Sterile environment and skin protection with medical adhesive film
Hospitals, especially operation theaters, or OR rooms, require a high standard of sterility at all times. This is where medical adhesive film can be of great help as it maintains a sterile environment during operations as well as guaranteeing maximum efficiency of surgical procedures.
Medical adhesive film systems exist as different types, however, here we will focus on sterile incision film which is applicable to disposable surgical drapes and skin prior to sterilization. The sterile incision film increases sterility while at the same time protecting the skin around the operated area during, for instance a c-section or an abdominal surgery.
Components and uses of sterile incision film
Medical adhesive film for drapes and skin often consist of a transparent polyurethane layer, a special UV adhesive and a release liner as well as a finger lift. An additional polyethylene layer is possible in order to provide support.
Incision films are the most common in operations such as cesarean sections and abdominal surgery. They are applied for two main reasons:
- To maintain a sterile environment during surgical operations.
- To protect the skin around the area that is being operated.
Sterile incision films come in all shapes and sizes and are available with custom dimensions, special adhesive systems, customized perforation and print depending on what is needed.
The adhesive used in incision films
One of the most important components of sterile incision films is the adhesive as the characteristics of the film greatly depend upon the properties of the adhesive.
Typically film systems make use of pressure sensitive adhesives which implies that bonds are formed as pressure is applied. This is no different for medical adhesive film. However, the adhesive in incision films is often also temperature sensitive meaning that the body heat of the patient enhances the bonding process. Also UV adhesives are common in medical adhesive films as they are easy to apply and guarantee an efficient film production process.
In sterile incision film systems one side is commonly coated with an UV pressure sensitive adhesive. Due to the pressure and temperature sensitive nature of the adhesive it adheres well and easily to surgical drapes and skin.
Benefits of medical adhesive film provided by the adhesive
The purpose of the adhesive is not limited to sticking but it also provides the medical adhesive film with beneficial properties. Some properties of the film are increased or supported by the adhesive. The benefits, the adhesive contributes to include the following.
- Breathability: as the adhesive comes in contact with skin, breathability is crucial to avoid any post-surgery skin irritation. Depending on the adhesive and the design of the medical adhesive film (perforated or non-perforated) different levels of breathability can be reached. UV curing adhesives allow for breathability of the adhesive.
- Resistance to fluids: the adhesive used in incision films is resistant to water and body fluids as well as alcohol and detergents. This prevents the fluids from affecting the skin under the film and so maintains sterile environment during surgical operations.
- Disinfection: resistance to alcohol and detergents makes it possible to disinfect the film after it has been placed on the drapes and skin to minimize the presence of bacteria and other microorganisms.
- Maximum performance: during surgical procedures, the medical adhesive film allows for maximum performance as sterilization can be done on the spot and the clean environment is maintained throughout the operation.
In addition to the benefits the film receives from the adhesive, the adhesive also has advantages regarding the manufacturing process. UV curing adhesives are usually environmentally friendly and allow for efficient, low waste medical adhesive film production. Even though the UV pressure sensitive adhesives are most common in incision films, they are suitable for many more innovative purposes. Contact us to find out whether UV pressure sensitive adhesive is what your product, project or process needs!
Medical adhesive film application procedure
Sterile incision films can be applied to the drapes prior to being supplied to the end user or at the operation theater setting right before the surgery. In both cases, before placing the film on the patient’s skin, the skin is disinfected by iodium or another disinfectant. The skin is let dry, as the adhesive forms better bonds when applied to a dry surface. Letting the disinfectant dry also increases the level of sterilization. Once the film is in its place, and the liner is removed, it gets sterilized to avoid any microorganisms interfering with the operation.
During the operation incisions are made through the film. Afterwards, the film is removed, appropriately disposed and the wound can be stiched. Note that it is not possible to stitch through the film.
Relevant certification of sterile incision film systems
As the medical industry is strictly regulated by standards and tests by various parties, it is crucial to be aware of some when looking for a medical adhesive film. Next to paramount CE marking according to the EU Medical Device Regulation (MDR) 2017/745, it is important to look for adhesive film suppliers who have obtained the ISO 13485 certificate which proves their ability to produce approved medical devices and related products and services.
Additionally, when looking at the adhesive several international standards are applicable. The adhesive should be tested for instance for cytotoxicity, skin irritation and skin sensitization. These are included in ISO 10993-5 and ISO 10993-10.
Looking for medical adhesive film – or just the adhesive?
As medical adhesive film for surgical operations come in all shapes and sizes, one should always opt for the most suitable product. In case you are looking for a reliable supplier with a proven track record of adhesive film approved for medical use, do not hesitate to contact us. Our experts are determined to connect your enquiry with the most suitable medical adhesive film manufacturer who can provide you with custom dimensions, perforation, special adhesive systems and print on the film.