Introduction to X-Versus

The ever increasing demand for high performance and technologically advanced products has led us to invest more in Research & Development for the medical
sector, in order to bring improvements to the market.

Much progress has been made also in the radiology sector regarding clothing for protection from ionizing radiation.

In particular, the elimination of lead from the radiopaque foil production processes has resulted in lighter weight materials, ensuring the same protection for operators and patients, but also enabled the use of articles that are more sustainable in the composition of the materials as well as the production processes.

X-Versus is the result of meticulous analysis and research work for the creation of a truly unique product.

X-Versus is patent pending for the creation of garments that offer protection from ionizing radiation. This is the first line of products
on the market, certified as PPE category III and for sanitizing by means of industrial processes validated according to the reference standards and sterilizable.

X-Versus product line garments are made from fabrics that offer high performance in terms of duration and radiation protection.

The fabric used for the X-Versus garments has basic features for manufacturing medical and healthcare clothing, taking into account the operational needs of users and providing them with high guarantees of protection and comfort.

The many models range from the non-sterile classic for diagnostic radiology procedures to dedicated solutions for surgery in the operating theater: in fact, X-Versus is the first ionizing radiation protection garment on the market that can be supplied in a sterile state and certified as a medical device.

The ability of the X-Versus fabric to withstand high temperatures allows its treatment in a steam autoclave.

In addition to sterile gowns for operating theaters, also cloths with the same characteristics (with and without hole) for protection against diffuse radiation have been created.

NOTES TAKEN FROM THE TALKS BY DR ALDO VALENTINI

Coordinator of the AIFM (Italian Association of Medical Physics) DPI_DPC_DPP Working Group, given at the “G. Marani” medical-cultural center, Verona, on 03-02-1914 and Ospedale Poliambulanza, Brescia, on 16-01-2015.

The current occupational safety and health regulations in Italy, and in particular Leg. Decree 81/2008 (TUSL), require a safety organization that always privileges collective preventive and protection measures and the elimination at source of any type of pollutant present in the work environment.

The use of Personal Protective Equipment is therefore always subject to proper verification of the implementation of all possible technical and organizational measures for the limitation or elimination of risk factors.

In fact, art. 75 of Leg. Decree 81/2008 (Compulsory use) reiterates the concept that PPE must be used when the risks cannot be avoided or reduced by technical preventive measures, means of collective protection or work reorganization methods.

Personal protective equipment (PPE) is understood as any equipment designed to be worn and kept by workers to protect them against any hazards likely to endanger their safety or health at work, and any addition or accessory intended for this purpose (Leg. Decree 81/2008, Article 74, Definitions)”.

“PPE must be used when the risks cannot be avoided or sufficiently reduced by technical preventive measures, means of collective protection, measures, methods or work reorganization procedures (Leg. Decree, 81/2008, Article 75, Compulsory use)”.

The requirements of PPE are laid down by art. 76 of Leg. Decree 81/2008:

PPE must comply with the provisions of Leg. Decree no. 475 of December 4, 1992, as amended, and must also:

a) be adequate for the risks to be prevented, without involving a greater risk in itself;

b) be appropriate for the existing conditions in the workplace;

c) take into account workers’ ergonomic or health requirements;

d) be adaptable to users according to their needs.

The protection of workers from ionizing radiation is regulated solely by Leg. Decree no. 230 of March 17, 1995, as amended (1).

Art. 61 of Leg. Decree 230/1995 as amended lays down the obligations of employers, managers and persons in charge.

“Employers and managers who respectively exercise and direct the activities regulated by this decree and the persons in charge who supervise must, within their respective functions and responsibilities, implement the protection and safety measures required by this article and the provisions enacted under it and, where
necessary, provide workers with means of dosimetric monitoring and protection, in relation to the risks they are exposed to.”

Art. 78 of Leg. Decree 81/2008 and Art. 68 of Leg. Decree 230/1995 as amended lay down the obligations of Workers, i.e.:

  • workers shall undergo the instruction and training program organized by the employer (for PPE category III);
  • workers shall use the PPE made available to them, observing the regulations and according to the specific instructions given by the Employer and in compliance with the information, instruction and training received;
  • workers shall take care of the PPE made available to them and not alter it on their own initiative;
  • workers shall immediately report to the employer, manager or person in charge, any defect,
  • inconvenience or deficiency they find in the PPE made available to them.

(1) Leg. Decree 230/1995 as amended, LEG. DECREE no. 230 of March 17, 1995. Implementation of Directives 89/618/Euratom, 90/641/Euratom, 92/3/Euratom and 96/29/Euratom regarding ionizing radiation. amended by: LEG. DECREE no. 241 of May 26, 2000, Ordinary Supplement to the OFFICIAL GAZETTE General series – no. 203 of August 31, 2000. LEG. DECREE no. 257 of May 9, 2001, Official Gazette – General Series no. 153 of July 4, 2001 LAW no. 39 of March 1, 2002. Official Gazette – General Series no. 72 of March 26, 2002