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December 19, 2014 Download print version

FDA issues update on UDI implementation for registered medical

Medical breakthroughs and discoveries in 2014 that prove the future really is here

Should we worry about low fertility?

A flip flop? CME payments to doc must be reported to Sunshine Database

How prepared are states for infectious disease outbreaks?

Doctors prescribing most potent painkillers face scrutiny

Public easily swayed on attitudes about health law, poll find

In Epilepsy, surgery tops drugs for most patients

Daily Update Archives



Self Study Series:
December 2014

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FDA issues update on UDI implementation for registered medical

Having passed the first Unique Device Identification System compliance date of September 24, 2014 (for Class III devices and devices licensed under the Public Health Service Act), the FDA’s Center for Devices and Radiological Health (CDRH) would like to take this opportunity to summarize recent and upcoming UDI activities and deadlines.

The next two compliance dates for UDI requirements are:

  • September 24, 2015 for non-class III implantable, life-supporting, and life-sustaining (I/LS/LS) devices

  • September 24, 2016 for class II devices

Global Unique Device Identification Database (GUDID) Data Submission:

In January 2015, FDA will begin accepting GUDID account requests from labelers of I/LS/LS devices. Later in 2015, we plan to accept GUDID account requests from labelers of class II devices. FDA strongly encourages all device labelers to take steps to ensure their readiness to meet UDI requirements well before actual data submission to GUDID. This will provide labelers with ample opportunity to assess their ability to meet requirements, including data submission to the GUDID, by their deadline and to work with us if they have any difficulties coming into compliance. Suggested steps are included on the UDI website.

Also in January, FDA will host a webinar to help Class II and I/LS/LS device labelers prepare to comply with the UDI rule.

FDA will continue to work with industry on UDI implementation issues that surfaced in 2014, including GUDID data submission for contact lenses/IOLs and development of approaches to ensure the UDI is available at the point of use for non-sterile implants. FDA recognizes there are several other policy issues that are of significant interest to industry; FDA hope to address a number them in 2015, such as UDI direct marking requirements, convenience kits, posting of decisions on UDI exceptions and alternatives, and issuance of additional Frequently Asked Questions (FAQs).

The use of National Health Related Items Code (NHRIC) and National Drug Code (NDC) numbers for devices is being phased out over a time period that corresponds with the compliance dates for UDI requirements. Device labelers that want to retain the use of FDA-issued NHRIC or NDC labeler codes under a system for the issuance of UDIs were required to request such continued use by September 24, 2014. If you intend to retain the use of a previously issued FDA labeler code within your UDI system but have not made such a request, we urge you to do so as soon as possible.

FDA continues to collaborate with stakeholders, such as the Pew Charitable Trusts, the Office of the National Coordinator for Health IT (ONC), and the Brookings Institution to promote and facilitate UDI adoption in healthcare settings.

 For additional information, please see

Medical breakthroughs and discoveries in 2014 that prove the future really is here

The best thing about medicine is that it’s always finding ways to reinvent itself. This year has been a great year for health innovation, and humans are living longer and healthier lives than ever before. Here’s a breakdown of some medical breakthroughs that we at Medical Daily felt truly stood out this year.

Heart Transplant From A Cadaver: When it comes to body transplants, it’s pretty much a necessity that the donor is alive, but this year all that changed. In October, a team of Australian scientists made history when they revived dead hearts from cadavers and successfully transplanted them into awaiting patients. About 20 minutes after the hearts had stopped beating, doctors put them inside a machine, dubbed the “heart in a box,” which supplied the vital organ with oxygen. After removing the heart from the box it was injected with a preservation solution, designed to keep it fresh. This was done thanks to a perfusion-based machine, named OCS-HEART.

Measles Vaccine Makes Cancer Undetectable: 2014 has seen a lot of innovations in cancer treatment, but one of the most remarkable was seen in May, when a measles vaccine overdose made one woman’s blood cancer go into complete remission. Stacy Erholz was injected with a truly tremendous amount of the measles vaccine, a treatment which ended up targeting and killing her blood cancer.

It’s a landmark. We’ve known for a long time that we can give a virus intravenously and destroy metastic cancer in mice. Nobody’s shown that you can do that in people before,” said Dr. Stephen Russell, lead researcher of the project, the Star Tribune Health reported.

Surgeons Use 3D Printer To Perform World’s First Skull Transplant: The year 2014 has been great for 3D technology, as we’ve learned that it can not only help make our lives easier, but also help make them longer. In May, a team of surgeons from the Netherlands performed the world’s first complete skill transplant using a plastic tailor-made 3D-printed piece. The recipient of the printed skull was a 22-year-old woman suffering from a condition that thickened the bone structure on the skull. This increased the pressure on her brain and seriously affected her ability to function normally. Following the operation, the patient reported that she had regained her vision and was able to return to work.

"We used to create an implant by hand in the operating theater using a kind of cement, but those implants did not have a very good fit," Dr. Bon Verweij, leader of the team at University Medical Center in Utretch, said in a statement. "Now we can use 3D printing to ensure that these components are an exact fit. This has major advantages, not only cosmetically, but also because patients often have better brain function compared with the old method."

Lab-Grown Vaginas: This year doctors revisited four teenage girls who were fitted with the world’s first lab-grown vaginas, and reported that they are still enjoying normal, pain-free function, Medical Dailyreported. Eight years ago, the girls, who were born with a genetic disease that prevented their reproductive organs from fully forming, were fitted with vaginas constructed from samples of their own muscles and cells. These samples were then expanded in the laboratory and engineered into the shape of a vagina with the help of biodegradable scaffolding.

The follow-up study demonstrated that vaginal organs can not only be constructed in a lab, but also successfully implanted in humans, lead researcher Dr. Anthony Atala explained in the press release. "This may represent a new option for patients who require vaginal reconstructive surgeries.”

Prosthesis Which Converts Muscle Signals Into Movement: 2014 saw the arrival of the most complex prosthesis technology to date. In May, the Food and Drug Administration approved the marketing of the first prosthetic arm that translates electrical signals from people’s muscles to help them perform tasks with the upmost accuracy. The arm, known as the DEKA Arm System, controls movement via electromyogram electrose. This allows people with certain types of amputations to have a new prosthesis option. Subjects who used the arm were able to complete tasks such as stacking cones, moving objects, shaking hands, and most importantly feed themselves.

Legally Blind Can See With Bionic Eye: The bionic eye was dramatically improved in 2014, allowing the legally blind to finally see, as they had long dreamed.The bionic eye, known as the Argus II Retinal Prosthesis System, was approved by the FDA in 2013, but this year engineers further improved its visual system. It is the world’s first implanted device to treat people with retinitis pigmentosa, one of the leading causes of blindness. The bionic eye consists of a device implanted into the eye, a video camera in a pair of glasses, and a video processing unit carried by the patient.

Longest-Ever Preservation of Lungs Outside The Body: Transplant specialists at University Hospitals Leuven in Belgium were able to preserve donor lungs outside of a human body for a full 11 hours, the longest time in medical history. The feat was possible thanks to OCS LUNG, a perfusion-based machine that supplies the quarantined lungs with a continual, refreshing supply of oxygen. The machine is now commercially available in Europe and Australia, clinical trials in the U.S. are expected to start soon.

Visit Medical Daily for the article

Should we worry about low fertility?

The five-year decline in fertility in the U.S. has ended, according to the latest statistics. Before we cheer this development, we should ask whether low fertility rates are a problem. In particular, if we want more upward mobility, perhaps low fertility is not such a bad thing. With fewer children to support, parents and society can both invest more in each child, helping them to climb the ladder and become productive citizens in their adult years.

So why are so many rich countries worried about population decline? The concern, of course, stems from fears that there will be too few people to support us in our old age. The greying of the population could be addressed by reforming immigration laws to allow more immigrants to come to America: unfortunately, growing nativism may make that a politically unacceptable solution.

Are pro-natalist policies a viable option? Japan and Singapore offer instructive case studies. Like other Asian societies, their fertility rates are very low. At 1.2 births per woman in Singapore and 1.4 in Japan, they are well below a replacement rate of 2.1 and well below the current U.S. rate of 1.9.

Women are delaying marriage because of their careers, having children at older ages, and having fewer of them. Because unwed births are still stigmatized in these Asian cultures, births among young singles are almost nonexistent.

Singaporean parents receive paid maternity leave for 4 months, 6 days of paid child care leave per year per parent, large baby bonuses (cash and matched savings) of between $10,000 and $24,000 per child, tax savings, and many other benefits. But none of these benefits appear to have had much effect on the fertility rate.

First, a fertility rate of 1.9 is nothing to worry about. It is still high by international standards and likely to tick back up as the economy recovers.

Second, young people cannot be “bribed” into having children through lower taxes or large baby bonuses. (Organizing work and school schedules to suit modern family life is likely to be more effective.)

Third, with fewer children, more public funds could be devoted to investments in education – expenditures that are badly needed if we want to remain economically competitive

Fourth, drops in fertility mean a smaller youth cohort 15 to 20 years later – a development that in the past has been associated with less crime and more jobs for new entrants.

Fifth, a comprehensive immigration bill could quell anxieties about financing our retirement costs, by allowing skilled workers from other countries to join our labor force.

Sixth, and most important of all, parents do a better job when they delay childbearing until they are ready to commit to both parenthood and marriage. If we could reduce early, unwed (and typically unplanned) parenting to Asian levels, lower fertility wouldn’t be a bad thing. Children would be better cared for and more upwardly mobile. Visit Brookings for the study.

A flip flop? CME payments to doc must be reported to Sunshine Database

In what appears to be an about face, the Centers for Medicare & Medicaid Services has revised a controversial provision of the Open Payments program and will now require companies to report payments to physicians who speak at, or attend, continuing medical education seminars.

The change comes less than two months after the agency declared there are circumstances in which such payments would not have to be disclosed. In fact, this marks the fifth time that CMS has offered yet another interpretation of its final rule on disclosing CME payments.

“This appears to be one of the biggest flip flops I have ever seen,” says John Kamp, who heads the Coalition for Healthcare Communication, a trade group for ad agencies and medical publishers that supported an exemption for disclosing CME payments to physicians.

In a phone conversation, Shantanu Agrawal, director of Center for Program Integrity at CMS, tells us that the agency has not actually changed its position and believes “we’ve been entirely consistent” in attempting to craft a final rule. “We embarked on the rule-making process specifically to remove the exemption” that would have blocked disclosure of payments for CME.

At issue is the extent to which CME payments should be included in the Open Payments system, which maintains a federal database of payments made by drug and device makers to physicians. The program was created as part of the Affordable Care Act in response to concerns that financial ties may unduly influence medical practice and research.

These CME payments are made by drug and device makers, as well as group purchasing organizations, to CME providers, which are either commercial firms or non-profits that organize courses for physicians. From there, payments may be made to physicians who speak at or attend CME events.

As a result, these are referred to as indirect payments, but increased scrutiny of financial ties between companies and physicians has caused a shift – 83% of all CME courses are now funded by non-commercial providers, according to the Accreditation Council for Continuing Medical Education.

As noted previously, consumers groups argue that indirect payments for speaking at and attending CME courses should be included in the Open Payments database and fought against industry efforts to exclude such payments from reporting requirements.

“This new clarification is in line with the intent of the Sunshine Act which is to disclose financial relationships between companies and doctors,” says Danny Carlat, who until recently headed the Prescription Project at The Pew Charitable Trusts, which argued for including CME payments.

There may be loopholes, though. For instance, the latest rule includes examples of reporting requirements and one indicates that a drug or device maker does not have to report payments made to physicians if the funds given to the CME provider were part of an unrestricted grant.

The language suggests that companies could avoid reporting payments, depending upon how they dole out funds. But this is causing confusion, because it also appears to contradict reporting requirements stipulated elsewhere in the CME rule change.

Meanwhile, the final rule on CME payment disclosure does not go into effect until 2016, which means there is time for still more changes. The CME Coalition, in fact, hopes to meet with CMS officials to sort out the latest change and persuade the agency to reconsider.

Visit the Wall Street Journal for the story.

How prepared are states for infectious disease outbreaks?

Arkansas is the state least prepared for an infectious disease outbreak, according to a new analysis. But no state is perfect: none scored higher than an eight on the 10-point scale used in “Outbreaks: Protecting Americans from Infectious Disease,” a new report assessing readiness for infectious threats and conducted by the Trust for America’s Health and the Robert Wood Johnson Foundation.

“It is not a comprehensive review; but collectively, it provides a snapshot of efforts to prevent and control infectious diseases in states and within the healthcare system,” the report’s authors write of their scoring system, based on 10 indicators of preparedness. The states that scored highest—8 points each—were Maryland, Massachusetts, Tennessee, Vermont and Virginia. Half the states scored a six, seven or eight. Arkansas alone scored two. D.C. earned a score of five.

The scores were determined by how states ranked along 10 indicators chosen by consulting with leading public health officials. Together, they “offer a composite snapshot of strengths and vulnerabilities across the health system,” the authors write. But the scores should not be taken as a reflection on state health departments or systems. Some are attributable to broader factors, such as resources, policies, community health status and attitudes.

The indicators evaluated such things as public health funding, information management, childhood and flu vaccination rates, preparedness for the public health impacts of climate change and food safety.

The indicator on which states were most successful measured the capabilities of public health laboratories during emergencies or drills. Between July 2013 and July 2014, 47 states and D.C. conducted an exercise or used a real event to test how long it took for urgent information to travel between labs.

The indicator on which the fewest states succeeded measured efforts to minimize health care-associated infections, in which patients contract an infection while receiving medical treatment. The study evaluated two such types, but the one on which states scored worst evaluated those in which infections were spread by the insertion of a central line, a tube often placed in a large vein, often in the neck, chest, arm or groin, to provide medical treatment. Only 10 states saw such infections fall from 2011 to 2012.

Thirty-five states and D.C. have already met a federally-set child vaccination goal as part of the Healthy People 2020 initiative to improve the nation’s health by that year. The goal is to ensure that at least 90 percent of children aged 19 months to 35 months get at least three doses of the Hepatitus B vaccine.

The CDC estimates that anywhere from 700,000 to 1.4 million people are infected with Hepatitus B and nearly two in three of them don’t know it. It is typically transferred from mother to child during birth and the vaccine has been available since 1982.

Just 14 states vaccinated at least half their population aged six months or older for the seasonal flu during last year’s flu season, according to the study. South Dakota had the highest vaccination rate, of 57.4 percent. Wyoming’s was lowest, at 37.6 percent. Historically, children and seniors have been encouraged to get vaccinated but there are benefits to everyone getting the vaccination.

The majority of states scored well on food safety, with 38 meeting national goals of testing reported cases of the common food-borne illness E. coli (Escherichia coli O157, to be precise). The national goal is to test 90 percent of reported cases within four days. Sixteen states achieved that goal 100 percent of the time.

Visit the Washington Post for the article.

Doctors prescribing most potent painkillers face scrutiny

Doctors who are the most prolific prescribers of powerful narcotic painkillers and stimulants often have worrisome records, a ProPublica analysis of Medicare data shows.

In 2012, 12 of Medicare's top 20 prescribers of drugs such as oxycodone, fentanyl, morphine and Ritalin have faced disciplinary actions by their state medical boards or criminal charges related to their medical practices, and another had documents seized from his office by federal agents. These drugs have a high potential for abuse and are classified as Schedule 2 controlled substances by the Drug Enforcement Administration.

The No. 1 prescriber Shelinder Aggarwal of Huntsville, AL, with more than 14,000 Schedule 2 prescriptions in 2012 — had his controlled-substances certificate suspended by the state medical board in March 2013. He surrendered his medical license four months later.

Prescribing high volumes of Schedule 2 drugs can indicate a doctor is running a pill mill, said Andrew Kolodny, chief medical officer of Phoenix House, a New York-based drug treatment provider. "We wait 'till these doctors kill people … It doesn't make any sense," said Kolodny, founder of Physicians for Responsible Opioid Prescribing, which advocates for tighter regulation of painkillers.

Medicare's drug program, known as Part D, now covers about 38 million seniors and disabled people and pays for more than one of every four prescriptions dispensed in this country. Concerns about oversight of controlled substances date back to at least 2011, when the Government Accountability Office highlighted abuse of opioids in Part D and called on Medicare to take action.

Within the past year, Medicare has started to use prescribing data to identify potentially problematic doctors, as have some state medical boards. Beginning in mid-2015, Medicare will have the authority to kick doctors out of the program if they prescribe in abusive ways.

The 2012 data shows the upward trend line for prescriptions of controlled substances before these initiatives took hold as USA TODAY reported in Peter Eisler's June 2014 story,

Aggarwal's Medicare prescribing history had plenty of red flags. The pain-medicine specialist has consistently shown up in Medicare's data as a top prescriber of narcotics. By 2012, the year before he stopped practicing, more than 80% of his Medicare patients received at least one prescription for a Schedule 2 drug, in many cases oxycodone.

It took a complaint from pharmacies near Aggarwal's office to alert the Alabama Board of Medical Examiners to his unusual prescribing habits, said Larry Dixon, the board's executive director. Board investigators subsequently made undercover visits to the doctor's office and videotaped him prescribing drugs without an exam.

"If you paid $1,200 in cash, they would put a VIP stamp on your medical records and you didn't ever have to have an appointment," Dixon said.

Medicare's Part D data draws a roadmap to the doctors who prescribe controlled substances most frequently.

In 2012, 269 providers wrote at least 3,000 prescriptions for Schedule 2 drugs, ProPublica's analysis shows. They were concentrated in a handful of states. Florida led the country with 52 providers, followed by Tennessee with 25.

About one in five doctors who wrote at least 3,000 prescriptions for Schedule 2 drugs have faced some kind of sanction or investigation, ProPublica found. Because of their risk of abuse and dependence, these drugs require written prescriptions and cannot be refilled.

In September, Medicare sent 760 letters to doctors who prescribed far more Schedule 2 drugs than others in their medical specialty and state. Officials hope the initiative will cause doctors to examine their prescribing and make changes.

Some medical licensing boards are also expanding their efforts to use data to spot problematic prescribing. North Carolina's medical board has proposed new regulations allowing the agency that runs the state's prescription drug monitoring program to share data with the board. The board currently can only access the data when it is pursuing an active investigation into a particular physician.

Similarly, Alabama's Legislature recently authorized its medical board to regulate pain medicine clinics and proactively access data from its prescription monitoring database.

Visit USA Today for the story.

Public easily swayed on attitudes about health law, poll find

Just days before the requirement for most large employers to provide health insurance takes effect, a new poll finds the public easily swayed over arguments for and against the policy.

Six in 10 respondents to the monthly tracking poll from the Kaiser Family Foundation (Kaiser Health News is an editorially independent program of the foundation) said they generally favor the requirement that firms with more than 100 workers pay a fine if they do not offer workers coverage.

But minimal follow-up information can have a major effect on their viewpoint, the poll found.

For example, when people who support the “employer mandate” were told that employers might respond to the requirement by moving workers from full-time to part time, support dropped from 60 percent to 27 percent. And when people who disapprove of the policy were told that most large employers will not be affected because they already provide insurance, support surged to 76 percent.

Opinion also remains malleable about the requirement for most people to have health insurance – the so-called “individual mandate.”

It remains among the least popular aspects of the law – with just a 35 percent approval rating. But when people are told that the mandate doesn’t affect most Americans because they already have coverage through an employer, support jumps to 62 percent. Conversely, when supporters are told that the requirement means some people might have to purchase insurance “they find too expensive or don’t want,” opposition grows from 64 percent to 79 percent.

The poll also found that a year into full implementation, most Americans, and most of those without insurance, remain unaware about many of the health law’s major features. Nearly four in 10 people say the law allows immigrants in the country illegally to get financial help to purchase insurance (it does not), and more than 40 percent say (incorrectly) that the law creates a government panel to make decisions about end-of-life care for Medicare recipients.

At the same time, only about 3 percent were able to correctly say what the fine will be in 2015 for lacking insurance (the greater of $325 or 2 percent of household income).  Among those without insurance, only 5 percent knew that the deadline for 2015 sign-ups is Feb. 15.

The poll was conducted between Dec. 2 and 9 among a nationally representative sample of 1,505 adults age 18 and over. The margin of error is plus or minus three percentage points for the full sample.

Visit Kaiser for the report.

In Epilepsy, surgery tops drugs for most patients

Patients with seizure disorders who have had surgical treatment tend to do better over time than otherwise similar patients managed solely with drugs, according to two studies presented at the recent American Epilepsy Society annual meeting. But surgery is rarely a first-line option, and for patients who seem amenable to drug therapies, a third AES study suggested that a new investigational agent may be helpful.

For most patients with drug-refractory epilepsy who are eligible for surgical treatment, their outcomes end up better than continuing on medical therapy in most cases, two new studies suggested.

In the first study, which was based on published data from various sources, researchers led by Ivan Sanchez Fernandez, MD, of Boston Children's Hospital calculated that the average 10-year-old undergoing surgery for drug-refractory temporal lobe epilepsy has a life expectancy of 55.2 additional years -- versus 49.3 years for those managed with drug therapy.

Results were similar for modeled outcomes in patients with extratemporal lobe epilepsy, he reported, with a nearly 6-year extension in life expectancy with surgical treatment.

A second study by researchers at the Cleveland Clinic, reviewing outcomes of 36 children with Lennox-Gastaut syndrome, found that 15 became seizure-free (shortly after surgery in most cases) and another nine had reductions in seizure frequency in excess of 90%. An additional 10 patients showed reductions of 50% to 90%.

Although the study did not have a medically managed control group, senior investigatorAhsan Moosa Naduvil, MD, said at an AES press briefing that these outcomes could not have been achieved solely with drug therapy. He said the findings were important because it is only recently that children with Lennox-Gastaut syndrome have not been considered candidates for surgical therapy.

Of the 36 patients included in the study, 21 had undergone hemispherectomy while the other 15 had received lobar or multilobar resections. Patients receiving vagal nerve stimulator implants or corpus callosotomy were excluded from the analysis. Mean follow-up was a little less than 2 years, ranging from 6 months to more than 6 years.

The Boston Children's study was a modeling effort using data on mortality in patients with and without refractory epilepsy over their lifetimes, as well as on mortality associated with the surgical procedures usually performed for epilepsy treatment. The model also included data on the likelihood of achieving seizure freedom after surgery and on recurrence of regular seizures after initially successful surgery, all from previously published studies.

Computer simulations indicated that, for a cohort of 10-year-olds with temporal lobe epilepsy, 92.8% would benefit more from surgery than medical management in terms of overall life expectancy. In other forms of epilepsy, surgery would be optimal for 88%.

Both studies reinforce what epileptologists have been saying for some time, which is that surgery is a curative option whereas medical management is not, and that surgery should be considered - and discussed with patients (or their parents) - when drug therapy is not providing seizure freedom.

Visit MedPage Today for the study.