Tuesday, November 29, 2011

Australian regulatory guidelines for medical devices (ARGMD)

The TGA in collaboration with the medical devices industry sector has developed a consolidated reference document detailing the Australian regulatory requirements for medical devices.

This document has been developed as a guide to assist sponsors and manufacturers understand the regulatory requirements for medical devices in Australia. The information in this document replaces many of the existing guidance documents and information sheets for medical devices that were on the TGA website.

It should be noted that this document is for guidance. All regulatory decisions are made using legislation as set out in the Therapeutic Goods Act 1989, Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002.

This document will continue to evolve over time. Updates/clarifications will be included from time to time. Users should check that they have the most up to date version when referring to this Guidance. Comments and suggestions for future versions are welcomed and should be sent to ODAConsult@tga.gov.au.

Establishing an eBusiness account

Each company must have an eBusiness account with the TGA. Once a company has an eBusiness account, the administrator within the company can establish and maintain individual access for any staff within the company who require it.

If a company does not have a master account then they will need to establish an eBusiness account with the TGA. This is done on the TGA eBusiness website.

Click on the New User section of the page and download the:
Client Details Form - only to be completed if the company does not already have a CLIENT identification number. For first time sponsors, this form must be completed.
EBusiness Access Form - needs to be completed to establish an eBusiness account with the TGA and to obtain an account name and password. Complete these forms and fax them to the TGA on 02 6232 8581. An account name and password will be sent to the email address specified on the form within three working days of the TGA receiving a correctly completed form.
Logging on

Applications are submitted via the TGA eBusiness website.
User instructions

Once logged on, the user will be taken to the medical devices home page, which will provide a number of options.
User documentation

User documentation is available online or can be downloaded and printed. This document gives valuable information and assists in navigating through the various options available.


Thursday, November 24, 2011

Sleep Helps Us Remember What We Need To


Sleep Helps Us Remember What We Need To.


The jury is back and the verdict is in. The long-term storage of memories occurs during sleep. It's not just a passive process of forgetting--in which useless or trivial short-term memories fade into obscurity. Memory storage during sleep is an active process. Several researchers have shown that neuronal representations of memories are reactivated during sleep, as if the brain were replaying a recording. The replay is essential to long-term memory storage, possibly because it redistributes neuronal connections from short-term memory to long-term storage sites in the neocortex.
The brain constructs and reorganizes its circuits while we sleep. Yet, it is apparent that there must be some selectivity involved. Most of the enormous amount of information that comes into us everyday is encoded for a short time; today we remember what we had for breakfast and where we parked the car. But as we sleep, most of that knowledge is discarded. So what we know today may be lost tomorrow--or not. Although most of what was encoded into memory is shed, the "important stuff" remains. We don't forget a disagreement with a spouse or a promising job interview.

The pivotal question is, How does the brain "decide" what to keep and what to dump? This past week, a significant study caught my eye, one that can help us eventually answer that question. German researchers have garnered evidence that the brain sorts through memories during sleep and preferentially retains the ones that are most relevant. The study, published in the Journal of Neuroscience, concludes that the brain evaluates information based on future expectations. After a good night's sleep, we remember information better when we know it will be useful in the future.




Sleep researcher Jan Born.
In this study, a team of researchers led by Jan Born of the University of Lübeck set up two experiments to test memory. In the first experiment, volunteers attempted to learn 40 pairs of words. Participants in the second experiment played a card game in which they matched pictures of animals and objects (similar to the game "Concentration") and also practiced sequences of finger taps.




In both groups, half the volunteers were told immediately following the learning tasks that they would be tested in 10 hours. In truth, all of the participants were tested later, but only half of them expected the test. Also, some, but not all, of the volunteers were allowed to sleep between the time they learned the tasks and the time they took the tests.

Sleep compared with wakefulness produced a strong improvement on test performance only if the subjects had been informed about the test. For subjects who had not been informed, retrieval after sleep was no better than after wakefulness. Retention during the wake intervals was not affected by expectance of a test. In sum, only the people who slept and knew a test was coming had substantially improved recall. Thus, the mere expectation that a memory will prove useful in the future causes sleep to consolidate the memory.

The researchers also recorded electroencephalograms (EEGs) from the individuals who slept. Subjects who expected a test displayed a strong increase in slow oscillation activity during their slow-wave sleep. The more slow-wave activity the sleeping participants had, the better their memory during the test. Born and colleagues think that the process may involve at least two parts of the brain. The brain's prefrontal cortex appears to "tag" memories deemed potentially useful for the future, while the hippocampus consolidates those memories during sleep.

"Our results show that memory consolidation during sleep indeed involves a basic selection process that determines which of the many pieces of the day's information are sent to long-term storage," Born says. "Our findings also indicate that information relevant for future demands is selected foremost for storage."

Saturday, November 19, 2011

Vivekananda Quote's


My Master used to say, "This world is a huge lunatic asylum where everyone is mad, some after money, some after sex, some after name or fame, and a few after God. I prefer to be mad after God. God is the philosophers' stone that turns us to gold in an instant. The form remains, but the nature has changed--the human form remains, but no more can we hurt or sin."

Tuesday, November 1, 2011

The Food Movement: Its Power and Possibilities

For years I've been asked, "Since you wrote Diet for a Small Planet in 1971, have things gotten better or worse?" Hoping I don't sound glib, my response is always the same: "Both."

As food growers, sellers and eaters, we're moving in two directions at once.

The number of hungry people has soared to nearly 1 billion, despite strong global harvests. And for even more people, sustenance has become a health hazard—with the US diet implicated in four out of our top ten deadly diseases. Power over soil, seeds and food sales is ever more tightly held, and farmland in the global South is being snatched away from indigenous people by speculators set to profit on climbing food prices. Just four companies control at least three-quarters of international grain trade; and in the United States, by 2000, just ten corporations—with boards totaling only 138 people—had come to account for half of US food and beverage sales. Conditions for American farmworkers remain so horrific that seven Florida growers have been convicted of slavery involving more than 1,000 workers. Life expectancy of US farmworkers is forty-nine years.

That's one current. It's antidemocratic and deadly.

There is, however, another current, which is democratizing power and aligning farming with nature's genius. Many call it simply "the global food movement." In the United States it's building on the courage of truth tellers from Upton Sinclair to Rachel Carson, and worldwide it has been gaining energy and breadth for at least four decades.

Some Americans see the food movement as "nice" but peripheral—a middle-class preoccupation with farmers' markets, community gardens and healthy school lunches. But no, I'll argue here. It is at heart revolutionary, with some of the world's poorest people in the lead, from Florida farmworkers to Indian villagers. It has the potential to transform not just the way we eat but the way we understand our world, including ourselves. And that vast power is just beginning to erupt.

The Work

In a farmworker camp in Ohio, a young mother sat on her bed. She was dying of cancer, but with no bitterness she asked me a simple question: "We provide people food—why don't they respect our work?" That was 1984. She had no protection from pesticides, or even the right to safe drinking water in the field.

Twenty-five years later, in Immokalee, Florida, I walked through a grungy, sweltering 300-foot trailer, home to eight tomato pickers, but what struck me most was a sense of possibility in the workers themselves.

They are among the 4,000 mainly Latino, Mayan Indian and Haitian members of the Coalition of Immokalee Workers, formed in 1993—more than two decades after Cesar Chavez's United Farm Workers' victorious five-year grape strike and national boycott. In the 1990s, CIW's struggle over five years, including a 230-mile walk and hunger strike, achieved the first industrywide pay increase in twenty years. Still, it only brought real wages back to pre-1980 levels. So in 2001, CIW launched its Campaign for Fair Food. Dogged organizing forced four huge fast-food companies—McDonald's, Taco Bell, Burger King and Subway—to agree to pay a penny more per pound and adhere to a code of conduct protecting workers. Four large food-service providers, including Sodexo, were also brought on board. Beginning this fall, CIW will start implementing these changes at 90 percent of Florida tomato farms—improving the lives of 30,000 tomato pickers. Now the campaign is focused on supermarkets such as Trader Joe's, Stop & Shop and Giant.

The Land

In Brazil, almost 400,000 farmworker families have not only found their voices but gained access to land, joining the roughly half-billion small farms worldwide that produce 70 percent of the world's food.

Elsewhere, calls for more equitable access to land in recent decades have generally gone nowhere—despite evidence that smallholders are typically more productive and better resource guardians than big operators.

So what happened in Brazil?

With the end of dictatorship in 1984 came the birth of arguably the largest social movement in the hemisphere: the Landless Workers Movement, known by its Portuguese acronym MST. Less than 4 percent of Brazil's landowners control about half the land, often gained illegally. MST's goal is land reform, and in 1988 Brazil's new Constitution gave the movement legal grounding: Article 5 states that "property shall fulfill its social function," and Article 184 affirms the government's power to "expropriate…for purposes of agrarian reform, rural property" that fails to meet this requirement. Well-organized occupations of unused land, under the cover of night, had been MST's early tactic; after 1988 the same approach helped compel the government to uphold the Constitution.

Because of the courage of these landless workers, a million people are building new lives on roughly 35 million acres, creating several thousand farming communities with schools serving 150,000 kids, along with hundreds of cooperative and other enterprises.

Nevertheless, MST co-founder João Pedro Stédile said early this year that the global financial crisis has led "international capitalists" to try to "protect their funds" by investing in Brazilian "land and energy projects"—driving renewed land concentration.

And in the United States? The largest 9 percent of farms produce more than 60 percent of output. But small farmers still control more than half our farmland, and the growing market for healthy fresh food has helped smallholders grow: their numbers went up by 18,467 between 2002 and 2007. To support them, last winter the Community Food Security Coalition held community "listening sessions," attended by 700 people, to sharpen citizen goals for the 2012 farm bill.

The Seed

Just as dramatic is the struggle for the seed. More than 1,000 independent seed companies were swallowed up by multinationals in the past four decades, so today just three—Monsanto, DuPont and Syngenta—control about half the proprietary seed market worldwide.

Fueling the consolidation were three Supreme Court rulings since 1980—including one in 2002, with an opinion written by former Monsanto attorney Clarence Thomas—making it possible to patent life forms, including seeds. And in 1992 the Food and Drug Administration released its policy on genetically modified organisms, claiming that "the agency is not aware of any information showing that [GMO] foods…differ from other foods in any meaningful or uniform way."

The government's green light fueled the rapid spread of GMOs and monopolies—so now most US corn and soybeans are GMO, with genes patented largely by one company: Monsanto. The FDA position helped make GMOs' spread so invisible that most Americans still don't believe they've ever eaten them—even though the grocery industry says they could be in 75 percent of processed food.

Even fewer Americans are aware that in 1999 attorney Steven Druker reported that in 40,000 pages of FDA files secured via a lawsuit, he found "memorandum after memorandum contain[ing] warnings about the unique hazards of genetically engineered food," including the possibility that they could contain "unexpected toxins, carcinogens or allergens."

Yet at the same time, public education campaigns have succeeded in confining almost 80 percent of GMO planting to just three countries: the United States, Brazil and Argentina. In more than two dozen countries and in the European Union they've helped pass mandatory GMO labeling. Even China requires it.

In Europe, the anti-GMO tipping point came in 1999. Jeffrey Smith, author of Seeds of Deception, expects that the same shift will happen here, as more Americans than ever actively oppose GMOs. This year the "non-GMO" label is the third-fastest-growing new health claim on food packaging. Smith is also encouraged that milk products produced with the genetically modified drug rBGH "have been kicked out of Wal-Mart, Starbucks, Yoplait, Dannon, and most American dairies."

Around the world, millions are saying no to seed patenting as well. In homes and village seed banks, small farmers and gardeners are saving, sharing and protecting tens of thousands of seed varieties.

In the United States, the Seed Savers Exchange in Decorah, Iowa, estimates that since 1975 members have shared roughly a million samples of rare garden seeds.

In the Indian state of Andhra Pradesh—known as the pesticide capital of the world—a women-led village movement, the Deccan Development Society, puts seed-saving at the heart of its work. After the crushing failure of GMO cotton and ill health linked to pesticides, the movement has helped 125 villages convert to more nutritious, traditional crop mixes, feeding 50,000 people.

On a larger scale, Vandana Shiva's organization, Navdanya, has helped to free 500,000 farmers from chemical dependency and to save indigenous seeds—the group's learning and research center protects 3,000 varieties of rice, plus other crops.

Agri-Culture

In all these ways and more, the global food movement challenges a failing frame: one that defines successful agriculture and the solution to hunger as better technologies increasing yields of specific crops. This is typically called "industrial agriculture," but a better description might be "productivist," because it fixates on production, or "reductivist," because it narrows our focus to a single element.

Its near obsession with the yield of a monoculture is anti-ecological. It not only pollutes, diminishes and disrupts nature; it misses ecology's first lesson: relationships. Productivism isolates agriculture from its relational context—from its culture.

In 2008 a singular report helped crack the productivist frame. This report, "The International Assessment of Agricultural Knowledge, Science and Technology for Development" (known simply as IAASTD), explained that solutions to poverty, hunger and the climate crisis require agriculture that promotes producers' livelihoods, knowledge, resiliency, health and equitable gender relations, while enriching the natural environment and helping to balance the carbon cycle. Painstakingly developed over four years by 400 experts, the report has gained the support of more than fifty-nine governments, and even productivist strongholds like the World Bank.

IAASTD furthers an emerging understanding that agriculture can serve life only if it is regarded as a culture of healthy relationships, both in the field—among soil organisms, insects, animals, plants, water, sun—and in the human communities it supports: a vision lived by many indigenous people and captured in 1981 by Wendell Berry in The Gift of Good Land and twenty years later by Jules Pretty in Agri-Culture: Reconnecting People, Land and Nature.

Across cultures, the global food movement is furthering agri-culture by uniting diverse actors and fostering democratic relationships. A leader is La Via Campesina, founded in 1993 when small farmers and rural laborers gathered from four continents in Belgium. Its goal is "food sovereignty"—a term carefully chosen to situate "those who produce, distribute, and consume food at the heart of food systems and policies, rather than the demands of markets and corporations," says the declaration closing the group's 2007 global gathering in Nyeleni, Mali. La Via Campesina connects 150 local and national organizations, and 200 million small farmers, in seventy countries. In 2009 it was included among civil society players on the UN Committee on Food Security.

And in the urban North, how is the food movement enhancing agri-culture?

For sure, more and more Americans are getting their hands in the dirt—motivated increasingly by a desire to cut "food miles" and greenhouse gases. Roughly a third of American households (41 million) garden, up 14 percent in 2009 alone. As neighbors join neighbors, community gardens are blooming. From only a handful in 1970, there are 18,000 community gardens today. In Britain community gardens are in such demand—with 100,000 Brits on waiting lists for a plot—that the mayor of London promised 2,012 new ones by 2012.

And in 2009 the Slow Food movement, with 100,000 members in 153 countries, created 300 "eat-ins"—shared meals in public space—to launch its US "Time for Lunch" campaign, with a goal of delicious healthy school meals for the 31 million kids eating them every day.

An Economics of Agri-Culture

Agri-culture's unity of healthy farming ecology and social ecology transforms the market itself: from the anonymous, amoral selling and buying within a market structured to concentrate power to a market shaped by shared human values structured to ensure fairness and co-responsibility.

In 1965 British Oxfam created the first fair-trade organization, called Helping-by-Selling, in response to calls from poor countries for "trade, not aid." Today more than 800 products are fair-trade certified, directly benefiting 6 million people. Last year the US fair-trade market passed $1.5 billion.

The Real Food Challenge, launched by young people in 2007, is working to jump-start a US swing to "real food"—defined as that respecting "human dignity and health, animal welfare, social justice and environmental sustainability." Student teams are mobilizing to persuade campus decision-makers to commit themselves to making a minimum of 20 percent of their college or university food "real" by 2020. With more than 350 schools already on board, the Challenge founders have set an ambitious goal: to shift $1 billion to real food purchases in ten years.

Farmers' markets, the direct exchange between farmer and eater, are also creating a fairer agri-culture. So rare before the mid-'90s that the USDA didn't even bother to track them, more than 7,000 farmers' markets dot the country in 2011, a more than fourfold increase in seventeen years.

Other democratic economic models are also gaining ground:

In 1985 an irrepressible Massachusetts farmer named Robyn Van En helped create the first US Community Supported Agriculture (CSA) program, in which eaters are no longer just purchasers but partners, helping to shoulder the farmer's risk by prepaying for a share of the harvest before the planting season. On weekends, "my" CSA—Waltham Fields, near Boston—is alive as families pick and chat, and kids learn how to spot the yummiest strawberries. Now there are 2,500 CSAs across the country, while more than 12,500 farms informally use this prepay, partnership approach.

The cooperative model is spreading too, replacing one dollar, one vote—the corporate form—with one person, one vote. In the 1970s, US food cooperatives took off. Today there are 160 nationwide, and co-op veteran Annie Hoy in Ashland, Oregon, sees a new upsurge. Thirty-nine have just opened, or are "on their way right now," she told me.

Funky storefronts of the 1970s, famous for limp organic carrots, have morphed into mouthwatering community hubs. Beginning as a food-buying club of fifteen families in 1953, Seattle's PCC Natural Markets has nine stores and almost 46,000 members, making it the largest US food cooperative. Its sales more than doubled in a decade.

Producer co-ops have also made huge gains. In 1988 a handful of worried farmers, watching profits flow to middlemen, not to them, launched the Organic Valley Family of Farms. Today Organic Valley's more than 1,600 farmer owners span thirty-two states, generating sales of more than $500 million in 2008.

The Rules

The global food system reflects societies' rules—often uncodified—that determine who eats and how our earth fares. In the United States, rules increasingly reflect our nation's slide into "privately held government." But in rule-setting, too, energy is hardly unidirectional.

In 1999, on the streets of Seattle, 65,000 environmentalists, labor and other activists made history, blunting the antidemocratic agenda of the World Trade Organization. In 2008 more citizens than ever engaged in shaping the farm bill, resulting in rules encouraging organic production. The movement has also established 100 "food policy councils"—new local-to-state, multi-stakeholder coordinating bodies. And this year, eighty-three plaintiffs joined the Public Patent Foundation in suing Monsanto, challenging its GMO seeds' "usefulness" (required for patenting) as well as the company's right to patent seeds to begin with.

Even small changes in the rules can create huge possibilities. Consider, for example, the ripples from a 2009 Brazilian law requiring at least 30 percent of school meals to consist of food from local family farms.

Rules governing rights are the human community's foundational guarantees to one another—and the 1948 Universal Declaration of Human Rights gave access to food that status. Since then, nearly two dozen nations have planted the right to food in their constitutions. If you wonder whether it matters, note that when Brazil undertook a multifaceted "zero hunger" campaign, framing food as a right, the country slashed its infant death rate by about a third in seven years.

Food Power: Only Connect

This rising global food movement taps universal human sensibilities—expressed in Hindu farmers in India saving seeds, Muslim farmers in Niger turning back the desert and Christian farmers in the United States practicing biblically inspired Creation Care. In these movements lies the revolutionary power of the food movement: its capacity to upend a life-destroying belief system that has brought us power-concentrating corporatism.

Corporatism, after all, depends on our belief in the fairy tale that market "magic" (Ronald Reagan's unforgettable term) works on its own without us.

Food can break that spell. For the food movement's power is that it can shift our sense of self: from passive, disconnected consumers in a magical market to active, richly connected co-producers in societies we are creating—as share owners in a CSA farm or purchasers of fair-trade products or actors in public life shaping the next farm bill.

The food movement's power is connection itself. Corporatism distances us from one another, from the earth—and even from our own bodies, tricking them to crave that which destroys them—while the food movement celebrates our reconnection. Years ago in Madison, Wisconsin, CSA farmer Barb Perkins told me about her most rewarding moments: "Like in town yesterday," she said, "I saw this little kid, wide-eyed, grab his mom's arm and point at me. 'Mommy,' he said. 'Look. There's our farmer!'"

At its best, this movement encourages us to "think like an ecosystem," enabling us to see a place for ourselves connected to all others, for in ecological systems "there are no parts, only participants," German physicist Hans Peter Duerr reminds us. With an "eco-mind" we can see through the productivist fixation that inexorably concentrates power, generating scarcity for some, no matter how much we produce. We're freed from the premise of lack and the fear it feeds. Aligning food and farming with nature's genius, we realize there's more than enough for all.

As the food movement stirs, as well as meets, deep human needs for connection, power and fairness, let's shed any notion that it's simply "nice" and seize its true potential to break the spell of our disempowerment.

Can Apple really sue Google or Microsoft for using its patented sliding on/off switch?

In last week's episode of "Can you top this dumb patent?" we discovered that Apple had patented the design element of sliding to unlock a device. Gosh, and I recall my grandpa's front gate having a slide-to-unlock device in the 60s! Boy those Apple guys had to get up early in the morning to invent that one

Sarcasm aside, does" every Android device now infringe this Apple patent?" Or, for that matter, every Windows 8 device? Well, yes, they probably do. But does that mean that Apple is really going to be using this patent to sue everyone and anyone who uses the slide metaphor in their design? I asked some prominent intellectual property (IP) lawyers about it and this is what they said.

Thomas Carey, a partner at Sunstein, a major intellectual property (IP) law firm and chair of its Business Department, said that, "In this particular case, it appears that there is prior art that may render the patent invalid." Carey points out that this video of the Neonode N1m device at the 4 minute mark appears to pre-date Apple's devices.

"However," Carey continued, "The Apple patent claims refer to a touch screen, which is not what the device in the video contains. Nonetheless, applying the same technique to a touch screen would seem obvious. Hence, invalidity. (The priority date on the patent is 12/23/2005, which comes after the date of the Neonode N1m.)"

If Apple were to sue someone with this patent, Carey suspects Microsoft, rather than Google and its Android partners, might be targeted. After all, "Apple has had its innovations ripped off by Microsoft for years, so you would surely expect them to start seeking patent protection for their innovations."

Even so, Daniel Ravicher, an attorney and executive director of the Public Patent Foundation, doesn't see Apple suing anyone with this particular patent. "Getting a silly patent takes a few thousand dollars and can stealthily contribute to quantity metrics. Deciding to assert a silly patent in litigation takes a few million dollars and can't hide from quality requirements. I doubt they'd ever assert this patent."

So, the consensus seems to be that this particular patent won't be seen used in anger inside a courtroom any time soon. Other dumb patents, that's another matter. With patents likes these, the mobile patent wars look certain to go on for years—decades—more. Now, just so long as no lawyer comes to my grandpa's old door I guess I can put up with it.

Search This Blog