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March 27, 2015   Download print version

FDA Safety Communication: New duodenoscope Model TJF-Q180V by Olympus reprocessing instructions validated

Ebola more deadly for young children

American College of Surgeons hails U.S. House passage of Medicare Access Bill

Mercy supply chain talent recognized with Visionary Award

Indiana is battling the worst HIV outbreak in its history

Report: Spectra254 ultraviolet light system 99.9 percent effective in killing Human Enterovirus

Amazon robot contest may accelerate warehouse automation

From pills that snitch to Xbox sensors, drugmaker goes high tech


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FDA Safety Communication: New duodenoscope Model TJF-Q180V by Olympus reprocessing instructions validated

Olympus has issued new, validated manual reprocessing instructions for the TJF-Q180V duodenoscope to replace those provided in the original labeling. The FDA has reviewed these new reprocessing instructions and the validation data as part of its ongoing review of the 510(k), and recommends that any facilities that are using Olympus’ TJF-Q180V duodenoscope train staff on the new instructions and implement them as soon as possible. Visit here for more information.  

The FDA is closely monitoring the possible association between reprocessed duodenoscopes and the transmission of infectious agents, including multidrug-resistant bacterial infections caused by Carbapenem-Resistant Enterobacteriaceae (CRE) such as Klebsiella species and Escherichia coli. If not properly reprocessed, residual body fluids and organic debris may remain in microscopic crevices of the device following an attempted cleaning and high level disinfection.

The FDA’s investigation into the possible association between inadequately reprocessed duodenoscopes and patient infections, including the agency’s recommendations for healthcare facilities, is more fully discussed in the following recent communications: February 2015 Safety Communication and FDA’s Updated Information for Healthcare Providers Regarding Duodenoscopes issued March 4, 2015.

FDA has been working with duodenoscope manufacturers as they modify and validate their reprocessing instructions to further enhance the safety margin of their devices and show with a high degree of assurance that their reprocessing instructions, when followed correctly, effectively clean and disinfect the duodenoscopes.

In September 2014, Olympus initiated testing to validate new reprocessing instructions. The cleaning validation reports were provided to FDA in October 2014. While FDA found Olympus’ cleaning validation data acceptable, initial high level disinfection reports did not demonstrate an adequate safety margin, and so Olympus conducted additional testing.

At the end of February 2015, Olympus submitted new high level disinfection validation data to FDA. The agency has reviewed this data and believes that, when followed, the new, validated reprocessing instructions for the Olympus TJF-Q180V duodenoscope are robust, and demonstrate consistent and reliable cleaning and high-level disinfection. At FDA’s request, Olympus has issued the new, validated instructions for reprocessing the TJF-Q180V duodenoscope.

To validate reprocessing instructions for duodenoscopes, manufacturers should soil their device with bacteria to simulate use in a procedure and then demonstrate that the device can be adequately disinfected through a sufficient reduction in microbes when the reprocessing instructions are correctly followed. To support high level disinfection of duodenoscopes, the disinfectant should result in a six-log reduction in the number of microbes at each of several locations on the scope – that is a one million-fold reduction; or a reduction of 99.9999%.

Olympus sent letters dated March 26, 2015 to healthcare facilities and other users of the TJF-Q180V outlining the new, validated reprocessing instructions, and will soon be distributing revised user manuals. Key changes have been made to the Precleaning, Manual Cleaning, Manual High Level Disinfection reprocessing procedures for Olympus’ TJF-Q180V duodenoscope. 

In addition, FDA has the following recommendations for facilities and staff that use and reprocess the Olympus TJF-Q180V: Implement the new manual cleaning and high level disinfection procedures for the Olympus TJF-Q180V duodenoscope in accordance with the manufacturer’s reprocessing instructions; Train appropriate staff on Olympus’ new reprocessing instructions and implement them as soon as possible.

Read the MedWatch Safety Alert, including links to the FDA Safety Communication.



Ebola more deadly for young children

Ebola progresses more quickly and is more likely to be fatal for children under five, according to new research. An international group of scientists led by Imperial College London and the World Health Organization analyzed data on Ebola cases in children under 16 during the current outbreak in Guinea, Liberia and Sierra Leone, comparing them to cases in adults.

The results show that although the rate of infection is lower in children than adults, young children who get the disease have a lower chance of surviving it.

As of March 2015, nearly 4,000 children under 16 have been affected by Ebola in the current epidemic, around a fifth of all confirmed and probable cases. The proportion of cases made up by children has been gradually increasing over the course of the epidemic, but the explanation for this is unclear.

Ebola has affected young children most severely, killing around 90 percent of children aged under a year and around 80 per cent of children aged one to four years who are infected. Older children are much more likely to survive the disease – it has killed 52 percent of children infected aged 10 to 15. For adults aged 16 to 44, the case fatality rate is 65 percent.

The incubation period – the time between becoming infected and showing symptoms – was 6.9 days in children under a year, compared with 9.8 days in children aged 10 to 15. Younger children also had shorter times from the onset of symptoms to hospitalization and death.

There were also differences in the symptoms experienced by children. Children were more likely to have a fever when they first see a doctor, and less likely to have pain in the abdomen, chest, joints, or muscles; difficulty breathing or swallowing; or hiccups.

The findings are published in the New England Journal of Medicine. Visit the Imperial College of London for the article.



American College of Surgeons hails U.S. House passage of Medicare Access Bill

The American College of Surgeons (ACS) is optimistic that much-needed Medicare program reforms are within reach following Thursday’s vote in the U.S. House of Representatives on H.R. 2, the Medicare Access and CHIP Reauthorization Act of 2015. ACS congratulates representatives for working together to develop a bill that implements meaningful reforms to the Medicare program, including permanent repeal of the broken sustainable growth rate formula (SGR) used to calculate physician reimbursement.

“The American College of Surgeons commends the U.S. House of Representatives for their pivotal vote today passing the Medicare Access and CHIP Reauthorization Act,” said David B. Hoyt, MD, FACS, Executive Director of the American College of Surgeons. “Speaker Boehner and Minority Leader Pelosi have demonstrated admirable leadership in working across the aisle to usher through legislation that ensures seniors have uninterrupted access to the medical care they need.  The College calls on the U.S. Senate to follow the House example and pass the bipartisan Medicare reform bill before adjourning for its two-week break.”

Visit ACS for the announcement.



Mercy supply chain talent recognized with Visionary Award

SCM World, the supply chain talent development partner for the world’s leading companies, recently honored Vance Moore, senior vice president of operations for Mercy, and current board chairman for ROi (Resource Optimization & Innovation), Mercy’s supply chain company, with its inaugural Supply Chain Visionary Award.

“Vance’s contributions to supply chain in healthcare go back a long way,” explained Kevin O’Marah, chief content officer and head of research, SCM World. “He is part of a history at ROi that has produced exceptional, visionary leadership in healthcare and will no doubt continue to influence the sector for years to come.”

Moore joined ROi in 2002 and served as president and CEO from 2007 to 2011 before transitioning to his current role within Mercy.

The Supply Chain Visionary Award is part of SCM World’s Power of the Profession awards program, which, according to Matt Davis, SCM World’s senior vice president of research, was created to recognize supply chain leaders that are not only driving breakthrough innovations, but also sharing their practices to advance the entire supply chain profession.

“It is such an honor to see ROi and its leadership recognized by SCM World,” said Gene Kirtser, president and CEO of ROi. “We are very proud of our continued heritage of visionary leaders, starting from our three founders Lynn Britton, Mike McCurry and Shannon Sock, elevating the strategic role of supply chain in health care, and continuing today with our current leadership team.”

Visit ROI for the release.



Indiana is battling the worst HIV outbreak in its history

The HIV epidemic that now grips Austin, IN, seemed to come out of nowhere. Since the first diagnosis in mid-December, the number of infected there and in the surrounding region has skyrocketed — 26 by the beginning of March, 72 as of this Wednesday. It’s the worst HIV outbreak in state history, and has local and federal officials scrambling to stem the spread of the disease.

But to William Cooke, who runs the only doctor’s office in this city of about 4,300, this epidemic has been years in the making. “We identified long ago there was an undercurrent there that was very unhealthy,” he told NBC. Poverty and drug addiction in Austin created “a recipe for disaster.”

Long before the first HIV diagnosis, the city has been coping with another epidemic: intravenous drug use. Used needles can be found strewn across yards and roadsides, but just as often wind up in the hands of other users, contributing to the spread of infection.

In the 10 years since he established his family practice here, Cooke has watched drugs and disease take hold — first the opiate addiction, driven by the trafficking of painkillers up nearby Interstate 65, then the increased rate of overdoses, then the spread of hepatitis C, another blood-borne disease.

On Monday, investigators from the Centers for Disease Control and Prevention were dispatched to Scott County, where Austin is located, to investigate the outbreak and determine whether the virus is a new strain or one that has been circulating for a while.

They agreed with Cooke’s assessment that this epidemic is driven by drug use, epidemiologist Pam Pontones told the Associated Press. Intravenous drug use has been identified as the mode of infection in nearly all of the 72 confirmed cases, she added — the vast majority of those infected shared a syringe with someone else while injecting a liquid form of a prescription painkiller called Opana.

Indiana Gov. Mike Pence (R), said he would consider implementing a targeted needle exchange program to combat the disease’s spread. Such programs, which allow people to trade-in used hypodermic needles for clean ones, are currently illegal in Indiana.

But a needle exchange isn’t the only program Scott County needs, Cooke said. He is petitioning for an addiction treatment center — right now, the nearest such facility is in the next county over, and many residents lack the means to get there — and for more infectious-disease experts, addiction councilors, cardiologists and pulmonary doctors. He also wants more funds and training for his staff to serve the growing number of HIV patients. Visit the Washington Post for the story.



Report: Spectra254 ultraviolet light system 99.9 percent effective in killing Human Enterovirus

Spectra254, a developer of UVC light decontamination systems, announced that results from an independent laboratory study finds Spectra254’s 1000 Series ultraviolet light system to be 99.9 percent effective in killing the Human Enterovirus, the virus that causes known diseases such as hand foot and mouth disease, conjunctivitis and Aseptic Meningitis.

The study, by Antimicrobial Test Laboratories, found the ultraviolet light system is 99.9 percent effective at killing the Human Enterovirus on surfaces at a distance of up to 10 feet in five minutes. The laboratory measured efficacy at distances of five, 10 and 15 feet, both vertically and horizontally.

The study tested the microorganism Human Enterovirus 68 (EV68), a non-enveloped, single-stranded RNA member of the Picornavirus family. Once considered rare, outbreaks of this virus appear to be on an upswing as the United States experienced a national outbreak in 2014 that resulted in an unusually high number of respiratory illness hospitalizations.

The Spectra 1000 Series UVC light decontamination systems use high-intensity UVC light to eliminate pathogens on surfaces. The company’s devices are currently in use at hospitals throughout North America, as well as ambulatory care, medical clinics and education facilities.

Multiple analyses performed for Spectra254 in further independent scientific testing documented that UVC light from the Spectra Systems was also highly effective (greater than 99 percent) in killing MRSA and C. difficile spores on solid surfaces and in inhibiting the growth over a range of exposure times and distances.

Visit Spectra254 for the study.



Amazon robot contest may accelerate warehouse automation

Packets of Oreos, boxes of crayons, and squeaky dog toys will test the limits of robot vision and manipulation in a competition this May. Amazon is organizing the event to spur the development of more nimble-fingered product-packing machines.

Participating robots will earn points by locating products sitting somewhere on a stack of shelves, retrieving them safely, and then packing them into cardboard shipping boxes. Robots that accidentally crush a cookie or drop a toy will have points deducted. The people whose robots earn the most points will win $25,000.

Amazon has already automated some of the work done in its vast fulfillment centers. Robots in a few locations send shelves laden with products over to human workers who then grab and package them. These mobile robots, made by Kiva Systems, a company that Amazon bought in 2012 for $678 million, reduce the distance human workers have to walk in order to find products. However, no robot can yet pick and pack products with the speed and reliability of a human. Industrial robots that are already widespread in several industries are limited to extremely precise, repetitive work in highly controlled environments.

Pete Wurman, chief technology officer of Kiva Systems, says that about 30 teams from academic departments around the world will take part in the challenge, which will be held at the International Conference on Robotics and Automation in Seattle (ICRA 2015). In each round, robots will be told to pick and pack one of 25 different items from a stack of shelves resembling those found in Amazon’s warehouses.

Some teams are developing their own robots, while others are adapting commercially available systems with their own grippers and software.

The challenge facing the robots in Amazon’s contest will be considerable. Humans have a remarkable ability to identify objects, figure out how to manipulate them, and then grasp them with just the right amount of force. This is especially hard for machines to do if an object is unfamiliar, awkwardly shaped, or sitting on a dark shelf with a bunch of other items. In the Amazon contest, the robots will have to work without any remote guidance from their creators.

The contest could offer a way to judge the progress that has been made in the past few years, when some cheaper, safer, and more adaptable robots have emerged thanks to advances in the technologies underlying machine dexterity. Visit Technology Review for the story.



From pills that snitch to Xbox sensors, drugmaker goes high tech

A decade ago, Joe Jimenez was peddling ketchup and baked beans. Now he’s using Microsoft Corp.’s gaming technology and embedding Google Inc. sensors in contact lenses to reinvent the world’s biggest drugmaker.

As Novartis AG’s chief executive, Jimenez is barreling down untested paths at the frontier of biology and digital technology to prepare for a future in which the use of smartphones and other digital devices to monitor health will be the key to getting paid.

Jimenez is also taking an axe to the empire built by his flamboyant predecessor, Daniel Vasella, with a complex asset swap worth more than $30 billion that closed this month. By offloading vaccines and adding cancer drugs, the 55-year-old former competitive swimmer is preparing Novartis for the loss of patents on medicines that make up a fifth of its sales.

“Our view has to be based on how healthcare is going to change,” Jimenez said in an interview at the company’s headquarters in Basel, Switzerland. “If you look at what led to the transformation that we just went through, it was a view of what’s going to happen in 10 years externally.”

Projects and products include pills and inhalers with sensors that tell on patients who miss a dose; clinical tests that rely on Microsoft’s Kinect, the motion-sensing technology used with Xboxes, to measure walking speed and balance in people with multiple sclerosis; and Google contact lenses that focus automatically and can deduce diabetics’ blood-sugar levels from their tears -- a gamble that Jimenez says could transform eyesight.

There’s more to come. Novartis and U.S. chipmaker Qualcomm Inc. in January agreed to invest up to $100 million to find and fund startups that enable devices such as smartphones to monitor a patient’s health remotely.

Vasella built Novartis with acquisitions and a handful of blockbusters like Gleevec, a leukemia drug that garnered $4.7 billion in sales last year but will face a generic contender next February. Jimenez, who took over as CEO in February 2010, started out with prudent steps as long as Vasella remained as chairman, buying out the Alcon eye-care unit and trimming costs.

Jimenez has boosted research and development spending in the pharma unit by 25 percent in his five years at the helm, an increase second only to Johnson & Johnson’s 64 percent among the world’s five biggest drugmakers. Besides ensuring Novartis researchers get funds and autonomy, Jimenez says he’s working to foster an environment in which they feel safe to take risks -- even if that means admitting defeat.

For Jimenez, the digital initiative is about bracing for the day when public health spending will be so stretched that drugmakers will get paid only when they can show a patient’s condition improved. That means delivering technology to show the treatment works. Novartis is planning about 10 pilot projects, including one in the U.K. with Google designed to experiment with conditional reimbursement for heart failure by using remote patient monitoring systems in conjunction with its LCZ696 drug. Visit Bloomberg for the story.