Q: What does a monofilament do?

A:

The 10 gram monofilament is designed to test pressure sensation in the foot. If a patient is unable to feel a 10 gram monofilament pressed against their skin, they are deemed to have lost their protective sensation. This lack of sensation then puts the foot “at risk” meaning the patient is likely to damage their foot without realising it.
Q: Why is accuracy so important ?

A:

Being a diagnostic tool, it is essential that the monofilament used is accurate. The diagnostic test indicates the monofilament needs to bend at 10 grams. At that point the clinician knows if the patient is unable to feel it, then they will have been deemed to have lost protective sensation, therefore increasing their ulcer risk. Booth & Young found that only two monofilaments were found to be accurate enough to be recommended for clinical use. These are the Bailey Retractable Monofilament and Owen Mumford Neuropen.
Q: Why is 10 gram the threshold level?

A:

10 grams was set as the threshold level of pressure sensation in a number of medical articles. See References
Q: Why is it so important to have an accurate monofilament?

A:

If the monofilament is over the 10 gram level then the patient may be passed as being sensate when in fact they are ”at risk”.
If the monofilament bends at less than 10 degrees the patient may be misdiagnosed as being neuropathic.

Having an accurate monofilament is as important as having an accurate blood pressure monitor.
Q: Why are some monofilaments less accurate?

A:

Not all monofilaments are the same. This cornerstone of neuropathy testing has been corrupted by a wealth of inaccurate monofilaments.

Countless monofilaments have been manufactured in China and imported by large pharmaceutical companies as free gifts.

These monofilaments are made using nylon. This is not a good material for an accurate monofilament. Nylon can absorb a high percentage of atmospheric moisture. This has the effect of altering the filament’s modulus of elasticity which in turn affects its performance. This leads to an erroneous filament i.e. an inaccurate diagnostic test.

These imported filaments have been tested using a Lloyds RX testing rig and found to vary between 6 and 21 grams. This produces false positives where the patient may be incorrectly diagnosed as being at risk from ulceration thus creating unnecessary concern for the patient as well as unnecessary time investment by the clinician due to the perceived increase in risk. Want to know more ? Go to the Technical Page

If the filament bends at 21 grams, then neuropathic patients run the risk of being undiagnosed. their higher ulcer risk category will not be noted. This can have profound impact on the patient morbidity, and indeed their mortality. It is possible these patients may injure their foot without realising it leading to ulceration, infection and ultimately amputation. After amputation 100% of diabetes patients die within 5 years.

Q: Is my free monofilament illegal?

A:

As well as being inaccurate, some of these cheap monofilaments are illegal. Every product marketed, whether sold or given away free, in the European Union is obliged to have a CE mark. Check your monofilament for the CE mark, it should be on the product or on the instructions. No instructions ? – then your monofilament is an illegal import.
Q: What should I do with my illegal and inaccurate monofilament?

A:

What to do with your monofilament if it is inaccurate or illegal.

We suggest you either throw it away, or even better return it to whoever issued it with a letter. In your letter,point out that the monofilament is a diagnostic tool – it ought to be accurate. The authority to report an illegal monofilament is the :-

Medicines and Healthcare products Regulatory Agency

10-2 Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Q: I want more technical data on monofilaments?

A:

For more technical information, go to our Technical Page. This technical page will consist of monographs and pressure measurements.

Q: How long will my monofilament last?

A:

Bailey Instruments advises replacement after testing 10,000 times. If you use 5 sites per foot in your assessment, this is 10 sites per patient. Therefore you need to replace your monofilament after` 1000 patients have been tested. Another consideration found by Booth & Young is that the monofilament’s accuracy is maintained if allowed to rest. Their advice is to use one monofilament in the morning, and a different one in the afternoon. Ideally, in clinical practice you should alternate between two monofilaments.

Q: What is Duraban™ antimicrobial product protection?

A:

Duraban™ technology is built-in antimicrobial protection for products, coatings, fibres and surfaces. Duraban™ antimicrobial protection gives products an added level of protection against damaging microbes such as bacteria, mould, mildew, fungus, and algae that cause stains, odours and product deterioration.
Q: How does the Duraban™ technology work?

A:

The active ingredient in Duraban™ forms a colourless, odourless, positively charged polymer that molecularly bonds to your products surface. You could think of it as a layer of electrically charged swords on the molecular level. When a microorganism comes in contact with the treated surface, the C-18 molecular sword punctures the cell membrane killing the cell and as an added measure the electrical charge shocks the cell. Since nothing is transferred to the now dead cell, the antimicrobial doesn't lose strength and the sword is ready for the next cell to contact it.
Q: What benefit do customers get from products with Duraban™ antimicrobial protection?

A:

Duraban™ protection continuously fights the growth of damaging microbes such as, bacteria, mould and mildew that can cause stains, odours and product degradation. Duraban™ protection makes products easier to clean and keeps them cleaner and fresher between cleanings. Duraban™ is environmentally safe, permanent and does not give off harmful volatile organic compounds (VOC's) that are associated with climate change.
Q: What is the difference between Duraban™ and other antimicrobials on the market?

A:

Conventional antimicrobials and biocides penetrate living cells and kill by way of poisoning the organism or disrupting a vital life process. They are designed to act quickly and dissipate quickly. Most commercial antimicrobials used for treating surfaces do an adequate job of killing bacteria and fungi, although most have a limited range of effectiveness. The Duraban™ technology takes a totally unique approach. It provides an effective initial microbial kill when applied, but, unlike the conventional methods, it also provides long-term control of growth on treated surfaces, often for the life of that surface. The surface itself is modified to make it actively antimicrobial.
Q: Against what types of bacteria is Duraban™ effective?

A:

Duraban™ is effective against nearly all bacteria, plus fungus, algae, and mould. A representative list of microbes against which Duraban™ has been tested may be obtained by contacting us.
Q: Can Duraban™ be washed off?

A:

No. Duraban™ forms a permanent covalent or ionic bond to most surfaces and cannot be washed off or leach into the environment. For example, testing has proven that Duraban™ still provides 94% reduction of standard test organisms on polypropylene fabric through more than 40 launderings at 60 C (hot water). Details may be obtained by contacting your sales representative.
Q: Will this technology adversely affect the skin or environment?

A:

No. Since the antimicrobial is permanently bound to the surfaces it protects, it does not leach from the fabric to the skin or into the environment. Extensive toxicological testing shows the antimicrobial does not cross the skin barrier.
Q: What biocide is used?

A:

Duraban's active ingredient is 3-trihydroxysilylpropyloctadecyldimethyl ammonium chloride. The application level can vary by substrate, but generally the level is approximately 0.25% - 1% of the antimicrobial's active ingredient onto the weight of the substrate. The most commonly used product contains 0.5-1.25% active material.
Q: Does the biocide use a heavy metal?

A:

No. Duraban™ does NOT contain any heavy metals. Tin, arsenic and copper are often used in other antimicrobials.
Q: Does Duraban™ give off gases after application?

A:

No. Duraban™ does not volatilize, dissipate, or leach onto other surfaces or into the environment. The chemistry polymerizes where it is applied and forms a permanent bond that typically lasts for the life of the treated surface. Normal cleaning should not remove the treatment; although it can be abraded away.
Q: How is Duraban™ applied?

A:

Duraban™ is applied in aqueous solution and can be inserted into almost any wet process during manufacturing. They can also be applied directly onto finished goods. The antimicrobial is easily integrated into most jet, spray, bath, pad, and batch processes. The antimicrobial is cationic so it mixes well with other cationic and non-ionic finishes (most softeners) and performs well in the same bath.
Q: How long does the Duraban™ last?

A:

Since the cured antimicrobial is non-volatile, insoluble, and non-leaching, Duraban should last for the life of the treated surface. The life of a treated surface depends on a number of factors, not the least of which is surface preparation. If you treat a dirty or unstable surface, when the dirt comes off or the surface is disturbed, some of the antimicrobial will be removed with it. Abrasive or caustic (pH>10.5) cleaners will also shorten effective life.
Q: What tests show that the growth of bacteria has been prevented?

A:

Microbiological testing is what establishes the baseline standard that is used. Duraban's scientists have more than 15 years of experience performing extensive microbiological tests such as bacterial retrievals, fungal growth tests (AATCC 30, ASTM G-21, ASTM D3273) and bacterial growth tests (AATCC 100, ASTM 2149-01).
Q: Why is Duraban™ so durable?

A:

Because of the exceptional chemical bond to the surface that is being protected, the bonded polymer is neither soluble nor volatile. The unique bond results in the Duraban™ antimicrobial polymer becoming an integral part of the substrate.
Q: Will its use result in "super bugs"?

A:

No. Adaptation studies show that microbes do not adapt to Duraban™ and no "zone of Inhibition" develops. Therefore, micro organisms cannot adapt to Duraban™
Q: Will its use change the feel of the surface?

A:

No. The chemicals adhere at the molecular level and form an extremely thin film (typically 3 nanometres' - a human hair is about 10,000 nanometres'). This extremely thin layer does not affect the look and feel of the surface.

Spare monofilaments?

Bailey Instruments Retractable Monofilaments have one filament. No “spare” filaments are included. By using two monofilaments, the clinician does not have to change monofilaments, or indeed to remember where the spare ones are.

Incorrect placement of the filament may influence the modulus of elasticity. this may result in an inaccurate test. Want to know more ?

Click here to go to our Technical Page




Bailey Instruments
Tel:0161 872 8707
email:sales@baileyinstruments.co.uk
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