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SURGICAL MASK MAKER PRESTIGE AMERITECH REBORN IN NORTH RICHLAND HILLS

Star-Telegram
March 29, 2010

NORTH RICHLAND HILLS -- Surgical mask producer Prestige Ameritech returned to its roots Monday with a celebration to mark its expansion and resumption of work at a facility shuttered nearly five years ago when Kimberly-Clark moved production to Mexico.

The company, a small startup formed as Kimberly-Clark was shutting down its U.S. mask production, is now the largest producer of surgical masks in the nation. It's a testament to the importance of keeping jobs at home, according to a host of state and local officials who helped cut the ribbon on the newly reopened facility at 7201 Iron Horse Blvd.

"This is good news, and we are celebrating in North Richland Hills," Gov. Rick Perry told a crowd of more than 100 dignitaries and workers. "Texas is becoming an epicenter for companies like Prestige Ameritech."

The company's newly christened Global Pandemic Preparedness and Response Center is expected to expand to about 250 jobs over the coming year, with hopes of eventually restoring the 1,000 jobs lost to Mexico.

The company has already expanded from about 80 employees to about 200 in the past year and begun round-the-clock production in response to mask shortages after the spread of the H1N1 virus and a renewed appreciation for products made closer to home.

Most masks now are made in Mexico and China, but Prestige Ameritech is gradually reclaiming the market, said company vice president Mike Bowen.

"Prestige Ameritech is taking back America's mask supply," he said.

Who are they?

The company was started in 2005 in a pool house belonging to company president Dan Reese, a former president of Tecnol Technologies Group, which was sold to Kimberly-Clark in 1997. The company had about 87 percent of the market for U.S. hospital masks and employed about 2,000 people, but eventually shut down the plant.

Bowen, who was Tecnol's director of new product development, joined the effort to form Prestige Ameritech. It started operations in a small facility in Richland Hills that eventually included 50,000 square feet in three facilities.

The manufacturing facility in North Richland Hills -- which still housed furnishings left behind by Kimberly-Clark -- has about 220,000 square feet and large warehouse capabilities. The company leased the 17-acre property with an option to buy it, officials said.

"At this very plant, face-mask manufacturing left America," Reese told the enthusiastic crowd Monday. "It ... went 426 miles south to Acuna, Mexico."

The company is expected to begin hiring again in the next 90 to 120 days.

Getting a boost

The city of North Richland Hills approved an incentive package for the company to return to the plant. It includes a 75 percent rebate of real and business personal property tax for 10 years and a 25 percent sales tax rebate for five years. In exchange, the company must stay for 10 years and employ 400 people by 2015.

"Prestige Ameritech is a great American company with a great American success story," Mayor Oscar Trevino said. "It is exciting to see this facility reopened and bringing jobs back to Texas."

Reps. Joe Barton and Michael Burgess and state Sen. Jane Nelson joined Perry at the event along with other elected officials.

John Gaida, senior vice president of Texas Health Resources, said his company's 18,000 employees and 14 hospitals rely on masks from Prestige Ameritech.

Burgess, a physician who has worn such surgical masks, said healthcare workers should have American-made products to protect them and their patients.

"It is important for these masks to function as required," Burgess said. "We need to produce these supplies at home."

Dianna Hunt

 

 

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BENEFITING FROM H1N1 FALLOUT

Dallas Business Journal
November 13, 2009



Spurred in part by demand caused by spread of the H1N1 virus, Tarrant County surgical mask maker Prestige Ameritech plans to add hundreds of employees and more than quadruple its manufacturing space.


Prestige Ameritech has leased a 220,000-square-foot plant formerly used by Kimberly-Clark as a surgical mask production factory, said Dan Reese, founder and president of Prestige Ameritech. Beginning Dec. 1, the company will move its operations out of about 50,000 square feet at three locations in Richland Hills into the much larger facility at 7201 Iron Horse Blvd. in North Richland Hills.


The North Richland Hills City Council approved economic incentives for the move, which is being prompted by both immediate demand for Prestige Ameritechs surgical masks and the companys long-term growth plans, on Monday.


Twelve years ago, 90% of surgical masks were made in the United States, but today only 10% are, he said. That shift, Reese said, has given Prestige Ameritech a strategic advantage.

 













































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Surgical-Mask Company Might Soon Move to North Richland Hills
Star-Telegram
November 6, 2009

NORTH RICHLAND HILLS  Prestige Ameritech, the largest maker of surgical masks in the U.S., could soon move to a former Tecnol surgical-mask plant in North Richland Hills to gain much-needed expansion space, a company executive said.


The company, which has three facilities in Richland Hills and Fort Worth totaling 50,000 square feet, wants to consolidate those operations into the 220,000-square-foot industrial building at 7201 Iron Horse Blvd. by years end, said Mike Bowen, Prestiges executive vice president.


Prestige Ameritech has leased the property, which includes 17 acres, and will exercise an option to buy it, Bowen said.


"We anticipate being there long term," Bowen said. "During the next two to four years, we should be able to pretty well fill up the facility."


Prestige Ameritech has been growing exponentially since the beginning of the year to keep up with demand from the spread of the H1N1 virus and to replenish a stockpile for normal needs and future pandemics.


In the spring, the company increased its work force to 200 from about 80 to keep operations running 24/7. Bowen said he anticipates employment to reach 400 in the move.


The company leases its facilities in Richland Hills and Fort Worth.


The North Richland Hills City Council is scheduled to vote Monday on an incentive package for Prestige Ameritech that includes a 75 percent rebate of real and business personal property tax for 10 years and a 25 percent sales tax rebate for five years. The city will also waive fees for a year.


Under the terms, Prestige Ameritech must move in by Jan. 31, stay for 10 years and have a work force of 400 by 2015.


"The bottom line is they wanted to feel welcomed by the city, and they are," said Craig Hulse, the citys economic development director.


Bowen and Dan Reese, Prestiges president, were executives at Tecnol, the Kimberly Clark company that made surgical masks at plants in North Richland Hills. Those facilities were shuttered by 2006 when Kimberly Clark moved operations to Mexico and China, eliminating more than 1,000 jobs.


Prestige Ameritech was founded in 2005.


Mark Graybill with Lee & Associates represented Prestige. Trey Fricke, also with Lee & Associates, represented the owner. Lee & Associates listed the property for $8.3 million.


A California-based real estate investment company bought the property in 2007. Earlier this year, AIC Ventures bought the 129,000-square-foot Fitz Manufacturing aircraft component plant on 9 acres at 6625 Iron Horse Blvd., also a former Tecnol facility. Fitz Manufacturing has a long-term lease with AIC Ventures.


SANDRA BAKER, 817-390-7727



































































































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A New Pandemic Fear: A Shortage of Surgical Masks

TIME Magazine Online
May 19, 2009

The surgical face mask has become perhaps the most recognizable symbol of the H1N1 pandemic threat, but if the currently circulating flu virus does in fact reach full-fledged pandemic proportions, U.S. health officials say there won't be enough face masks to go around.

The Department of Health and Human Services (HHS) says the nation would need more than 30 billion masks  27 billion of the simple surgical kind, which can be worn safely for only about two hours before needing replacement, and 5 billion of the sturdier respirator variety, which also requires regular replacement  to protect all Americans adequately in the event of a serious epidemic. But the Centers for Disease Control and Prevention (CDC) Strategic National Stockpile currently contains only 119 million masks  39 million surgical and 80 million respirator. That's less than 1% of the goal health officials set in 2007 following the devastation of Hurricane Katrina, which highlighted the country's shortages of vital medical gear. (See pictures of the swine flu in Mexico.)

The U.S. mask gap stands in stark contrast to what other nations have on hand: the U.S. has one mask for every three Americans (masks are not supposed to be shared), while Australia has 2.5 masks per resident and Great Britain boasts six. "With the recent outbreak of the novel H1N1 influenza virus," warned Representative Kay Granger, a Texas Republican, "it has become clear that we need to purchase more medical supplies and replenish the Strategic National Stockpile." (Read "How to Prepare for a Pandemic.")

Maskmakers are worried too, especially since ramping up production in the midst of a pandemic won't be easy. Most maskmaking operations have moved outside the U.S., and 90% of masks sold in the U.S. now come from Mexico or China. But if the U.S. suddenly put in orders for millions of masks, Mexico and China would be unlikely to export their supplies before making sure their own populations were fully protected. "HHS knows the problem exists and yet they won't tell the health-care industry," says Mike Bowen of Texas-based Prestige Ameritech, the largest and one of the last remaining American mask manufacturers. "If they would only admit the problem exists, American hospitals would buy American masks and the manufacturing infrastructure would return." (Read "Battling Swine Flu: The Lessons from SARS.")

Of course, the more basic question is, How much do masks really help to stem the spread of disease? It's unclear, according to the CDC, which isn't recommending that people wear masks amid the current H1N1 outbreak. The CDC website says that "very little is known about the benefits" of wearing masks during a pandemic, and that the best preventive steps are frequent hand-washing and covering one's mouth when coughing or sneezing. Along with these strategies, the most effective techniques for preventing contagion are so-called social-distancing measures, such as closing schools, churches, theaters and other public gatherings, and generally keeping people apart from one another  efforts that may be further encouraged by the presence of face masks.

Surgical masks by themselves may not do much to prevent transmission within the community in part because they are loose fitting, offering a weak barrier between infected and uninfected people  hence, the government's better advice to wash hands and cover up sneezes and coughs  and masks must be changed frequently to avoid contamination. Respirator masks, which have a tighter fit, filter 95% of airborne particles to give wearers better protection, so long as they wear them consistently  which most people generally fail to do.

Where masks do make a demonstrable difference is in the health-care setting, protecting caregivers from sick patients  both in hospitals and at home  and a national shortage could impact these front-line responders most severely. "Much of what is contained in the Strategic National Stockpile are vaccines and medicines," including 50 million doses of Tamiflu, says CDC spokesperson Von Roebuck, noting that more medical supplies must be purchased.

Meanwhile, as the H1N1 virus continues its rapid spread around the world  as of May 18, 40 countries had officially reported 8,829 cases, including 74 deaths  nervous customers have been snapping up face masks in the U.S. Prestige Ameritech's sales have doubled in recent weeks, forcing the company to maintain a seven-days-a-week production schedule to keep up with demand. Even though Prestige Ameritech is a wholesaler that sells its products to retailers, such as 3M, there have been so many people trying to buy masks directly from the Prestige factory in suburban Fort Worth that the company has had to lock all its doors. Whether or not face masks will protect people from disease, sometimes it helps just to have the illusion of security.















































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Flu has Sole US Surgical Mask Producer Scrambling
CNNhealth.com
April 30, 2009

RICHLAND HILLS, Texas (CNN) -- The machines are buzzing as dozens of workers package freshly made surgical masks. More than 1 million will be made in one day inside Prestige Ameritech's manufacturing facility near Fort Worth, Texas.

The swine flu outbreak has made this small company a big deal.

Everyone knows who we are now," said Mike Bowen, executive vice president of the surgical mask manufacturer. "It's actually been pretty crazy."

Prestige Ameritech is ramping up production. For the first time in the company's history, it will be manufacturing masks 24 hours a day, seven days a week. Bowen also is looking to hire up to 20 workers to handle the workload.

Ever since Bowen and his business partner, Dan Reese, showed up to work Monday morning, the phones haven't stopped ringing. With the World Health Organization and national governments confirming cases of swine flu in at least 11 countries, orders for masks are coming in from around the world.

"We're still trying to get a handle on everything," Bowen said.

Prestige Ameritech is the only surgical mask manufacturing company in the United States. Most surgical masks are made in Mexico and China. The company, with a workforce of 80 people, makes masks for major distributors, like 3M, who sell the masks to hospitals and doctors across the country.

Health care suppliers say if the swine flu outbreak becomes a pandemic, it could severely strain hospitals' efforts to get necessary equipment like masks, gloves and antibiotics.

"What this situation should teach us is that we need to take a critical look at where we source pandemic supplies and in what quantities," said Mike Alkire, president of Purchasing Partners for Premier Inc., a North Carolina-based healthcare improvement alliance with a division that negotiates supply contracts for its more than 2,100 member hospitals.

"We feel that they are in good shape overall, provided the disease doesn't overwhelm our current resources or spread to a large number of additional communities," Alkire said.

With Prestige Ameritech operating at capacity, Bowen worries that a pandemic would create a surgical mask shortage in the United States.

The first cases of swine flu in humans were detected in Mexico, where health officials suspect the virus in more than 150 deaths. Scenes of Mexican citizens walking city streets with masks are playing out daily. The Mexican government has handed out masks to the public. Bowen says the United States is not equipped to handle that kind of demand.

"Surgical masks are used in hospitals. They're not used in the general public," Bowen said. "So when the general public starts wanting face masks, the supply gets short really quickly."

He added: "If there's a pandemic, America won't be able to supply its own needs, because we're pretty much it."

Bowen said that if the situation gets worse worldwide, countries like China and Mexico would keep surgical masks for their own citizens.

He said he wants to make sure the surgical masks are going to health care professionals and not brokers looking to take financial advantage of this health scare.

The shortage of American surgical-mask manufacturers is a critical weakness in the country's ability to battle a pandemic outbreak, he said.

"Hopefully, this isn't the big one," Bowen said. "What we're hoping is that this is just a wake-up call."


 

 

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Surgical Mask Shortage
The 33-TV Online
April 28, 2009

As the nation's largest manufacturer of surgical masks, Prestige Ameritech makes millions a week. But with fears of swine flu racing faster than their machines, the North Texas company can't make enough. Not even close.

Executive Vice President, Mike Bowen, says, "On an hourly basis we're getting calls from people we're never heard from before. Normally we're making outbound calls trying to get people to buy American face masks. Uh, it's a totally surreal situation."

Surreal, because founders Mike Bowen and Dan Reese saw this coming. For years they've been preaching the possibility of a pandemic, saying the US wouldn't be ready. 90% of the masks it uses are made in China and Mexico, where labor is cheaper. President Dan Reese says, "We hope this isn't the big one in terms of the pandemic. What Mike and I hope is that this is a wakeup call." Especially to the federal government.

Reese and Bowen say officials with the Department of Health and Human Services visited their Richland Hills company in November 2007, saying if a pandemic hits demand for masks and respirators would go beyond capacity. Yet, key stockpiling orders were never placed.

Dan Reese says, "I wish we'd had a little more support from our federal government along the way. It would have been nice if they had the money to help us build equipment and prepare and we did talk to them about that and at the time the funding just wasn't available."

Prestige Ameritech is hiring employees to meet the 24-7 demand. They say there's no celebration in the being right, just the hope the message is finally heard.

 

MASKMAKER ON THE MOVE

Star-Telegram
December 9, 2009

Prestige Ameritech -- the Tarrant County-based surgical mask company that shot to prominence this year amid concerns about the H1N1 flu and foreign goods -- has come full circle.

During the weekend after Thanksgiving, the company moved back into the same headquarters in North Richland Hills where Kimberly Clark once operated its Tecnol surgical-mask plant before closing it and moving the jobs to Mexico and China.

"We gave thanks and ate turkey on Thursday, and moved on Friday, Saturday and Sunday," said Mike Bowen, executive vice president. "Were home."

The company is consolidating its three facilities into the 220,000-square-foot industrial building on 17 acres at 7201 Iron Horse Blvd. They have leased the property with an option to buy.

The company has increased its work force from about 80 to more than 200 to meet the demand for American-made surgical masks. Bowen said the company hopes to have 400 workers by the end of 2010 and up to 1,000 in a few years. It is already the largest maker of surgical masks in the U.S.

The new plant has been dubbed the Global Pandemic Preparedness and Response Center. The facility was still full of the upscale Kimberly Clark office furniture -- down to the prints on the wall and a video conference room -- when Ameritech moved in, Bowen said.

"Were sick of seeing jobs leave the U.S. and are committed to making our stand right here," Bowen said. "We hope to one day bring back the thousand-plus jobs that were lost when Kimberly Clark moved mask production to Mexico."

 







































































































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PRODUCTION OF SURGICAL MASKS AND RESPIRATORS RETURNING TO NORTH RICHLAND HILLS

City of North Richland Hills Press Release
November 10, 2009

(North Richland Hills, Texas) - Prestige Ameritech, L.P., the largest manufacturer of surgical masks in the United States, is expanding operations and moving to North Richland Hills. The company will occupy the facility at 7201 Iron Horse Boulevard starting in January 2010. The move will allow Prestige Ameritech to continue meeting the growing demand for surgical masks and respirators in the United States and around the world.

The North Richland Hills facility, where 87% of Americas surgical face masks were once made, has sat vacant since Kimberly-Clark moved manufacturing and jobs to Mexico in 2001.

We are thrilled to see this facility being re-occupied by a company that is working to protect our nations health and security, said Mayor Oscar Trevino. This is good for North Richland Hills and it is good for America.

Ninety percent of surgical masks used in the United States are currently made in other countries including Mexico and China.  With recent threats of a global pandemic, Prestige Ameritech has become the largest domestic manufacturer of surgical masks and has outgrown its current facility. 

Prestige Ameritech plans to occupy the 220,000-square-foot facility on Iron Horse Boulevard by January 31, 2010. The company will employ 400 plus workers by 2015 and will remain compliant with laws prohibiting the employment of undocumented workers. The City of North Richland Hills has provided an incentive agreement that will keep Prestige Ameritech and its 400 plus jobs in North Richland Hills for many years to come.

For additional information, please contact North Richland Hills Economic Development Director Craig Hulse at 817-427-6090 and Prestige Ameritech President and CEO Dan Reese at 817-595-1131.

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Windowed Carton Unveils Masks During Swine Flu Outbreak
Packaging World Magazine

June 9, 2009
*After this article was published, Prestige Ameritech purchased the ProGear® line from Encompass Medical.  ProGear® masks can be obtained from a Prestige Ameritech distributor.

It turns out there's actually a healthy viewpoint regarding the frenzy over the "swine flu," or to be more precise, the 2009 H1N1 influenza virus. At least that's the prognosis from partner companies Prestige Ameritech and the Encompass Group. Beginning in late April, the surge of public demand for protective facial masks turned Prestige's world upside-down as the sole U. S. manufacturer of the devices.

The Encompass Group now markets the ProGear line of masks in windowed cartons, enabling medical professionals to identify mask varieties without having to first open the carton in the hospital or clinic.

"The swine flu is a reminder of how quickly a pandemic can be upon us," says Tony Hanson, managing director of marketing for McDonough, GA-based Encompass. "We are keeping in touch with our government contacts to get the latest updates as we learn more about the swine flu. The Centers for Disease Control and Prevention (CDC) is recommending the use of certain types of face masks if you are in close contact with someone who has, or may have the swine flu, even though the airborne contaminate issue is still being debated."


Mike Bowen, executive vice president for Richland Hills, TX-based Prestige Ameritech, says the masks help to protect both the wearer and those around the wearer.


Prestige designs and builds the equipment that takes rolls of propylene-based nonwoven materials and manufacturers it into masks, either with or without ties or headbands. At this point, different varieties of masks are manually placed into hand-erected paperboard cartons, although Bowen is considering automating the process. At press time, the company planned to add 20 workers to help with skyrocketing orders.


"Surgical masks are used in hospitals. They're not used by the general public," Bowen said in an April 30 CNN.com online report. "So when the general public starts wanting face masks, the supply gets short really quickly."


An eye for unique design


Knocked-down carton blanks are supplied by Southern Champion Tray. The 18-pt SBS board is offset-printed in two colors, which vary based on the type of ProGear mask. Cartons are color-keyed to match mask varieties. Southern Champion Tray glues in the circular polypropylene film window that allows medical personnel to identify the mask type. Different packaging will be used for consumer sales, Bowen notes.


Bowen says that the cost for employing the window "was inconsequential." He explains, "It lets people see the mask variety and our patent-pending bent-nose piece that helps show users how to wear them.

"In the medical industry, a lot of the [packaging] is pretty boring. We wanted people to take notice of the box on the shelf when it was in the hospital. If a worker has 15 different boxes of masks on the shelf, we wanted his or her eyes drawn to our masks because we believe once they try our masks, they're going to like them."


The companies employed design/branding/public relations firm The Young Co. Bowen explains, "Bob Young met with us and Encompass at a sales meeting and designed a carton that one rep [found so appealing that he] thought it was an iPod giveaway.


"We are always interested in making our product more appealing, without adding a lot of cost. We're some of the most outside-the-box people you can imagine. When a supplier comes to us, invariably we're the ones who want to see that box that glows in the dark.'  We want whatever the new thing is, and we think we'll get the return [on investment] by doing something unique in the marketplace."


Buying American


Therefore, a slight cost upcharge isn't an overwhelming concern, he says, even in a recessed economy. "As stupid and politically incorrect as this may sound, we buy American products, even if they're more expensive.  We believe in America. We believe in putting people to work here. Americans are fixated on price, price, price. In a price game, we know that [China and/or Mexico] wins."


Bowen's strong "buy American" sentiment traces back in part to when the face-mask maker's predecessor company moved its operations from Texas to Mexico to reduce its labor costs. "We saw 2,000 of our friends sent home in one day. It was sickening," he says.


Looking to the future, Bowen recognizes there is an element of uncertainty. "We're a private company, and we're trying to make rational decisions about the future, how fast and how many mask manufacturing machines we should make, how many products to produce, and if this current growth of volume is real and sustainable, because the last thing we need to do is build too many machines and then go bankrupt because nobody is buying masks." What he can't mask is that the present is quite healthy for the partnering companies.


Interestingly, Prestige Ameritech and The Encompass Group view potential protectionism by other countries as a potential business ally. "There are concerns that other countries may stockpile masks for their own citizens," says Encompass's Hanson. "Since our masks are manufactured in the United States, we are ready to supply U.S. citizens with large quantities of masks, should it become necessary. There is also a concern that face masks manufactured in Mexico may become difficult to get if Mexican workers are ill, or their plants are closed. Additionally, masks could become the target of the drug cartels operating in Mexico if the demand becomes great enough."

 


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Cartons unveil masks during swine flu outbreak

Healthcare Packaging
May 18, 2009

It turns out there's actually a healthy viewpoint regarding the frenzy over the "swine flu," or to be more precise, the 2009 H1N1 influenza virus. At least that's the prognosis from partner companies Prestige Ameritech and the Encompass Group. Beginning in late April, the surge of public demand for protective facial masks turned Prestige's world upside-down as the sole U. S. manufacturer of the devices. The Encompass Group now markets the ProGear line of masks in windowed cartons, enabling medical professionals to identify mask varieties without having to first open the carton in the hospital or clinic.

"The swine flu is a reminder of how quickly a pandemic can be upon us," says Tony Hanson, managing director of marketing for McDonough, GA-based Encompass. "We are keeping in touch with our government contacts to get the latest updates as we learn more about the swine flu. The Centers for Disease Control and Prevention (CDC) is recommending the use of certain types of face masks if you are in close contact with someone who has, or may have the swine flu, even though the airborne contaminate issue is still being debated."


Mike Bowen, executive vice president for Richland Hills, TX-based Prestige Ameritech, says the masks help to protect both the wearer and those around the wearer.


Prestige designs and builds the equipment that takes rolls of propylene-based nonwoven materials and manufacturers it into masks, either with or without ties or headbands. At this point, different varieties of masks are manually placed into hand-erected paperboard cartons, although Bowen is considering automating the process. At press time, the company planned to add 20 workers to help with skyrocketing orders.


"Surgical masks are used in hospitals. They're not used by the general public," Bowen said in an April 30 CNN.com online report. "So when the general public starts wanting face masks, the supply gets short really quickly."


An eye for unique design


Knocked-down carton blanks are supplied by Southern Champion Tray. The 18-pt SBS board is offset-printed in two colors, which vary based on the type of ProGear mask. Cartons are color-keyed to match mask varieties. Southern Champion Tray glues in the circular polypropylene film window that allows medical personnel to identify the mask type. Different packaging will be used for consumer sales, Bowen notes.


Bowen says that the cost for employing the window "was inconsequential." He explains, "It lets people see the mask variety and our patent-pending bent-nose piece that helps show users how to wear them.


"In the medical industry, a lot of the [packaging] is pretty boring. We wanted people to take notice of the box on the shelf when it was in the hospital. If a worker has 15 different boxes of masks on the shelf, we wanted his or her eyes drawn to our masks because we believe once they try our masks, they're going to like them."


The companies employed design/branding/public relations firm The Young Co. Bowen explains, "Bob Young met with us and Encompass at a sales meeting and designed a carton that one rep [found so appealing that he] thought it was an iPod giveaway.


"We are always interested in making our product more appealing, without adding a lot of cost. We're some of the most outside-the-box people you can imagine. When a supplier comes to us, invariably we're the ones who want to see that box that glows in the dark.'  We want whatever the new thing is, and we think we'll get the return [on investment] by doing something unique in the marketplace."


Buying American


Therefore, a slight cost upcharge isn't an overwhelming concern, he says, even in a recessed economy. "As stupid and politically incorrect as this may sound, we buy American products, even if they're more expensive.  We believe in America. We believe in putting people to work here. Americans are fixated on price, price, price. In a price game, we know that [China and/or Mexico] wins."


Bowen's strong "buy American" sentiment traces back in part to when the face-mask maker's predecessor company moved its operations from Texas to Mexico to reduce its labor costs. "We saw 2,000 of our friends sent home in one day. It was sickening," he says.


Looking to the future, Bowen recognizes there is an element of uncertainty. "We're a private company, and we're trying to make rational decisions about the future, how fast and how many mask manufacturing machines we should make, how many products to produce, and if this current growth of volume is real and sustainable, because the last thing we need to do is build too many machines and then go bankrupt because nobody is buying masks." What he can't mask is that the present is quite healthy for the partnering companies.


Interestingly, Prestige Ameritech and The Encompass Group view potential protectionism by other countries as a potential business ally. "There are concerns that other countries may stockpile masks for their own citizens," says Encompass's Hanson. "Since our masks are manufactured in the United States, we are ready to supply U.S. citizens with large quantities of masks, should it become necessary. There is also a concern that face masks manufactured in Mexico may become difficult to get if Mexican workers are ill, or their plants are closed. Additionally, masks could become the target of the drug cartels operating in Mexico if the demand becomes great enough."





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As Swine Flu Fears Spread Surgical Mask Sales Double Says Prestige Ameritech of Richland Hills
Dallas Morning News
April 30, 2009

As the recession has prompted many companies to pull back production, Prestige Ameritech in Richland Hills is working double time.


Prestige, the nation's largest maker of surgical masks, is flooded with orders in response to heightened fear of a swine flu pandemic, executive vice president Mike Bowen said.


"I just got a call from 7-Eleven," Bowen said Wednesday. Earlier this week, he said federal officials phoned to ask about pricing and availability.

"Our sales are doubling because of this," said Bowen, who declined to specify the private company's sales. "We don't know why  if it's people stockpiling, or panicking or if it's a shortage. All we know is that we're getting orders and we're having people call us."


The problem is that Prestige has no extra capacity, so orders are piling up, Bowen said. The 85-employee company is shifting to a seven-day-a-week production schedule from five, is trying to add machines to the factory floor and plans to hire 15 to 20 people as soon as possible, he said.


Since last week, the swine flu has spread to at least 10 states and into Europe. The first U.S. death, a Mexican toddler who traveled with his family to Texas, was recorded Monday. Total U.S. cases on Wednesday topped 90.


The Centers for Disease Control and Prevention is not recommending that people wear masks unless they have swine flu or are in close contact with others who do.


The agency's Web site says "very little is known about the benefits" of wearing masks to control the spread of pandemic flu.


Debra Squyres, director of human capital consulting for professional employer organization TriNet, said companies should prepare for a potential flu outbreak, but she's not advising companies to require workers to wear masks.


"Employee wellness is a high priority, and we encourage employers to let employees wear a mask if they want to," she said.


Still, people are trying to walk into Prestige off the street to buy masks, Bowen said. He had to lock the front doors Wednesday.


Prestige doesn't sell directly to the public. It typically makes millions of masks a week for distributors and suppliers such as 3M, which sells them to health care workers.


Prestige is one of the few remaining mask manufacturers in the United States. Most masks are made in China and Mexico.


Brown and partner Dan Reese started Prestige in 2005 after their employer, Tecnol Technologies Group in Fort Worth, was sold to Kimberly-Clark and its mask production moved to Mexico.


People interested in wearing a surgical mask should make sure it fits correctly, Bowen said. It should cover the nose, fit under the chin and be molded to the face, he said.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


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Swine Flu Fears have Tarrant County Surgical-Mask Maker Ramping Up to Meet Demand
Star-Telegram
April 27, 2009

Surgical masks are rolling off the production lines as fast as they can be made at Prestige Ameritech in Richland Hills.


A major U.S. producer of surgical masks, the company is ramping up to meet the demand for the protective masks amid growing concern over the spread of swine flu.


Partners Dan Reese and Mike Bowen hope it will be enough. Federal health officials concluded more than a year ago that the nation could face a shortage of surgical masks if a pandemic were to strike, because 90 percent of the masks used in the United States are made elsewhere, largely Mexico and China.


"We're hoping it's not the big one," said Bowen, the company's executive vice president. "And we hope it makes our country wake up to the fact that we're dependent on foreign products."


For now, the company is expanding its production line to capacity, producing boxes of surgical masks for wholesale distributors and suppliers, including 3M, who sell to hospitals and doctor's and dentist's offices. And it is looking to hire additional workers to go to seven-days-a-week production while demand is high.


They're expecting a shortage of masks, if only because of the expected demand from nonmedical workers. Federal officials called the company within the past several days asking about production capacity, pricing and other supply details.


"We think it won't be long until there is a short supply," Bowen said. "Everyone's buying a mask."


What's happening


In a November 2007 report by the U.S. Health and Human Services Department, researchers concluded that an influenza pandemic would increase demand for surgical masks and respirators beyond capacity. The report, which assessed problems after Hurricane Katrina in 2005, concluded that the government would need to stockpile more than 30 billion protective masks to meet needs during a pandemic.


At the time, less than 1 percent of the surgical masks and 2 percent of respirators had been stockpiled, but no further action appears to have been taken toward increasing national production. Mexico, the epicenter of the swine flu outbreak, is one of the top producers of surgical masks used in the United States, but it could need as many as 30 million or more masks to meet its own needs.


Close to home


Prestige Ameritech figures that it's uniquely positioned to respond to the crisis. The company was started in 2005 by Reese and Bowen, who had worked for Tecnol Technologies Group, which was sold to Kimberly-Clark in 1997. Reese, who was president of Tecnol when it was sold, said the company had about 87 percent of the market for U.S. hospital masks and employed about 2,000 people.


Kimberly-Clark eventually shuttered the plant, however, and moved the jobs to Mexico and China.


Reese and Bowen, who was Tecnol's director of new product development, formed Prestige Ameritech and began production in a 20,000-square-foot Tecnol building in Richland Hills. The company now has 85 to 90 employees and is hoping to exceed 100 employees in coming weeks.


Orders have been pouring in to Prestige Ameritech, and calls from federal officials suggest that the government may be considering placing its own order, the company said.


"At this point, we're trying to make as many masks as we can," Bowen said. "We anticipate going to seven days a week, 24 hours a day. We're going to add Saturdays starting this weekend.


"We don't know if there will be any supply disruption. The problem is in Mexico, and the masks are in Mexico. That is not a good scenario."

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US Pandemic Could Severely Strain Facemask and Other PPE Supply Pipeline

Infection Control Today
October 24, 2008



Fears of an avian influenza or Severe Acute Respiratory Syndrome (SARS)-like pandemic in the United States may have subsided somewhat in the years since H5N1 first ravaged parts of Asia, but concerns linger about our nations supply of face masks should a pandemic erupt. Pandemic planning is an imperfect science because it is difficult to impossible to know when and where the outbreak will occur, as well as the duration and severity of the event. Also, it is challenging to predict which influenza strains will be implicated in a pandemic outbreak, with annual influenza strains often evading public health experts forecasts and scientists formulations for the current seasons flu vaccines.


According to the Pandemic Influenza Plan of the Department of Health and Human Services (DHHS), the U.S. must have a national stockpile of 40 million doses (two doses per person) of vaccine against influenza virus subtypes considered to pose a substantial pandemic risk (currently avian H5N1). Additionally, the plan calls for domestic influenza vaccine manufacturing capacity to produce sufficient pandemic vaccine for the U.S. population within six months of the onset of an influenza pandemic. The plan also calls for the availability of at least 81 million treatment courses of approved antiviral drugs, enough for treatment of approximately one-quarter of the U.S. population, and 6 million additional treatment courses in reserve for domestic containment. The plan alludes briefly to the necessity of maintaining equipment and supplies in the Strategic National Stockpile (SNS) and state stockpiles sufficient to enhance medical surge capacity.1


Influenza vaccines and antiviral drugs are normally the first defense against the flu, but availability and immediacy could be problematic during a pandemic. A pandemic may be particularly devastating because human populations will have little, if any, baseline immunity to an entirely new, mutated viral strain. What is critical to remember is that during a pandemic, the primary prevention strategies of vaccines and antiviral prophylaxes are likely to be either unavailable or initially limited in quantity and availability, so reliance upon secondary prevention strategies, including the use of face masks and respiratory etiquette, may be more of a last resort. In the absence of primary prevention, measures to prevent or slow transmission of the virus in both the healthcare and community sectors must be used. Such measures include isolating patients, limiting contacts with infected persons, and otherwise minimizing the likelihood of exposure to the virus, as well as frequent handwashing and requiring infected individuals to be quarantined or equipped with medical masks that might limit respiratory transmission of the virus.2

 

A report from the Institute of Medicine noted, In the event of pandemic influenza, supplies of effective vaccines and antiviral medications are likely to be inadequate to treat a very large number of affected individuals. Therefore, non-pharmacological interventions will be important, including the use of respiratory protection through respirators or medical masks or both. WHO recommends non-pharmacological interventions that focus on delaying the spread of infection and reducing the impact of the disease. WHOs recommendations include permitted, but not required, routine mask use by the general public.2


Masks will be needed to limit or prevent human-to-human transmission of influenza among healthcare providers and members of the general public. And thats where it becomes dicey. In the past decade, most U.S. face mask sellers have moved their manufacturing operations overseas. A handful of U.S.-based manufacturers remain, and they cannot produce enough masks to protect Americans during an impending pandemic.


The DHHS recognizes that an inadequate stockpile of face masks and other items of personal protective equipment (PPE) could pose a national security threat. How bad could it get? No one really knows, as the utilization of healthcare during a pandemic is mostly suppositions on paper currently. The DHHS pandemic flu plan attempts to characterize the damage, noting, Pandemic planning is based on the following assumptions about pandemic disease: susceptibility to the pandemic influenza subtype will be universal; the clinical disease attack rate will be 30 percent in the overall population; illness rates will be highest among school-aged children (about 40 percent) and decline with age; among working adults, an average of 20 percent will become ill during a community outbreak; of those who become ill with influenza, 50 percent will seek outpatient medical care. The number of hospitalizations and deaths will depend on the virulence of the pandemic virus. Estimates differ about 10-fold between more and less severe scenarios.1


Chettle3 paints a picture for us: In a severe pandemic, millions of desperately ill people needing hospitalization will quickly overwhelm the healthcare system to the point of collapse. There will be an immediate shortage of hospital beds; critical supplies (surgical gloves, masks, gowns, IV bags, and antibiotics); and trained staff to care for patients. For example, in the U.S., there are about 965,300 staffed hospital beds  not nearly enough. During the peak week of a pandemic, the following numbers of staffed beds and ventilators would be needed in the U.S. for influenza patients alone: 191 percent of current non-ICU beds, 461 percent of ICU beds, 198 percent of all available ventilators. Projections of hospitalizations are only estimates. However, the gap between our current resources and our needs is staggering. These numbers assume that 25 percent to 30 percent of the U.S. population will fall sick and that illnesses will be spaced over eight weeks. It is expected that even in the peak weeks of a pandemic, no more than 10 percent of a communitys population will be ill at any one time.


Chettle3 adds, For the healthcare providers who do care for patients with pandemic influenza, the risk of infection is likely to be significantly increased by a lack of PPE. Supply chain problems are expected to develop once a pandemic begins, and most hospitals, with their just-in-time delivery of supplies, have not stockpiled PPE. Without N95 masks, goggles, and gloves, will HCWs put themselves at risk taking care of infectious patients?


The move of face mask manufacturing overseas has weakened the nations domestic pipeline and opened the U.S. to unnecessary risk, says Mike Bowen, executive vice president of Prestige Ameritech, a Texas-based company with a history. In 1997, a leading face mask manufacturer, Tecnol Medical Products, Inc. was acquired by Kimberly-Clark Health Care; at the time of the merger, Tecnol had an 87 percent market share, according to Bowen. Prestige Ameritech was started in 2004 by former Tecnol executive Dan Reese; two years later, Reese was joined by Bowen, also from Tecnol. Bowen and Reese realized that when the major mask makers took their manufacturing overseas, the remaining domestic producers of face masks would be sorely pressed to meet the need during a pandemic or bioterrorism event.


Bowen reports that in the last year, Prestige Ameritech has gained 5 percent in market share due to private-label arrangements with bigger mask manufacturers that import most of their masks from China, Thailand and Mexico. According to Bowen, about 90 percent of U.S. masks are foreign made. Taking part in the exodus overseas since the late 1990s were many of the largest glove manufacturers, including Kimberly-Clark Health Care, 3M, Medline, Precept, Cardinal Healthcare, and Molnycke, who manufacture mainly in Mexico, China, and Thailand. Companies that still manufacture all or most of their masks in the U.S. are Prestige Ameritech, Alpha Protec, Crosstex and Gerson.


In late 2007, U.S. mask manufacturers met with representatives from the DHHS to discuss the pandemic readiness problem. Bowen says at that time meeting participants were given a copy of a DHHS presentation outlining these shared readiness concerns, something Bowen adds that Prestige Ameritech has been voicing for several years. Bowen says DHHS told him a directive from the Department of Homeland Security prompted the agency to address gaps in the countrys pandemic plan, including the fact that countrys few remaining face mask companies supply just 10 percent of the mask supply. DHHS has no money allocated to fix the problem, Bowen says. So far, DHHS has conducted facility tours and submitted questionnaires to mask sellers, but as yet, they do not appear to have a plan.


Bowen believes moving manufacturing operations overseas severely hampers the ability to provide the basics of barrier protection in a pandemic. When DHHS came to visit Prestige Ameritech last November, they echoed what weve been saying for nearly three years: In the event of a pandemic, foreign suppliers will divert mask supplies to their own people (under orders from their respective governments), leaving America to fend for itself. Bowen adds, In the event of a pandemic, mask-producing countries will divert mask supplies to their own people, removing up to 90 percent of Americas ongoing supply. Prestige Ameritech and the few remaining American mask producers could not make up the difference. Hospitals would be out of masks in days or weeks at the most. When the masks run out, there would be no protection for Americas HCWs. If, however, Americas healthcare facilities began buying American masks, the mask makers would return to the U.S. and we would, soon, have the necessary infrastructure with which to build stockpiles to protect America during a pandemic."


In todays global economy, the healthcare industry is more vulnerable than ever before. Gihring4 cautions that many of the raw materials used in medical supplies and pharmaceuticals come from foreign suppliers and if global supply chains are damaged, U.S. supplies are threatened. A survey conducted by Novation and the University HealthSystem Consortium (UHC) that asked materials managers to determine the status of their pandemic disaster preparations revealed that many hospitals would run out of supplies in less than a week during a pandemic. More than half of the materials managers surveyed (68 percent) reported that their facilities developed comprehensive pandemic-specific disaster plans. Seventy-nine percent said they could continue operations without external resources for less than one week, while 54 percent said operations could continue for one to three days. The majority of managers (93 percent) surveyed have made arrangements with product suppliers to receive critical items. More than half of the survey participants have arranged for products to be delivered automatically if a pandemic event occurs. More than half also claim they can manage critical business functions offsite and can support existing business functions with limited staffing through cross-training. More than half of survey participants (60 percent) keep their pandemic supplies separate from standard inventory and almost one-third (31 percent) of the participants have preprinted disaster preparedness order forms.


Healthcare has embraced the just-in-time (JIT) concept of supply (maintaining minimal inventories and delivering products only when needed) procurement, an idea that works under normal utilization scenarios, but may crumble under the weight of a pandemic. Not because of what the healthcare institution is doing, but because of factors out of the hospitals control, such as reduced manpower and transportation challenges within medical-supply delivery channels. JIT purchasing is at odds with the very idea of pandemic planning and stockpiling, which is a just-in-case approach. Detractors of JIT point to the 2003 SARS outbreak during which healthcare professionals in Toronto reported a shortage of N95 respirators because much of the supply was diverted to Asia, which suffered the greatest number of illnesses and deaths. Healthcare providers hoarded and rationed these respirators, or made do with face masks with lesser protective properties.


Masks arent the only PPE item subject to potential scarcity. In early July, Hong Ray Enterprises, one of the largest manufacturers of vinyl gloves and a major manufacturer of nitrile gloves, announced that it would be unable to fulfill some of its contracts because of a number of factors, including Chinas restrictions on industry in order to help reduce air pollution levels in time for the 2008 Summer Olympics held in Beijing in August. The restrictions were in effect until mid-September, in time for the Paralympics to wrap up.


Hong Ray Enterprises notified Medline Industries, Inc. and other U.S. customers that they are facing force majeure conditions and that they will be unable to meet their normal agreements to customers; Hong Ray is Medlines largest exam glove supplier. This disruption to supply will have a cost impact on the entire industry, said Tripp Amdur, president of Medlines glove division, in a press release issued July 3. We are moving quickly to secure adequate supply for our customers through alternative factories, at ultimately a much higher cost. It is crucial that we act fast for exam gloves, however, because its a high-demand item that can spike in times of crisis situations such as SARS and the pandemic flu.


In its letter to its U.S. customers, Hong Ray Enterprises cited a number of events and government actions that have led to its inability to fulfill its contracts, including a fire at a major raw material manufacturer, dramatic changes in government policy impacting labor, taxes and credit and pollution-control measures associated with the Beijing Olympics. According to Amdur, Hong Rays situation is by no means unique: All of our suppliers are facing enormous and unexpected obstacles in fulfilling their contract obligations. While Hong Ray is the first factory to formally declare force majeure, other factories, including those that manufacture latex gloves, face similar circumstances. In Malaysia, for example, the government recently declared a change in pricing for natural gas, almost tripling the price overnight.


In mid-August, Kimberly-Clark Health Care also issued a press release addressing Hong Rays production shortfalls, shipping delays and price increases. With the market changing over the past several months, we ramped up our production of Sterling Nitrile Exam Gloves in October 2007 as one of many safeguards to ensure we could supply a superior alternative to vinyl and latex gloves should predictions of production shortfalls hold true, said John Dodd, vice president of global healthcare product supply. We will continue to invest in our nitrile glove processes to make certain that we can support our customers in what has become a very volatile global market. Kimberly-Clark Health Care reaffirmed that its current supply of nitrile gloves are stocked and available, as they are manufactured at two Kimberly-Clark-owned facilities in Thailand and are not subject to the shortages or quality concerns of the heavily outsourced vinyl glove market.


While a perfect storm of market conditions and labor costs had a hand in the manufacturing migration overseas, Bowen points to the chokehold group purchasing organizations (GPOs) have on companies access to the marketplace. Selling individual products to individual hospitals became impossible over a decade ago, Bowen says. In order to gain price-sensitive GPO contracts, Americas medical companies utilize cheap offshore labor. The GPO focus on price tends to turn products into commodities and give foreign suppliers the advantage.


Bowen adds, The head of infection control at a leading GPO thinks that America has a glut of face masks and respirators. Today, price is the most important consideration in face masks. As long as this is true, America wont be ready for a pandemic. Bowen adds, Public and governmental pressure will increase to the point that the GPOs will voluntarily institute buy American policies for pandemic medical countermeasures in order to be good corporate citizens.


A sense of apathy about a potential pandemic has settled in five years after SARS and two years after the initial avian influenza scare. Bowen says the lack of pandemic preparedness is a critical concern, but more importantly, the federal government is saying it. Bowen adds, The DHHS recently wrote, Annual production of surgical masks to the U.S. market is about 3.8 billion masks; 90 percent comes from overseas (Asia). Additionally, they said: Industrial surge capacity of respiratory protection devices will not be able to meet need and supplies will be short during a pandemic. They went on to say that America needs 5.3 billion respirators and 26.9 billion surgical masks in stockpiles and that we only have 0.2 percent of that number in stockpiles today.


In the DHHS presentation by Brenda Hayden, RN, and Robert C. Huebner, PhD, Discussion with Respirator Protection Device Manufacturers on Preparedness and Surge Capacity, given to Prestige Ameritech last November, the agency touches on several important items: there will be a significant increase in the need for respiratory protection devices (RPDs) during an influenza pandemic; this need will be all across all sectors including healthcare, public safety, business, government and the public; and industrial surge capacity of RPD will not be able to meet the need and supplies will be short during a pandemic. The DHHS presentation addressed N95 supply issues by reporting that annually, about 900 million N95s per year are available in the U.S. (most are used in non-medical settings). Of those, 25 percent to 30 percent are produced overseas. About 10 percent to 20 percent of annual sales are going to stockpiling, and the SNS represents about 2 percent of the emergency stock needed. In terms of surgical mask stockpiles, the HHS presentation reports that the SNS has a stock representing 0.2 percent of the emergency stock needed.


The answer to PPE shortfalls during a pandemic, it might seem, rests on two action plans: increased stockpiling and increased domestic manufacturing. Within the last several years, then-HHS secretary Mike Leavitt announced that the supplies within the Strategic National Stockpile (SNS) would be boosted with the addition of 73 million N95 respirators with another 32 million ordered, and 37.4 million surgical masks with another 14 million ordered.


For those skeptical of the federal and state stockpiling and distribution process, stepping up domestic manufacturing of PPE items is the single best way to be prepared for a pandemic or other emergency event.


Masks and respirators are vital to the protection of Americans during a pandemic, but the U.S. government and healthcare systems continue to buy foreign made masks, Bowen says. Prestige Ameritech has been very vocal about the dangers of relying on foreign countries for masks and respirators. With the exception of DHHS, our warnings have been met with ambivalence. DHHS fully understands the seriousness of the situation, but has yet to do anything to change it. Bowen continues, Currently, the materials to make face masks and respirators are made in the U.S. It is our belief that soon, this will not be true, and that like others before them, the raw materials will follow the manufacturing operations to Asia. When this happens, it will not longer be possible for America to protect its fact mask and respirator supplies. Now is the time to act.


Prestige Ameritechs proposed solution is for the country to embrace American manufacturing again. Bowen says that all healthcare GPOs should designate masks, respirators and other pandemic medical countermeasures as a special class of products that must be made in the U.S., and that all American healthcare institutions  from large healthcare systems down to small clinics and physician offices  should buy American-made PPE products exclusively. This purchasing exclusivity should be adopted by the U.S. government as well, Bowen emphasizes, adding that this plan will give the U.S. a stockpile to draw from during a pandemic and will ensure that the mask supply cannot be cut off by foreign governments. Existing mask companies will grow, new mask companies will form, and mask companies who have left America will return, Bowen says. A few years ago, the French government discovered that in a pandemic, they would be reliant on China for masks. To remedy the problem, they issued government contracts for hundreds of millions of French-made masks. This spurred the creation of new face mask companies in France, thus solving the problem.


Bowen says he is confident the U.S. will adopt a made-in-the-USA policy sooner rather than later. Homeland Security Presidential Directive 21 directed the Department of Homeland Security to identify and remedy gaps in Americas pandemic preparedness plans, he says. The Biomedical Advanced Research and Development Authority (BARDA) of the DHHS has identified the problem and is in the beginning stages of coming up with a remedy. We firmly believe that mask production will come back to America and are making preparations for it.


Bowen reports that political inroads are being made. Were been very active politically, and support for American-made masks is growing. Recently, U.S. Congressmembers Kay Granger, Joe Barton, and Michael Burgess wrote a letter to Mike Leavitt about American-made masks. We have heard that Pat Leahy of Vermont supports American masks as well. We have very been successful garnering support from many of our Texas state representatives, including Jane Nelson, who chairs Texas Senate committee for the Texas Department of Health and Human Services, and Tom Craddick, the speaker of the Texas House of Representatives. We will continue our vigorous effort to gain political support for American-made masks. Protecting America is a bi-partisan concern and politicians are listening.


At press time, many on Capitol Hill are consumed with the presidential election and the state of the economy, and may not have pandemic planning on their minds. Bowen says the feds cant afford to take another misstep, adding, The federal government got a black eye over how it handled the Katrina disaster. Homeland Security Presidential Directive 21 was a result. The Feds have identified this problem as a national security threat. Now that the issue has been identified as such, they cannot simply ignore it. I see massive government stockpiling of masks on the horizon, as well as political pressure on the GPOs and healthcare systems to purchase American-made masks in order to rebuild Americas mask manufacturing infrastructure.


In the worst-case scenario  if the foreign pipeline closes and domestic manufacturers cant meet quotas, and we cant stockpile enough disposable face masks  can we reuse RPDs? In the presentation supplied to Prestige Ameritech, the DHHS noted, There are several RPD options (re-usable devices, etc.) that can be employed to meet the projected needs and that All sectors must contribute to efforts to prepare in order to meet the needs for RPD during a pandemic. While the DHHS presentation did not specify which RPDs can and should be reused, medical face masks and N95 respirators are the most likely items.


Currently, medical masks are recommended by the CDC for use in healthcare settings for routine patient care, while the National Institute for Occupational Safety and Health (NIOSH) recommends certified N95 respirators be used in high-risk activities such as aerosol-generating procedures in healthcare settings where SARS and tuberculosis could lurk. However, most medical masks and disposable N95 filtering face-piece respirators have a limited effective life span, according to the CDC: Once worn, they can become damaged or deformed or develop intolerable levels of breathing resistance from moisture buildup. If worn in an environment with high probability of exposure to infectious agents, they can become contaminated.2


The reuse of RPDs was the subject of scrutiny in January 2006 when DHHS asked the Institute of Medicine (IOM) to convene the IOM Committee on the Development of Reusable Facemasks for Use During an Influenza Pandemic to conduct a 90-day assessment of measures that can be taken that would permit the reuse of disposable N95 respirators in healthcare settings, as well as the need for and development of reusable face masks for healthcare providers and the public. The committee met in January and March 2006 to convene public workshops and develop a report, available through the National Academies Press, on an analysis of the potential for respirator and medical mask reuse.2


The first issue addressed in the report concerns measures taken to permit the reuse of disposable N95 respirators, and issues such as what modifications can be made in the manufacturing process that would permit these respirators to be reused without increasing the likelihood of infection with the flu virus, and what practices in caring for, wearing, and cleaning could be implemented to safely extend the effective lifetime of disposable N95 respirators. Another issue is the need for reusable masks for healthcare providers and the general public. The IOM committee report states, In the event of an extended pandemic, there will be the inevitable increasing demand by the public for masks, which cannot be met by the current, or even ramped-up U.S. production of disposable masks. Examples of the types of questions related to design of reusable masks that will be considered include: what materials would be effective; what would be an acceptable level of fluid resistance and filtration efficiency (e.g., individual to prevent respiratory droplets from being dispersed, and to reduce exposure to potentially infectious material, that is, to ensure that reusable masks for non-infected individuals filter inflowing air to minimize exposure to the flu virus, and reusable masks for compliance with existing standards and legal requirements, but the committee acknowledges that there may be difficulty in meeting such standards during a pandemic situation.2


Many agencies and professional societies have weighed in on reuse issues and most recommend one-time use and disposal of medical masks and filtering face-piece respirators or, at the least, that a wearer change the device when it becomes moist. Generally, medical masks should be changed between uses and whenever they become moist. The FDA and World Health Organization (WHO) recommend disposal of medical masks after one use by one patient, and that HCWs don a new medical mask or respirator each time they come into contact with a new patient. Because laundering disposable medical masks will destroy their barrier properties, there is no way to disinfect them. The IOM committee heard from manufacturers who said that currently marketed disposable medical masks are made of materials that are likely to deteriorate with the usual methods of disinfection. And because medical masks are intended for disposal (and are submitted to FDA with that labeling), manufacturers have no incentive to develop methods for decontamination. Additionally, manufacturers said they would incur increased liability if devices designed and intended for disposal were recommended for reuse.2


The IOM report states, If a sufficient supply of respirators is not available, NIOSH and CDC recommend that healthcare facilities may consider reuse as long as the device has not been obviously soiled or damaged (e.g., creased or torn). Reuse may increase the potential for contamination; however, this risk must be balanced against the need to provide full respiratory protection to healthcare personnel. The agency recommends that if disposable N95 respirators are reused for contact with SARS patients, institutions should implement a procedure for safer reuse to prevent contamination through contact with infectious droplets on the outside of the respirator.2


The IOM committee examined various forms of respiratory protection and suggests that N95 filtering face-piece respirators that are NIOSH-certified and properly fit-tested are likely to provide the best protection against influenza to the extent that it may be spread via an airborne route. As well, the committee suggests a closely fitting, high-efficiency medical mask is likely to provide appropriate protection against droplets, whereas a surgical N95 will provide protection against both droplets and aerosols. The IOM report notes, While recognizing the methodological and data limitations regarding the efficacy of medical masks as a form of respiratory protection against avian influenza, and in the absence of data to the contrary, the committee concluded that masks are likely to provide far less protection against aerosols than an N95 filtering face-piece but may offer better protection than cotton masks, homemade alternatives such as handkerchiefs and scarves, or no protection at all. No device is fail-safe, and its effectiveness depends on fit, level of exposures, and appropriate use. Finally, none of these devices protects against contact transmission, and appropriate hand hygiene is necessary when using and after removing these devices.2


The IOM committee also acknowledges that during a pandemic, PPE usage may be far from ideal: With adequate time and planning, stockpiling or ramping up production, or both, would ensure that there would be enough respirators or medical masks for all those who may need them, but with limited resources and time, supplies are likely to be insufficient. Thus, reality may require that disposable N95 respirators and medical masks be pushed beyond their approved uses in the hope that they can offer some level of protection beyond their intended limits of use. Moreover, individuals with no access to respirators or masks, even disposables, may feel driven to invent their own respiratory protection measures; for example, they may don woven masks not approved for medical uses in the United States, or use household items such as towels or sheets.2

 

References:


1. Pandemic Influenza Plan of the Department of Health and Human Services. Accessed at: http://www.hhs.gov/pandemicflu/plan/


2. National Academies Press (NAP). Committee on the Development of Reusable Facemasks for Use During an Influenza Pandemic. Reusability of Facemasks During an Influenza Pandemic: Facing the Flu. 2006.


13. Chettle CC. Are you prepared for a flu pandemic? Available at: http://www.nurse.com/ce/anthology.html?CCID=4599&Chapter=3833&ChapNum=4



4. Gihring T. The pandemic prophecy. Minnesota Monthly. April 2006. Available at: www.minnesotamonthly.com/articles/pandemicProphecy.html.

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3M Healthcare Launches New High-Performance Surgical Mask

3M Press Release

June 24, 2008

3M Health Care today announced the launch of the 3M™ Filtron™ 1900 tie-on duckbill surgical mask to meet the needs of clinicians seeking a premium surgical mask. The new 3M Filtron 1900 surgical mask incorporates proprietary filtration media and a rayon outerlayer to deliver increased breathability and comfort, traits highly preferred by clinicians.


Featuring a popular "duckbill" design, the 3M Filtron 1900 surgical mask provides off-the-face comfort and unmuffled speech. The unique filter combination reduces fogging that results from breathing into a surgical mask, and has a lower delta P, a measurement sought by clinicians performing longer surgical procedures.


"In response to customers seeking a higher-performing surgical mask, we are pleased to be able to offer the 3M Filtron 1900," said DeAnn Hammer, marketing manager, 3M Health Care. "We understand our customers' need for a premium-quality mask that can be quickly ordered and received, so we've decided to have the 3M Filtron 1900 manufactured exclusively in the United States." The 3M Filtron 1900 surgical mask is manufactured in the United States of 89 percent U.S. components, 11 percent Austrian components and is latex-free.


The 3M Filtron 1900 surgical mask is supplied by Prestige Ameritech, run by Dan Reese and Mike Bowen, long-time experts in manufacturing high quality surgical masks.  Prestige Ameritechs operations are solely based in the United States.


"Manufacturing surgical masks in the United States is an important strategy to pursue, not only for the convenience of hospitals and clinicians, but to enable a quick ramp-up on production and delivery should unplanned events require it," said Mike Bowen, executive vice president of Prestige Ameritech. "We are pleased to manufacture this product exclusively for 3M and to help them deliver high quality, high performance, surgical masks to clinicians."


The 3M Filtron 1900 surgical mask is one of many 3M Health Care infection prevention products. Other products include 3M™ Avagard™ (Chlorhexidine Gluconate 1% Solution and Ethyl Alcohol 61% w/w) Surgical and Healthcare Personnel Hand Antiseptic with Moisturizers, and 3M™ Duraprep™ Surgical Solution (Iodine Povacrylex [0.7% available iodine] and Isopropyl Alcohol,74% w/w) Patient Preoperative Skin Preparation.



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They'll Have Us Covered

Star-Telegram

April 2, 2007

After spending time early in their careers at Tecnol Medical Products, Dan Reese and Mike Bowen have come full circle.

The two have launched Prestige Ameritech, a maker of medical face masks that hopes to compete against rivals who've moved most manufacturing overseas.

Their start-up's location: A vacated 20,000-square-foot Tecnol building in North Richland Hills.

"All of the major competitors that we used to fight against, back when we were with Tecnol, are all overseas," Bowen said. "They just all left. We believe they created a vacuum."

Kimberly-Clark, which bought Tecnol in 1997, shuttered its main North Richland Hills plant late last year, ending the factory's 30-year run.

Tecnol employed as many as 1,100 people a decade ago, but the plant had been steadily trimming jobs since Kimberly-Clark's announcement in 2005 that it would move the plant's operations to Mexico.

Now, Prestige Ameritech is hoping to convince hospitals and other customers that American-made masks are worth the extra expense. The founders say that, in a medical emergency, masks bound for the U.S. would be nabbed by foreign governments for their own stockpiles.

"We believe that in an epidemic of any kind, there's going to be massive mask shortages," Bowen said. "If you want a safe supply, you need to buy American face masks."

Reese, the company's chief executive, and Bowen, executive vice president, now have eight employees. They hope to expand to 30 by year's end.

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Prestige Ameritech Opens New Facility

Textile World

April 24, 2007

Disposable medical and consumer products manufacturer Prestige Ameritech, Richland Hills, Texas, has opened a new facility in Forth Worth, Texas, for the production of disposable medical products including facemasks. The new facility offers contract manufacturing through such services as product design, high-speed rotary manufacturing, laminating, ultrasonic bonding, radio frequency bonding, heat sealing and pressure-sensitive adhesives.

The companys development team has 30 patents issued and pending for its technologies.

"We are very excited about our new facility and about our business prospects," said Dan Reese, founder and CEO. "We believe that offering increased quality and protection, plus the peace-of-mind that stems from having a secure, US mask supply, satisfies unmet needs in the market."

Ten associates are currently employed at the Fort Worth operation. The company expects to add an additional 20 positions by the end of 2007, and an additional 30 to 50 positions by the end of 2008, according to Mike Bowen, vice president.