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Biodex asks...Do you Know Where Your Lung Vent Kits are Made?
Keeping standards high to keep products great!
Biodex lung ventilation kits and accessories come with an assortment of pre-packaged disposables. Air-cushioned face masks mold to the contour of the patient’s face, providing a tight, leak-proof seal. Other accessories, such as disposable mouthpieces, bacteria filters and nose clips provide users with choices and convenience—
It is important for patient contact devices to be assembled in a cleanroom because particulate matter takes all forms and shapes. It can be any material: organic or inorganic, of microscopic dimensions that bring about infection. A cleanroom environment can limit the number of airborne particulate on products. They provide a positive control over atmospheric conditions including temperature, humidity and airborne particles within a specific area. Due to the immense number of different types of material found in everyday living, cleanroom assembly of products is the first line of defense against spreading contaminants in a health care facility or hospital.
Unfortunately, there are products that are sold to unsuspecting customers, finding their way into the health care setting not having been assembled in a cleanroom environment. “There are sub-standard products available and everyone needs to be aware they exist and take the corrective actions to verify that their products are assembled in a cleanroom environment and from a reputable manufacturer,”
There are a few recommendations Ranieri has for customers making purchases. Always check out the vendor, he says. Also ask such questions as “How long have they been in business? Are the kits assembled in a cleanroom? Is the company an FDA registered manufacturer?
Biodex Medical Systems has a Class 10,000/ ISO 7 Classified cleanroom on site, as per Federal U.S. Standard 209E for dust particle levels. Daily readings are taken to insure all requirements of the standard for particle, temperature and humidity monitoring are met. The air is decontaminated through a HEPA air filtration system which runs 24 hours a day to keep the rooms clean and maintain pressurization in the cleanroom.
For more information, contact Biodex directly at: 1 800-224-6339 (Int’l 631-924-9000)
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Biodex Medical Systems Inc. offers high quality innovative products and services to the medical profession designed to solve clinical problems for customers and improve the lives of patients in the physical medicine, imaging and nuclear medicine markets