Third Infant Ill With Bacteria That Led To Enfamil Being Pulled From Store Shelves

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Posted on 29th December 2011 by gjohnson in Uncategorized

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Just days after the manufacturer of Enfamil said its tests found the baby formula to be safe, a third infant has tested positive for a rare bacterial infection, according to Reuters.

http://www.huffingtonpost.com/2011/12/27/enfamil-recall_n_1171915.html?ref=parents&icid=maing-grid7|myaol|dl1|sec3_lnk1%26pLid%3D123522

An Oklahoma infant has come down with Cronobacter, a bacteria that has been found in some milk-based powdered baby formula, according to Reuters. 

Retailers such as Wal-Mart pulled Enfamil Premium formula off their shelves after one infant in Missouri died as a result of Cronobacter, and a second one in Illinois became ill with the bacteria, after having the formula. 

Those incidents lead to a probe of Enfamil by federal health officials as well as the formula’s maker, Mead Johnson Nutrition Co.  The baby in Oklahoma had not had Enfamil, and was treated and released, Reuters reported.

Over the weekend Mead Johnson announced that it had tested batches of the suspect Enfamil formula, and found no contamination.

  

 

Baby Formula Maker Claims Product, Suspected In Infant’s Death, Is Safe

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Posted on 25th December 2011 by gjohnson in Uncategorized

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The maker of Enfamil baby formula, which has been pulled from the shelves by retailers after a baby’s death, said Sunday that its tests didn’t find any deadly bacteria in the product.

In a statement, Mead Johnson Nutrition said it tested the same batch of formula that is  being tested by the Food and Drug Administration, which is investigating the cases of two babies in Missouri who fell ill after having the formula. One of them, 10-day-old infant Avery Cornett, died.    

http://www.nytimes.com/2011/12/26/business/baby-formula-is-called-safe.html?_r=1&pagewanted=print

Mead Johnson stated that it didn’t find any Cronobacter, a bacteria than can be lethal, in its formula. Cornett was diagnosed wth Cronobacter, as was a second baby who survived.

Last week retailers such as Wal-Mart, Walgreen, Kroger and Super-Valu pulled the formula, 12.5-ounce cans with the batch code ZP1K7G, off their shelves. They said  they were taking the precautionary measure until regulators tested the formula.

 http://online.wsj.com/article/SB10001424052970204552304577116651051958544.html?KEYWORDS=enfamil

On Sunday Mead Johnson officials told Bloomberg News that they didn’t know how long it would take the FDA and the Centers for Disease Control to complete their investigations.

Arizona Husband-And-Wife Doctors Awarded $12 Million In Defamation Case Against Patient

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Posted on 21st December 2011 by gjohnson in Uncategorized

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Usually patients sue and win judgments against doctors, but in Arizona last week a plastic surgeon and his doctor wife received a $12 million verdict against a patient, according to The Arizona Republic. They alleged that the patient defamed them on her website.

http://www.azcentral.com/community/scottsdale/articles/2011/12/16/20111216scottsdale-doctors-win-lawsuit.html

Following a trial, last week a jury awarded Dr. Albert Carlotti of Scottsdale and his wife, Dr. Michelle Cabret-Carlotti, $11 million in actual damages and $1 million in punitive damages from Sherry Petta, a local singer, The Republic reported.

In 2007 Petta had work — including a nose job – done by the Carlottis, who run the Desert Palm Surgical Group. But the relationship went sour when Petta, a jazz singer, alleged she got a skin infection after having work done by the Carlottis, according to The Republic.

In 2008 Petta launched a website that was critical of the husband-and-wife doctor team, prompting the Carlottis to sue her for defamation that same year. They obtained a temporary restraining order that directed Petta to immediately take down the website, The Republic reported.

But she did not relent. Petta filed a complaint against the Carlottis with the Arizona Medical Board, and would pop up at its public meetings to voice criticism of the two doctors. And she posted negative items about the Carlottis on various websites.

The Carlottis claimed that their medical practice took a nosedive, drawing less patients for cosmetic procedures, because of the false information that Petta posted about them on the Internet, The Republic reported.   

First Driver Distraction, Now ‘Doctor Distraction,’ Threatens Lives

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Posted on 16th December 2011 by gjohnson in Uncategorized

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Distracted driving had been a hot topic this year, with states and federal officials passing laws banning the use of cellphones and texting by drivers. But these devices are now being blamed for causing “distracted doctoring,” with physicians and nurses being accused of paying more attention to their new-media gear than their patients.

The New York Times Thursday outlined the problem in a Page One story, where it reported that “some hospitals have begun limiting he use of devices in critical settings, while schools have started reminding medical students to focus on patients instead of gadgets.”

http://www.nytimes.com/2011/12/15/health/as-doctors-use-more-devices-potential-for-distraction-grows.html

The Times quoted an official from the University of Rochester Medical Center who was disturbed by the doctors and nurses that he has spotted using iPhones, iPads and computers. That official, Dr. Peter Papadakos, authored a recent article on ”electronic distraction” for Anesthesiology News, according to The Times.

Another article in the medical journal Perfusion talked about research that found roughly half  of the techs who are in charge of bypass machines had chatted on their cellphones and texted during heart surgery.

If you believe these fears about doctor distraction are overstated, try this on for size. In Denver a patient whose left side became partly paralyzed after surgery filed a medical malpractive suit, The Times reported. Guess what the neurosurgeon was doing during the surgery? Talking on his cellphone via a wireless headset. The case was settled before trial.

In another eyebrow-raising anecdote, a doctor at Yale-New Haven Hospital told The Times that he has seen youthful anesthesiolgists in the OR using a compuer during surgery, for tasks such as checking their email. In the intensive care unit, this doctor has seen his colleagues use computers to shop on Amazon and eBay.

A hospital in Oregon, according to The Times, has made operating rooms “quiet zones” that prohibit multi-tasking that isn’t specificaly related to a patient.

As many of the doctors quoted by The Times said, computers and iPads are a boon that can help prevent errors by giving physicians immediate access to patient records and data.

But the patient must not be neglected while doctors fiddle with these devices during surgery.            

Illinois Hospital To Pay $7.5 Million Settlement For Girl With Cerebral Palsy

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Posted on 4th December 2011 by gjohnson in Uncategorized

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The grandparents of a 9-year-old girl who got cerebral palsy as the result of alleged malpractice at Christ Medical Center in Oak Lawn, Ill., will get a $7.5 million settlement, according to the Southtown Star. 

http://southtownstar.suntimes.com/news/9180559-418/advocate-agrees-to-75m-malpractice-award.html

 Advocate Health and Hospitals Corp., parent company of Christ Medical, agreed to the settlement of a lawsuit filed by Tom and Donna Tribble, legal guardians for Elliana Tribble. The suit, filed in 2009, alleged that the physicians and nurses at Christ Medical “delayed in responding to signs of fetal distress before” Elliana’s birth in August 2002, the Southtown Star reported Friday.

Elliana sustained brain damage from oxygen deprivation during her birth, and has cerebral palsy.

Under the settlement, the hospital does not admit any malpractice on the part of its staff, according to the Southtown Star. 

Tom and Donna Tribble, who live in Northbrook, Ill., are the parents of Elliana’s father, Sean Tribble. Sean and Joan Soka, Elliana’s parents, never got married, and the grandparents got custody of the child.

Elliana is disabled and in a wheelchair. Her grandparents told the Southtown Star that they will take part of the settlement to buy her a wheelchair that she will be able to steer with head movements and to make the doors in their home handicapped accessible.   

  

Family Awarded $1 Million From Medical Examiner’s Office That Kept Their Son’s Brain

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Posted on 27th November 2011 by gjohnson in Uncategorized

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Justice sometimes does triumph.

A Staten Island, N.Y., couple has won a $1 million judgment against the New York City Medical Examiner’s Office, which retained their dead son’s brain without their permission or knowledge, the New York Post reported Saturday.

http://www.nypost.com/p/news/local/staten_island/sitting_on_their_brains_rYp0ijgNEZRVOmtijfRMMK

In a macabre twist in an already freaky case, the parents of Jesse Shipley, 17, didn’t discover that they didn’t have his brain until some of his high school friends saw it in a marked jar during a field trip to Staten Island’s morgue.

Jesse was killed in a car crash in January 2005, and was autopsied by the local medical examiner. But the Medical Examiner’s Office returned Jesse’s body to his parents for burial without his brain, without mentioning that little tidbit to the Shipley family. Doctors wanted to perform tests on the organ, according to the Post.

Jesse’s family only learned that their son’s body was missing its brain when they buried it because of the shocking incident during the field trip. That when Jesse’s schoolmates chanced upon his brain in the jar, the Post reported.

Needless to say, the teens told Shipley’s surprised family what they had seen. If that wasn’t disturbing enough, ”a Catholic priest told the family that Jesse’s burial wasn’t proper without his brain,” according to the Post.

The family didn’t get the brain back until October 2005, and they subsequently filed suit against the Medical Examiner’s Office. The city was liable, according to a Staten Island Supreme Court judge, under the so-called right of sepulcher, which says that a family is entitled to all the remains of a relative, according to the Post.

The defense didn’t have a leg to stand on. The city apparently contended that Jesse’s father Andre Shipley “would have known his son’s brain were being kept for further testing if he’d known to ask,” the Post reported.

What?

It probably didn’t help the defense’s case, either, when a medical examiner said he keep Jesse’s brain hanging around in a jar because he waits until he has a half dozen brains before calling in a neuropathic examiner to study them, the Post said.

We hope in those other cases that the families knew their loved one’s brains had been withheld from them, unlike the Shipleys.

The Shipleys did lose one legal acton last year, when the family sued claiming that their son’s brain had been displayed unlawfully. An appellate court threw that claim out, the Post reported.     

 

Two Reports Explain Why Medical Malpractice Caps Hurt Consumers

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Posted on 19th November 2011 by gjohnson in Uncategorized

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Despite the rheroric of many lawmakers and the misconceptions of the public, putting caps on medical practice cases doesn’t hold down spiraling health care and insurance costs, according to two recent reports on the topic.  

“A Failed Experiment: Health Care in Texas Has Worsened in Key Respects Since State Instituted Liability Caps in 2003,” done by the public advocacy group Public Citizen, and “Can Mandatory Caps on Medical Malpractice Damages Harm Consumers?,” by the think tank the Cato Institute, were both released last month.  

http://www.citizen.org/documents/a-failed-experiment-report.pdf

http://www.cato.org/pubs/pas/pa685.pdf

And they both come to somewhat similar conclusions, namely that medical malpractice awards don’t drive up the cost of health care.

But what is disturbing in these reports is that consumers, people who have been harmed and have a cause of action against a medical provider, are being short-changed because of the caps. In fact, even worse, they are losing their ability to sue as lawyers shy away from bringing litigation that is expensive to try, with little potential reward.

The Public Citizen report dealt with Texas, which set a $250,000 limit on noneconomic damages for medical malpractice suits in 2003.

“A common misconception among policymakers and pundits is that medical malpractice litigation is significantly, or even chiefly, to blame for our country’s skyrocketing health care costs and steadily diminishing access to care,” the report said. “Those who blame malpractice litigation for the broken economics of our health care system typically tout laws limiting physicians’ liability as the answer.”

But the data in Texas doesn’t bear that out, despite the claims to the contrary by Texas Gov. Rick Perry,  who spearheaded the legislation limiting cap awards, according to the Public Citizen report.

“While litigation over malpractice in Texas has plummeted dramatically since the caps were imposed, residents of Texas (except for people with financial connections to liability insurance companies and, to a lesser extend, doctors) have realized few, if any, benefits. Instead, the health care picture in Texas has worsened significantly by almost any measure,” the report said.         

Since the Lone Star State imposed the caps, its Medicare spending has outpaced the national average. 

“Per enrollee spending for Medicare’s two main programs ranked second-highest in Texas among the 50 states in 2009,” the report said. “In 2003, Texas ranked seventh … These figures contradict the theory that medical malpractice litigation is driving health care costs.”

In addition, premiums for private health insurors have risen and outpaced the national average. Oh, by the way, the percent of Texans who are uninsured has also increased, “solidifying the state’s dubious distinction of having the highest uninsured rate in the country,” according to the report.

In addition, the per capita increase in the number of doctors practicing in Texas has been slower than prior years, and ”the prevalence of physicians in non-metropolitan areas has declined,” according to the report.

The cap in Texas appears to have been a boon to insurance companies and doctors. For one insuror, premiums for doctors were 50 percent less in 2010 versus 2003.  But the medical malpractice payments that insurors are issuing have dropped 74 percent, adjusted for inflation, from 2003 to 2010, the report said. That translates into a “windfall” for insurance companies, according to the report.

“But the benefits realized by these two groups have not translated into savings for regular Texans or for the taxpayers who  fund Medicare,” the report said.

The Public Citizen report is very detailed, and it all can’t be presented here. But one of the highlights is the section on health insurance premiums. Caps have not kept those costs down.

“Although health insurance costs in Texas have not outpaced national rates as dramatically as have Medicare expenditures in the state, they have risen faster than the national average since the caps were imposed,” according to the report. “Family health insurance premiums in Texas rose by 51.7 percent between 2003 and 2010. Nationally, they rose by 50 percent. Since 2004, health insurance premiums in Texas have risen 13.1 percent faster in Texas than nationally.”

Here are the report’s conclusions.

“Despite the sales campaign to promote Texas as an exhibit of the merits of limiting doctors’ liability for mistakes, the real world data tell the opposite story. Health care in Texas has become more expensive and less accessible since the state’s malpractice caps took effect.

The beneficiaries of the new system are the doctors who escape accountability for their errors and the liability insurance  companies that reap a windfall of inflated premiums. Regular Texans are the losers. They include not only the victims of medical malpractice who are deprived of the chance to recover damages but also the taxpayers who must foot the bill for the future medical costs of seriously injured patients.”

That conclusion is similar to the one made in the study by the Cato Institute, on whether mandatory caps on medical malpractice damages harm consumers. The executive summary of that report makes its position pretty clear.

“Supporters of capping court awards for medical malpractice argue that caps will make health care more affordable,” the Cato report said. “It may not be that simple.”

That’s the understatement of the year.

“First, caps on awards may result in some patients not receiving adequate compensation for injuries they suffer as the result of physician negligence,” the Cato report said.

“Second, because caps limit physician liability, they can also mute incentives for physicians to reduce the risk of negligent injuries,” the report added.

And contrary to what supporters of caps claim, “medical malpractice awards do track actual damages,” according to the Cato report.

But here is the heart of the matter, from the report.

“If the medical malpractice liability insurance industry does indeed protect consumers, then policies that reduce liability or shield physicians from oversight by carriers may harm consumers,” it said.

In its conclusion, the Cato report said that patients are protected by a interdependent system of oversight that includes evaluations, hospital oversight and the medical malpractice industry.

“Underlying nearly all of these activities is the threat of legal liability for negligent injuries,” the report said. “Reducing physician liability for negligent care by capping court awards, all else equal, will reduce the resources allocated to medical professional liability underwriting and oversight and make many patients worse off. Legislators who see mandatory liability caps as a cost-containment tool should look elsewhere.”

Amen.           

                      

Victims, Survivors Of Fort Hood Massacre Seek $750 Million Compensation From Army

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Posted on 12th November 2011 by gjohnson in Uncategorized

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Did the U.S. Army ignore the increasingly obvious radicalization of a Muslim psychiatrist at Fort Hood, Texas., out of political correctness? And did that alleged negligence lead to the worst-ever mass shooting at an American military installation?  And if there was negligence, does it add up to $750 million in compensation?

Those are the issues that have to be decided in response to administrative claims filed by 83 victims and family members involved in the Nov. 5, 2009, massacre engineered by Major Nidal Hasan, according to the Associated Press. He is awaiting trial on charges of the premeditated murder of 13 soldiers and civilians, as well as 32 counts of attempted premeditated murder for those he wounded.

http://www.washingtonpost.com/politics/apnewsbreak-83-victims-family-members-seek-750m-for-preventable-fort-hood-tragedy/2011/11/10/gIQALoqL9M_story.html

The attorney representing the claimants, Neal Sher, told AP Hasan has been the only one able to commit a terrorist attack in the United States since 9/11.

Claims have been filed by: 54 relations of eight of the soldiers that were slain; one civilian police officer and nine wounded soldiers; and 19 people related to the police officer and wounded soldiers.

One of the police officers who shot Hasan and ended his murderous rampage, Sgt. Kimberley Munley, is among those who have filed claims, AP reported. She was wounded during her exchange with Hasan, and has had to leave law enforcement. She is currently on unpaid leave.

In a statement, Munley said that she believes the tragedy at Fort Hood could have been prevented if the Army hadn’t “swept under the rug” all the warnng signals it had about Hasan. And she’s got a good point.

Hasan had become increasingly vocal and radical, outspoken in his growing support of Islamist extremism and the violence that comes with it. At one point, according to AP, this American-born Muslim defended of suicide bombings.   

Authorities believe that Hasan’s deadly actions were prompted by his association with American-born Anwar al-Awlaki, AP reported, and both men had exchanged emails. A U.S. drone killed al-Awlaki in September.

With his actions before the slaughter, Hasan was essentially walking around with a sign that said “I’m dangerous, stop me.” But no one in the Army did.

Someone in an airport saying the things that Hasan was saying on a military base would be locked up. Yet he got away with it. Perhaps the military didn’t want to appear as if it was profiling or harassing Muslims in the service. 

As a result, 13 people are dead.    

Glaxo To Pay U.S. Record $3 Billion Settlement Of Probes Into Its Sales Practices

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Posted on 5th November 2011 by gjohnson in Uncategorized

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In what will be the largest settlement of its kind, GlaxoSmithKline plc has reached a deal to pay $3 billion to resolve a variety of pending criminal and civil probes into its marketing of drugs for unapproved uses.

But some consumer advocates were arguing that an executive from the drug giant should be going to prison for what happened.

The British pharmaceutical giant issued a press release Thursday announcing the agreement in principle with the U.S. government.

http://www.gsk.com/media/pressreleases/2011/2011-pressrelease-710182.htm

That settlement will put an end to “significant ongoing Federal government investigations, specifically: the investigation into GlaxoSmithKline’s sales and marketing practices begun by the US Attorney’s office of Colorado in 2004 and later taken over by the US Attorney’s Office of Massachusetts;  the U.S. Department of Justice’s investigation of possible inappropriate use of the nominal price exception  under the Medicaid Rebate Program;  and the Department of Justice’s investigation of the development and marketing of Avandia.”

Avandia is a medication for diabetes whose use in the United State was restricted last year after it was tied to an increased risk of heart attacks.

“Federal prosecutors said the company had paid doctors and manipulated medical research to promote the drug,” The New York Times reported. 

http://www.nytimes.com/2011/11/04/business/glaxo-to-pay-3-billion-in-avandia-settlement.html?_r=1

The GlaxoSmithKline settlement tops the previous highest, when Pzifer paid $2.3 million in 2009, according to The Times. Both cases involved the illegal marketing of drugs.  

The final GlaxoSmithKline settlement, which is expected to address civil and criminal liabilities, remains subject to negotiation of specific terms and is expected to be finalized in 2012.  The company  expects to make payments under the final agreement in 2012.

“This is a significant step toward resolving difficult, long-standing matters which do not reflect the company that we are today,” GlaxoSmithKline CEO Andrew Witty said in a statement. “In recent years, we have fundamentally changed our procedures for compliance, marketing and selling in the U.S. to ensure that we operate with high standards of integrity and that we conduct our business openly and transparently. We reiterate our full commitment to ensuring appropriate promotion of our medicines to healthcare professionals and to the standards rightly expected by the U.S. government.”

In its press release, GlaxoSmithKline made the case that it has remedied issues relating to its sales practices.

“Since 2008, GSK has established a new framework for compliance in the U.S., based on the company’s values, policies and established industry codes of practices,” the company said. “It is supported by a larger compliance staff and strengthened training programs that require certification by employees.”

GlaxoSmithKline also said that it had undertaken other changes in its commercial procedures, “including the implementation of a new incentive compensation system for its professional sales representatives who work directly with health care professionals.”

The pharmaceutical giant said, “The new system eliminates individual sales targets as a basis for bonuses, and instead bases incentive compensation on the quality of the service these representatives deliver to customers to support improved patient health.  The Company’s U.S. Commercial Practices Policies now meet or exceed the US PhRMA Code governing interactions with healthcare professionals.”

The drug firm ended its press release with this self-righteous comment, which is rather ironic when one considers what the company was under investigation for allegedly doing.

“GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.”

The Times noted that last year, a former attorney for GlaxoSmithKline, Lauren Smith, was tried and acquited of charges of obstruction of justice and making false statement relating to the accusations against the drug giant.

According to Bloomberg News, the settlement covered both a Justice Department probe of the marketing of Avandia and also GlaxoSmithKline and a federal Medicaid rebate program.   

http://www.bloomberg.com/news/2011-11-03/glaxo-agrees-to-pay-3-billion-to-settle-u-s-probe-into-sales-marketing.html
 

“Drugmakers are required to give rebates to Medicaid, the government health incurance program for the poor,” Bloomberg wrote. “The investigation examined how Glaxo reported prices charged to other payers, which are used in calculating the Medicaid rebates.”

The financial wire service also noted that GlaxoKlineSmith’s compensation system for its sales reps had been changed to eliminate “the link between sales goals and bonuses, which are now based on selling competency, customer evaluations and overall performance ot the representative’s business unit.”

All in all, we’d have to say that we agree with the consumer groups: GlaxoSmithKline got off easy.  

Pediatricians Nix Use Of Crib Bumper Pads For Infants

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Posted on 29th October 2011 by gjohnson in Uncategorized

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The American Academy of Pediatrics (AAP) this month updated its recommendations of ways to prevent sleep-related deaths for infants, and as part of that move it is now suggesting that crib bumper pads not be used by parents. 

http://www.aap.org/pressroom/sids.pdf

“Bumper pads should not be used in cribs,” the AAP said. “There is no evidence that bumper pads prevent injuries, and there is a potential risk of suffocation, strangulation or entrapment.”

In its press release, the AAP also said that when it recommended all babies should be placed on their backs to sleep in 1992, deaths from Sudden Infant Death Syndrome (SIDS) have declined dramatically. But it said that sleep-related deaths from other causes, including suffocation, entrapment and asphyxia, have increased.

In an updated policy statement and technical report, the AAP expanded its guidelines on safe sleep for babies.

“We have tried to make it easier for parents and providers to understand the recommendations by providing specific answers to common questions,” said Dr. Rachel Moon, chair of the AAP SIDS task force and lead author of the new guidelines. “As a health care community, we need to do a better job translating what the research identifies as ‘best practices’ into the day-to-day practice of caring for infants in both the hospital and home environment.”

The policy statement, “SIDS and Other Sleep-Related Infant Deaths: Expansion of Recommendations for a Safe Infant Sleeping Environment,” and an accompanying technical report, were unveiled Oct. 18 at the AAP National Conference & Exhibition in Boston.

The policy statement and technical report provide global recommendations for education and safety related to SIDS risk reduction. In addition, the AAP is providing recommendations on a safe sleeping environment that can reduce the risk of all sleep-related infant deaths, including SIDS.

Three important additions to the recommendations included: Breastfeeding is recommended and is associated with a reduced risk of SIDS; and infants should be immunized because evidence suggests that immunization reduces the risk of SIDS by 50 percent.

“It is important for health care professionals, staff in newborn nurseries and neonatal intensive care units, and child care providers to endorse the recommended ways to reduce the risk of SIDS and other sleep-related deaths, starting at birth,” Dr. Moon said. “There needs to be more education for health care providers and trainees on how to prevent suffocation deaths and to reduce SIDS and other sleep-related infant deaths – our goal is to ultimately eliminate these deaths completely.”

The report also included these recommendations:

1. Always place your baby on his or her back for every sleep time.
2. Always use a firm sleep surface. Car seats and other sitting devices are not recommended for routine sleep.
3. The baby should sleep in the same room as the parents, but not in the same bed (room-sharing without bed-sharing).
4. Keep soft objects or loose bedding out of the crib. This includes pillows, blankets and bumper pads.
5. Wedges and positioners should not be used.
6. Pregnant woman should receive regular prenatal care.
7. Don’t smoke during pregnancy or after birth.
8. Breastfeeding is recommended.
9. Offer a pacifier at nap time and bedtime.
10.  Avoid covering the infant’s head or overheating.
11. Do not use home monitors or commercial devices marketed to reduce the risk of SIDS.
12. Infants should receive all recommended vaccinations.
13. Supervised, awake tummy time is recommended daily to facilitate development and minimize
the occurrence of positional plagiocephaly (flat heads).