Biodex asks...Do you Know Where Your Lung Vent Kits are Made?

Oct. 17, 2011 - PRLog -- Sometimes, it’s not just what goes into a product that makes it great, it’s also what stays out! The cleanroom at Biodex Medical Systems, Inc. is maintained at a high standard and is dedicated to the assembly of our lung ventilation kits. Not all companies who sell these patient contact products can make this statement. If you don’t know who is making and assembling the kits you purchase, you may be putting your patients and facility at risk.

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—just some of the product offerings assembled in the cleanroom here in Shirley, New York. Stringent standards are followed to maintain the product’s integrity.

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,” explained Bob Ranieri, vice president of sales for Biodex Medical Systems. Ranieri first heard of this happening from several new customers who had the regrettable experience of purchasing these products and now purchase only from Biodex under a “Blanket Ordering” procedure. The blanket ordering system allows customers to lock in prices, secure products when they need them and have their inventory remain stable under a non-binding purchasing program.

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? Do they have ISO certification?” Sometimes appearances are not what they appear to be, so due diligence is always prudent when purchasing medical products and devices.

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), Email: info@biodex.com, or www.biodex.com/nuclearmedicine

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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