News.Yahoo.com, April 28, 2011, New York – The FDA gives the nod to a machine that plucks bits of flesh off bald heads, helping doctors perform hair transplants. Is this better than Rogaine?
The image: The FDA has approved a device called the Artas System (see image below), which removes small pieces of skin from hairy parts of a balding man’s head, so they can be implanted in areas that need follicular assistance. As Tim Hornyak at CNET describes it, “the patient sits in the Artas chair, and his hair is cut to about 1 millimeter. A camera-equipped robotic arm under the control of a doctor then initiates ‘small dermal punches’ while harvesting individual follicles.” They are later manually transplanted, develop their own blood supply, and eventually grow their own hair. Artas’s function is one step in a process known as Follicular Unit Extraction, which avoids the sutures and bandages common to some hair-transplant procedures, like “strip harvesting.” As of now, the machine can only be used on patients with straight, brown or black hair — blonds and redheads need not apply.
The reaction: There’s “something about knowing that a robot arm will harvest your hair using ‘small dermal punches’ that’s a little bit unsettling,” says Graeme McMillan at TIME. “But to have a full head of hair for the first time in over a decade? I have to admit, I’d probably be okay with that.” Blond people are lucky in that they “still have a convenient excuse to not pay Artas a visit,” says Patrick Morgan at Discover Magazine. That is, “in addition to the whole ‘I’m not going near a flesh-harvesting robot’ thing.” See the Artas machine below:
FDA Panel Endorses Vertex Hepatitis C Drug
Chronic Hepatitis – Microscopic Photo. Chronic hepatitis C. Reticulin stain demonstrates bridging fibrosis with architectural distortion, no obvious cirrhosis (Stage 4). Reticulin Stain. Jian-Hua Qiao, MD, FCAP, Los Angeles, CA, USA (乔建华医师，病理学家)
The Food and Drug Administration’s panel of viral experts voted unanimously, 18-0, that the drug is a safe and effective treatment for hepatitis C. The agency generally follows the recommendations of its panels. A final decision is expected by May 23.
The most significant side effect with the drug was a sometimes severe rash in roughly half of patients.
The FDA convened a two-day meeting to review two new drugs that block the enzyme which allows the hepatitis virus to reproduce. On Wednesday the same panel unanimously recommended approval for Merck ( MRK – news - people )’s drug boceprevir.
WASHINGTON – Federal health officials said Tuesday a highly anticipated hepatitis C drug from Vertex Pharmaceuticals successfully treats the majority of patients with the virus in less time than older medicines that have been used for 20 years.
The Food and Drug Administration posted its review of Vertex’s telaprevir ahead of a meeting Thursday where outside experts will vote on the benefits of the experimental drug. On Wednesday the experts will review a similar drug from Merck & Co. Inc.
Both new drugs work by blocking the enzyme protease, which allows the hepatitis virus to reproduce. The new approach represents a breakthrough from older medicines, which are designed to help boost the immune system to fight hepatitis.
Like HIV drugs, the new drugs will be prescribed as part of a cocktail with the two older drugs to help lower viral levels.
“A drug like telaprevir does an amazing job clearing the virus, but there’s a small portion that is just intrinsically less responsive and it’s the job of the older drugs to clear up that mess that’s left behind,” said Dr. Camilla Graham, Vertex’s vice president for global medical affairs.
The current two-drug treatment for the virus cures only about 40 percent of people and causes side effects like nausea, fatigue and vomiting.
FDA scientists said 79 percent of first-time hepatitis C patients taking telaprevir and the older medicines were cured, compared to 46 percent of those taking the older medications alone, according to Vertex’s studies. Among patients who had already been treated for hepatitis C once, 65 percent achieved a cure after taking telaprevir, compared with 17 percent of those taking the older medications.
In general, telaprevir’s cure rates are higher than those seen with Merck’s boceprevir. The two drugs are expected to compete in a multibillion dollar global market.
Shares of Vertex Pharmaceuticals Inc. rose $5.96, or 12.4 percent, to $54 in midday trading.
Vertex’s studies were designed to show that adding telaprevir to the older drug combination could cure most patients in six months — cutting the standard treatment time in half and reducing exposure to negative side effects.
According to the FDA, 58 percent of new patients were eligible for this shorter treatment regimen based on reduced viral levels after four or 12 weeks. The FDA’s review states that patients who have previously been treated for the disease should respond similarly.
FDA notes that the drug was significantly less effective for African Americans. The most common side effect with the drug was a skin rash and fatigue.
The agency will ask its panel to comment on those issues on Thursday. The FDA is not required to follow the advice of its panelists, though it usually does
Hepatitis C is a major cause of liver transplants, and it kills about 12,000 U.S. patients a year, a number expected to triple by 2030 as baby boomers succumb to the disease.
The disease is often associated with users of illegal injectable drugs like heroin, though it could also be picked up from blood transfusions before 1992, when testing of the blood supply began.
Most people with hepatitis C don’t even know they have the virus until years later when liver damage has occurred, which can cause abdominal pain, fatigue, itching and dark urine.
Vertex Pharmaceuticals is based in Cambridge, Mass., and was founded in 1989 by a former Merck scientist. If approved, telaprevir would be the company’s first commercialized product in the U.S. Vertex holds marketing rights for North America, while Johnson & Johnson will market the drug in other parts of the world.
Mehmet Oz at the 2010 Time 100 Gala
Mehmet Cengiz Oz (Turkish: Öz, pronounced [ˈøz]; born June 11, 1960), best known as Dr. Oz, is a Turkish – American cardiothoracic surgeon, author, and host and commentator for the syndicated daily television program focusing on medical issues/personal health, The Dr. Oz Show.
Mehmet Oz was born in Cleveland, Ohio, to Turkish parents, Suna and Mustafa, who had emigrated from Konya, Turkey. Mustafa Öz was born in Bozkır, a small town in central Turkey. Mustafa did very well in school and earned scholarships that allowed him to emigrate to the United States as a medical resident in 1955. Suna comes from a wealthy family that includes writers, civil engineers, and businessmen. Several of her great-grandparents came from the Caucasus mountains, leaving the region after the Russian Empire took it over in the 1860s.
Oz was educated at Tower Hill School in Wilmington, Delaware. In 1982 he received his undergraduate degree from Harvard University. In 1986 he obtained a joint MD and MBA degree from the University of Pennsylvania School of Medicine and The Wharton School. He was awarded the Captain’s Athletic Award for leadership in college and was Class President followed by President of the Student Body during medical school.
Oz is Vice-Chair and Professor of Surgery at Columbia University. He directs the Cardiovascular Institute and Complementary Medicine Program at New York-Presbyterian Hospital. His research interests include heart replacement surgery, minimally invasive cardiac surgery, and health care policy. He has authored over 400 original publications, book chapters, and medical books and has received several patents. He performed around 250 heart operations annually.
Oz is the founder and chairman of HealthCorps, a non-profit organization that pays a small stipend to recent college graduates to spend two years in high schools mentoring students about health, nutrition, and fitness.
Television, radio and movies
Oz appeared as a health expert on The Oprah Winfrey Show for five seasons. On the show, he addressed issues like diabetes and promoted resveratrol supplements, which he claimed were anti-aging. His Transplant! television series won both a Freddie and a Silver Telly award. He has appeared on Good Morning America, the Today show, Larry King Live and The View, as well as guest-hosting the Charlie Rose show. In addition, he served as medical director of Denzel Washington’s John Q and participated in several other feature films. He currently hosts The Dr. Oz Show on television and a talk show on Sirius XM Radio. In January 2011, Oz premiered as part of a weekly show on the Oprah Winfrey Network called “Oprah’s Allstars”. In each episode, he, Suze Orman and Dr. Phil answer various questions about life, health and finance.
Oz authored six New York Times best sellers including YOU: The Owner’s Manual, YOU: The Smart Patient, YOU: On a Diet, YOU: Staying Young, YOU: Being Beautiful as well as the award winning Healing from the Heart. His new book, YOU: Having a Baby, was published by Free Press on December 1, 2009. He has a regular column in Esquire magazine and O, The Oprah Magazine and his article “Retool, Reboot, and Rebuild” was awarded the 2009 National Magazine Award for Personal Service.
Awards and honors
Mehmet Oz at ServiceNation in 2008
Time magazine ranked Oz 44th on its list of the 100 Most Influential People in 2008 and Esquire magazine placed him on its list of the 75 Most Influential People of the 21st Century. He was called a Global Leader of Tomorrow by the World Economic Forum and one of “The Harvard 100 Most Influential Alumni” by 02138 magazine. He won the Gross Surgical Research Scholarship. He was listed in “Doctors of the Year” by Hippocrates magazine and in “Healers of the Millennium” by Healthy Living magazine. Oz is annually listed in the Castle Connolly Guide of the top United States doctors, as well as other ranking groups.
Other awards and honors include:
- Honored by the New York Open Center for “outstanding research in writing and communication (and for) bridging Western and alternative/complementary medicine”, 2007
- Listed in Best Doctors of the Year, New York Magazine
- Turkish American of the Year, 1996
- Books for a Better America award for Healing from the Heart, 1999
- Robert E. Gross Research Scholarship, American Association for Thoracic Surgery, 1994–1996
- Research Award, American Society of Laser Medicine and Surgery, 1991
- Blakemore Research Awards, Columbia University College of Physicians and Surgeons, 1988–1991
- One of the 500 most influential Muslims 2009
- 2010 Daytime Emmy Award For Outstanding Talk Show Host
- 2011 James Randi Educational Foundation Media Pigasus Award, which the foundation states is for promoting “nonsense”. The foundation complained about Oz’s support of energy medicine, faith healing and psychic mediums, among other controversial practices. Oz is the first person to receive a Pigasus Award two years in a row.
Oz lives in Cliffside Park, New Jersey with his wife Lisa. They have been married since 1985 and have four children: Daphne Nur, Arabella Sezen, Zoe Yasemin, and Oliver Mustafa.
His father’s family believes in the integration of Islam and government, his mother’s family are secular Muslims. He has been influenced by the mysticism of Sufi Muslims, as well as the ideas of Emanuel Swedenborg, the Swedish scientist, philosopher, and Christian theologian. He recently wrote in Spirituality and Health Magazine that “As I came into contact with Swedenborg’s many writings, I began to understand Swedenborg’s profound insights and how they applied directly to my life”. He mentions Swedenborg’s ideas that marriage lasts to eternity, everyone has a purpose in this world, God is love, and Swedenborg’s answers to “Why do bad things happen?”.
Oz is a practitioner of Transcendental Meditation. “When I meditate, I go to that place where truth lives,” he said. “I can see what reality really is, and it is so much easier to form good relationships then.”
RealAge drug marketing
Oz is a spokesman and advisor, with Michael Roizen MD (of the Cleveland Clinic), of their website RealAge.com, which The New York Times has criticized for its pharmaceutical marketing practices. The site solicits medical information from visitors to determine a visitor’s biological age and then uses the visitor’s medical profile for pharmaceutical marketing purposes. As The Times reporter explained the significance of this fact: “While few people would fill out a detailed questionnaire about their health and hand it over to a drug company looking for suggestions for new medications, that is essentially what RealAge is doing.”
Oz is a supporter of integrative medicine, combining alternative therapies with conventional medical treatments. Some conventional medical practitioners allege that Oz is promoting unproven and harmful alternative medicine practices on The Oprah Winfrey Show and elsewhere. Appearing in surgical scrubs on the show’s set in Chicago, Oz has promoted self-described energy based practices and acupuncture on the show.
Dr. Mehmet Oz On Lap Band Surgery:
FDA Says You Could Be Eligible
The Dr. Oz Show, April 2011 – Dr. Oz, “Lap Band Surgery; Is Weight Loss Surgery for You?”
Once only for the morbidly obese, people only 30-pounds overweight may now be eligible for gastric-band surgery. The FDA says you could be eligible for lap band surgery if you are 30 pounds over weight. This could help 25 million people help shed the pounds and keep them off. Comments from: Dr. Shawn Garber, Dr. Louis Aronne, Dr. Diana Zuckerman.
Doctor Oz asks, “Are You A Candidate For Weight Loss Surgery?”
Normally for patients to be eligible for gastric band surgery you had to be morbidly obese with a body mass index of 40 or more. The FDA has broadened the approval to include people with a BMI of 3o as long as they have at least one health related condition such as diabetes or high blood pressure. Kathy weighs 200 pounds and her problem is that she has battled with her weight all her life, lose 10-20 pounds and then gain it all back. She now has high blood pressure and considering weight loss surgery, and does not not want to wait until she is morbidly obese to have lap band surgery.
Dr. Oz Is Gastric Band Surgery The Right Surgery For Me?
Is gastric band surgery the most effective way to lose weight? Dr. Oz had two women ask this question today, is the lap band the right thing -Vanessa weighs 193 pounds whose said she has tried every diet out there and nothing seems to work.
Gastric-band surgery was once only for the morbidly obese. Now, new rules say people only 30-pounds over weight may be eligible for this procedure.
Dr. Oz asks his guests, “How does a Lap-Band work?”
A Lap-Band on your stomach reduces the room for food so that you feel full after eating very small amounts. If you eat too much, especially too much of certain kinds of food, you will feel nauseous or will vomit. Unfortunately, these are factors that will help you lose weight.
Dr. Zuckerman testified before the FDA that the lap band requirements should not be be lowered.
Dr. Oz asked Dr. Louis Aronne “Why would someone 30 pounds over weight may be a candidate for lap band surgery?
Dr. Louis Aronne says “we will be catching people in a good spot where there is a lot of risk. The FDA has approved lap band surgery for people with diabetes, sleep apnea, heart disease, people who are already sick and if they lose weight with this and the evidence is that they will lose 40 pounds, that’s very good weight loss, not only will that problem get better about three quarters of the people in the study diabetes goes away, but the other problems will also get better.”
Dr. Louis Aronne went to say “why wait until someone is morbidly obese and gets really sick, we are waiting too long to treat obesity. Evidence from places like Columbia is that the more weight you gain the harder it is to control your weight, you’ve got to intervene sooner.”
FDA Guidelines For Lap Band Surgery
BMI over 40
For the average 5’4″ women 233 pounds
Someone who is 204 pounds with one of the following-hypertension, type 2 diabetes, heart disease, sleep apnea.
New FDA Lap Band Surgery Guidelines
175 pounds-30 pounds over weight with one of these complications-hypertension, type 2 diabetes, heart disease, sleep apnea.
Dr. Diana Zuckerman argues that people with only 30 pounds or even 50 pounds should not be eligible for lap band surgery. She agrees that it is a great idea to lose the weight sooner but the problem is that the science just isn’t there.
Dr. Zuckerman told the FDA ” They studied 145 people for about a year and that included about 14 men, they have very little information, there are complications and many insurance companies will only pay for one bariatric surgeries. If a patient gets a lap band and hates it because they feel nauseous all the time, or don’t like not being able to have meals with their family, or it’s starts deteriorating in their body body they have a real problem their insurance company can say too bad.”
Dr. Oz’s biggest concern is how sustainably effective is lap band surgery and asks Dr. Aronne what is the long term success of weight loss surgery.
Dr. Aronne said “What was presented at the FDA hearings was 2 year evidence that people were able to maintain a twenty percent weight loss, if you were 200 pounds you would lose about 40 pounds. About 600,000 people around the world have had lap band surgery and on average the long term evidence is exactly the same. There is somewhere between 17 and 20 percent weight loss and maintain this over 6 years. The evidence is showing that people who are heavier have more difficulty with the lap band, it’s easier when your in the lower weight ranges. ”
“This is not the cure, it is something that helps you to stick to a diet, so if you think you are going to go into this and this is the miracle cure and you can eat whatever you want, that is not going to work. Dr. Oz & Dr. Shawn Garber
Dr. Garber Bariatric Surgeon has performed over 200 lap band procedures and joined Dr. Oz on stage. Oz threw the question at him “What do you have to say to someone who can’t get rid of those last 30 pounds and who thinks the lap band is a solution?”
New York Bariatric Group: “We try to offer advice on diets, exercise, and offer information on weight loss surgeries beyond what you might find on the more formal sections of our site…Dr. Shawn Garber’s Blog
Dr. Garber Said “I think now more than ever the lap band is a great option for patients, it is minimally invasive we go in through the belly button, virtually scarless, no scars, more than ever it’s a great procedure for the patients. The data from FDA study for the lower BMI showed 85 percent of patients were successful with the lap band as apposed to regular diets, non surgical diets which has an over 85 percent failure rate. Were giving them something that is a great option and to remember bariatric surgery is a tool not a cure.”
Doctor Oz asks his guests, “What Are The Complications Of Lap Band Surgery?”
Complaints Of Heartburn
Vomiting If They Eat Too Much
Don’t Chew Their Food
Eat Too Fast
Dr. Garber some of these complications can be fixed with an office visit by adjusting the bad, if the bad is too tight it will cause heartburn or vomiting. So just by adjusting the bad these symptoms can be alleviated or by medications.
More serious complications from lap band surgery is that the band can erode through the stomach wall. Dr. Garber said in over his 2000 surgeries he has never seen a band erode through the stomach wall. There is a 1 percent chance the band could slip on the stomach out of position which is very easy to fix, to take a band out is a very simple 15 minute operation. It takes 20 to 30 minutes to put a lap band in, it is easier to take a lap band out than it is to put it in.
Dr. Oz asked Vanessa and Kathy what conclusion they have come too after hearing what Dr. Shawn Garber, Dr. Aronne, Dr. Zuckerman had to say about lap band surgery and Vanessa says the benefits of weight loss surgery out weighs the risks, Kathy feels the same way.
The Wall Street Journal Health Blog, April 28, 2011, By Laura Landro
New efforts are underway to help patients to take their prescription drugs correctly, amid a rise in emergency room visits and hospitalizations related to adverse outcomes from taking medications, today’s Informed Patient column reports.
The FDA, through its Safe Use Initiative, is working with the Brookings Institution to evaluate a new single-page standard medication-information document — to be known as PMI, for Patient Medical Information. It would replace the plethora of material now handed out to patients with their prescriptions, including the FDA-approved package inserts from drug companies.
In February, Brookings’ Engelberg Center for Health Reform convened a workshop to discuss pilot programs testing the distribution to patients of prototypes of the one-page format. But it won’t be an easy undertaking: federal funds for the project are yet to be approved, and some in the industry believe more work needs to be done to test the effectiveness of the PMI concept, especially the scaled-down format.
While FDA officials acknowledge that there is no evidence regarding optimal page length, the agency says a single-sided page of information would provide essential information; for more detailed resources, patients could be referred online. “We think we can get the paper document down to one page [if] you take out [what] we feel is repetitive information, or information that a typical patient wouldn’t want or need to know,” FDA senior program manager Denise Hinton tells the Health Blog.
She says the FDA doesn’t plan to have a review or approval process for the PMI documents, which would cover thousands of drugs, and instead will develop standards for drug manufacturers to comply with.
That also worries some, including third party independent drug information publishers. Gerald McEvoy, assistant vice president of the American Society of Health-System Pharmacists, which provides the medication information on the National Library of Medicine’s MedlinePlus website, says he is concerned that one page may not be enough for more complex or risky drugs. He also questions the ability of manufacturers to provide “objective, balanced information about their drugs in an unregulated setting.”
In a presentation at an FDA hearing last year, McEvoy warned that consumers don’t trust manufacturers’ information and called on the FDA to ensure that new proposed content standards provide all information that is essential for patients and that they not be inferior to existing materials about safe and effective medication use.
Dorothy Smith, founder and president of Consumer Health Information Corp., which develops patient medication instructions and patient education programs, agrees the one-page format is too constricting. But she says all the consumer medical information in the world won’t ensure that patients take their medications correctly unless they’ve been verbally counseled by health professionals such as doctors and pharmacists.
What about consumers who are embarrassed about asking a pharmacist about their medications in front of others? Smith suggests asking to be counseled in a private room or area behind the counter. “Don’t leave the pharmacy or doctor’s office until you understand what the drug is for and how you should be taking it,” she tells the Health Blog.
It could take years before a final rule on the PMI goes into effect, and in the meantime, other efforts are underway to provide consumers with easy-to-understand information at the pharmacy. The Institute for Safe Medication Practices has designed more than a dozen eye-catching, colorful single sheets — printed on both sides — for so-called high-alert medications (such as Fentanyl pain patches and the long-acting insulin Levemir) that pose the greatest risks if used incorrectly. ( Here’s an example.)
ISMP President Michael Cohen tells the Health Blog the sheets, which will be tested with pharmacists and patients, were designed to educate patients about side effects and the avoidance of the serious medication errors that are common with those drugs.
“Our hypothesis is that a more attractive, bulleted, easier-to-read document will be more helpful in communicating safety information to patients than what you get at the drugstore,” Cohen says.
Suggestions for Making Prescription-Drug Labels More Clear
The Wall Street Journal Health Blog, By Katherine Hobson
A report by the Institute of Medicine estimates that 90 million Americans can’t fully understand and act upon health information. The U.S. Pharmacopeial Convention, which sets drug standards, today proposed changes to chip away at some of that confusion, at least when it comes to the labels that pharmacists put on prescriptions they fill.
The USP is offering standards that it says will make label information and instructions more comprehensible. For example, instructions to “Take two tablets twice daily” can raise confusion; saying “Take 2 tablets in the morning and 2 tablets in the evening” makes the numbers more explicit and also specifies exactly when to take the medications.
The recommendations also suggest that if it’s okay with the patient, labels should include the purpose of the drug, and in plain language, i.e. “for high blood pressure” rather than “for hypertension.”
And, the proposed standards recommend formatting that can make labels easier to read, including using regular sentence structure, and laying out labels so users don’t have to rotate the container to read them.
Here are the details (click on the link below) of the USP’s proposed standards. If they are finalized, they could be adopted by state pharmacy boards or other authorities.
Confusion Over Sound-Alike Drug Names Can Harm Patients
Wall Street Journal Health Blog, By Jacob Goldstein
A doctor means to prescribe primidone, an anti-seizure drug. But because of a miscommunication somewhere along the line, the patient gets prednisone, a steroid that affects the immune system and reduces inflammation — a potentially deadly mistake, according to a report from the U.S. Pharmacopeia, a group that sets drug standards.
The report mined records from a national database between 2003-2006 and found more than 25,000 “look alike /sound alike” errors. (Reporting is voluntary and doesn’t include all errors.) The vast majority of those errors didn’t cause patients any harm, but several hundred did. Primidone-prednisone was one of a handful of mix-ups that may have contributed to a patient’s death.
When the Health Blog first looked at the report, we assumed that this sort of problem was an artifact of docs’ messy handwriting and other hold-overs from the pre-computer era. But though computers may solve some problems, they can create others: “look-alike drug names in computerized direct order entry systems are a source of confusion for prescribers,” the report says.
The report also lists several ways to minimize the errors. One common-sense step: Doctors should write not only the name of the drug they’re prescribing, but what it’s being used for. And this information should be communicated down the line to patients picking up prescriptions. That would make it significantly less likely that a patient who needed a drug to control seizures, for example, would wind up with pills that reduce inflammation.
Bonus confusion: The report lists drugs that may be especially likely to be confused because their names look or sound like the names of so many other drugs. Topping the list was the antimicrobial cefalozin, a name that looks or sounds like 15 other drugs. That was followed by lisinopril with 13 and enalapril, prednisone, and trazodone with 12 a piece.
Justices’ Debate Turns to Privacy for Doctors
The New York Times, By ADAM LIPTAK
Published: April 27, 2011
WASHINGTON — A somewhat esoteric Supreme Court case on Tuesday about data mining by drug companies turned into a debate over a fundamental First Amendment principle that has much engaged the justices lately: What role may the government play in regulating the marketplace of ideas?
In assessing the Vermont law at issue Tuesday (Sorrell v. IMS Health, No. 10-779), which bars some but not all uses of prescription drug data, several justices indicated that they viewed government efforts to alter the mix of available information as constitutionally problematic.
That principle animated last term’s decision in Citizens United, which struck down part of a federal law regulating speech about politics by corporations and unions. The tenor of Tuesday’s arguments suggested that a majority of the justices had similar concerns about the Vermont law, which regulates the use of information collected about doctors by records kept by pharmacies.
The case is not about patients’ privacy rights, as individual information about them is meant to be stripped from the data. Rather, the Vermont law restricts tailored efforts to market drugs to doctors aided by databases showing what medicines they have been prescribing.
The state law forbids the sale of prescription data to market drugs and bars drug companies from using the data to market drugs, unless the prescribing doctor consents. But other uses of the same data are allowed, including ones by law enforcement, insurance companies and journalists. And drug companies remain free to market their drugs in a more indiscriminate fashion, without knowing the prescribing habits of individual doctors.
Bridget C. Asay, an assistant state attorney general defending the law, tried to frame it as one meant to protect doctors’ privacy. But the argument gained little traction, and several justices noted that the law permitted uses that seemed to invade doctors’ privacy as much as the forbidden ones, and in any event doctors remain free to decline to meet with marketers.
Some of the justices also seemed concerned about what the law meant to achieve, as reflected in legislative findings justifying the law.
There is, the state Legislature said, a “massive imbalance in information presented to doctors” and “the marketplace for ideas on medicine safety and effectiveness is frequently one-sided.” The point of the law, several justices suggested, was therefore to protect doctors from hearing from drug marketers that might suggest more expensive drugs even as the state pushed cheaper generic drugs.
“You want to lower your health care costs, not by direct regulation, but by restricting the flow of information to the doctors,” Chief Justice John G. Roberts Jr. told Ms. Asay. “To use a pejorative word,” he went on, the state is “censoring what they can hear to make sure they don’t have full information.”
The chief justice’s two most senior colleagues, Justices Antonin Scalia and Anthony M. Kennedy, forcefully made similar points. The three justices sit at the center of the Supreme Court bench and at times they seemed a juggernaut bearing down on Ms. Asay.
Other members of the court were also skeptical about the way Vermont had chosen to regulate the distribution of prescription data.
Justice Ruth Bader Ginsburg said the state “is interested in promoting the sale of generic drugs and correspondingly to reduce the sale of brand-name drugs.” But she said that goal ran up against a basic First Amendment problem.
“You can’t lower the decibel level of one speaker,” she said, “so that another speaker, in this case the generics, can be heard better.”
Thomas C. Goldstein, a lawyer for several data mining companies challenging the law, said that sort of government manipulation of information is impermissible.
“The way the First Amendment works in the marketplace of ideas that so upsets Vermont is that both sides get to tell their story,” he said. “The thing that is supposed to be biased here is that the drug companies have too much money. That is not a basis for restricting speech.”
New Hampshire and Maine have laws similar to the one in Vermont, and those have been upheld by the federal appeals court in Boston. The Vermont law at issue in Tuesday’s case was struck down last year by a divided panel of the federal appeals court in New York.
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The MagMite is made out of magnetic material and is controlled by OctoMag, an electromagnetic system that allows for wireless micromanipulation. OctoMag sits around the head of the patient and consists of eight electromagnets which can be controlled individually to guide the microdevice – which currently measures around 0.3mm in length — around the eye.
Dr. Bradley Nelson’s remotely-controlled MagMite may pave the way
to future nanotechnology-based medicine.
Bradley Nelson is a Professor of Robotics and Intelligent Systems at ETH-Zürich and is the founder of the Institute of Robotics and Intelligent Systems where he leads the Multi-Scale Robotics Lab. Dr. Nelson and his team have created a robot that, once injected into the eye, can be moved forwards, backwards, and turned in place–all by remote control. If they can shrink their micrometer-scale robot enough to fit into a 23 gauge needle it could be injected into the eye with little or no anesthetic.
The MagMite, as it’s called, is driven by magnetic propulsion. At the center of 8 overlapping magnetic fields (and their magnets) the MagMite’s movements are the net result of changes in the strengths of the magnetic fields. It has a mass of 30-50 µg and, measuring 300 µm x 300 µm x 70 µm, the microbot (a nanobot, of course, would have dimensions in the hundreds of nanometers) is comparable in size to the blood vessels in the human retina having diameters of approximately 150 µm. This is important as Dr. Nelson hopes MagMite will one day be used to treat retinal vein occlusion, a common cause of glaucoma or macular edema. The spatial resolution afforded by the MagMite would allow physicians to deliver drugs in a precise, site-specific manner. People with age-related macular degeneration, the most common cause of blindness among older people, would also benefit. Age-related macular degeneration is often treated with injections directly into the eye. But this leads to rapid diffusion of the drug and the need for regular injections. MagMite could remain in the eye for months, dispensing the drug in a time-release fashion.
So far it’s only been tested in synthetic eyes or eyes dissected from animals (the demonstration in the clip below is in a pig eye). Plans are in the works for human trials. Any takers? Try not to look at the needle headed right for your eye. Remember, it probably won’t hurt.
The magnetic control system developed by Dr. Nelson’s group is a major improvement over robotic propulsions systems of the past. A common strategy for designing medical robots has been to give it a kind of motor with the idea of enabling them to swim their way to targets in the body such as a tumor where they could deliver local chemotherapy. As we’ve pointed out before these mechanical approaches have several drawbacks including tissue damage caused by moving parts and the possibility of the motor getting snagged. These robots would also require nano-sized batteries which simply don’t exist yet. The ideal situation would be a robot that doesn’t require internal propulsion or power. That’s what Dr. Nelson has in his MagMites. We can conceive of letting them course through the bloodstream, passively going with the flow, until they near their target where the magnets could then be turned on and guide it the rest of the way.
The MagMite is a major achievement, but there are some additional major advances that need to be developed before anything like the scenario I described above becomes a reality. For one, the robot has to be seen. Dr. Nelson’s group chose to develop their MagMite in the eye because they can watch it from the outside-in (I’m certain it was experimental feasibility rather than a desire to treat eye conditions that drove their test target–but I digress). But even the eye presented difficulties. The various types of tissues that make up the eye scatter light differently. It was a major challenge for the team to tweak the optics so they could properly monitor the MagMite’s movements. Good luck trying to reach that lung tumor. For that to happen, the MagMite technology will probably have to be merged with that of carbon nanotube transmitters that would transmit the robot’s precise location. Again, this technology is a ways off yet.
But Dr. Nelson’s proof of principle is indeed a beautiful display of technological finesse. To manipulate 8 magnetic fields with such a soft touch as to precisely control a micrometer-sized robot is mastery. The MagMite’s speed tops out at 12.5 mm/s or 42 times the robot’s body length per second. At such speeds the robot can produce enough force to push objects of comparable size. It’s easy to get excited about the prospects of using MagMites for noninvasive surgery, at least in the eye where small changes in structure lead to big changes in vision. And the magnetic power required to move it is 2 mT, about 50 times the average magnetic field of the Earth and a thousand times less power than a typical MRI magnet.
At this point, the MagMite is really just a small magnet, not much of a robot at all. But that’ll change soon when Dr. Nelson enables it with drug delivery capabilities. At hundreds of microns the MagMite is not the ideal vehicle for drug delivery. Nanobots, with dimensions in the hundreds of nanometers, would be able to go where MagMite cannot (nanoparticles small enough to pass through cell membranes are already being created in labs). The dream application, of course, is to unleash trillions of robots into the body that would deliver drugs to specific sites, including specific organelles inside of cells. And yes, again, this technology is quite a ways off. But with Dr. Nelson’s demonstration, it was brought that much closer.
SingularityHub.com, by Peter Murray April 27th, 2011
Two 510 PackBots enter one of the Fukushima Daiichi reactors damaged by the March 11 earthquake to find radiation levels were too high for humans.
The trend to put robots in harm’s way, instead of humans, continues. On April 17th a pair of robots entered two reactor buildings of Japan’s Fukushima Daiichi power plant–the plant most severely damaged by the March 11th earthquake. Their job was to determine whether or not the plant was safe for reentry by human repair crews. The robots confirmed what Japanese officials feared: radiation levels were way too high for humans.
The robots used by the Japanese officials were a pair of 510 PackBots. Built by iRobot, the Bedford, Mass. company that makes the Roomba vacuum cleaner, PackBots are already being used by U.S. forces to carry out dangerous operations in Iraq and Afghanistan.
PackBots have helped save soldiers lives by neutralizing roadside bombs, car bombs, and other improvised explosive devices (IEDs); they screen vehicles, buildings and people, and they search through high-risk structures such as buildings and sewers.
Upon request by Japanese officials, iRobot sent over a pair of PackBots to help in the “war zones” of crippled nuclear factories. The company modified its 510 PackBots to better investigate the ruined factories, outfitting it with the company’s full hazmat gear: an array of sensors able to detect air oxygen levels, temperature, gamma radiation, as well as hazardous materials and chemicals. The PackBots’ lightweight frames–between 48 and 60 pounds–allow them to nimbly navigate factory debris. Precise control of the manipulator arms enable controllers to adjust equipment or objects inside the plant. The robots are also fitted with a camera that sees in either visible light or infrared and streams the images through a fiber optic cable to a control team safely located hundreds of feet away. In addition to the radiation readings, the video data will allow repair teams to map out salvage strategies for other, heavy-lifting robots as well as for human crews.
After pushing their way through the outer doors of reactor buildings Unit 1 and Unit 3 the PackBot pair collected and analyzed air samples. The news was not good. Radiation levels were 49 millisieverts per hour in unit 1; in Unit 3 they reached 57 millisieverts per hour. To put that into perspective, workers in the U.S. can legally be exposed to 50 millisieverts per year and radiation sickness occurs at 1,000 millisieverts, according the associated press. Prior to the earthquake the radiation limit for Japanese workers was 125 millisieverts. Japanese authorities doubled the limit after the earthquake to 250 millisieverts per year. But even at the increased limit workers at Fukushima Daiichi would absorb their year’s worth of exposure in just 5 hours. The video below shows some great footage from the PackBots as they maneuver inside one of the debris-strewn reactors.
Robots show inside Fukushima reactor buildings
With more than 3,000 PackBots in military and civil service around the world, the 510 PackBot is one of the world’s most successful battle-tested robots. Behind its versatility is its capacity to accommodate a wide range of payloads and sensors, including manipulators, all of which are controlled by iRobot’s Aware 2 intelligence software that allows for modular, mission-specific configuration.
The PackBots are joined at Fukushima Daiichi by two other types of robots: two 710 Warriors–also made by iRobot–and a more rugged robot called Talon, created by a British defense firm called QinetiQ (QinetiQ’s American group, QinetiQ North America sent the robots to Japan). Like the PackBots, both the Warriors and Talons specialize in high-risk reconnaissance and the disposal of explosives and hazardous materials–they just do it with more muscle. The Talon weighs about twice as much as a PackBot and its not-so-delicate platform can be outfitted with ordinance from rifles to anti-tank missiles in combat theaters. The Warrior, also much larger and stronger than the PackBot, is able to carry payloads up to 68 kilograms (150 pounds). iRobot engineers attached an arm to the Warriors that is capable of dragging a fire hose and potentially positioning it to cool off the hot reactors. A Warrior can also carry a PackBot, which comes in handy if the PackBot needs to be placed through a raised target such as a window.
Even with the brawn of the Warrior and Talon robots, the capacity to move objects inside the factories without human help is extremely limited. Nevertheless, given the high levels of radiation any amount of removal is precious. Japanese safety officials are hopeful that the robots can get rid of some of the contaminated water and other debris before having to send in their crews.
The Fukushima Daiichi robots are the most recent examples of the ever-increasing reach of robotic helping hands. As was the case for the PackBot, Warrior, and Talon, modern warfare has been the main proving grounds for removing humans from danger and replacing them with robots. The most extraordinary example as of late is the U.S. Navy’s X-47B, an unmanned aerial vehicle with strike capabilities. Northrop Grumman’s Global Hawk drone is being used to take crucial video in the radioactive skies above Fukushima Daiichi.
Sitting on the rim of the so-called Pacific Ring of Fire, Japan’s high risk for earthquakes and volcanic eruptions has given rise to a country with an emphasis for natural disaster rescue technologies. On the other side of the Ring, California too is developing technologies to prepare for the inevitable. In natural disaster as in war, robots are already rapidly stepping up to the front lines so we don’t have to. In the future we’ll see them grow even more integral, and we’ll see even more human lives be saved.
[video credit: IDG Communications via youtube]
video: IDG Communications
Kurzweil gives his now famous speech on the Singularity at the Presidential Conference in Israel.
If at first you don’t succeed in convincing the world that a Technological Singularity is near then try, try again. Ray Kurzweil has been sharing his predictions about the disruptive effects of exponential growth in technology for decades now, but he never seems to get tired of bringing his message to a new audience. Case in point, the Presidential Conference in Israel. At the second annual Conference in 2009, Kurzweil gave his standard speech on the Singularity to Shimon Peres, the President of Israel, along with hundreds of other dignitaries, industrial leaders, and average citizens who were in attendance. You can watch his opening day comments, followed by his full 40+ minutes presentation, in the video below. If you’ve never sat through and listened to Kurzweil’s entire pitch before, now is the time.
The Presidential Conference has only recently started to release these videos online. Thankfully they decided to break them up into easy to digest pieces. The first clip covers most of Kurzweil’s opening remarks while the following four videos are his main presentation in its entirety.
If you’ve heard Kurzweil speak before, the videos above were probably nothing new. Honestly, I’ve seen this presentation so often I think I can quote much of it verbatim. Yet I’m delighted to share these videos with readers because even after listening to this talk dozens of times, I still find it pretty damn good. There are many other futurists out there that discuss the potential of the Singularity, but Kurzweil has a clarity of vision and a logical progression that make his presentations stand out. You can argue about his predictions, scrutinize his life for two years while filming him, or just subtly tease him about his beliefs, but you have to show the guy some respect. When he believes in something he’s not afraid to tell you about it. Again, and again. And again. And again…
Raymond “Ray” Kurzweil – Part 1, Tomorrow
Raymond “Ray” Kurzweil – Part 2, Tomorrow
Raymond “Ray” Kurzweil – Part 3, Tomorrow
Raymond “Ray” Kurzweil – Part 4, Tomorrow
“Fixes“ looks at solutions to social problems and why they work. Why can’t hospitals get health care workers to wash their hands?
The New York Times, April 26, 2011, by Tina Rosenberg – Hospitals in the United States enjoy access to running water. Virtually all of them have alcohol-rub dispensers, hundreds of them, in the hallways. Using one takes a few seconds. Yet health care workers fail to wash hands a good percentage of the times they should. Doctors are particularly bad.
A health care worker’s hands are the main route infections take to move from one patient to another. One recent study of several intensive care units — where the patients most vulnerable to infection reside — showed that hands were washed on only one quarter of the necessary occasions.
It’s not that hospitals are ignoring the problem — indeed, they are implementing all kinds of strategies to promote hand-washing. Nevertheless, it is rare to find a hospital that has been able to keep the hand-washing rate above 50 percent.
Readers of Fixes know our skepticism about relying on things that beep in health care. In general, the American health care system depends too much on technology and not enough on human connection. But in the case of hand-washing, the opposite may be true. Improving hand-washing rates is not simple – if it were, we wouldn’t have a problem. It requires many steps that take into account human foibles. But for measuring compliance — one of the most important and difficult steps — we may have been relying too much on people to do a machine’s job. There is a new technological fix available that — when accompanied by other changes — may be key to reducing dangerous infections.
Why is this even a problem at all? There cannot be a single trained health care worker, anywhere in the world, who is unaware of the importance of hand-washing. Yet 2 million patients in America acquire an infection in the hospital every year — about one in 20 patients — and 100,000 people die of them. This is the fourth leading cause of death in America. Few families don’t have some horror story that started with a hospital-acquired infection. And hand-washing rates in other wealthy countries are not much different.
Hospital-acquired infections cost the American health care system between $30 and $40 billion annually. Simple division puts the rough average cost of treating of a hospital-acquired infection at $15,000 to $20,000. One study that gathered data from other studies found the average cost of treating an infection with MRSA, a staph bacteria resistant to many antibiotics, is $47,000.
There are several reasons, however, that hospital hand-washing rates may be about to improve. One reason is that hospitals have a strong financial incentive to reduce infections. In 2008, hospitals were told that Medicare would no longer reimburse them for the cost of treating preventable hospital-acquired conditions it calls “never events,” which includes many kinds of hospital-acquired infections. The new health care reform bill instructs states to do the same with Medicaid. Many insurance companies also now refuse to pay for never events. This tends to concentrate the minds of hospital executives.
Another powerful incentive to prevent infection is the rise of superbugs, like MRSA, that are increasingly resistant to our arsenal of antibiotics. Infections are getting more and more deadly. No one is more aware of this than the people most in contact with these bugs. Hand-washing is not only protective for patients.
Patients are also more knowledgeable about hospital infections and more empowered. Hospitals are increasingly required to report their incidence of hospital-acquired infections, and those results will be posted online. Patients can use this information to help them choose a hospital.
Many people have studied why hand-washing rates are so dismal. On Friday I will write about the reasons, and what has helped — although not enough — to fix the problems. The most important reason is probably that health care workers are so busy; stressed-out people with too much to do often forget to wash their hands, or it just gets skipped.
Using alcohol rub takes only a few seconds, but many nurses should be doing this dozens of times a day — in some intensive care wards, 100 times a day for each patient.
It will be very difficult to improve compliance unless hospitals can tell who is and isn’t cleaning hands, and in what circumstances. Individual doctors and nurses need to know their own hand-washing rates.
“Data really helps us work backwards,” said Katherine Ellingson, an epidemiologist at the Centers for Disease Control in the Division of Healthcare Quality Promotion. “If hospitals can identify wards that have problems or wards that are doing very well, they can learn where the gaps are or how people have found a way to get adherence up. And when people have data, they pay attention. The CEO may pay attention. The health workers themselves will pay attention if you provide data on their performance.”
Until now, hospitals have had two ways to measure hand-washing. One is by monitoring how often each soap or alcohol gel dispenser needs to be refilled. By tracking how much product a unit uses, you can get a rough idea of how much hand-washing is going on. The limits here are obvious: there is no way to tell who is washing hands and when.
The method currently considered the gold standard is using human observers: nurses or other health care workers who roam halls and patient rooms with a clipboard, recording who does and doesn’t wash hands. Sometimes they’re like secret shoppers and sometimes they’re announced.
This system, too, is woeful. Spending health care workers’ time in observing is expensive. And they can monitor only a small sample of health care workers. A recent study at the University of Iowa to test whether observers should stand still or move around found that moving more was better, but the real news was this: “All observation schedules capture at best 3.5% and at worst 1.2% of all daily opportunities” for handwashing.
When the monitors are announced, it’s bound to inflate compliance, in part because their presence reminds workers to wash hands. Their data may be entered into a computer and analyzed only weeks or months later. It isn’t enough. Hospitals need accurate information about who is and isn’t washing hands, and they need to be able to remind people to do so in real time.
Enter technology. In the last year or two, several new ways to promote hand-washing – all things that beep – have made their debut: HyGreen, BioVigil, Patient Care Technology System’s Amelior 360 and Proventix’s nGage are some of them, but there are others. Some are spinoffs of systems widely used to track hospital equipment (this is how hospitals can find a wheelchair when it is needed). All employ new technology that can detect alcohol — which in hospitals is a component not only of rubbing gel but also soap.
They work like this: every health care worker wears an electronic badge. When she washes her hands or uses alcohol rub, a sensor at the sink or dispenser or her own badge smells the alcohol and registers that she has washed her hands. Another sensor near the patient detects when her badge enters a room or the perimeter around a patient that the hospital sets. If that badge shows that her hands were recently washed, it displays a green light or something else the patient can see. If she hasn’t washed, her hands, the badge says so and emits a signal to remind her to do so. The sensor also sends this information to a central data base. Information about the hand-washing practices of a particular unit, shift or individual is instantly available.
Do they work? It is early yet — these systems are largely in the pilot phase or in use in only a handful of hospitals. But several different studies have shown that they greatly improve hand-washing compliance. There is some evidence that the systems are associated with a drop in infections. Proventix claims its nGage system saw a 22 percent drop in infection in the units where it was used in a seven-month trial, while elsewhere in the hospital the drop during that time was only 4 percent.
Miami Children’s Hospital said that during the time it used the HyGreen system in its oncology unit, the unit had a whopping 89 percent drop in infections. Deise Granado-Villar, chief medical officer, said that the gains have been maintained eight months later. These studies should be read cautiously; they are very small – Granado-Villar would not say how many infections were being counted – and not peer–reviewed.
The drawback to these systems is that they are much more expensive than other measures hospitals have tried. This is the “hand hygiene-industrial complex,” as Philip Polgreen, an infectious-disease specialist at the University of Iowa Carver College of Medicine, calls it. These systems are brand new and their price is likely to drop substantially, but right now they are expensive — Amelior, for example, costs $1,500 to $2,000 per hospital bed to install. Most offer hospitals the option to buy a system or lease it.
Hospital-acquired infections are so expensive, however, that a system that proves effective will pay for itself in the first year. “It paid for itself with the avoidance of one infection,” Granado-Villar said of the HyGreen system. “It cost $50,000 to implement, which can be the cost of one infection today.” An article in the journal Infection Control and Hospital Epidemiology found that if a hospital improved hand-washing rates by 5 percent, it would save $1,000 per bed each year in averted MRSA infections alone – and MRSA infections make up only 8 percent of all hospital-acquired infections.
The technological approach is expensive enough that hospitals struggling with raising hand-washing rates will likely first want to make sure they are getting other things right — creating a culture of accountability, redesigning hand hygiene systems to make hand-washing easy and automatic, and other strategies. These improvements are necessary whether or not hospitals add the technological piece. “I come back to: what do you pair it with?” said Lisa McGiffert, campaign director for Consumer Union’s Safe Patient Project. “When you implement something like this technology you also have to do some culture change.”
On Friday, I’ll look at how some hospitals are changing hand-washing culture, and what we can learn from an absurdly simple idea that has already brought a deadly type of hospital infection down to near zero in Michigan.
April 26th, 2011
Tina, this is a great article. Shedding light on hand-hygiene compliance and the pros and cons to various solutions is becoming a life-saving effort. What I would add to the conversation is that when it comes to health and safety it is NOT a new phenomenon, that the overwhelming majority of people (clinicians as well as patients) actually reject things that make them safe. It sort of defies common sense, especially in matters of life and death. But, as you stated – if everyone washed their hands we would not be having this dialog – and HAI’s would not be the 4th leading cause of death in America. Do you know that many patients will not utter these simple words – “excuse me, Dr. Smith but you didn’t wash your hands” due to fear of alienating the care giver. And Nurse Jones may avoid hand-washing because it’s too time consuming or may cause dry skin. There is a practical and logical science to understanding the behaviors associated with these risk factors that cause people to reject things that make them safe. I see it as part of my role to as the CTO of one of the companies you mentioned to understand the social behavior of how to overcome what people inherently fear – so that the patient has no longer fears or better yet ever needs to utter those simple words to his or her Doctor and creating an environment where ‘doing the right thing’ – or being “compliant” is part of the fabric of each and every health-care worker, and weaves its way up and down the entire organization is much more than producing medical devices or software. Compliance for hand-washing should not be measured or counted by Secret Shoppers, Watchers, or even systems. The true measure of compliance is what the health-care worker does when no one is looking.
CTO/CIO bioVIGIL Systems
Westerner in NYC
New York, NY
April 26th, 2011
Nurses and other hospital workers are not the only ones broadcasting MRSA and other infections.
A frequent visitor to our elderly friend hospitalized with MRSA and other infections balked at being gowned-and-gloved. He refused to don the gown and gloves. The nursing staff alerted the hospital’s Infectious Disease Officer who rushed down to the patient’s room to instruct the visitor on what he should be doing. That didn’t work. After holding our elderly, MRSA-infected friend’s hand, the gentleman visitor would often reach into his back pocket with the same gloved hand that had touched the patient, pull out his cloth handkerchief, blow his nose on it and then replace the soiled–and probably MRSA-coated handkerchief–back into his pocket. Other visitors to the same patient just refused to don gowns and gloves–even when it was explained to them that it was for their safety.
Another problem is scrubs and white coats worn by medical personnel, nursing staff and other hospital workers, especially the cleaners. They wear their “scrubs” and other uniforms around infected patients in the hospital and then leave the hospital often getting onto crowded buses and trains. Doesn’t this spread infections? I know healthcare workers are exhausted after long days and double shifts, but wearing clothing and shoes that have been exposed to blood, bodily fluids, infections and MRSA is dangerous to the public.
April 26th, 2011
Patients and their family members should remind doctors and other caregivers to wash their hands. More people should be cared for at home, rather than going into a hospital. Patients should not have to wait in waiting rooms to see doctors. They should wait outside in their cars, and be fetched with a cell-phone call.
April 26th, 2011
I was, very recently, a patient at NYC Memorial Sloan Kettering Cancer Centers’ Surgical Day Hospital. I was extremely pleased to see everyone involved in my care, pre and post treatment, washed their hands or used an alcohol rub before they touched me. One nurse was in and out of my room, but washed every time she came back in. Every treatment area had hand sinks, and bedside sanitizing dispensers, facilitating frequent use.
Using the Six Sigma Process to Implement the Centers for Disease Control and Prevention Guideline for Hand Hygiene in 4 Intensive Care Units
Noel E Eldridge, MS,1 Susan S Woods, BS, MBA,2 Robert S Bonello, MD,3 Kay Clutter, RN, BSN, MBA,3 LeAnn Ellingson, BSN, RN, CIC,3 Mary Ann Harris, RN, BSN, CIC,4 Barbara K Livingston, RN, BSN, MPH, CIC,5 James P Bagian, MD, PE,1 Linda H Danko, RN, MSN,6 Edward J Dunn, MD, MPH, MBA, MPA,1 Renee L Parlier, BSN, MPA,7 Cheryl Pederson, RN, BA,2 Kim J Reichling, MBA,8 Gary A Roselle, MD,6 and Steven M Wright, PhD9
1Department of Veterans Affairs, Veterans Health Administration, National Center for Patient Safety, Washington, DC, USA
The Centers for Disease Control and Prevention (CDC) Guideline for Hand Hygiene in Health Care Settings was issued in 2002. In 2003, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) established complying with the CDC Guideline as a National Patient Safety Goal for 2004. This goal has been maintained through 2006. The CDC’s emphasis on the use of alcohol-based hand rubs (ABHRs) rather than soap and water was an opportunity to improve compliance, but the Guideline contained over 40 specific recommendations to implement.
To use the Six Sigma process to examine hand hygiene practices and increase compliance with the CDC hand hygiene recommendations required by JCAHO.
Six Sigma Project with pre-post design.
Physicians, nurses, and other staff working in 4 intensive care units at 3 hospitals.
Observed compliance with 10 required hand hygiene practices, mass of ABHR used per month per 100 patient-days, and staff attitudes and perceptions regarding hand hygiene reported by questionnaire.
Observed compliance increased from 47% to 80%, based on over 4,000 total observations. The mass of ABHR used per 100 patient-days in 3 intensive care units (ICUs) increased by 97%, 94%, and 70%; increases were sustained for 9 months. Self-reported compliance using the questionnaire did not change. Staff reported increased use of ABHR and increased satisfaction with hand hygiene practices and products.
The Six Sigma process was effective for organizing the knowledge, opinions, and actions of a group of professionals to implement the CDC’s evidence-based hand hygiene practices in 4 ICUs. Several tools were developed for widespread use.
Keywords: hand hygiene, alcohol-based hand rub, JCAHO National Patient Safety Goals, Six Sigma, intensive care units
Hand decontamination has been shown to reduce the spread of infectious agents for more than 150 years.1 The Institute of Medicine has identified nosocomial infections as the most common complication for hospital inpatients,2 and hands are the most common mode of transmission for many important nosocomial pathogens such as methicillin-resistant Staphylococcus aureus (MRSA).3,4 The 1991 Harvard Practice Study on adverse events in health care5 indicated that surgical site infections were the second most frequent type of adverse event for inpatients, constituting 13% of adverse events. This study did not include other hospital-acquired infections such as urinary tract infections or central line infections. A subsequent study by the Centers for Disease Control and Prevention (CDC) of 1992 to 1996 data6 indicated that surgical site infections constituted only 17% of all hospital-acquired infections. This suggests that only 1 in 6 hospital-acquired infections were counted in the Harvard Practice Study, and that hospital-acquired infections are almost certainly the most frequent adverse event for inpatients.
In 2002, the CDC issued a new Guideline for Hand Hygiene in Health Care Settings,7 which elucidated many points related to hospital-acquired infection. The 2 most basic findings were: (1) the hands of health care workers are regularly contaminated with pathogenic microorganisms; and (2) the hands of health care workers are a major route of transmission of pathogens throughout the hospital environment and from the body of one patient to another. These findings were already well known, but the primary recommendation was new: alcohol-based hand rub (ABHR) should be used for “routinely decontaminating hands.” The 2002 CDC Guideline noted that ABHRs are faster and easier to use than soap and water, more effective at killing most microorganisms, and are less likely to cause dermatitis. Recent studies have shown that use of ABHRs results in fewer infections. Using products other than soap is not new; the original hand decontamination process established by Semmelweis in the 1850s used a decontaminating rinse with chlorinated lime rather than soap.
In total, the 2002 CDC Guideline provided over 40 recommendations, with 4 categories for the level of evidence and for 8 different aspects of practice. In 2003, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) added “comply with current CDC hand hygiene guidelines” to its list of National Patient Safety Goals for 2004. Although this goal was clear, how to achieve it in hospitals was not.
In 2003, the 3M Company approached the Department of Veterans Affairs (VA) and Veterans Health Administration (VHA) about conducting a joint project using the Six Sigma methodology. After discussions, VHA and 3M signed a memorandum of agreement to work together to develop methods to comply with JCAHO’s required hand hygiene practices. We report on the implementation and results of this agreement.
METHODS AND DEVELOPMENT OF INTERVENTIONS USING THE SIX SIGMA PROCESS
The lead representative for VA was the National Center for Patient Safety. The first challenge was to understand which of the over 40 CDC recommendations were required by JCAHO. Discussions revealed that JCAHO would require CDC Category IA, IB, and IC recommendations, and VA staff composed a 1-page summary of the required CDC recommendations. It contains 19 consolidated recommendations on 4 topics and was used to simplify the CDC Guideline, and specify what to address using the Six Sigma process.
The Six Sigma process focuses on identifying critical points where changes should be made, making those changes, and ensuring that the changes are established as permanent practice.12,13 The version of the Six Sigma process developed and implemented by 3M has 5 steps, Define, Measure, Analyze, Improve, and Control, which are referred to as the acronym DMAIC.
In the Define step, a “project charter” is developed that explicitly defines the problem or opportunity using a standard 1-page format that is agreed upon by all participants. This ensures that everyone understands what is to be addressed.
The Measure step includes development of a “process map” that describes the way that things currently occur, a “cause and effect matrix” linking actions and missed actions to good and bad outcomes, and quantitative measurement of the baseline performance parameter(s) to develop the “initial capability,” i.e., initial performance level(s).
In the Analyze step, “Failure Modes and Effects Analysis (FMEA)” is performed, and the data collected previously in the Measure step is analyzed using appropriate statistical methods (“multi-vari studies”) to determine/confirm sources of variation and opportunities to improve.
The Improve step involves adjusting processes and implementing improvements that address, fix, and/or prevent problems. After implementation of the improvements, data are collected again and the improvements may be refined.
The final Control step (1) codifies the improvements into a “Control Plan” that describes the interventions, who is responsible for each, and how and when they will be monitored and/or measured; and (2) sustains the gains by assuring continued adherence to the Control Plan to maintain improved performance and results. The points of the Control Plan, translated out of the Six Sigma format and into a checklist format, are seen in the list of interventions more detailed version in the Appendix, and online at VA web site).
The Six Sigma process was used to organize and focus efforts to implement JCAHO’s hand hygiene goal in 4 intensive care units (ICUs) at 3 VA medical centers. These ICUs are coded as Medical ICU-1 (MICU-1), Surgical ICU-1 (SICU-1), ICU-2, and ICU-3. MICU-1 and SICU-1 are in a Midwestern city, in a large hospital affiliated with a university medical school; MICU-1 is a “closed” ICU staffed by full-time intensivist physicians. Surgical ICU-1, ICU-2, and ICU-3 are “open” ICUs not staffed by full-time intensivists. Intensive care unit-2 is in a Southern city, in a small hospital not affiliated with a medical school. Intensive care unit-3 is in a Midwestern city, in a medium-sized hospital affiliated with a medical school.
3M provided Six Sigma training to VA staff, and assigned 2 team members and a program manager (a “Six Sigma Black Belt”) to the project. Weekly teleconferences with representatives from the hospitals, 3M, and VA Central Office took place over a 6-month period. Control charts were used to track the monthly grams of ABHR used per 100 patient-days, providing monthly performance data and reducing reliance on observation data, which are time consuming to collect, inherently intermittent, and have more potential for unintentional bias.
To track the mass of ABHR used, the number of containers of ABHR replaced at each ICU was recorded monthly by staff responsible for this duty as part of the project. This was challenging because it required scrupulous measurement of something not previously controlled, monitored, or measured. Each container held 198 g of ABHR, and ICU staff already recorded monthly patient-days of care provided in each ICU, so grams of ABHR used per 100 patient-days was easy to compute. Working with foam, gel, and liquid products, and based on a combination of information from manufacturers, the CDC Guideline, and empirical tests with the products, it was determined that an appropriate usage quantity of ABHR was approximately 1.4 g. A template for recording and calculating this data is shown in the Appendix.
To collect data on observed hand hygiene practices, a tool was developed to allow observers to record caregiver compliance with 10 required hand hygiene practices (see Appendix). Intensive care unit (ICU) staff used the tool to monitor the practices of their colleagues without notification as to when the observations would take place. A special instruction sheet was developed to accompany the tool and standardize its use. Data were collected over several days at different times by persons who would typically be in the ICU, i.e., ICU staff rather than Infection Control Staff. The observation method and tool allowed the recording of several hand hygiene opportunities during a single patient encounter. The objective was to record at least 400 opportunities per ICU. This sample size was sufficient to show statistically significant changes as small as 10%. Staff professions or titles were noted, but names were not. There were many categories of staff recorded, but these were later recategorized as MD, RN, or “Other.”
A questionnaire was developed to record ICU staff attitudes and perceptions (Appendix). This questionnaire contained a Hand Assessment Scale15 and questions developed during the Six Sigma process. The questionnaire was used before and after interventions. The questionnaires provided insights into staff attitudes as well as data for a Six Sigma “counterbalance.” The idea for a counterbalance is to measure a parameter that might get worse as the desired parameters get better. In this study, staff satisfaction with hand hygiene practices was the counterbalance. We did not want to increase observed compliance, or the use of ABHR, at the cost of making ICU staff dissatisfied. We believed that improvements were unlikely to be sustainable if the ICU staff were unhappy about the improvement mechanisms.
Reviewing hand hygiene processes systematically, it became clear that widespread and easy access to hand hygiene products such as ABHR, antimicrobial soap, and sterile and nonsterile gloves, must be provided before anything else. First, ABHRs must be available at the bedside and/or the entryway to all patient rooms, and antimicrobial soap at all sinks. In discussions, it became clear that health care workers had not established the frequently repeated hand hygiene practices required by JCAHO as part of their routine, and that they did not feel comfortable reminding each other to decontaminate their hands. Also, health care workers did not know the specific recommendations in the CDC Guideline, and many believed that they were practicing hand hygiene at an unrealistically high rate. The latter point has been previously reported. This meant that health care workers did not fully comprehend the need to increase hand hygiene practices. The most challenging improvement identified to improve staff hand hygiene practices was for patients and visitors to remind staff to decontaminate their hands, and for patients and visitors to also decontaminate their hands.
Of note, a major educational effort was not identified as a critical aspect of the intervention by the Six Sigma process. Education-oriented items focused only on updating and reorienting existing educational training materials and providing new posters presenting new information or perspectives. The posters developed during the project and redesigned subsequently are online at a VA web site. There were no special training sessions, and no exams based on the CDC Guideline. Other educational interventions were relatively simple: a 1-page summary document and updating preexisting Power Point presentations. An 8-minute video on hand hygiene was also provided to each ICU and shown at an ordinary staff meeting.
Results are presented on (1) the mass of ABHR used per 100 patient-days, the observed rate of compliance with hand hygiene practices and (3) the responses to items on the hand hygiene questionnaire before and after the interventions
Each ICU started interventions at a different time and MICU-1 and SICU-1 were tracking the containers of ABHR used per patient-day prior to the project (Fig. 3). Intensive care unit-2 started tracking later. Intensive care unit-3 tracked ABHR use, but partway through the project they discovered that the containers being counted included containers used in areas other than the ICU, so these data were not included in the study. Alcohol-based hand rub use nearly doubled at MICU-1 and SICU-1 (P<.001 for both pre-post comparisons), and increased by 70% at ICU-2 over the period of the study. Data on observed hand hygiene practices are based on the overall percent “yes” responses to observed hand hygiene opportunities noted using the Observation Tool. All 4 ICUs showed statistically significant increases in observed compliance with hand hygiene practices, with relative improvement ranging from a 55% to 95%. All 3 provider groups (RNs, MDs, and others) demonstrated statistically significant improvements, with nurses starting and ending with the highest observed rate of compliance (53% and 82%, respectively). Of the 10 practices measured with the Observation Tool, those with the lowest average baseline and final compliance were numbers 5 and 6: “before patient contact” and “after patient contact upon exiting the room” The practices with the highest average baseline and final compliance were numbers 2 and 7: “after contact with blood, body fluids, secretions or excretions, mucous membranes, nonintact skin” and “upon entering the room before equipment contact.” Observation of practices 9 and 10 was added near the end of the project and the results of those questions are not shown.
Baseline and final responses to the hand hygiene questionnaire were similar for almost all questions (Table 2; Appendix). The measure selected as a Six Sigma counterbalance, staff satisfaction, increased slightly, a satisfactory result as the goal was to maintain a baseline level of staff satisfaction while ABHR use and observed compliance improved. Also, the reported use of ABHRs increased significantly. Data shows the responses to “When you don’t disinfect your hands (use soap or an alcohol hand rub to kill microbes) when you should, what is the reason why?” The reduction in the “too busy” response, and the increase in the “forget” response suggest that postintervention noncompliance was increasingly accidental rather than intentional. The mean estimated rate of self-compliance with hand hygiene practices (87%) was virtually unchanged. However, the distribution of responses changed; the final data contained fewer unrealistic self-responses of 99% to 100% and an increase in the more realistic response of 90% to 95% (Appendix).
DISCUSSION AND CONCLUSIONS
We demonstrated that VA personnel working with a 3M project manager to employ the Six Sigma process were able to develop and implement effective interventions that improved hand hygiene practices. The Six Sigma process proved to be an effective tool for organizing the knowledge, opinions, and actions of health care professionals on an important clinical issue that has been historically intractable.
Many studies have reported that from 5% to 15% of inpatients acquire an infection while in the hospital6,18–21 or that about 2 million infections occur annually.6,22 One study established an excess mortality because of nosocomial infection of 44% in ICU patients.23 Despite the long-established, widespread, and injurious problem of hospital-acquired infections, numerous studies have shown that health care workers do not regularly perform hand hygiene practices consistent with the policies established by their professional groups, employers, etc.7,16,24 There is perhaps no aspect of inpatient care where the divergence between evidence and practice is so pervasive, damaging, long established, and well known.
Our observed 80% compliance after interventions was comparable with the most successful reports in the literature and superior to most published studies attempting to improve hand hygiene compliance.7 Furthermore, we observed statistically significant and sustained increases in the mass of ABHRs used in the observed ICUs per 100 patient-days, consistent with the compliance that we also observed. We validated monthly monitoring of ABHR use per 100 patient-days as a timesaving proxy for observed compliance with required hand hygiene practices. Data from the staff questionnaire indicated that improved compliance did not result in diminished staff satisfaction. Our finding that mean self-reported rate of compliance with hand hygiene practices was unchanged suggests that self-reported rates should not be used to indicate actual compliance rates, trends, or other changes in hand hygiene practices.
The Six Sigma process is different from the “Plan, Do, Study, Act” (PDSA) cycle used in many clinical quality improvement efforts. One important difference was evident in this study. The first 3 Six Sigma steps, “Define, Measure, and Analyze,” focus on studying the problem in depth using various prescribed methods and acquiring high-quality baseline data before doing anything else. These steps may make the Six Sigma process especially appropriate for patient safety improvement initiatives because they address a common problem in patient safety: the lack of reliable baseline data on the current or preexisting status.
Additional aspects of the Six Sigma process that were important to the success of our study included the focus on identifying the subset of potential interventions that will be especially effective, using control charts to separate normal variation from real performance changes, and using a control plan to “maintain the gains” achieved. The project generated several tools for widespread use in VA and elsewhere: a 1-page summary of the JCAHO-required CDC recommendations (which continue to be required through at least 2006), an observation tool, a staff questionnaire, a summary checklist of hand hygiene interventions, and a series of posters designed to remind staff of required hand hygiene practices and encourage compliance.
We thank Carol Meeter and Chris Hughes of 3M for help with planning data collection and data analysis, and staff at the 4 VA Medical Center Intensive Care Units for enthusiastic participation and help with data collection.
Hospital Checklists Save Lives
Simple measures such as hand washing and disinfecting skin make a difference
April 26, 2011
Simple things like hand washing and disinfecting the skin before a tube is inserted by needle into a patient’s vein, help reduce hospital infections.
A new program to reduce hospital infections with relatively simple and inexpensive quality control measures is saving lives, according to a new study.
Hospitals can be dangerous places. We go there to get well, but sometimes people get sicker or even die because of infections they contract in the hospital.
Johns Hopkins University Medical School professor Peter Pronovost pioneered the use of hospital checklists to reduce infections.
He and his colleagues started with a list of about 90 recommendations from the U.S. Centers for Disease Control and Prevention, “and we elected to say, well, I can’t do 90 things as a practicing [doctor]. Let me cull it out and pick the five most important things on that guideline and make sure we do those.”
They focused their program on reducing infections in the central line, the tube inserted by needle into a patient’s vein to deliver medications and for other purposes. Central lines are a common source of serious infection in hospital intensive care units.
The checklist includes simple things like hand washing and disinfecting the skin before the central line is inserted. It has previously been shown to reduce the infection rate to near zero.
But did a lower infection rate translate to a lower death rate?
To find out, Pronovost and his colleagues compared hospital deaths in the state of Michigan, where the checklist program was in use, with nearby states that weren’t in the program.
“What we found was that the mortality of patients in Michigan went down by 10 percent more than if they were in the 11 surrounding states.”
While the quality improvement program may be built around a simple checklist, Pronovost stresses that it really is about changing how medical staff work together so that, for example, doctors listen to nurses, not just the other way around.
“A big part of our program was this culture change, because when doctors were using the checklist, 25 percent of the time they forgot [one of the items], so we asked the nurses to work with the doctors. And if the nurses saw the doctors not comply with the checklist, they can make the doctors go back and fix the mistake.”
Pronovost says the quality improvement program is cost-effective and well-suited to resource-poor hospitals and clinics. “We’ve done it in Peru and we’ve just started a program in Pakistan and we’re looking to put it into Africa. So it absolutely works.”
PATIENTS IN PERIL?: Careful hand-washing shown to save lives
Simple handwashing procedures by health care professionals can cut the risk of bloodstream infections in hospitals. A researcher has developed a five-step checklist for reducing such infections.
By Jodie Jackson Jr. Columbia Daily Tribune
To see hospitals participating in the “On the CUSP” program, go to www.safercare.net/OTCSBSI/Participation.html.
That simple, time-honored command mothers give to their children is one of the earliest lessons of manners and hygiene.
Now, health care regulators and patient-safety advocates are giving that command to hospitals and health care providers with a sense of urgency. Good hand-cleansing policies and enforcement are among the most simple steps to reducing or eliminating infections — and saving lives.
The Centers for Disease Control and Prevention estimates as many as one-third of the 99,000 people who die each year as the result of a hospital-acquired infection were struck with a bloodstream infection.
Health workers who make contact with patients should apply antibacterial gel “immediately before and after touching the patient,” national infection control specialist Marcia Patrick said.
“Patients or family members should say, ‘Please clean your hands,’ ” if a health care worker approaches a patient without doing so, Patrick said. “But they shouldn’t have to say that.”
Examples of poor hand hygiene were cited in a recent report on infection control and sterile processing deficiencies at University Hospital. Patrick called the handwashing observations and a nurse’s statement that dirty floors were not an infection control concern “inexcusable.”
Incidents cited in the Centers for Medicare and Medicaid Services report were observed Nov. 4. The incidents included:
- “RN entered patient’s room without cleansing her hands. The RN removed the patient’s intravenous lock (IV) without wearing gloves. The RN left the room without cleansing his/her hands. The RN went into another patient’s room and opened a drawer getting a flashlight and brought it back to patient’s room.”
- “RN entered room without cleansing hands, put on non-sterile gloves; checked patient’s ID bracelet on the ankle; wrote on the patient’s medical chart; opened a refrigerator door and poured liquid into a cup and gave it to the patient. Left the patient’s room without cleansing her hands.”
Patrick, a board member of the Association for Professionals in Infection Control and Epidemiology, is the director of infection prevention and control for a four-hospital system in Tacoma, Wash. That system has a stringent hand-cleansing policy enforced from the hospital’s top administrator.
Any unit that achieves less than 100 percent compliance gets a personal call from the CEO, “and that’s not a call you want to get as a manager,” she said.
MU Health Care officials said yesterday in an electronic newsletter to employees that the CMS report “only includes those observations when staff members do not comply to the letter of a regulation. The report does not include observations when staff complied nor does it give perspective on what a small percentage the times of non-compliance represent.”
Many patient-safety advocates suggest infections were once considered a normal risk of being in the hospital. But that attitude apparently is changing. The growing list of hospitals that dramatically lowered their infection rates by implementing rigid hand hygiene policies indicates the “average” infection rates were anything but “normal.”
Kathleen Sebelius, secretary of the U.S. Department of Health and Human Services, called on hospitals in 2009 to reduce central line-associated bloodstream infections by 75 percent over the next three years. Thomas Frieden, director of the CDC, has listed hospital-acquired infections as one of the seven “winnable battles” for public health organizations.
Peter Pronovost, a patient-safety researcher and physician at Johns Hopkins School of Medicine, has developed a five-step checklist that targets eliminating bloodstream infections related to the use of catheters and central lines.
He refers to elimination of those infections as “the polio campaign for the 21st century.”
A national initiative to combat such infections is using a Comprehensive Unit-based Safety Program supported by a number of health care-monitoring and patient-safety advocate organizations.
“On the CUSP: Stop BSIs” adopts Pronovost’s checklist, first implemented in 127 intensive care units in Michigan hospitals in 2003. The pilot project targeted central line-associated bloodstream infections and ventilator-associated pneumonia. After 18 months, those ICUs had a median central line-associated bloodstream infection rate of zero. The project saved an estimated 1,500 lives and $200 million. Advocates of the campaign say those rates have been sustained for five years.
The five steps to inserting central lines or catheters are:
- Wash hands to prevent bacteria from the caregiver’s hands from entering the catheter directly or getting into the vein through the opening on the skin.
- Disinfect the patient’s skin.
- Use barrier precautions — such as masks, gowns and gloves — to prevent bacterial contamination when the catheter is put in.
- Avoid placing the catheter in the groin area, which is inherently difficult to keep clean.
- Remove unnecessary catheters. The risk of infection increases the longer the catheter is in place.
Pronovost insisted the CUSP program could have “the potential to save more lives than virtually any other medical discovery of the last quarter-century.”
CUSP advocates suggest patients and their families should take the checklist with them to the hospital and insist all health care providers follow the steps.
“On the CUSP” came to Missouri in 2010, with 15 hospitals — all in the Kansas City area — signing on. The program will expand to more Missouri hospitals in the coming months, but none of Columbia’s three hospitals plans to participate. Those hospitals say they already have stricter hand hygiene programs.
University Hospital, for instance, had several representatives on advisory boards for the Missouri Center for Patient Safety, which coordinates the statewide “On the CUSP” effort. MU Health officials helped the Center for Patient Safety establish several safety priorities, said Jo Ann Wait, MU Health’s director of public relations.
She said University Hospital has been using the same strategies outlined in CUSP to improve infection rates for the past five years.
“Because these efforts have lowered our infection rates to rates below the national average, we chose not to participate in the statewide collaborative,” Wait said, “but to focus our ongoing improvement efforts in other areas.”
In an internal electronic newsletter for employees, MU Health officials yesterday stated state health inspectors returned to the hospital Jan. 18 and found “instances when we did not follow proper hand hygiene.”
“No hospital in the country achieves a 100 percent hand hygiene rate,” the newsletter stated. “Our most recent compliance rate is at 89 percent.”
Stephen Gaither, public affairs director for Truman Memorial Veterans’ Hospital, said all Veterans Administration health facilities have adopted Institute for Healthcare Improvement infection control standards and other programs “more robust than the CUSP program.”
Boone Hospital Center extensively educates staff about critical safety procedures, including hand sanitation, media relations specialist Jacob Luecke said.
Each hospital uses a “secret shopper” method of monitoring hand hygiene policies. Luecke said Boone Hospital recorded some 3,000 hand hygiene observations in 2010. “Anyone spotted not sanitizing his or her hands before and after entering a patient room is given immediate correction and is reported to their manager for follow-up education,” he said.
Patrick said hospitals need to add an additional step — to publicly report their hand sanitation compliance rates along with infection rates.
All hospitals report data on select infections and other statistics to CMS. That information is reported on several websites, including hospitalcompare.hhs.gov.
MU Health announced last week it is making plans to post its health and safety statistics online. Boone Hospital also lists some of the information on its website.