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Morris Garcia

Morris Garcia

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Why not optimally protect our front line emergency personnel?

Irvine, CA – May 6, 2009  -- Front line laboratory, medical, and civil service personnel are critical to the containment and cure of the virus. While out there working to save our lives, are they deployed with proper Personal Protective Equipment (PPE) to keep them safe?

Or, are they only minimally protected due to out-of-date information?

News reports everywhere are full of images of people wearing simple masks. Some are N95 respirator masks. Rarely, as recently in some AP photos (right), do we see use of more optimum PPE for protection against aerosolized and droplet pathogens as bacteria and virus.

Is it because protection from different devices is about the same? Definitely Not. Most masks in current news reports are simple dust masks or surgical masks that were not even designed to provide OSHA recommended protection against the spread of bacteria and virus.

OSHA only recommends1 N95 Mask Respirators as the minimum PPE for these situations, but they are limited to a 95% filtration efficiency rating.

What is less known is that this performance is only valid when the N95’s have been properly fit tested2. Fit testing must be done in a test environment, which is no assurance that the mask is properly fit when in actual use. Actual on the job working efficiencies for those that pass a fit test are difficult to maintain.

Worse, many people with different facial irregularities, particularly men with facial hair (mustaches, beards) will not pass fit testing. Masks are not recommended if you don’t pass a fit test.

Another, higher performance respirator type is the PAPR, Powered Air Purifying Respirator. Brands and configurations of PAPRs are readily available, as the MAXAIR System from Bio-Medical Devices Intl, and provide 99.97% filtering efficiency due to their HE Level filters. Because of their positive pressure design, (versus negative pressure masks) they do not need to be fit tested3. PAPRs achieve this much higher protection level for virtually anyone who wears them, without testing and regardless of facial characteristics.

Aren’t PAPRs only for in-laboratory use? Quite the contrary. PAPRs can be lightweight and compact to allow normal activity maneuverability in most any environment. MAXAIR, for example, has even eliminated the awkward air hose and bulky belt mounted blower unit of conventional PAPR designs so that simple activities, like mowing the lawn, can be comfortable.

Are they safe enough for daily use? PAPRs are routinely acquired by hospitals to protect their staff for emergency preparedness situations. Designs like the MAXAIR 700 even provide real time visual display status of continuously self-monitored filter air flow and battery charge remaining. This insures the wearer that everything is fine, all during actual use.

Aren’t PAPRs too costly? They may be for individuals who are not that likely to be close, within 3 feet, of a person infected with the H1N1 Influenza. But not for those with a likely high exposure to a critically infectious and potentially death causing disease.

For multiple personnel, particularly our front line laboratory, medical and civil service people, this is not the case. They are often in high risk positions and they should have the optimum protection to be able to safely continue their work to contain and develop cures for these infectious diseases.

With continuing decreases in disposable costs as with the cuff and face seal of the MAXAIR PAPR, the overall 3-5 year useful life cost projections are comparable, and can even be less than the proper implementation of masks.

And, in another perspective, individuals will spend $800-$1,200 and more for an exercise tread mill because its long term use can help maintain their health. A PAPR like MAXAIR is less than that, will last as long as a tread mill, and may save their life!
About Bio-Medical Devices:
Bio-Medical Devices is a recognized leader in developing, manufacturing, and marketing innovative and cost effective personal respiratory systems for health, pharmaceutical, bio-research, and industrial applications.

For more information contact Corey Wick, Marketing Manager, Bio-Medical Devices Intl, 800-443-3842 or visit www.maxair-systems.com.

Irvine CA, June 5, 2009  –  Bio-Medical Devices Intl (BMDI) today announced they will release their new MAXAIR 710-DLC Computerized Air Purifying Respirator (CAPR) at the 2009 APIC exhibition in Ft. Lauderdale, FL the week of June 7, 2009.

The 710-DLC CAPR provides a combination of high protection performance, user comfort, convenience, and economic cost effectiveness unprecedented in the respirator industry.

This latest evolution of the patented hose-free MAXAIR Systems design is targeted specifically for routine infection prevention in hospitals and long term care units.

According to BMDI Marketing Director Allan Schultz, “The DLC System represents the culmination of the last several years of market input. Customers have accepted our current MAXAIR 2000-700 System as the preferred respirator for emergency preparedness, ED, and a growing amount of routine use on the med/surg units.”

“However, there continues to be some concern that it can actually be price competitive to the use of N95 mask respirators. The 710-DLC is a more obvious answer to that question.”

The key ingredient of the new MAXAIR System is the DLC itself, a unique Disposable Lens-Cuff. When compared to an N95 mask respirator and goggles, it is easier to don and doff and provides inherently greater protection. It is price competitive with the N95 mask plus goggles that the health care professionals need to wear for minimum protection when caring for isolation patients with TB, various influenzas, etc.

According to Wang, “When the full cost impact of N95 Fit Testing and the management issues associated with staff that cannot be fit tested are considered, cost analyses demonstrate that the 710-DLC System can be implemented at lower cost that a N95 program. The new MAXAIR 710-DLC System works for all employees without the costly required fit testing. It will provide superior protection for everyone.”

The release of the 710-DLC at the 2009 Association of Professionals of Infection Control Exhibition is in support of APIC’s mission to improve health and patient safety by reducing risks of infection and other  adverse outcomes, and their taking a lead role in helping fight the current H1N1 Influenza outbreak.

APIC’s more than 12,000 members focus on infection prevention to save lives and improve cost effectiveness for hospitals and other healthcare facilities. They are focused on providing education and practical tools to support and further the efforts of infection prevention professionals everywhere.  “We believe they will find the 710-DLC to be Personal Protection Equipment (PPE) of fundamental benefit to their efforts” Wang concluded.

For more information, contact Corey R. Wick, Marketing Manager, BMDI, 800-443-3842, This email address is being protected from spambots. You need JavaScript enabled to view it..

The MAXAIR 710-DLC CAPR provides unprecedented comfort, convenience, ease-of-use, and simple maintenance for a powered air purifying respirator. It provides a higher level of safety and cost effectiveness than an N95 Mask Respirator program.
BMDI is a recognized leader in the development and manufacturing of personal respiratory safety products for various environments in healthcare, pharmaceutical manufacturing, bio-research labs and industrial markets. Bio-Medical Devices, Inc has its corporate headquarters in Irvine, California.

All Bio-Medical Devices products are audited and certified to meet the rigorous standards of the Food and Drug Administration (FDA), Good Manufacturing Practice Regulations (GMP), National Institute for Occupational Safety and Health (NIOSH), and all manufacturing is ISO Certified, 13485 ver 2003.

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NO FIT TESTING – In addition to providing superior protection compared to traditional N95 face masks, the MAXAIR system also eliminates the need for annual “fit testing” for workers.  Therefore, MAXAIR dramatically reduces lost productivity and expenses associated with these programs, potentially saving hospitals thousands of dollars annually.

Safety & Peace of Mind – LED indicators strategically located within the field of vision provide the user with critical information regarding airflow (filter efficiency) and battery life, so he/she can always be assured of proper protection.

MAXAIR Applications

The MAXAIR system is ideally suited for most healthcare and medical environments requiring respiratory and facial protection, including:

1.      Infection Control/Emergency Response Personnel – Quick to don and doff, MAXAIR’s simple-to-use design is perfect for fast-paced disease outbreak or infection control environments.  With its low cost, minimal training requirements and compact storage, MAXAIR is becoming the personal protective equipment (PPE) of choice for emergency medical service and infection control personnel.

MAXAIR is currently being used by numerous U.S. and Canadian governmental agencies, as well as within private research facilities, around the country for use in infection control environments.  Most recently, the system has been used to protect workers facing strains of SARS, drug-resistant tuberculosis, Aviana Influenza, Hantavirus and other communicable diseases flaring up around the globe.

2.      Pharmaceutical and Research Laboratories – The MAXAIR system, with its lightweight Lithium Ion battery, is specifically engineered to provide HE level protection from particulate matter.  The lightweight design and increased mobility allow users to sustain high productivity in their demanding schedules.

3.      Forensics/Pathology – The lightweight MAXAIR system provides much needed comfort for the user in both the field and clinical environments.  While providing the necessary protection to the user, it also helps reduce the potential for cross-contamination of crime scene investigations.

About Bio-Medical Devices International Inc.

Bio-Medical Devices International Inc. was founded in 1991 and began developing and manufacturing respiratory and surgical products to meet the distinct needs of the healthcare and medical markets.  BMDI develops and manufactures its products from facilities located in Irvine, Calif., Chino, Calif., and Tijuana, Mexico. For more information about BMDI, call (800) 44-DEVICE (443-3842) or visit www.BMDI.com.

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MAXAIR® hose-free PAPR provides healthcare workers with unparalleled comfort and efficiency in particulate protection

(Irvine, Calif.; Feb. 15, 2005):  Proper respiratory protection for healthcare workers no longer means being encumbered by heavy, awkward and loud powered-air purifying respirators (PAPRs) or inefficient and uncomfortable face masks.  Bio-Medical Devices International Inc. (BMDI), a leader in personal respiratory protection and infection control barriers, has introduced the MAXAIR® Respiratory Protection System to the healthcare and safety markets.  This innovative hose-free PAPR sets a new standard for the industry, offering healthcare workers the ultimate in both protection and comfort.

Features/Benefits

Mobility – MAXAIR’s patented hose-free design provides healthcare workers complete freedom of movement.  This increased mobility translates into improved productivity, as well as increased comfort and satisfaction.

Protection – MAXAIR has an HE-approved rating with an efficiency level of N100 from the National Institute for Occupational Safety and Health (NIOSH).  MAXAIR provides the highest level of protection from dust and mist particles, as well as protection from aerosolized and blood-borne pathogens.  The system provides HEPA*-level protection, not just around the user’s nose and mouth (as with face masks), but also protection of the entire face, head and neck.  MAXAIR is the first and only hose-free PAPR system receiving both NIOSH approval and FDA allowance for the industrial and healthcare fields.

Independent studies have shown that surgical face masks offer minimal protection.  In fact, many healthcare workers have a false sense of security, believing that they are better protected than they actually are.  The MAXAIR system provides healthcare workers with an assigned protection factor (APF) of 1000 and above, as compared to N95 dust masks and surgical masks that are generally worn by healthcare workers, which have an APF of five and under respectively.

Comfort – A whisper-quiet motor contained inside the helmet provides improved hearing and communication in the work environment.  The expansive 20-millimeter polycarbonate lens offers unobstructed views and continuous positive pressure airflow of six to eight cubic feet per minute (CFM) over the user’s face, providing a fog-free field of vision and a cooling effect for the user.  The ergonomically designed, lightweight helmet and battery minimize user fatigue and stress.

About Bio-Medical Devices International Inc.

Bio-Medical Devices International Inc. was founded in 1991 and began developing and manufacturing respiratory and surgical products to meet the distinct needs of the healthcare and medical markets.  BMDI develops and manufactures its products from facilities located in Irvine, Calif., Chino, Calif., and Tijuana, Mexico. For more information about BMDI, call (800) 44-DEVICE (443-3842) or visit www.BMDI.com.

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The NIOSH approved MAXAIR PPE line of PAPRs includes several configurations to meet the needs of many diverse industrial applications ranging from woodworking and powder coating to construction and CAFOs.

All MAXAIR powered air purifying respirators include key advantages compared with conventional PAPRs, highlighted by:

  • An integrated helmet design that is hose-free (no air tube) and therefore eliminates the need for a bulky blower unit as with conventional PAPRs. This minimizes overall weight while providing unrestricted, full maneuverability.
  • The unique channeled air flow provides the quietest and coolest PAPR for excellent communications and protection against heat stress.
  • The exclusive always on and visible safety LEDs provide unobtrusive visual monitoring, in the users peripheral vision, of all important indications of battery charge status and filter air flow. These indicators eliminate the need for additional equipment and off-use time for manually measuring these key operational safety parameters.

Please contact Customer Service for further information and direct contact with your system specialist, 800-443-3842.

Pharmaceutical Manufacturing

The MAXAIR 2000-800 and 2000-300 Series Configurations provide protection against biological agents in R&D areas and airborne dusts that can carry drug substances in the pharmaceutical manufacturing environment.

The performance of high filtration efficiencies and application protection factors are complemented by the complete barrier protection of shroud, hood, and double shroud configurations.

As with all our NIOSH approved PPE systems, MAXAIR PAPRs have exclusive comfort, convenience, safety, and cost effective advantages over conventional PAPR systems, highlighted by:

  • An integrated helmet design that is hose-free (no air tube) and therefore eliminates the need for a bulky blower unit as with conventional PAPRs. This minimizes overall weight while providing unrestricted, full maneuverability.
  • The unique channeled air flow provides the quietest and coolest PAPR for excellent communications and protection against heat stress.
  • The exclusive always on and visible safety LEDs provide unobtrusive visual monitoring, in the users peripheral vision, of all important indications of battery charge status and filter air flow. These indicators eliminate the need for additional equipment and off-use time for manually measuring these key operational safety parameters.

Please contact Customer Service for further information and direct contact with your system specialist, 800-443-3842.

Nuclear Power Stations

MAXAIR 2000-800 Hood Systems are optimized for respiratory protection for use in various activities at Nuclear Power Stations, including scheduled and emergency outages and general maintenance.

Whether refueling only or performing major backfittings or plant modifications, these specialized NIOSH approved PPE system configurations include all the user comfort, convenience, and safety advantages as all MAXAIR Systems.

Of particular advantage, MAXAIR Systems include:

  • An integrated helmet design that is hose-free (no air tube) and therefore eliminates the need for a bulky blower unit as with conventional PAPRs. This minimizes overall weight while providing unrestricted, full maneuverability.
  • The unique channeled air flow provides the quietest and coolest PAPR for excellent communications and protection against heat stress.
  • The exclusive always on and visible safety LEDs provide unobtrusive visual monitoring, in the users peripheral vision, of all important indications of battery charge status and filter air flow. These indicators eliminate the need for additional equipment and off-use time for manually measuring these key operational safety parameters.

Please contact Customer Service for further information and direct contact with your system specialist, 800-443-3842.

Laboratory and Bio-Medical

MAXAIR 2000-800 Hood and 2000-300 Double Shroud Hood Systems are optimized for respiratory and contact protection for use in various laboratory and bio-medical research situations, including Coroner's, Forensics, and BSL-3 Labs.

These more specialized NIOSH approved PPE respiratory protection system configurations include all the user comfort, convenience, and safety advantages over conventional PAPRs as all MAXAIR Systems, highlighted by:

  • An integrated helmet design that is hose-free (no air tube) and therefore eliminates the need for a bulky blower unit as with conventional PAPRs. This minimizes overall weight while providing unrestricted, full maneuverability.
  • The unique channeled air flow provides the quietest and coolest PAPR for excellent communications and protection against heat stress.
  • The exclusive always on and visible safety LEDs provide unobtrusive visual monitoring, in the users peripheral vision, of all important indications of battery charge status and filter air flow. These indicators eliminate the need for additional equipment and off-use time for manually measuring these key operational safety parameters.

Please contact Customer Service for further information and direct contact with your system specialist, 800-443-3842.

 

What is the current “standard” for hospital worker respiratory protection?

N95 Mask style respirators are the historical "minimum protection" standard for respiratory infection prevention in hospital isolation areas, ED, and even for much or emergency preparedness.

For greater protection in high risk situations, e.g., high airborne transmissibility, aerosolizing procedures, users that can't pass fit testing, etc., a NIOSH PAPR is typically recommended.

What is their primary design purpose?

Respirators protect users from aerosolized and droplet contaminants. Extreme morbidity and death can result if not properly protected.

N95’s and surgical masks are common. Use of PAPRs (Powered Air Purifying Respirators) is increasing due to inherently higher filtration efficiency, elimination of fit testing, and increased comfort to the wearer.

Aren’t N95 Respirators and Surgical Masks good enough protection for HCWs?

Surgical masks protect the surgical field and others from the spread of droplets from the users. Masks can protect users from splash during surgery.

Masks are typically not designed to seal against the user’s face; protection against viral and bacterial contaminants is poor.

N95 respirators are receiving scrutiny relative to their cost effective bacterial and viral protection, their lower filter efficiency, and need for fit test verification for each HCW, each brand and style of respirator, annually.

Qualitative testing is “you get what you pay for” as results are variable.

Quantitative fit testing requires more technical skill and $10,000-$20,000 of test equipment.

Even with proper and accurate fit testing, HCW’s are only assured of good fit for masks used during the testing. Back in Med-Surg with pressing conditions of the infected patient care regime, do they put it on the same … with the same accuracy? If not, disaster can happen as in the SARS epidemic in Toronto.

What if the N95 Mask is not positioned properly each time it is put on?

N95 and surgical masks can not be fitted to HCWs with facial hair and other variables, e.g. scars, weight gain or loss, etc.

Their inherent filtering efficiency is less than PAPRs.

FDA (OSHA/NIOSH) does not test surgical masks as they do respirators. Manufacturers’ reported efficiencies may be higher than if using NIOSH N-95 test methods, as much as 95% versus 70%.

Filtration efficiency of N95’s is only guaranteed at 95%. With excellent fit, 5% contamination has to be expected to get through.

What is the better alternative?

PAPRs use inherently higher efficiency filters.

PAPRs are positive pressure systems; no fit testing is required.

PAPRs are reusable and interchangeable between HCWs, with appropriate decontamination between uses.

Masks and N95s are negative pressure devices. On inhalation, the negative pressure within the mask pulls in contaminated air from an incomplete seal.

PAPRs are positive pressure devices. For example, the MAXAIR System pulls contaminated air through filters with 99.97% to 99.997% efficiency.

Only .03% to .003% of the contaminant may get through - between 150 to 1,500 times less than N95’s and masks.

MAXAIR pulls in outside air, filters it, and passes it gently in front of the face at a user selectable 6 CFM to 9 CFM. This provides sufficient air for all working conditions, and a cooling effect to the user.

PAPRs’ high air flow volume creates positive pressure within the helmet so HCW’s can not pull in contaminated air. No fit testing is required and all HCW’s can safely use them.

PAPRs’ air flow control ensures normal breathing conditions. N95’s and masks add resistance, which the HCW must adjust to and overcome.

But what about costs, aren’t PAPRs prohibitively costly compared to masks?

As a leading health care institution published in 2005, you can achieve better respiratory protection and long term cost advantages, particularly with a non conventional PAPR solution, such as MAXAIR.

What qualities and characteristics should purchasers look for in surgical masks and/or respirators?

Lack of proper respiratory protection can be life threatening. Purchasers of protection should not accept minimum protection. OSHA says, “NIOSH-approved disposable particulate respirators (e.g., N95, N99, or N100) are the minimum level of respiratory protection that should be worn.” NIOSH says “Surgical masks are recommended only as a last resort for health care and medical transport workers exposed to SARS patients when no NIOSH-approved respirator equivalent to or greater than the N-95 is available.”

Key qualities for proper respiratory and contact protection, include:

  • NIOSH approved ≥ 99.97% filtration efficiency (minimum HE level efficiency).
  • Universal fit – no fit testing for any employee, sharable with proper decontamination between uses.
  • Reusable for long term cost effectiveness.
  • Free of weighty or extending apparatus so not to impede maneuverability in the work area.
  • Comfortable and convenient to facilitate use compliance.
  • Rugged and reliable for routine, daily use and extended periods during emergencies.
  • Provide visual indication of filtering and operation effectiveness and safety.

Implementing a PAPR-based program for your healthcare workers can both increase occupational safety and the bottom line.

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