Why looks aren’t everything: the importance of quality diagnostics

10 gram force range

Fit2Walk monofilament measuring within the 10gram force range.

Today a drug rep came to my podiatry office to drop off some samples of a popular medication indicated for treating diabetic neuropathy. She was also excited to offer me something new from her company: monofilaments. The monofilaments came in an attractive package, and each was attached to a nicely designed plastic handle. They certainly looked professional in every way, except there was no information on the packaging about the manufacturer.

When I asked the drug rep about the quality of the monofilaments, she seemed unsure of what to say. She could not verify that the monofilaments were 10-gram monofilaments, and clearly had no idea why that would even matter. So this afternoon I decided to test the quality myself.

Using a calibrated gram force scale, I found that the monofilaments gifted to me delivered almost 15 grams of force. This amount may seem small, but it is actually significantly higher than the medical standard of 10 grams needed to diagnose severe neuropathy or loss of protective sensation (LOPS). The 10-gram force range is recommended by the Bureau of Primary Healthcare and monitored by the FDA, but this is not the only reason it is important. If I had used this attractive monofilament on a patient to screen for LOPS, most likely I would have gotten a “False Negative” result. Even if my patient was severely neuropathic, I could have missed his diagnosis. I would not have recommended appropriate preventative measures, and he would have been at higher risk for developing foot complications or even a diabetic foot ulcer.

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Gifted Monofilament from drug rep, testing out of range (too high) giving false results.

My dad used to say, “do it right or don’t do it at all!” His statement rings true after my experience this afternoon. If your health care provider is not using quality monofilaments, you are not getting the benefits of a monofilament test! Always make sure to ask if your provider is using a 10-gram monofilament, and don’t be afraid to ask questions, such as:

  • Where do you get your monofilaments?
  • How can you be sure of the quality and 10 gram force range?
  • How old is your monofilament and when was it replaced?
  • Were the monofilaments made in the USA? Were they made according to US FDA guidelines?
  • Does the manufacturer guarantee the 10 gram force range?

The truth is, not all monofilaments are created equal, which is why I’m so proud of the high quality, reliable monofilaments we produce at Fit2Walk. Beware: looks aren’t everything!

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