 laser models add to the variety and versatility of the laser marking solutions available to us. These laser marking machines have high efficiency and can work on multiple products including Composite materials and medical hoses.
You can find the complete list of HeatSign’s CO2 laser marking solutions for the medical industry here.
- UV Laser Models for the Medical Industry
UV laser marking is the best for marking glass-based materials like glass tubes, test tubes, blood sample tubes, etc. The UV laser marking provides a great solution to mark the ceramics and other such materials that can be used in the implants industry.
You can find the complete list of UV laser engraving machines here.
Best Suitable Laser Marking Machines for Medical Products
Now it all comes down to the elephant in the room. That is how to select the best laser marking machine for the medical industry. First of all, there is no single machine that contains all the benefits that you are looking for.
There are specific laser machines that are suitable for the various processes and products of the medical industry. Thus, all you have to do is chalk out the exact requirements of your marking products.
In order to do so, you will have to specify the material, size, quantity, color, and other such details of the product that you want to mark. Once done with that, you can easily choose from the various laser marking machines available in the market.
However, we can save you the research work. Since our team of experts is always researching the field of laser marking machines, we can provide you with guidance to get the best laser marking solutions for the medical industry.
Furthermore, you can also contact us for any query or guidance related to the application of laser engraving solutions for any industry. And we will guide you with in-depth knowledge about the laser marking machine that will suit the industry of query.
So to choose the best laser engraving solution for the medical industry, all you have to do is contact us here. And we will guide you with the best machine for your needs.