Hospira says FDA blocks import of Symbiq infusion pump

(Reuters) – The U.S. Food and Drug Administration has prohibited Hospira Inc from importing its Symbiq medication infusion pumps, which are manufactured in Costa Rica, into the United States, the company said Tuesday in a regulatory filing.

Hospira in the filing did not say why the FDA imposed the restriction. A Hospira spokesperson could not be immediately reached.

The company said the FDA’s action does not restrict importation of its other medication management products, and the company does not expect it will have a material impact on its ability to achieve its 2012 financial projections.

In August, Hospira announced it received a warning letter from the FDA over quality problems at the Costa Rica plant where it makes most of its infusion pumps. Among the issues cited were alarm failures on the company’s Plum brand of infusion pump.

At the time, the company said it was switching alarm components for the Plum pump, which was recalled in February 2011, and expected to complete that process by early 2013.

Hospira on November 7 said it had placed a voluntary hold on shipments of the Symbiq pumps to new U.S. customers. A day later, the FDA notified the company of the import restriction, Hospira said.

Last month, the FDA said some Symbiq models were recalled due to software issues after Hospira received reports from customers of touch screens that were not responsive, delaying therapy.

The Lake Forest, Illinois-based maker of medical devices and injectable specialty drugs said it will support the repair and replacement of Symbiq pumps to existing customers.

Hospira has been working for several years to resolve manufacturing issues at some of its plants. In February, it resumed production of injectable drugs at its Rocky Mount, North Carolina, plant after a maintenance shutdown. Manufacturing problems at that plant had let to shortages of anesthesia and other drugs for its customers.

Hospira shares were little changed in after-hours trading from Tuesday’s close of $ 29.60 on the New York Stock Exchange.

(Reporting by Susan Kelly in Chicago; Editing by Leslie Adler and Phil Berlowitz)

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Best Buy CEO sets goals; Wall Street begs for more details

(Reuters) – Best Buy Co Inc hopes to triple its operating margins over time, the company said on Tuesday, though investors and analysts were left wanting for details on how – and how soon – the new chief executive would turn around the world’s largest consumer electronics chain.

The aggressive new targets come as Best Buy faces cut-throat competition from online and discount retailers like Wal-Mart Stores Inc and Amazon.com Inc .

CEO Hubert Joly got a difficult reception at an investor day in New York, as people questioned whether management was focusing too much on wringing higher sales out of existing customers rather than attracting new ones. Joly was named CEO on August 20.

“I still think I am a little bit mixed on digesting the take-aways of the presentation. I think they said a lot of good things, but I think people were looking for a little bit more of a playbook and the next steps,” said John Tomlinson, an analyst with ITG Investment Research, in New York. “There’s a lot of pieces to the fixing story that seemed a little opaque and vague.”

Best Buy’s stock closed nearly 1 percent lower at $ 15.70 on Tuesday, continuing a slide that has knocked off a third of the company‘s market capitalization this year. The stock touched a 10-year low of $ 14.39 a week ago.

Dimitri van Toren, senior portfolio manager at Dutch asset manager Syntrus Achmea, which holds about 200,000 Best Buy shares, said he was worried about structural issues and a “management vacuum” at the retailer, but that he would stay in the stock despite concerns about the upcoming holiday season.

The meeting took place against the backdrop of a potential buyout offer from founder and former CEO Richard Schulze, who is expected to make an offer as soon as next month.

“I spend no time worrying about what our corporate structure will be,” Joly told reporters after the event. “I tend to focus on decisions I can influence rather than decisions I can’t influence.”

A representative for Schulze did not immediately respond to a request seeking his thoughts on Joly’s plan.

Joly said “it would have been ridiculous” to offer more concrete details after only a few weeks on the job. He said this meeting was more about setting the record straight and reassuring investors about the company’s future.

“The perception was that Best Buy was dying,” Joly said.

MARGIN TARGETS

In a statement on Tuesday, the company said its short-term goal will be “to stabilize and then begin increasing its comparable-store sales and operating margin.” Over time, it is aiming for a return on invested capital of 13 percent to 15 percent, in addition to a 5 percent to 6 percent operating margin target.

In the last fiscal year, Best Buy had an operating margin of about 2.1 percent. The last time that margin exceeded 5 percent was in the fiscal year that ended in early 2008.

Joly said a mixture of excessive costs and price competition hurt margins, and that the retailer would turn to a wider variety of higher-margin, private-label products to boost results. One example is the company’s own Insignia-brand electronics.

Best Buy has been struggling to combat a phenomenon known as “showrooming,” where people visit its stores to look at products and then buy them online for less.

Joly acknowledged the company has suffered from a “price perception issue” among customers that it needed to address, as well as weakness in its online operations.

The head of the company’s digital business said its online conversion rate – which measures how successfully Best Buy translates customer visits into actual sales – was only about half of what it should be.

“Many of these problems are a result of our own making,” Joly said during the investor presentation.

HOLIDAYS COMING

Best Buy also said on Tuesday that it would pursue a plan to “optimize its store footprint on an ongoing basis,” which suggested the company may look at ways to shrink or close stores, as some other big-box retailers have done. In late March, the company said it would close 50 large U.S. stores.

Joly warned that merely closing stores would not boost operating income, as most of the big-box stores are already profitable. Relocation to smaller space may be an option, however; he said 71 percent of the large-format stores have leases expiring within the next six years.

The details of Joly’s long-awaited plan came roughly a week before the unofficial start of the year’s biggest selling season.

The retailer, which has posted declines in same-store sales in eight of the last nine quarters, warned last month it expected earnings and same-store sales to fall again in the third quarter.

“I am already sick and tired of negative comps,” Joly said, referring to same-store sales figures.

The CEO also admitted a number of past investments have not paid off and promised the new leadership would be “prudent” about that in the future, a nod to Wall Street’s lingering concerns about spending by past management.

(Reporting by Dhanya Skariachan in New York; Writing by Ben Berkowitz; Editing by Maureen Bavdek, Phil Berlowitz, Matthew Lewis and Jan Paschal)

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General investigated for emails to Petraeus friend

PERTH, Australia (AP) — In a new twist to the Gen. David Petraeus sex scandal, the Pentagon said Tuesday that the top American commander in Afghanistan, Gen. John Allen, is under investigation for alleged “inappropriate communications” with a woman who is said to have received threatening emails from Paula Broadwell, the woman with whom Petraeus had an extramarital affair.

Defense Secretary Leon Panetta said in a written statement issued to reporters aboard his aircraft, en route from Honolulu to Perth, Australia, that the FBI referred the matter to the Pentagon on Sunday.

Panetta said that he ordered a Pentagon investigation of Allen on Monday.

A senior defense official traveling with Panetta said Allen’s communications were with Jill Kelley, who has been described as an unpaid social liaison at MacDill Air Force Base, Fla., which is headquarters to the U.S. Central Command. She is not a U.S. government employee.

Kelley is said to have received threatening emails from Broadwell, who is Petraeus’ biographer and who had an extramarital affair with Petraeus that reportedly began after he became CIA director in September 2011.

Petraeus resigned as CIA director on Friday.

Allen, a four-star Marine general, succeeded Petraeus as the top American commander in Afghanistan in July 2011.

The senior official, who discussed the matter only on condition of anonymity because it is under investigation, said Panetta believed it was prudent to launch a Pentagon investigation, although the official would not explain the nature of Allen’s problematic communications.

The official said 20,000 to 30,000 pages of emails and other documents from Allen’s communications with Kelley between 2010 and 2012 are under review. He would not say whether they involved sexual matters or whether they are thought to include unauthorized disclosures of classified information. He said he did not know whether Petraeus is mentioned in the emails.

“Gen. Allen disputes that he has engaged in any wrongdoing in this matter,” the official said. He said Allen currently is in Washington.

Panetta said that while the matter is being investigated by the Defense Department Inspector General, Allen will remain in his post as commander of the International Security Assistance Force, based in Kabul. He praised Allen as having been instrumental in making progress in the war.

The FBI’s decision to refer the Allen matter to the Pentagon rather than keep it itself, combined with Panetta’s decision to allow Allen to continue as Afghanistan commander without a suspension, suggested strongly that officials viewed whatever happened as a possible infraction of military rules rather than a violation of federal criminal law.

Allen was Deputy Commander of Central Command, based in Tampa, prior to taking over in Afghanistan. He also is a veteran of the Iraq war.

In the meantime, Panetta said, Allen’s nomination to be the next commander of U.S. European Command and the commander of NATO forces in Europe has been put on hold “until the relevant facts are determined.” He had been expected to take that new post in early 2013, if confirmed by the Senate, as had been widely expected.

Panetta said President Barack Obama was consulted and agreed that Allen’s nomination should be put on hold. Allen was to testify at his confirmation hearing before the Senate Armed Services Committee on Thursday. Panetta said he asked committee leaders to delay that hearing.

NATO officials had no comment about the delay in Allen’s appointment.

“We have seen Secretary Panetta‘s statement,” NATO spokeswoman Carmen Romero said in Brussels. “It is a U.S. investigation.”

Panetta also said he wants the Senate Armed Services Committee to act promptly on Obama’s nomination of Gen. Joseph Dunford to succeed Allen as commander in Afghanistan. That nomination was made several weeks ago. Dunford’s hearing is also scheduled for Thursday.

___

Associated Press writer Slobodan Lekic in Kabul, Afghanistan, contributed to this report.

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Engineers of the Future Design Star Trek-Inspired Tricorder Device

A group of college and high school students has designed a Star Trek-inspired sensing device that can beam environmental data to a smart phone. The team developed their project during a summer internship program run by the Wright Brothers Institute and the Air Force Research Laboratory. and shared their results at this fall’s World Maker Faire in New York City–a showcase of DIY ingenuity. The Summer at the Edge program gives student teams ten weeks to work on science and engineering projects. The tricorder device is the team’s response to a challenge from the U.S. Environmental Protection Agency: “Is there an effective way to integrate external sensors with smart phones and can we globalize this information?” Applications could range from data collection for research to educational hands-on activities to disaster-zone assessment. The description reminded the students of a Star Trek gadget. In the sci-fi television series, the tricorder is a hand-held device used to diagnose illness, scout alien planets and more. Several real-life tricorders have been developed or proposed and the 15-member student team decided to take a crack at designing their own. The device itself looks like a clear brick filled with computer parts and batteries. It is built around an open-source computing platform called an Arduino microcontroller and transmits data via Bluetooth. An environmental sensing pod connects to the controller and collects measurements on variables like temperature, wind speed and radiation levels. Users can view data collection in real time via Google maps or an interactive graph and monitor changes and search for patterns. The tricorder’s modular design lets the team swap functionalities while still using the same Arduino controller and software. To demonstrate, the team built an additional pod equipped with an infrared beam and motion detector–a security sensor. Along the way, the team faced some challenges. Getting the sensors and the tablet to talk to each other involved a lot of troubleshooting. “We were having a lot of trouble with the Bluetooth communications,” says Lujack Prater, a junior studying electrical engineering at Ohio State University, who worked on the software design. “It was a few days that we didn’t get it. We were working on it and working on it.” Then a breakthrough: “It was really exciting–I remember the first time we started getting data streaming to the tablet,” says Grace Crumrine, part of the hardware sub-team and a sophomore in electrical engineering at Ohio State University. “But it was completely corrupt and didn’t mean anything.” The team needed to iron out software glitches and calibrate their sensors. Crumrine explains that the wind sensor was just “spitting out analogue values and we didn’t know what they meant.” So they took the sensor for a ride. While her teammate drove, Crumrine stuck the sensor out the car window. They were able to determine which values corresponded to specific speeds by rolling down the road at five, then 10 miles per hour and so on. The EPA was impressed, says Rob Williams, head of the internship program and research director of the Air Force Research Laboratory‘s Discovery Lab. “The tricorder was one of the more ambitious research projects,” he adds. “I think it validated the model that we’ve been an advocate of–bringing together motivated students and giving them the opportunity to have fun learning while doing projects that have potential.” Other notable projects include a tablet-based virtual walkthrough of medical techniques to train physicians and a device that can detect the brain’s electrical signals to give quadriplegics control over robots. What’s the next step for Project Tricorder? Williams would like to find teachers and students around the country who want to use the team’s design. He says middle school students could use the device to see how technology can help protect the environment. The military could use it to download information to virtual command centers and guide decision-making during a search and rescue based on current conditions. The device’s multi-functionality and connection to a smart phone would be key advantage. Sensor pods could even be installed in remote or dangerous locations and still report via Bluetooth.

Lujack Prater and Grace Crumrine with their team's device at the World Maker Faire. Credit: Grace Crumrine

Both Prater and Crumrine say the program is hard work. Prater spent the first two weeks learning how to code and program Android devices. “You get so involved in the project that you forget what you are doing,” says Crumrine. “Then when you present it to people you see their face with all the excitement and astonishment. It is worth it.”

Follow Scientific American on Twitter @SciAm and @SciamBlogs. Visit ScientificAmerican.com for the latest in science, health and technology news.
© 2012 ScientificAmerican.com. All rights reserved.

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Meningitis-linked U.S. firm not a drug maker in 2003 -report

WASHINGTON (Reuters) – Government health regulators in 2003 told the pharmacy now at the center of a deadly meningitis outbreak that its drug compounding activities did not constitute a manufacturing operation that would merit strict federal safety standards, a congressional report said on Monday.

The report by the Republican staff of a U.S. House of Representatives committee, said the Food and Drug Administration and Massachusetts state officials decided to leave oversight of the New England Compounding Center to a state pharmacy board, despite evidence of health problems linked to two drugs in 2002.

One of the drugs was methylprednisolone acetate, the same steroid treatment health officials have identified as the source of a current U.S. fungal meningitis outbreak that the U.S. Centers for Disease Control and Prevention says has grown to 438 cases, including 32 deaths, in 19 states.

Where to draw the line between drug manufacturing and drug compounding is a central question for U.S. lawmakers, who will hold separate House and Senate hearings this week as part of two investigations to determine whether the FDA should be given stronger authority to regulate compounding operations.

The House Energy and Commerce Committee, which produced the Republican report, is scheduled to hold its hearing on Wednesday with testimony expected from FDA Commissioner Margaret Hamburg, interim Massachusetts health commissioner Lauren Smith and NECC co-owner Barry Cadden, who has been subpoenaed to appear.

A separate hearing before the Senate Health, Education, Labor and Pensions Committee is scheduled for Thursday with a similar roster of witnesses expected.

A handful of Democrats have called for new legislation to strengthen federal oversight of the compounding industry, in which pharmacists traditionally alter or recombine drugs to meet the special needs of specific patients.

Drug compounding has evolved in recent decades to include large-scale production that some experts view as drug manufacturing that should be subject to FDA regulation.

But the compounding industry is currently overseen mainly by state authorities that are often ill-equipped for the job.

Up to now, compounding pharmacies have waged long legal and lobbying battles to stave off federal regulation. And some in Congress worry that failure to act before the end of the current lame duck session could postpone legislation in 2013 and risk losing momentum driven by the growing number of cases.

The advocacy group Public Citizen earlier this month called on the Obama administration to launch an independent probe into FDA’s lack of action against NECC. The group alleges that FDA already has the authority it needs, but that agency officials failed to take steps that could have prevented the current outbreak

Responding to a Reuters query about Public Citizen’s claims, the Department of Health and Human Services, which oversees FDA, said the agency has limited powers over compounders and urged Congress to strengthen its authority.

SERIOUS CONSEQUENCES

The House Republican report does not say how health officials determined NECC to be a pharmacy instead of a manufacturer. But the decision came after NECC had doubled its production space and begun pursuing a marketing strategy that called for selling compounded drugs to customers in all 50 states.

“It was decided that ‘current findings supported a compounding role’ and that ‘the state would be in a better position to gain compliance or take regulatory action against NECC as necessary’,” said the report.

The decision came at a February 5, 2003 meeting between FDA and state officials that ended with federal regulators emphasizing the potential for “serious public health consequences” if NECC’s compounding practices, in particular those relating to sterile products, did not improve.

“It is noteworthy that after closing out the inspection … FDA’s primary NECC investigator and her supervisor recommended that the ‘firm be prohibited from manufacturing until they can demonstrate ability to make product reproducibly and dependably’.”

Cadden was informed soon after the meeting that FDA did not consider his company to be a manufacturer. On February 26, 2003, he responded in writing to an FDA document calling for corrective measures at NECC by saying: “We are not subject to (nor are we voluntarily subjecting ourselves to) current good manufacturing practices as promulgated by FDA, since we are a compounding pharmacy, not a manufacturer.”

The decision to leave oversight largely to state officials also followed an April 2002 encounter between FDA investigators and Cadden in which the report said the NECC executive challenged the FDA’s authority to be at his pharmacy and refused to provide information or records to the federal agency.

But problems continued at NECC, and the FDA finally issued a warning letter in 2006 warning that the company’s compounding operations had begun to resemble manufacturing operations and still posed potential health risks from the compounding of sterile drugs.

“NECC has a long history of very similar, if not identical, underlying misconduct,” said the congressional report.

“Some of the violations observed by regulators as early as 2002 include the company’s failure to maintain adequate safeguards for sterile injectable products — the very issue at the center of the current meningitis outbreak.”

On Monday, FDA said it discovered insects, a flying bird and other unsanitary conditions at NECC’s sister company, Ameridose LLC. [ID:nL1E8MCDDH]

(Reporting by David Morgan; Editing by Michele Gershberg and Tim Dobbyn)

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How To Tell If Gadgets Are Needlessly Complicated: The Mom Test

This is a rant, of the grumpy-old-man variety.

Two weeks ago I was staying at my parents’ apartment because my home in New Jersey was without power, thanks to Hurricane Sandy.

“Oh, Sonny, I’m glad you’re here,” my mother told me when I arrived. “I need you to help me set up the DVD player.”

I love my mom to bits and pieces, but sometimes it’s like a bad sitcom with her: The tech writer son tries to help his mother (who still refers to the refrigerator as the “icebox,” by the way) do something he thinks is the easiest thing in the world but to her is akin to landing the Mars Rover.

We went into her bedroom. She had a television that was connected to a cable box and a DVD player—simple. Even the universal remote that came with her cable box was already programmed to work with the TV and DVD player. Miracle of miracles.

“See, Mom, you’re going to want to change inputs when you switch from cable to DVD,” I said.

“Change inputs?” she replied. “Can’t I just have it set to channel 3?”

This is what I’m talking about: My mother has that Reagan-era notion that you can set a channel of the TV to be an auxiliary input, like I used to do when I wanted to fire up the VHS and watch The Last Starfighter. Again.

“No, Mom. It’s really simple. Let me show you.” This is where things fell apart. But not because of my mom. “OK,” I began, “you’re going to use the cable box remote. Remember to push ‘DVD’ at the top of the remote to send commands to the DVD. You’ll then have to push ‘STB’ when you want to go back to cable, but to change the TV’s input, push ‘TV.’”

The cable box remote did have a “video source” button on it. And pushing it did call up the TV’s video source menu. And pushing “video source” repeatedly did allow one to cycle through the available sources. I reached “DVD,” selected it, and then looked for the “exit” button to close out the source menu.

Except my remote didn’t have an “exit” button. Or, it did, but it wasn’t mapped to the TV’s exit function. So the TV’s source menu just sat there—on top of my mother’s DVD of The Thin Man playing underneath.

“OK, Mom, looks like this remote can’t access all the functions on your TV, so we’re going to get the TV’s original remote,” I said. Even as the words were coming out of my mouth, I knew this wasn’t going to work.

“Seriously?” my mother asked. “Lemme get this straight: If I want to watch the goddamn Thin Man on the DVD, I have to first get the TV remote, find the source menu, switch to ‘DVD,’ then go back to the cable remote, select ‘DVD,’ press ‘play,’ but don’t forget to switch the remote back to ‘STB’ when I want to control the cable box? Something like that?”

“Um. Yeah, Mom.”

“What the hell happened to channel 3?”

Here’s the thing about my technophobic mother: She’s absolutely right. The tiny hoops we are asked to jump through give lie to the idea that technology is going to make our lives easier. In some cases it does (I never get lost in my car anymore, thanks to GPS; I’m never bored anymore, thanks to my smartphone), but there are glaring omissions.

TV manufacturers, can you please get it together? Can there be some common standards so my TV knows when I’ve put a disc in the DVD player, and it can ask me if I’d like to watch it now? Can remotes and devices talk to each other automatically, with full functionality, without the need to program them? Can someone please let me access any and all on-demand, streaming, or downloaded video without having to switch from my set-top box to Netflix (NFLX) or iTunes? Can I have a TV setup that I don’t have to explain how to use to house guests and babysitters? (“… sometimes the sound bar will turn itself off because it gets confused by a signal from the remote to the TV. Just use this remote to …”)

Face it, TV people: Your products are commodities. No one cares about your hardware. One display is virtually indistinguishable from another. But if one of you actually made it easier to use your product? Let me tell you something—it wouldn’t just be 65-year-old Jewish women on the Upper West Side of Manhattan who would be interested. We’d all line up for that.

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Canada seen needing to spell out rules for natural gas projects

CALGARY, Alberta (Reuters) – The fate of a handful of liquefied natural gas projects planned for Canada’s Pacific coast may depend on the Canadian government‘s willingness to spell out rules for foreign investment in the country’s energy sector, according to a study released on Thursday.

Apache Corp, Royal Dutch Shell Plc, Petronas, BG Group Plc and others are in the planning stages for LNG projects that would take gas from the rich shale fields of northeastern British Columbia and ship it to Asian buyers.

But the federal government’s decision last month to stall the C$ 5.2 billion ($ 5.2 billion) bid by Malaysia’s state-owned Petronas C$ 5.2 billion for Canada‘s Progress Energy Resources Corp could lessen the appetite of Asian buyers for Canadian LNG, energy consultants Wood Mackenzie said.

“Some potential off-takers of Canadian LNG like the idea … because it’s perceived as having low political risk, and another reason is because they see the potential for investment opportunities,” said Noel Tomnay, head of global gas at the consultancy.

“If there are going to be restrictions on how they access those opportunities, if acquisitions are closed to them, then clearly that would restrict the attractiveness of those opportunities. If would-be Asian investors thought that corporate acquisitions were an avenue that was not open to them then Canadian LNG would become less attractive.”

The Canadian government is looking to come up with rules governing corporate acquisitions by state-owned companies and has pushed off a decision on the Petronas bid as it considers whether to approve the $ 15.1 billion offer for Nexen Inc from China’s CNOOC Ltd.

Exporting LNG to Asia is seen as a way to boost returns for natural-gas producers tapping the Montney, Horn River and Liard Basin shale regions of northeastern British Columbia.

Though Wood Mackenzie estimates the fields contain as much as 280 trillion cubic feet of gas, they are far from Canada’s traditional U.S. export market, while growing supplies from American shale regions have cut into Canadian shipments.

Because the region lacks infrastructure, developing the resource will be expensive, requiring new pipelines and multibillion-dollar liquefaction.

Still Wood Mackenzie estimates that the cost of delivery into Asian markets for Canadian LNG would be in the range of $ 10 million to $ 12 per million British thermal units, similar to competing projects in the United States and East Africa.

($ 1 = $ 1.00 Canadian)

(Reporting by Scott Haggett; Editing by Leslie Adler)

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Malaysian charged with Facebook insult of sultan; sister says he’ll file police complaint

KUALA LUMPUR, Malaysia – The sister of a Malaysian man who has been charged with insulting a state sultan on Facebook says he is innocent and plans to lodge a complaint over his detention.

Anisa Abdul Jalil, sister of Ahmad Abdul Jalil, says her brother was charged Thursday with making offensive postings on Facebook last month.

She says the charges are ridiculous because there is no evidence linking Ahmad to the posts in question, which were made by someone using the name “Zul Yahaya.”

Ahmad was freed on bail Thursday after six days of detention. Anisa says he will file a complaint with police for unlawful detention and intimidation.

Nine Malaysian states have sultans and other royal figures. Though their roles are largely ceremonial, acts provoking hatred against them are considered seditious.

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Judy’s Garland’s Oz dress fetches $480K in auction

BEVERLY HILLS, Calif. (AP) — The now-faded blue gingham dress Judy Garland wore in “The Wizard of Oz” has sold for $ 480,000.

Auction house Julien’s Auctions says the pinafore fetched the highest price of any item during a two-day auction of Hollywood memorabilia that attracted bids from around the world. The auction ended Saturday in Beverly Hills, Calif.

Steve McQueen‘s racing jacket sold for $ 50,000, as did a purple skirt worn by Marilyn Monroe while filming “River of No Return” in Canada. Julie Andrews‘ “Sound of Music dress” brought $ 38,400.

Sunglasses worn by Jean Reno in “Leon” went for $ 8,320, while Johnny Depp‘s shades fetched $ 3,250.

Bidders also snapped up pieces of royal wedding cakes. Prince William and Kate Middleton’s cake sold for $ 7,500 while Prince Charles and Princess Diana’s cake sold for $ 1,375.

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Next-day discharge after C-section may be okay: study

(Reuters) – Some women who deliver their babies by cesarean section may be able to check out of the hospital the next day without raising their risk of problems, according to a Malaysian study.

The study, which appeared in the journal Obstetrics & Gynecology, looked at 360 women in Malaysia, who were randomly assigned to go home either one or two days after having a C-section.

Both groups were equally satisfied with their care, and the women who were discharged sooner seemed to have no more problems with breastfeeding or mental well-being.

“Day 1 discharge compared with day 2 discharge after a planned cesarean delivery resulted in equivalent outcomes,” wrote lead author Peng Chiong Tan, at the University of Malaya in Kuala Lumpur.

Those results don’t mean that hospitals should start discharging women the day after a C-section, but they do suggest that a next-day discharge is something women can talk about with their doctors, researchers said.

In the United States, where C-sections are done in about one-third of births, women typically stay in the hospital for three to four days after the procedure. That compares with about two days for women who deliver vaginally.

In the past, there were concerns about insurers pushing mothers to leave the hospital before they’re ready. That led to a 1996 law requiring insurers to pay for a 48-hour hospital stay after a vaginal delivery and a 96-hour stay after a C-section.

Still, the American College of Obstetricians and Gynecologists (ACOG) says a shorter stay after a C-section is an option if the baby is ready to go home, though the mother should meet certain requirements first such as normal blood pressure, no signs of infection and adequate pain control.

At Tan’s hospital in Malaysia, women who have a C-section are routinely told to expect just a two-day stay, and some providers there have discharged new mothers the day after.

Tan’s team randomly assigned the 360 women having a planned C-section to go home either one or two days after delivering. In the end, 16 percent of the women in the day-after group were not discharged that early, because either they or their babies were having problems.

But when they did go home the day after, there didn’t seem to be a greater risk of difficulties. When the women were interviewed two weeks later, 87 percent were happy with their discharge timing.

The same was true for almost 86 percent of women who went home two days after their C-section.

While the findings would likely extend to women in other countries too, these Malaysian women typically went home to a lot of support – often, an extended family network, Tan said.

“Where this support is not available, next-day hospital discharge may not be associated with the same degree of satisfaction, acceptability and good outcome as we have found,” she added.

SOURCE:http://bit.ly/TzbGoz

(Reporting from New York by Amy Norton at Reuters Health; editing by Elaine Lies)

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