Medical Device for Diabetic Foot Screening

Monofilaments are the most effective method of testing for loss of protective sensation (LOPS) in diabetic patients. Testing for LOPS is a key care component for avoiding diabetic foot ulceration.  In order to be effective, monofilaments must be standardized. Our monofilaments use a proprietary polymer fiber that delivers 10 grams of force when bent to the point of flexion, which is the medical standard for screening for loss of protective sensation in the foot.

Monofilaments can be adversely affected by time, extreme temperature, and high humidity, and should therefore be stored appropriately at room temperature in a dry environment. Our monofilaments are designed to be used within 12 months after fabrication for best results, in order to comply with FDA guidelines.

Although they may seem simple at first glance, monofilaments are critical to reducing diabetic foot ulceration and subsequent limb loss. Individuals with loss of protective sensation (LOPS) are 6-7 times more likely to develop ulceration.

If healthcare providers and patients can identify loss of protective sensation (LOPS) early, they are able to take the necessary precautions to protect their feet and avoid diabetic foot ulceration. This is why monofilament testing has been widely adopted by the International Diabetes Federation, the World Health Organization and the American Diabetes Association.

It’s also important to know that you don’t need to be a healthcare professional to test with monofilaments – these products are easy-to-use and the majority of patients – 87% – can self-screen with high accuracy (ADA 1998).