A Challenge to BLOX-R and a warning to anyone involved in the use or procurement of flexible radiation materials.
A material, along with its associated products, has recently been launched on the US market by the start-up company BLOX-R, operating from a small office suite in Utah.
Despite their outlandish claims for their products, independent testing shows that their products completely fail to meet the specified level of protection claimed. Their claimed 0.5mm Lead Equivalency rarely shows more than 0.3mm LE and the best result obtained from the UK’s National Physical Laboratory failed to make even 0.35mm LE. (Download results). Both IEC 61331-1 and DIN 6857-1 (designed specifically for Lead-free materials) being used. The sample, taken from a BLOX-R apron was the heaviest we could find and weighed 4.71 Kilos/M2. Extrapolated to provide the stated protection value, this would actually be heavier than any standard Lead product on the market.
They claim that a disposable Thyroid Collar made from their ‘XPF’ material provides 0.5mm LE. In fact, when properly independently tested, the small patch at the front of the collar measured, at best, 0.289mm LE. The rest of the collar tested at 0.07mm LE, or less. The collar provided almost no protection whatsoever from any geometry outside a direct frontal approach of scatter radiation.
It is not clear where these products are being manufactured, but the standards observed from the sample products supplied and tested are extremely poor. The materials and layers are very uneven in terms of thickness; the layers are glued together in a rudimentary way; there are obvious striations in the materials suggesting a very uneven dispersion of the metal powders; the materials themselves are physically dirty and contaminated and the products could not meet any claim to be ‘machine washable.’
The sales material on their website along with any product literature supplied simply avoids mention of any proper certification against international standards. Instead it resorts to pseudo-science and innuendo in an attempt to cloud the issue and mislead the reader.
For example, they claim that their materials and products are ‘FDA Approved’. There is no such thing as FDA approval for these products as they are classified as a Class 1 medical device. As such, they are in fact exempt and clearance from the FDA is not required. To make any such claim clearly contravenes the FDA regulations.
They make claim to peer reviewed papers and publications that have nothing to do with their products, just the general physics involved in radiation protection. They claim that poster events have some meaning in terms of independent credibility, when they are nothing more than self-promotion.
They claim that …‘Owing to toxicity and other concerns, lead and antimony are being banned in medical products in 2014 in the European Union. Similar bans will go into effect in the US, just like lead paint and leaded gasoline have been banned in the past.’ This is complete nonsense and an outright lie.
They claim that their Barium Sulphate and Bismuth bi-layer construction is unique. It is not. Furthermore, it is physically impossible to achieve a reduction in weight with the use of Barium Sulphate. In fact, you require approximately twice the mass of BaSO4 in comparison to other non-Lead materials used in flexible radiation protection materials to achieve the same standard of protection. Furthermore, it is the BaSO4 itself that requires a bi-layer arrangement with a heavy metal in order to clean up the breakdown of the material at the lower levels of keV, along with the dangerous levels of fluorescence it produces under X-rays.
In fact, with BLOX-R, there is so little information that is based on fact and so much information that is a misleading or a total fabrication of the truth, one has to ask how this company is allowed to trade at all. It is fortunate that in Europe, due to the regulations and standards required for CE marking, BLOX-R products are in effect, self-banned and as a consequence, BLOX-R products have no market. But it has to be asked how a company, such as this, is allowed to trade and peddle their wears in the USA.
We welcome any comment that BLOX-R would like to make.
– Douglas Shankland, Kemmetech Ltd
Report and analysis provided by our Partner company Kemmetech Ltd in the UK. Kemmetech have been manufacturing and developing flexible radiation protection materials in the UK and exclusively use the UKs prestigious National Physical Laboratory for all independent testing. The NPL provide the world standards for calibration in the area of radiation physics