Biomedical adhesives: qualification, specification, quality control, and risk mitigation

Abstract

Adhesives as a fixing method in medical applications have been around since ancient times. Nowadays, biomedical adhesives play an important role in the medical field. Over the past few decades, the use of adhesives in a wide range of applications has been increasing. Among the clinical applications of adhesives, it is important to highlight wound healing, cosmetic and plastic surgeries, vascular surgery, dental adhesion, and orthopedics. Another important field of application has been the medical devices industry. Adhesives play an important role in the assembly of these devices, including surgical instruments, endoscopes, catheters, needles, drug delivery, pacemakers, imaging equipment, etc. Using adhesives in these applications requires them to meet certain characteristics. These necessary features are focused on biocompatibility, high bond strength, and fast curing to minimize surgical time in clinical applications or the production time in device manufacturing application. In addition, they should be sterilizable and easily stored in terms of ambient condition storage. There are numerous adhesive technologies available for medical purposes. This variety of adhesives allows selecting the most suitable adhesive for a specific application that best meets the required needs and characteristics. Available adhesive types are classified into synthetic and biological. The first usually comes from other areas of industrial applications, and their bond strength tends to be high. However, because of their synthetic nature, the main challenge is their biocompatibility and biodegradability. Synthetic adhesives include cyanoacrylates, acrylates, epoxies, urethanes, etc. Natural or biological adhesives have also been the subject of increasing interest. Biological adhesives are lower in strength, but offer high biocompatibility and biodegradability. They are usually used in tissue-bonding applications, therefore a typical challenge to meet is adhesion to wet tissues. Finally, common for any type of material used in biomedical applications is that the standards for biocompatibility require special attention to satisfy strict regulatory requirements of the US Food and Drug Administration and the European Union European Medicines Agency.Adhesives as a fixing method in medical applications have been around since ancient times. Nowadays, biomedical adhesives play an important role in the medical field. Over the past few decades, the use of adhesives in a wide range of applications has been increasing. Among the clinical applications of adhesives, it is important to highlight wound healing, cosmetic and plastic surgeries, vascular surgery, dental adhesion, and orthopedics. Another important field of application has been the medical devices industry. Adhesives play an important role in the assembly of these devices, including surgical instruments, endoscopes, catheters, needles, drug delivery, pacemakers, imaging equipment, etc. Using adhesives in these applications requires them to meet certain characteristics. These necessary features are focused on biocompatibility, high bond strength, and fast curing to minimize surgical time in clinical applications or the production time in device manufacturing application. In addition, they should be sterilizable and easily stored in terms of ambient condition storage. There are numerous adhesive technologies available for medical purposes. This variety of adhesives allows selecting the most suitable adhesive for a specific application that best meets the required needs and characteristics. Available adhesive types are classified into synthetic and biological. The first usually comes from other areas of industrial applications, and their bond strength tends to be high. However, because of their synthetic nature, the main challenge is their biocompatibility and biodegradability. Synthetic adhesives include cyanoacrylates, acrylates, epoxies, urethanes, etc. Natural or biological adhesives have also been the subject of increasing interest. Biological adhesives are lower in strength, but offer high biocompatibility and biodegradability. They are usually used in tissue-bonding applications, therefore a typical challenge to meet is adhesion to wet tissues. Finally, common for any type of material used in biomedical applications is that the standards for biocompatibility require special attention to satisfy strict regulatory requirements of the US Food and Drug Administration and the European Union European Medicines Agency.