Medical grade adhesives are often used in "stick-to-skin" applications. What are the benefits?
Using medical grade adhesives ensures that your stick-to-skin applications have been tested to ISO standards for skin irritation and sensitization. Using medical grade adhesives avoids any potential problems for users and suppliers alike.
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Craig McClenachan
Vice President Fabrication and Assembly Business Unit FABRICO To read Craig's opening, click here-
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As an experienced converter, Fabrico has found that using "medical grade" adhesives can help avoid potential problems in the design and manufacture of medical products such as surgical drapes, wound care dressings, ostomy devices, and other "stick-to-skin" applications. Medical grade adhesives are required to undergo several biocompatibility tests. The International Standards Organization (ISO) has devised a medical device industry standard that is used worldwide for medical grade adhesives - ISO:10993. The two sections that most adhesives need to meet or exceed are 10993-5 for cytotoxicity and 10993-10 for skin irritation and sensitization. Using medical grade adhesives will allow you to meet these standards and build adherence into your design. At Fabrico we help design engineers evaluate the different medical grade adhesives that would apply to an application and test those adhesives with the target substrate.
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Joe Musca
Converter Markets Account Representative 3M To read Joe's opening, click here-
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During the engineering and design phase of a new product, we typically will want to work with you so that we can suggest an adhesive solution and therefore design parts with the adhesive in mind. Solutions, in addition to medical grade adhesives could include: epoxies for rigid structural bonds; acrylics, when hard to bond surfaces are being used; urethanes for flexible and vibration needs; VHB tapes to replace mechanical fasteners; double coated tapes and adhesive transfer tapes that both offer thin consistent bonding methods that can be die-cut to your specific size for the application. In addition to recommending medical grade adhesives for "stick-to-skin" applications, we can also suggest better attachment methods by the means of testing our liquids and tapes on your existing parts. This might take care of a current issue you are experiencing, or simply offer an improvement in the means of performance or production assembly.
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Kris Godbey
Senior Technical Support Engineer 3M To read Kris's opening, click here-
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Why use “medical grade” tapes on skin? In order to use our tapes on human skin we are required to run several biocompatibility tests according to the ISO standards. Once those results are approved by a review board, we can test strips of the tape on human volunteers. 3M Medical Specialties helps to support a clinical department and utilizes their skills to design and run “skin panels” to test our adhesive products during the development phases and if formulation, process or raw material changes need to be made. The ISO regulations also are used to help define the requirements for documentation to support the manufacturing end of creating medical grade products. We can trace the codes in a core of medical tape back through each processing step to the lots used of incoming raw materials – and often back through their manufacturing. Changes to the processes and products are controlled by ISO & FDA requirements for medical devices – even though 3M Medical Specialties products are supplied as components not as finished devices.
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Fabrico is working closely with our vendor partners to roll out new solutions for wound care applications. We are able to convert and package these products to meet the needs of most demanding medical application. Do you have a new project in development we can discuss on the forum? Let us know. If you have a specific problem you want to discuss with a Fabrico engineer, please feel free to use the Ask an Engineer button.
Cool blog!
I enjoy your work, thanks for all the useful articles.
Are dielectric insulation films ever part of the tape construction for medical applications?
Is there a recommended procedure for removing tapes from skin, especially for older or younger patients with thinner and more fragile skin?
Try to wet the tape with mineral or olive oil . You can’t bond over the oil tape substrate absorbs oil tape loosen bond strength then you can remove the tape easily.
Are there any skin contact adhesives that can hold 4-5 oz of weight and still be removed from the skin an hour later without any injury to the patient?
Yes medical grade adhesives should not cause skin irritation and one of the benefits is low trauma during removal. Experience has shown that most medical grade adhesives still cause serious trauma during removal and unsuitable on frail skins. Formulating medical grade adhesives with low trauma during removal has been the focus of adhesive manufactures. On a general note, using medical grade adhesives for medical products may well be the shield a company needs in the face liability questions.
Is there a relationship between elongation and adhesion or can you increase both at the same time? Does the substrate effect this equation?
Are the different types of adhesive used categorized from most irritable to least irritable and does the substrate they are applied to have an impact?
Does it matter if the “patient” or “user” is an infant, a child, or an adult as to what adhesive strength would be used? I am thinking that if it was for an infant, one would not want a very strong adhesive that could “pull” on the skin.
Before joining FABRICO I worked for a few years in the pharmaceutical industry developing transdermal drug delivery devices. The study on type of medical adhesives used on different demographic groups is one major task. As the clinical study for most transdermal drug applications required skin contact over 24 hrs, the risk for skin irritation was a concern. Serious skin damage was exhibited among older subjects more often than younger ones due to character of the skin and adhesives used.
Yes, selection of the proper adhesive should consider the “sensitivity” of the patient’s skin. All suppliers have a variety of adhesives designed for different release values. While skin sensitivity is an item for consideration, there are other factors to be considered as well. We should review all the requirements of the application to be sure we understand them and make the best material selection.