FDA aims at reused medical devices

The FDA renewed its focus on reusable medical devices after receiving reports that patients were exposed to infection when the instruments weren’t properly cleaned.

While the federal watchdog agency urged patients not to delay or forgo medical procedures for fear of infection, the risks have roused concerns over multiple-use medical devices.

“Transmission of infection was extremely rare, but the potential for becoming infected by an inadequately processed device was there,” according to the FDA consumer update.

The risks result from improper “reprocessing,” the multi-step process for cleaning and disinfecting or sterilizing durable medical devices.

Inadequate reprocessing could mean that blood, tissue or other biological debris may remain stuck on the device, allowing microbes to survive further disinfection or sterilization measures.

The FDA noted that unclear, incomplete, difficult-to-obtain or impractical cleaning instructions provided by some device makers may contribute to the problem, but early studies conducted with the University of Michigan found that problem debris remained on some devices even when instructions were followed.

Patients could become infected by other patients, or may suffer tissue irritation from chemical disinfectants or other reprocessing materials left on the device.

If you or anyone you know thinks that you have been hurt by any reused medical device, call us at: 877 882 0095

For original article see: http://www.massdevice.com/news/fda-aims-reused-medical-devices

 

FDA aims at reused medical devices

The FDA renewed its focus on reusable medical devices after receiving reports that patients were exposed to infection when the instruments weren’t properly cleaned.

While the federal watchdog agency urged patients not to delay or forgo medical procedures for fear of infection, the risks have roused concerns over multiple-use medical devices.

“Transmission of infection was extremely rare, but the potential for becoming infected by an inadequately processed device was there,” according to the FDA consumer update.

The risks result from improper “reprocessing,” the multi-step process for cleaning and disinfecting or sterilizing durable medical devices.

Inadequate reprocessing could mean that blood, tissue or other biological debris may remain stuck on the device, allowing microbes to survive further disinfection or sterilization measures.

The FDA noted that unclear, incomplete, difficult-to-obtain or impractical cleaning instructions provided by some device makers may contribute to the problem, but early studies conducted with the University of Michigan found that problem debris remained on some devices even when instructions were followed.

Patients could become infected by other patients, or may suffer tissue irritation from chemical disinfectants or other reprocessing materials left on the device.

If you or anyone you know thinks that you have been hurt by any reused medical device, call us at: 877 882 0095

For original article see: http://www.massdevice.com/news/fda-aims-reused-medical-devices

 

Some girls overestimate HPV vaccine protection

Some adolescent girls who get the HPV vaccine to prevent cervical cancer wrongly think they no longer need to practice safe sex, U.S. researchers said on Monday.

The study, published in the Archives of Pediatric & Adolescent Medicine, shows the need for better education about the vaccines and their limitations.

Merck’s Gardasil and GlaxoSmithKline’s Cervarix vaccines protect against strains of the humanpapilloma virus or HPV that cause cervical cancer. Gardasil also protects against some strains of the virus that cause genital warts.

But neither vaccine can prevent other forms of sexually transmitted diseases such as syphilis, gonorrhea or human immunodeficiency virus or HIV that causes AIDS.

And HPV vaccines can only prevent HPV infections; they do not treat active infections.

Most girls who get the vaccine know its limitations, the researchers said, but the vaccines are recommended for all girls aged 11 to 12, and overestimating their effect could increase a young woman’s risk of contracting other sexually transmitted diseases.

For the study, Dr. Tanya Kowalczyk Mullins of Cincinnati Children’s Hospital Medical Center and colleagues surveyed 339 girls aged 13 to 21 about their perceptions of risk after their first HPV vaccination. Several mothers also took part.

Overall, most adolescent girls said they believed it was important to practice safe sexual behaviors after getting the shot. But a small group of girls — 23.6 percent — believed they were less at risk for getting sexually transmitted diseases after getting the vaccine.

For original article see: http://www.reuters.com/article/2012/01/02/us-cancer-cervical-idUSTRE8010QW20120102

 

Some girls overestimate HPV vaccine protection

Some adolescent girls who get the HPV vaccine to prevent cervical cancer wrongly think they no longer need to practice safe sex, U.S. researchers said on Monday.

The study, published in the Archives of Pediatric & Adolescent Medicine, shows the need for better education about the vaccines and their limitations.

Merck’s Gardasil and GlaxoSmithKline’s Cervarix vaccines protect against strains of the humanpapilloma virus or HPV that cause cervical cancer. Gardasil also protects against some strains of the virus that cause genital warts.

But neither vaccine can prevent other forms of sexually transmitted diseases such as syphilis, gonorrhea or human immunodeficiency virus or HIV that causes AIDS.

And HPV vaccines can only prevent HPV infections; they do not treat active infections.

Most girls who get the vaccine know its limitations, the researchers said, but the vaccines are recommended for all girls aged 11 to 12, and overestimating their effect could increase a young woman’s risk of contracting other sexually transmitted diseases.

For the study, Dr. Tanya Kowalczyk Mullins of Cincinnati Children’s Hospital Medical Center and colleagues surveyed 339 girls aged 13 to 21 about their perceptions of risk after their first HPV vaccination. Several mothers also took part.

Overall, most adolescent girls said they believed it was important to practice safe sexual behaviors after getting the shot. But a small group of girls — 23.6 percent — believed they were less at risk for getting sexually transmitted diseases after getting the vaccine.

For original article see: http://www.reuters.com/article/2012/01/02/us-cancer-cervical-idUSTRE8010QW20120102

 

Breast implant scandal: the whistleblowers

Brook Berry alerted colleagues to worries about PIP implants in a 2007 letter to the British Journal of Plastic Surgery.

The eminent surgeon was horrified by what he what he had just witnessed.

His patient, a 36-year-old woman, who had suffered from breast cancer, was undergoing surgery at an NHS hospital to repair the damage caused by the “massive failure” of silicone implants – which she had received as part of a reconstructive procedure.

“It was an almighty mess,” recalled Brook Berry, now 65 and retired to the south of France.

Formerly head of the department of plastic surgery at the University Hospital of North Durham, he was astounded that the implants – made by the French firm Poly Implants Protheses (PIP) – should have ruptured so catastrophically.

His patient had had the implants fitted only three years previously. And here she was undergoing further invasive, serious surgery because the implant in her right breast had leaked silicone into the lymph nodes in her armpit.

For original article see: http://www.telegraph.co.uk/health/healthnews/8986746/Breast-implant-scandal-the-whistleblowers.html

 

Breast implant scandal: the whistleblowers

Brook Berry alerted colleagues to worries about PIP implants in a 2007 letter to the British Journal of Plastic Surgery.

The eminent surgeon was horrified by what he what he had just witnessed.

His patient, a 36-year-old woman, who had suffered from breast cancer, was undergoing surgery at an NHS hospital to repair the damage caused by the “massive failure” of silicone implants – which she had received as part of a reconstructive procedure.

“It was an almighty mess,” recalled Brook Berry, now 65 and retired to the south of France.

Formerly head of the department of plastic surgery at the University Hospital of North Durham, he was astounded that the implants – made by the French firm Poly Implants Protheses (PIP) – should have ruptured so catastrophically.

His patient had had the implants fitted only three years previously. And here she was undergoing further invasive, serious surgery because the implant in her right breast had leaked silicone into the lymph nodes in her armpit.

For original article see: http://www.telegraph.co.uk/health/healthnews/8986746/Breast-implant-scandal-the-whistleblowers.html

 

Insight: Shortage of ADHD drug Adderall seen persisting in 2012

A shortage of Adderall, which is used to treat attention deficit hyperactivity disorder, shows little sign of easing as manufacturers struggle to get enough active ingredient to make the drug and demand climbs.

Adderall, a stimulant, is a controlled substance, meaning it is addictive and has the potential to be abused. The Drug Enforcement Administration tightly regulates how much of the drug’s active pharmaceutical ingredient (API) can be distributed to manufacturers each year.

The system is designed to prevent the creation of stockpiles that could be diverted for inappropriate use. Adderall and other stimulants are popular with students who may not have ADHD but are seeking to improve their test scores.

The DEA authorizes a certain amount of the API in Adderall – mixed amphetamine salts – to be released to drugmakers each year based on what the agency considers to be the country’s legitimate medical need.

Increasingly that estimate is coming into conflict with what companies themselves say they need to meet demand for the drug, which is reaching all-time highs. In 2010, more than 18 million prescriptions were written for Adderall, up 13.4 percent from 2009, according to IMS Health, which tracks prescription data.

Concerns are now rising among patient groups and doctors that the shortages seen in 2011 will continue into this year. Many orders remain unfilled, manufacturers say, and it may take several months before ingredient authorized under the new 2012 quota can be turned into new product.

“I am very concerned about the future,” said Ruth Hughes, chief executive of Children and Adults with Attention Deficit/Hyeractivity Disorder (CHADD). “No one seems to have much inventory to get us through the months ahead.”

For original article see: http://www.reuters.com/article/2012/01/01/us-adhd-adderall-shortage-idUSTRE80009E20120101

 

Insight: Shortage of ADHD drug Adderall seen persisting in 2012

A shortage of Adderall, which is used to treat attention deficit hyperactivity disorder, shows little sign of easing as manufacturers struggle to get enough active ingredient to make the drug and demand climbs.

Adderall, a stimulant, is a controlled substance, meaning it is addictive and has the potential to be abused. The Drug Enforcement Administration tightly regulates how much of the drug’s active pharmaceutical ingredient (API) can be distributed to manufacturers each year.

The system is designed to prevent the creation of stockpiles that could be diverted for inappropriate use. Adderall and other stimulants are popular with students who may not have ADHD but are seeking to improve their test scores.

The DEA authorizes a certain amount of the API in Adderall – mixed amphetamine salts – to be released to drugmakers each year based on what the agency considers to be the country’s legitimate medical need.

Increasingly that estimate is coming into conflict with what companies themselves say they need to meet demand for the drug, which is reaching all-time highs. In 2010, more than 18 million prescriptions were written for Adderall, up 13.4 percent from 2009, according to IMS Health, which tracks prescription data.

Concerns are now rising among patient groups and doctors that the shortages seen in 2011 will continue into this year. Many orders remain unfilled, manufacturers say, and it may take several months before ingredient authorized under the new 2012 quota can be turned into new product.

“I am very concerned about the future,” said Ruth Hughes, chief executive of Children and Adults with Attention Deficit/Hyeractivity Disorder (CHADD). “No one seems to have much inventory to get us through the months ahead.”

For original article see: http://www.reuters.com/article/2012/01/01/us-adhd-adderall-shortage-idUSTRE80009E20120101

 

Avastin Disappoints Against Ovarian Cancer Too

Avastin, the blockbuster drug that just lost approval for treating breast cancer, now looks disappointing against ovarian cancer, too. Two studies found it did not improve survival for most of these patients and kept their disease from worsening for only a few months, with more side effects.

The Genentech drug won approval in Europe last week for advanced ovarian cancer. But its maker has no immediate plans to seek the same approval in the United States. After talking with the Food and Drug Administration, “we do not believe the data will support approval” although no final decision has been made, said Charlotte Arnold, a spokeswoman for Genentech, part of the Swiss company Roche.

Results of the studies are in Thursday’s New England Journal of Medicine.

If you or anyone you know has been hurt from taking Avastin, call us at: 877 882 0095
Read more: http://healthland.time.com/2011/12/29/avastin-disappoints-against-ovarian-cancer-too/#ixzz1hw5xyf1U

 

BatteriesPlus Recalls Replacement Battery Packs Used with Cordless Tools Due to Explosion Hazard

WASHINGTON, D.C. – The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed. It is illegal to resell or attempt to resell a recalled consumer product.

Name of Product: Rayovac NI-CD Cordless Tool Battery Packs

Units: About 111,800

Importer: BatteriesPlus LLC, of Hartland, Wis.

Hazard: The replacement battery pack can explode unexpectedly, posing a risk of serious injury to consumers.

Incidents/Injuries: BatteriesPlus has received five reports of exploding batteries. No injuries have been reported.

Description: This recall involves RAYOVAC-branded replacement battery packs used with cordless power tools. “RAYOVAC,” “NI-CD” and a part number beginning with “CTL” are printed in white lettering on the product. The battery packs were sold in voltages ranging between 2.4 and 18 volts in various sizes and shapes. They were sold as replacement batteries to the following brand tools: Black and Decker, Bosch, DeWalt, Makita, Milwaukee, Panasonic, Ryobi and Skil.

Sold exclusively at: BatteriesPlus retail stores nationwide and online at www.batteriesplus.com between June 2008 and October 2011 for about $60.

Manufactured in: China

Remedy: Consumers should immediately stop using and remove the battery packs from cordless tools. Consumers can contact BatteriesPlus for instructions on how to return the product for a store credit.

Customer contact: For more information, contact BatteriesPlus toll-free at (877) 856-3232 between 9 a.m. and 4:30 p.m. CT Monday through Friday, or visit the firm’s website at www.batteriesplus.com

If you or anyone you know has been hurt by the Battery Plus Battery Packs, call us at: 877 882 0095

For original article see: http://www.cpsc.gov/cpscpub/prerel/prhtml12/12063.html?tab=recalls