TMI products are designed to provide eye and face protection when there is a potential for splashing, spraying or splattering of blood or other potentially infectious materials in compliance with AHA, CDC, OSHA, and EEC regulations.

OSHA Personal Protection Equipment Provision outlined in paragraph 1910.1030(d)(3)(i) states the following:

"When there is occupational exposure, the employer shall provide, at no cost to the employee, appropriate personal protective equipment such as, but not limited to, gloves, gowns, laboratory coats, face shields or masks and eye protection, and mouthpieces, resuscitation bags, pocket masks, or other ventilation devices. Personal protective equipment will be considered "appropriate" only if it does not permit blood or other potentially infectious materials to pass through to or reach the employee's work clothes, street clothes, undergarments, skin, eyes, mouth, or other mucous membranes under normal conditions of use and for the duration of time which the protective equipment will be used."

• The Resposables EyeShield™ and FaceShield™, and the Disposable FaceShield™ and SideShield™ conform to the AHA's (American Hospital Association) special briefing on OSHA's Final Bloodborne Pathogens Standard: "Face and eye protection is required when there is a potential for splashing, spraying or splattering of blood or other potentially infectious materials."
• Resposables EyeShield™ and FaceShield™, and SideShield™ conform with OSHA's regulations regarding: "Eye protection, such as goggles or glasses with side shields, must be provided if there is reasonably anticipated exposure of eyes."
• Resposables FaceShield™ and Disposable FaceShield™ conform to OSHA's "Chin-length face shield" requirements.

As OSHA continues to police its own regulations, levying fines on violators, TMI's user-friendly products gain in popularity and widespread acceptance. The company continues to design and supply essential, disposable personal protection products to the healthcare industry.

For more information on OSHA Standard 1019.1030 for bloodborne pathogens, go directly to the OSHA website.
 
TMI's EEC Council Directive 89/686 paragraph 2.3 addresses PPE requirements for Face, Eyes and Respiratory Tracts in the following statements:

• Resposables EyeShield™ and FaceShield™, Disposable FaceShield™ and SideShield™ comply with the following requirement: "Any restriction of the user's field of vision or sight by PPE for the face, eyes or respiratory tract must be minimized."
• Resposables EyeShield™ and FaceShield™, Disposable FaceShield™ and SideShield™ comply with the following requirement: "The degree of optical neutrality of the vision systems of these PPE classes must be compatible with the type of relatively meticulous and/or prolonged activities of the user."
• Resposables FaceShield™ and Disposable FaceShield™ comply with the following requirement: "PPE models intended for users requiring sight correction must be compatible with the wearing of spectacles or contact lenses".

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Yes. The Resposables EyeShield™ and FaceShield™ are both CE certified and defined as "Personal Protective Equipment" (PPE), not Medical Devices. They are of "simple" design, insofar as the user can easily determine the appropriate circumstances under which they can or should be used. Further, they are both in conformity with the provisions of Council Directive 89/686/EEC (let's see what this directive states). The Technical File is available for review through our Authorized Representative.

Authorized Representative:
M. Devices Group
Marlborough House
Riding Street
Southport, PR8 1EW, UK
Tel: +44 (0) 1704 544 944
Fax: +44 (0) 1704 544 050

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Yes. Both the lens and frame are made of commonly recyclable materials.

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The Resposables EyeShield™ is designed to protect the user's eyes from the hazards of splashing or spraying of potentially infectious fluids. If protective eyewear with impact resistance is required, as defined under the impact standards established by ANSI (American National Standards Institute), the Resposables EyeShield™ and other competitive products in the categories of either (1) glasses with replaceable lenses or (2) surgical mask/eye shield combinations will not provide sufficient impact resistance.

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The Resposables EyeShield™ and FaceShield™ lenses are intended to be disposable, but the frames/visors can be reused indefinitely. However, either may be replaced as needed, at the discretion of the user and/or the infection control department's protocol.

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While both the frames/visors and lenses for the Resposables EyeShield™ and FaceShield™ can be cleaned and reused, the lenses are intended to be disposable while the frames/visors are reusable. The frames can be cleaned with any common disinfectant or cold sterilant. Dirty or contaminated lenses should be discarded.

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The Resposables EyeShield™ frames and FaceShield™ visors are comprised of injection molded polypropylene, a common material out of which many products found in the hospital are made.

The Resposables EyeShield™ and FaceShield™ lenses are die-cut from optical grade polyester film.

All of TMI's products are latex-free.

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Because it is a Class 1 Medical Device the Resposables EyeShield™ is exempt from the premarket notification procedures set forth in Section 510(k) of CFR 21 (Food and Drug Administration). It is further classified as an Ophthalmic eye shield as described under CFR 21, Section 886.4750.

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OSHA creates, and monitors employer compliance with, regulations to protect employees from hazards in the workplace. The Resposables EyeShield™ and FaceShield™, the Disposable FaceShield™, and the reusable SideShield™ were designed to provide employees with comfortable, lightweight products for personal protection, while providing employers with cost-effective means for compliance with these regulations.

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