The Problem with PVC Materials
PVC materials, particularly those containing DEHP, have been linked to various health concerns due to their potential to act as endocrine disruptors. Endocrine disruptors are chemicals that can interfere with the body’s endocrine system, which regulates hormones and other bodily functions. The use of PVC materials in medical devices has raised concerns about the potential risks to patients. Key health concerns associated with DEHP include:
- Reproductive issues
- Developmental problems
- Cancer risks
- Neurological damage
- Improved Performance: Medical device adhesives must meet stringent performance requirements, including high strength, durability, and resistance to chemicals and biological fluids. Reliability and Safety: Adhesives used in medical devices must ensure the reliability and safety of the device, as well as minimize the risk of adverse reactions or complications. Cost-Effectiveness: Medical device adhesives must balance performance and cost, as the cost of adhesives can be a significant factor in the overall cost of a medical device. ## Henkel’s Portfolio for Medical Devices**
- Loctite AA 3952: A high-strength, low-viscosity adhesive for assembly and bonding of medical devices.
The Need for Alternative Adhesives
The shift away from PVC materials has created a pressing need for adhesives capable of bonding effectively with TPE substrates.
Henkel addresses these challenges with the launch of two innovative light cure adhesives: Loctite AA 3952 and Loctite SI 5057. These adhesives are specifically designed to bond TPE substrates and overcome the limitations of traditional assembly methods. The key benefits of the products include: Enhanced bonding performance: Reliable adhesion to TPE materials, especially TPE-S and TPE-O, ensuring robust and durable device assembly. Resistance to environmental factors: High performance under heat and humidity aging conditions. Regulatory compliance: Formulated to meet EU MDR 2017 standards regarding CMR and endocrine substances. Both products are also ISO 10993 tested for biocompatibility, ensuring safety in medical device applications.
The Rise of Medical Device Adhesives
The medical device industry is a rapidly growing sector, driven by advancements in technology and an increasing demand for innovative solutions. One area that has seen significant growth is the use of adhesives in medical devices. Adhesives play a crucial role in the assembly, testing, and packaging of medical devices, and their development has been driven by the need for improved performance, reliability, and safety.
Key Benefits of Medical Device Adhesives
Henkel’s Portfolio for Medical Devices
Henkel, a leading global adhesives and sealants company, has a comprehensive portfolio of adhesives for medical devices. Their products include:
