H & P Industries Povidine Iodine Prep Pads: Recall -

Potential Microbial Contamination

Including products under brand names Cardinal Health, Medical Specialties, VHA, Triad, Triad Plus, North Safety, Total Resources

[Posted 03/18/2011]

AUDIENCE: Pharmacy, Consumer, Risk Manager

ISSUE: H&P industries, Inc., a manufacturer of over-the-counter products, initiated a voluntary product recall of ALL LOTS of Povidine Prep Pads manufactured by H&P Industries, Inc. but which are private labeled for many accounts. Analytical testing showed the presence of Elizabethkingia meningoseptica. Use of contaminated Povidine Prep Pads could lead to life-threatening infections, especially in at risk populations, including neonates, immune suppressed patients, and surgical patients. Treatment options are limited for Elizabethkingia meningoseptica infections.

BACKGROUND: Povidine Iodine Prep Pads are used to prevent infection in minor cuts, scrapes and burns and are labeled as an antiseptic for preparation of the skin prior to surgery. They were distributed nationwide to healthcare customers and are packaged in individual packets and sold in a box of 100 packets.

RECOMMENDATION: Healthcare organizations should contact H&P Industries Customer Service to arrange a return. If a consumer has any of these types of products in their possession, they should not use the product.

 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm247743.htm

Cervical Collars are Insufficient for Immobilizing an Unstable Cervical Spine Injury
14 March 2011
MaryBeth Horodyski, Christian P. DiPaola, Bryan P. Conrad, Glenn R. Rechtine
Journal of Emergency Medicine

Study Objectives: The extent to which cervical orthoses immobilize the cervical spine in a cadaveric model with and without a spinal instability.

Results: Neither the one- nor the two-piece collar was effective at significantly reducing segmental motion in the stable or unstable condition. There was dramatically more motion in the unstable state……

Conclusion:  Cervical collar is better than no immobilization.  Collars do not effectively reduce motion in an unstable cervical spine cadaver model. http://www.jem-journal.com/article/S0736-4679%2811%2900171-5/abstract

Massive Hemothorax after Blunt Transverse Cervical Artery Injury
Published online: 14 March 2011
Shinsuke Tanizaki, Hiroyuki Hayashi
DOI: 10.1016/j.jemermed.2011.01.017
Journal of Emergency Medicine

Link:  http://www.jem-journal.com/article/S0736-4679%2811%2900170-3/abstract

Over Reliance on Computed Tomography Imaging in Patients With Severe Abdominal Injury: Is the Delay Worth the Risk?

http://www.indianapolisrecorder.com/health/article_4e69643e-50af-11e0-81f5-001cc4c002e0.html

New CPR devices improve survival after cardiac arrest

Thursday, March 17, 2011 11:59 am | Updated: 11:59 am, Thu Mar 17, 2011.

 Special to the Recorder Indianapolis Recorder |

“……..From February 2005 to July 2009 at seven study sites nationwide, a total of 3,032 cardiac arrest patients were enrolled in the study. Patients were treated with either standard CPR or CPR with the ResQPump/ResQPOD device combination. These devices, which are made by Advanced Circulatory Systems Inc. in Roseville, Minn., are designed to improve chest compressions and increase circulation during CPR. Patients who met the final study criteria were included in the primary analysis population.

The results showed that patients treated with the devices had an 8.9 percent survival-to-hospital- discharge rate with good neurologic function, compared to a 5.8 percent survival rate in patients who were treated with standard CPR, a 53 percent relative improvement in the device group…….”

http://www.washingtonpost.com/local/education/dc_elementary_students_sickened_by_cocaine/2011/03/17/AB4CPum_story.html?wprss=rss_homepage

Washington Post, 3/17/11

D.C. elementary students sickened by cocaine

By Bill Turque, Thursday, March 17, 9:52 PM

“A D.C. elementary school student was charged with possession of a controlled substance Thursday after being accused of taking cocaine to school and sharing it with four classmates who were hospitalized after ingesting the drug…..”

http://www.medicalnewstoday.com/articles/218874.php

Medical News Today

“NewCardio Study Of My3KG Performance In Diagnosis Of AMI Selected For Presentation At The Society For Academic Emergency Medicine Annual Meeting…..NewCardio’s innovative 3-D ECG platform technology dramatically improves the accuracy and significantly increases the diagnostic value of the standard 12L ECG…..”

http://www.newcardio.com/products-my3KG.php

“….my3KG™ extracts additional information from standard 12-lead ECG signals and uses it to generate a 3D representation of cardiac electrical activity as a function of time. To further enhance understanding and ease of use, the program superimposes the diagnostically relevant electrical information on an intuitive, revolving 3-D anatomic model of the heart…..Importantly, however, my3KG™ requires no change in standard 12-lead ECG practice. The ECG is obtained exactly as it is now, with the electrodes placed in the same locations without need for additional electrodes. Moreover, my3KG™ displays the standard 12-lead ECG along with its novel 3-D analytical presentations. This allows the physician to make correlations between displays and provides reassurance that no information has been lost.”

http://www.hhs.gov/news/press/2011pres/02/20110224b.html

News Release

Massachusetts General Hospital settles potential HIPAA violations

Large hospital system to improve policies and procedures safeguarding patient information

The General Hospital Corporation and Massachusetts General Physicians Organization Inc. (Mass General) has agreed to pay the U.S. government $1,000,000 to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule, the U.S. Department of Health and Human Services (HHS) announced today.

Mass General, one of the nation’s oldest and largest hospitals, signed a Resolution Agreement with HHS that requires it to develop and implement a comprehensive set of policies and procedures to safeguard the privacy of its patients. The settlement follows an extensive investigation by the HHS Office for Civil Rights (OCR), which enforces the HIPAA Privacy and Security Rules. The HIPAA Privacy Rule requires health plans, health care clearinghouses and most health care providers (covered entities) to protect the privacy of patient information through administrative, physical and technical safeguards at all times.

“We hope the health care industry will take a close look at this agreement and recognize that OCR is serious about HIPAA enforcement. It is a covered entity’s responsibility to protect its patients’ health information,” said OCR Director Georgina Verdugo.

The incident giving rise to the agreement involved the loss of protected health information (PHI) of 192 patients of Mass General’s Infectious Disease Associates outpatient practice, including patients with HIV/AIDS. OCR opened its investigation of Mass General after a complaint was filed by a patient whose PHI was lost on March 9, 2009. OCR’s investigation indicated that Mass General failed to implement reasonable, appropriate safeguards to protect the privacy of PHI when removed from Mass General’s premises and impermissibly disclosed PHI potentially violating provisions of the HIPAA Privacy Rule.

The impermissible disclosure of PHI involved the loss of documents consisting of a patient schedule containing names and medical record numbers for a group of 192 patients, and billing encounter forms containing the name, date of birth, medical record number, health insurer and policy number, diagnosis and name of providers for 66 of those patients. These documents were lost on March 9, 2009, when a Mass General employee, while commuting to work, left the documents on the subway train that were never recovered.

Mass General also agreed to enter into a Corrective Action Plan (CAP), which requires the hospital to:

• Develop and implement a comprehensive set of policies and procedures that ensure PHI is protected when removed from Mass General’s premises;
• Train workforce members on these policies and procedures; and
• Designate the Director of Internal Audit Services of Partners HealthCare System Inc. to serve as an internal monitor who will conduct assessments of Mass General’s compliance with the CAP and render semi-annual reports to HHS for a 3-year period.

“To avoid enforcement penalties, covered entities must ensure they are always in compliance with the HIPAA Privacy and Security Rules,” said Verdugo. “A robust compliance program includes employee training, vigilant implementation of policies and procedures, regular internal audits, and a prompt action plan to respond to incidents.”

The HHS Resolution Agreement and CAP can be found on the OCR website at http://www.hhs.gov/ocr/privacy/hipaa/news/mghnews.html.

Additional information about OCR’s enforcement activities can be found at http://www.hhs.gov/ocr/privacy/hipaa/enforcement/examples/index.html.

Microbiology and Antibiotic Management of Orbital Cellulitis
L Barry Seltz, Jesse Smith, Vikram D Durairaj, Robert Enzenauer, and James
Todd
Pediatrics 2011;127 e566-e572
http://pediatrics.aappublications.org/cgi/content/abstract/127/3/e566?etoc

http://www.cdc.gov/features/dsADHD/?source=govdelivery

A million more kids had a parent-reported ADHD diagnosis in 2007 compared to 2003; a 22% increase in 4 years. 4.1 million had a current diagnosis in 2007; 2.7 million were taking ADHD medications.

Attention-deficit/hyperactivity disorder (ADHD) is the most common neurobehavioral disorder of childhood, and often persists into adulthood. Children with ADHD have trouble paying attention, controlling impulsive behaviors (may act without thinking about what the result will be) and, in some cases, are overly active. CDC’s Morbidity and Mortality Weekly Report has published a new study: “Increasing prevalence of parent-reported attention-deficit/hyperactivity disorder among children: United States, 2003-2007.”

A 2003 survey of parents (the National Survey of Children’s Health) found an estimated 7.8% of children in the US aged 4-17 years had ever been given a diagnosis of ADHD. This new CDC study looked at the results of the second administration of the National Survey of Children’s Health in 2007.

This study found that the rate of parent-reported ADHD diagnosis among children 4-17 years of age increased by 22% between 2003 and 2007, from 7.8% to 9.5%. It also noted that the patterns of parent-reported ADHD diagnosis are changing in the United States.

Parents of an estimated 5.4 million children in the United States reported a history of ADHD diagnosis in 2007. That is nearly one in ten school-age children who had been given an ADHD diagnosis; a million more children than were reported in 2003.

Twelve states had significant increases in parent-reported ADHD, suggesting variation in diagnostic practice that may be determined by state-specific factors. In 2007, rates ranged from a low of 5.6% in Nevada to a high of 15.6% in North Carolina.

Approximately three quarters (78%) of children with a history of an ADHD diagnosis currently had the condition, 4.1 million children in total. Of these children, 2.7 million were currently taking medication for ADHD.

Among older teens, parent-reported ADHD diagnosis increased by 42% and among Hispanic children it increased 53%, suggesting that the epidemiology of ADHD in the United States may be changing. Hispanics have historically had some of the lowest rates of ADHD. Although still lower than non-Hispanics, the relatively large magnitude of change noted in this study suggests that there may have been a shift in the cultural perception of the disorder or a change in diagnostic practice for Hispanics.

Studies indicate that boys are more likely to be diagnosed with the disorder as compared to girls. Consistent with those studies, our two MMWR reports on ADHD indicate a male:female ratio of about 2.5:1.

Children with ADHD are more likely to have problems in school, have strained family and peer relationships, and suffer more injuries than children without ADHD. Adults who were children with ADHD are more likely to be underemployed, more likely to enter the justice system, and more likely to have marriages that end in divorce.

Treatment guidelines have been developed by the American Academy of Pediatrics and the American Academy of Child and Adolescent Psychiatry. Both recommend a combination of behavioral and medical (medication) interventions, depending on severity, functional impact, and family preference.

Data Source

CDC. Increasing Prevalence of Parent-Reported Attention-Deficit/Hyperactivity Disorder Among Children — United States, 2003 and 2007. MMWR 2010;59(44);1439-1443.

“Toenail Nicotine Level as a Novel Biomarker for Lung Cancer Risk.”
Wael K Al-Delaimy and Walter C Willett
Am. J. Epidemiol. kwq446, first published online 2 March 2011
DOI:10.1093/aje/kwq446

http://www.nytimes.com/2011/03/08/nyregion/08hcg.html?nl=todaysheadlines&emc=tha2

NY Times

By ANEMONA HARTOCOLLIS

“…..Ms. Brown, 35,…..believes that by combining the hormone injections with a 500-calorie-a-day diet, she will achieve a kind of weight-loss nirvana: losing fat in all the right places without feeling tired or hungry. “I had a friend who did it before her wedding,” Ms. Brown said. “She looks great.”

Women……are streaming into doctors’ offices and weight-loss clinics all over the country, paying upward of $1,000 a month for a consultation, a supply of the hormone and the syringes needed to deliver it……. there is scant evidence that it makes any difference.

The regimen combines daily injections with a near-starvation diet, and patients, mostly women, are often enticed by promises that they can lose about a pound a day without feeling hungry. Perhaps even more seductively, they are frequently told that the hCG will prompt their bodies to carry away and metabolize fat that has been stored where they least want it — in their upper arms, bellies and thighs…..”

http://consumer.healthday.com/Article.asp?AID=650341

1 in 5 Patients at California ERs Leaves Without Being Seen

While nationwide trends are unclear, experts blame state’s situation on overcrowding, ER closures

By Alan Mozes
HealthDay Reporter

FRIDAY, March 4 (HealthDay News) –” Upwards of one-fifth of patients who seek care at one of California’s hospital emergency departments leave before being seen by anyone, new research reveals….”

SOURCES: Renee Y. Hsia, M.D., assistant professor, department of emergency medicine, University of California, San Francisco, and attending physician, ER, San Francisco General Hospital; Marshall Morgan, M.D., chief, emergency medicine, Ronald Reagan UCLA Medical Center, Los Angeles; Feb. 22, 2011, Annals of Emergency Medicine, online

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm245902.htm

FDA PRESS RELEASE

For Immediate Release: March 5, 2011
Media Inquiries: Siobhan DeLancey, 301-796-4668, siobhan.delancey@fda.hhs.gov 
                        Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA: E. coli O157:H7 cases linked to hazelnuts
DeFranco & Sons voluntarily recalling in-shell hazelnuts and mixed-nut products in bulk and bags

Fast Facts

• DeFranco & Sons of Los Angeles, Calif. is voluntarily recalling bulk and consumer-packaged in-shell hazelnuts and mixed-nut products containing in-shell hazelnuts.
• The recalled products are linked to seven cases of Escherichia coli O157:H7 in Michigan, Minnesota and Wisconsin and may cause serious illness.
• Consumers who have purchased bulk in-shell hazelnuts or mixed-nut products containing in-shell hazelnuts should check with the retailer to determine if they are subject to the recall, or throw the nuts away.

What is the Problem?
DeFranco & Sons is voluntarily recalling in-shell hazelnuts, also called filberts, and mixed nuts containing in-shell hazelnuts that have been linked to seven cases of E. coli O157:H7 in Michigan, Minnesota and Wisconsin. These nuts were distributed nationwide and to Canada Nov. 2 to Dec. 22, 2010. The in-shell hazelnuts may have been sold in 2-pound and 4-pound packages of mixed nuts, 1-pound packages containing only in-shell hazelnuts or in open bins of nuts in grocery stores.

What are the Symptoms of Illness/Injury?
Most people infected with E. coli O157:H7 develop diarrhea (often bloody) and abdominal cramps 2-8 days (3-4 days, on average) after swallowing the organism, but some illnesses last longer and are more severe. Infection is usually diagnosed by stool sample culture. While most people recover within a week, some develop a severe infection. A type of kidney failure called hemolytic uremic syndrome (HUS) can begin as the diarrhea is improving; this can occur among persons of any age but is most common in children under 5 years old and the elderly. Signs and symptoms of HUS may include: fever, abdominal pain, pale skin tone, fatigue and irritability, small, unexplained bruises or bleeding from the nose and mouth, decreased urination and swelling of the face, hands, feet, or entire body. Persons who experience these symptoms and believe they are at risk for HUS should seek emergency medical care immediately.

Who is at Risk?
E. coli O157:H7 can cause serious and sometimes fatal infections in young children, frail or elderly people and others with weakened immune systems.

What Do Consumers Need To Do? 
Don’t eat recalled in-shell hazelnuts and mixed nuts containing in-shell hazelnuts. Consumers are advised to follow recall instructions and check with the retailer to see if the bulk nuts they purchased are among those being recalled, or throw the product away. Consumers should check the 1-pound, 2 pound and 4-pound products to see if the brand name and “Sell by Date” matches those listed below.

What Does the Product Look Like?
DeFranco & Sons received the in-shell hazelnuts from other suppliers and growers. In some cases, the in-shell hazelnuts were mixed and packaged with other nuts. The products were subsequently distributed nationwide and to Canada. The affected products listed below were distributed between Nov. 2, 2010 and Dec. 22, 2010.

The 50-pound bags of in-shell hazelnuts or mixed nuts with in-shell hazelnuts may have been repacked into smaller packages by other firms or sold from bulk containers to consumers. 

Where is it Distributed?
The affected nuts may have been sold by retailers nationwide and in Canada.      

What is Being Done about the Problem?
The FDA became of aware of the problem in late February and is actively working with the Centers for Disease Control and Prevention (CDC) and public health and agricultural agencies in those states where illnesses have occurred to investigate the source of the contamination. The investigation is still ongoing. The FDA is also working with state authorities to take appropriate action to address any product that may be remaining on the market. The FDA has also shared information with Canadian authorities about the problem.

Who Should be Contacted?
Consumers with questions about this recall should contact DeFranco & Sons at 1-800-992-3992 Monday through Friday from 2:00 p.m. to 4:00 p.m. Pacific time.

The FDA encourages consumers with questions about nut safety to call 1-888-SAFEFOOD.

The information in this press release reflects the FDA’s best efforts to communicate what it has learned from the distributer and the state and local public health agencies involved in the investigation. The agency will update this page as more information becomes available.

For more information:

• DeFranco & Sons press release¹
• CDC press release²
• California Department of Public Health press release³
• Minnesota Department of Health press release⁴
• Wisconsin Department of Health Services press release⁵
• FoodSafety.gov⁶
• CDC: Information about E. coli

http://www.fda.gov/Safety/Recalls/ucm245897.htm

Recall — Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Unilever Announces Recall of Skippy® Reduced Fat Peanut Butter Spread Due to Possible Health Risk Limited Recall of 6 Best-If-Used-By Dates

Contact:
Media Contact:
Anita Larsen
201-894-7760

Consumers:
800-453-3432

FOR IMMEDIATE RELEASE – March 4, 2011 – Unilever United States, Inc. today announced a limited recall of Skippy® Reduced Fat Creamy Peanut Butter Spread and Skippy® Reduced Fat Super Chunk Peanut Butter Spread, because it may be contaminated with Salmonella, an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

The recall is being conducted in cooperation with the U.S. Food and Drug Administration (FDA). No other Skippy® products are affected by this recall.

The product was distributed to retail outlets in Arkansas, Connecticut, Delaware, Illinois, Iowa, Maine, Minnesota, Missouri, Nebraska, New Hampshire, New Jersey, New York, North Dakota, Pennsylvania, Virginia and Wisconsin.

The affected product, which is packaged in 16.3 oz plastic jars, is as follows:

• UPCs: 048001006812 and 048001006782 (located on the side of the jar’s label below the bar code.)
• Best-If-Used-By Dates: MAY1612LR1, MAY1712LR1, MAY1812LR1, MAY1912LR1, MAY2012LR1 and MAY2112LR1 (Stamped on the lid of the jar.)

To date, no illnesses related to this issue have been reported.

The recall was initiated as the result of a routine sampling program by the company, which revealed that these finished products may contain the bacteria.

Consumers who have purchased Skippy® Reduced Fat Peanut Butter Spread with the above UPCs and Best-If-Used-By-Dates are urged to discard the product immediately and call the company for a replacement coupon. Consumers can contact the company at 1-800-453-3432, which is operational 24 hours a day, for information on the recall. In addition, a consumer services representative is available Monday through Friday between the hours of 8:30 AM and 6:00 PM EST.