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Silver Cross spins gold lining into sterile processing operations progress

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May 5, 2015   Download print version

FDA launches public access to Global Unique Device Identification Database

Pure Processing Technologies add new capabilities to pre-cleaning, flushing functions

3M Steri-Vac Sterilizer/Aerator GS series kills microorganisms on instruments safely, efficiently, and cost effectively

ReadySet surgical works to change surgery across the U.S.

New research could provide new and completely effective blood test for determining cancer

The key to reducing pain in surgery may already be in your hand

Officials worry Ebola now being spread by unprotected sex

Almost half of Obamacare exchanges face financial struggles in the future

Commonly used chemicals come under new scrutiny



Daily Update Archives


Self Study Series:
May 2015

Optimizing a sterile processing quality system

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FDA launches public access to Global Unique Device Identification Database

The FDA, in partnership with the National Library of Medicine (NLM), is pleased to announce that data submitted to FDA’s Global Unique Device Identification Database (GUDID) is now publicly available through a website called AccessGUDID.

Through AccessGUDID, anyone can search or download information that device labelers have submitted to the GUDID about their medical devices.

Because the UDI system is being phased in over the next several years, labelers are currently submitting data on only the highest risk medical devices, a small subset of marketed devices. But as the system is implemented according to the UDI compliance timeline, the records of all medical devices required to have a UDI will be included.

As we launch this beta version of AccessGUDID, we encourage everyone ---health care systems, clinicians, patients, researchers, industry and others--- to explore its contents, assess its functionality and provide us with feedback. This feedback will shape future enhancements, including advanced search and web services.

You can submit feedback through the Contact Us link at the bottom of the AccessGUDID landing page or the FDA UDI Help Desk.



Pure Processing Technologies add new capabilities to pre-cleaning, flushing functions

Pure Processing LLC is exhibiting its newest instrument flushing technologies at the International Association of Healthcare Central Service Materiel Management 50th Annual Conference & Exposition. Pure Processing, a developer of ergonomic instrument pre-cleaning technologies and accessories designed to enhance worker and patient safety, will exhibit in Booth 121. 

Among the many Pure Processing cleaning innovations visitors will see at the IAHCSMM exhibit, some featured products to look for this year are:

  • New Ergonomic stainless steel reprocessing sinks. These custom-designed, height-adjustable systems are specifically intended for safe, efficient, comfortable, high-
  • The FlexiPump Independent Flushing System. This compact and highly flexible lumen-flushing device helps departments improve flushing ergonomics, boost overall flushing capacity and improve process standardization and consistency.
  • New ProSpray one-step, ready-to-use disinfectant cleaner, specifically validated for disinfecting Pure Station and FlexiPump systems
  • The Pure Station Dedicated Eye Sink, a compact, lightweight, all-in-one system that enables separate, safe, effective and standardized cleaning and flushing of eye instruments

For more information, please visit



3M Steri-Vac Sterilizer/Aerator GS series kills microorganisms on instruments safely, efficiently, and cost effectively

Recent CRE outbreaks traced to inadequately processed duodenoscopes have highlighted the need for healthcare facilities to review cleaning and sterilization processes. In the case of a facility in northeastern Illinois, after the hospital changed its reprocessing procedure from automated high-level disinfection to ethylene oxide sterilization, no additional cases of CRE transmission were identified. Ethylene Oxide (EO) sterilization provides an overkill sterilization process which means that there is a large safety margin built in to the cycle.

For facilities looking for effective reprocessing methods for heat- and moisture-sensitive equipment, the new 3M Steri-Vac Sterilizer/Aerator GS Series may be the solution. Instruments made of sensitive materials require sterilization solutions that are both budget-friendly and effective at killing microorganisms; sterile processing managers require solutions to help them effectively manage the increasing complexity of instrument reprocessing.

The 100 percent Ethylene Oxide (EO) sterilant used in the Steri-Vac sterilizer GS series effectively penetrates the complex geometries of instruments, such as long-lumen flexible endoscopes; many instruments that require low temperature sterilization can be sterilized using EO (always refer to the instrument manufacturers’ Instructions for Use (IFU) for validated sterilization modalities and cycles).

EO is gentle on materials, which may extend the life of instruments or reduce the frequency or cost of repairs. EO has been safely used in the health care industry for more than 50 years, and EO has also been used in medical device, government, and other industries for decades. In fact, over half of all sterilized single-use medical products are sterilized with ethylene oxide, according to the Global Industry Analysts.

3M also provides the elements of a strong sterilization quality control system utilizing biological, chemical, and physical monitors for every cycle.

To monitor cleaning efficacy prior to sterilization, particularly for difficult to clean flexible endoscopes, sterile processing managers may establish a quality control protocol using the 3M Clean-Trace ATP Cleaning Monitoring System. The Clean-Trace system provides a quantitative measure of contamination at established test points to help facilities verify cleaning efficacy.

For more information about the 3M Steri-Vac Sterilizer/Aerator GS Series, visit For more information about the 3M Clean-Trace ATP Cleaning Monitoring System, visit  



ReadySet surgical works to change surgery across the U.S.

ReadySet Surgical, mission is to change the way surgery is done across the United States. Yet the company and its founders aren’t selling a new type of product or surgical instrument. Instead, they’re working to ensure that every surgeon from New York to Alaska has the right instruments for every surgery that they perform.

Founded by Keerthi V. Kanubaddi and Shawn Studdard in the summer of 2014, ReadySet Surgical is a company that is dedicated to improving surgical workflow.

“I have been witness to hundreds, if not thousands of surgical procedures that were negatively impacted by poor communication and coordination of surgical case needs with external vendors,” said Kanubaddi. “At its heart, ReadySet is a surgical coordination platform. It consolidates logistics and communication through one dashboard accessible by all members of the surgical team.

What this means for surgeons, surgical departments and sterile processing is that with ReadySet Surgical, they no longer have to suffer from poor vendor coordination and its effects on patient outcomes.

“Surgeons tell us there are countless delays related to issues with surgical equipment, operating room team members tell us that many hours each week are dedicated to vendor coordination and sterile processing staff tell us that department resources are regularly stretched thin to accommodate the variety and irregularity of vendor equipment,” said Studdard. “What we aim to accomplish with ReadySet is the elimination of all of these headaches so that surgical teams can focus less on the logistics and more on the patient. Visit them in booth #835 at IAHCSMM, or visit



New research could provide new and completely effective blood test for determining cancer

A group of researchers has recently developed a new test which, they claim, can determine if a person will develop cancer within 13 years; and, more importantly, that this test has 100 percent accuracy.

The researchers—out of Northwestern University and Harvard University—say that a small but very significant physiological change occurs over a ten year period before the diagnosis of cancer. Thus, finding this shift helps them note a marker for potential cancer diagnosis.

“Understanding this pattern of telomere growth may mean it can be a predictive biomarker for cancer,” explains lead study author Dr. Lifang Hou. The professor of preventive medicine with Northwestern’s Feinberg School of Medicine goes on to say, “Because we saw a strong relationship in the pattern across a wide variety of cancers, with the right testing, these procedures could be used to eventually diagnose a wide variety of cancers.”

The study authors indicate that they look for damage in telomeres. These are the protective caps on the ends of chromosomes which protect DNA. They say that when you find telomere damage it usually means that cancer is on its way.

The good news, then, is that these findings could lead to more effective cancer research and even prevention. It has the potential to become the type of test you might get at a simple checkup as part of, say, a blood screen. Visit Pioneer News for the story.



The key to reducing pain in surgery may already be in your hand

Imagine a hand-held electronic device – accessible, portable and nearly universal – that could reduce pain and discomfort for patients, and allow doctors the freedom to use less powerful and potentially risky medications to complement anesthesia. Now reach in your pocket, because chances are you already own one.

According to new research from a team led by Communication and Information Science Professor Jeff Hancock and Cornell doctoral student Jamie Guillory (now at RTI International), the simple act of texting someone on a mobile phone during a minor surgical procedure done under local anesthetic can significantly reduce a patient’s demand for narcotic pain relief. Make that text buddy a stranger, and the odds a patient will ask for medications to take the edge off could be as little as one-sixth of those who go under the knife with empty hands.

“These findings suggest that the simple act of communicating with a companion or stranger provides an analgesic-sparing effect,” the authors write in the journal Pain Medicine. “The data also suggest that text-based communication with a stranger is more effective.”

Building on research that has shown social support before and during medical procedures can reduce anxiety and perceptions of pain, Hancock and his team decided to test whether mobile phones that allow patients to send text messages or play games could bring that support benefit into settings where the company of family members or friends is not possible.

Together with Hancock and Guillory, physicians Christopher Woodruff and Jeffrey Keilman from McGill University working at LaSalle Hospital in Montreal used an experiment to track four groups – patients receiving standard mobile phone-free perioperative treatment, those using a mobile phone to play the game Angry Birds, patients using a mobile phone to text with a close friend or family member, and others invited to text with a research assistant instructed to focus on “getting to know you” conversations.

When the research team analyzed the results, they found that patients receiving “standard therapy” – meaning those not using mobile phones during surgery – were almost twice as likely to receive supplemental pain relief as patients who played the game Angry Birds before and during the procedure. The same patients were more than four times as likely to receive additional analgesic as those texting a companion and – most notably – more than six times as likely to receive additional narcotic relief as patients who engaged in a texting conversation with a stranger.

To verify that latter effect and explore its source, the team took the additional step of analyzing the language of the two groups allowed to text during their surgeries. Hancock and his team found that, while the text conversations with companions related more to biology, the body and negative emotions; the texts with a stranger included more words expressing positive emotions, with patients writing more often about self-affirming topics.

The authors say this study provides the first evidence that texting offers this benefit beyond traditional treatment or even “distraction” methods such as playing a video game. The team called for new work to explore exactly what type of conversations work best, and how far this benefit can be developed to assist patients and doctors. Visit Cornell for the study.



Officials worry Ebola now being spread by unprotected sex

Health officials believe that survivors of Ebola can spread the virus through having unprotected sex up to twice as long as was previously believed. Officials are telling male survivors of Ebola to avoid any unprotected sex for an indefinite period. Scientist thought the virus could remain for three months in the semen of an infected person. However, recently a case took place in West Africa that suggests infection through unprotected sex could happen for up to five months or longer.

Using that case as an example, officials are telling male survivors of Ebola to avoid any unprotected sex for an indefinite period. The officials said that they previously had advised that the men wore condoms for up to three months.

On Friday, a report was released that detailed the case of a Liberian woman who was 44 and whose infection is likely to have come from a man who is 46 and who had symptoms of Ebola in September of 2014.

She became ill during March in just a week following sex with the man and died. Another woman that he had sex with close to the same time was tested and her results were negative.

The virus spreads via direct contact with the blood or other bodily fluids of an Ebola patient, such as saliva, urine, sweat or semen.

Once a patient recovers, health officials have said they are not contagious except there remains a chance it remains in the semen.

Investigations of recent cases of Ebola in Sierra Leone, Guinea and Liberia have pointed toward sexual transmission from Ebola survivors, but there has been no confirmation on those cases.

However, there have been less than 10 of these cases, said a Center for Disease Control spokesperson. It has been difficult pin pointing that sexual relations was the only way that they might have been infected with the virus. Visit the Times Gazette for the story



Almost half of Obamacare exchanges face financial struggles in the future

Nearly half of the 17 insurance marketplaces set up by the states and the District under President Obama’s health law are struggling financially, presenting state officials with an unexpected and serious challenge five years after the passage of the landmark Affordable Care Act.

Many of the online exchanges are wrestling with surging costs, especially for balky technology and expensive customer call centers — and tepid enrollment numbers. To ease the fiscal distress, officials are considering raising fees on insurers, sharing costs with other states and pressing state lawmakers for cash infusions. Some are weighing turning over part or all of their troubled marketplaces to the federal exchange,, which now works smoothly.

The latest challenges come at a critical time. With two enrollment periods completed, the law has sharply reduced the number of uninsured and is starting to force change in the nation’s sprawling healthcare system. But the law remains highly controversial and faces another threat: The Supreme Court will decide by the end of June whether consumers in the 34 states using the federal exchange will be barred from receiving subsidies to buy insurance.

If the court strikes down subsidies in the federal exchange, the states that are struggling financially might be less likely to turn over all operations to the federal marketplace, because they will want to make sure their residents do not lose subsidies to help them buy insurance. If the court upholds subsidies for the federal exchange, some states might step up efforts to transfer operations to

Most exchanges have operating budgets of $28 million to $32 million. One of the biggest cost drivers is call centers, where operators answer questions and can sign people up. Enrollment can be a lengthy process — and in several states, contractors are paid by the minute. An even bigger cost involves IT work to correct defective software that might, for example, make mistakes in calculating subsidies.

In Vermont, where the system’s cost is projected to balloon to almost $200 million by the end of the year, officials are eyeing a move to the federal marketplace if things don’t improve. Officials from Vermont, Rhode Island and Connecticut met recently to explore banding together in some sort of regional effort.

In Maryland, where the exchange’s technology problems were so daunting that officials turned to Connecticut for help, officials expect to have enough revenue to cover operations for the fiscal year that begins July 1. If not, the exchange would need to ask the governor for more funds.

In Colorado, Connecticut, Kentucky, Maryland and the District, fees to support the exchange are imposed on plans sold on and off the marketplaces. In the District, about $25 million of the exchange’s $28 million budget comes from user fees assessed on insurance products not offered on the exchange. The exchange budget would increase to $32.5 million in the budget year beginning in September under the mayor’s proposed plan. Debra Curtis, deputy director of the exchange, said the marketplace estimates it will raise about $28 million from the assessments and “use existing federal grants for ongoing implementation.”

Even if some state exchanges wind up handing the reins to, doing so is not free. Each exchange would have to be made compatible with the federal marketplace at a cost of about $10 million per exchange, Jim Wadleigh, executive director of Connecticut’s exchange said. Visit the Washington Post for the story.



Commonly used chemicals come under new scrutiny

A top federal health official and hundreds of environmental scientists voiced new health concerns about a common class of chemicals used in products as varied as pizza boxes and carpet treatments.

The concerted public campaign renews a years-old debate about a class of chemicals known as poly- and perfluoroalkyl substances, or PFASs. After studies showed that some PFASs lingered in people’s bodies for years, and appeared to increase the risks of cancer and other health problems, the chemical manufacturer DuPont banned the use of one type of PFAS in its popular Teflon products, and other companies followed suit.

At issue now are replacement chemicals developed by those manufacturers and used in thousands of products, including electronics, footwear, sleeping bags, tents, protective gear for firefighters and even the foams used to extinguish fires.

The companies assert that the alternatives are safe and vehemently contest the scientists’ contentions, pointing to extensive studies conducted in the last decade or so. But two separate salvos fired on Friday question whether enough research has been done to justify the chemical industry’s confidence in the safety of this crop of PFASs.

The journal, published by the National Institutes of Health, devoted several pages to the issue, with articles from researchers and from the industry trade group. A statement signed by 200 international scientists — environmental health experts, toxicologists, epidemiologists and others — urged countries around the world to restrict the use of PFASs.

In a counterpoint, the American Chemistry Council, the industry trade association, argued that the statement ignored the fact that such chemicals use “essential technology for many aspects of modern life,” and that tests, reviewed by the Environmental Protection Agency, concluded that these alternatives were safer than the chemicals they were replacing.

The PFAS family of chemicals represents an important part of DuPont’s $34.7 billion in sales last year. Thomas H. Samples, the company’s head of risk management for the division that manufactures these chemicals, rejected the scientists’ concerns.

This class of chemicals is known for its durability. PFASs have strong water-resistant properties. Cardboard pizza boxes treated with the chemicals, for example, stay sturdy even when grease seeps into them.

But some of these same features worry environmental health specialists because traces of the chemicals linger and have been detected in the bloodstream of a large segment of the population, although typically at low levels. In some cases, detectable levels of the older class chemicals have been declining as major manufacturers have developed alternatives they say are safer.

Some researchers cite lingering concerns about a chemical spill more than a decade ago. The health of residents of Parkersburg, WV, is still monitored related to a spill of an older form of PFAS from a nearby chemical plant. A class-action lawsuit accused DuPont, which owned the plant, of knowingly contaminating the residents’ groundwater, and the company faces new accusations, in a separate report being issued Friday by the nonprofit Environmental Working Group, that it is not living up to the terms of a court settlement. Visit the New York Times for the article.