The use of textiles and fabrics is becoming increasingly prevalent in the development of wearable medical garments, wearable organ holsters, and even being utilized as flexible mesh for medical implants. During the development and prototyping of a medical garment, it is more than likely that there will be numerous textiles considered. Therein lies the question: what makes a fabric “medical grade”?

To this day, there are actually no regulated standards on what constitutes a medical grade textile or fiber. In this blog post published by the Industrial Fabrics Association International (IFAI) published in 2014, Brenda Gilchrist, vice president of operations, RxFiber LLC says, “We are in the process of pulling together the leading biomaterial experts to discuss what medical grade fiber is and to begin setting standards for the industry. What does medical grade really mean?”

What Defines a Medical Grade Textile:

• If used in a hospital or medical setting, the textile must meet hospital regulatory requirements.
• The textile must be biocompatible. Biocompatibility ensures that the textile will integrate with the wearer (a biological being) without harmful side effects.
• It must be clinically tested – extensively. The failure or malfunction of, say, a wearable medical garment could result in fatal damage.
• The textile must be durable and withstand reasonable wear. The durability of the garment or implant would be put to the test during the clinical trials.
• The textile must be clean or washable so as not to cause infection or contaminate the user.

These assumptions contribute to a picture of a medical wearable vest or a reusable medical garment. However, all things considered, a medical grade textile can be something as simple as sterile bandage, a hospital surgical tray cover, or gauze dressing for a wound.

No Formal Definition

Despite the lack of formal definition, the development of medical grade textiles has been a long time coming, as has the utilization of said textiles in the medical industry. We have worked with different companies using biocompatible textiles, conductive threads, and we are always looking for Start-ups or established companies that are experimenting in this field. We are no stranger to working with new materials.

On our contract sewing side, our medical grade – and often biocompatible  – textiles are used to create new medical vests and sleeves. As material science continues to advance and new materials are invented. Defining a standard for medical grade textiles is crucial to the future of universal health care and medical therapy products.