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May 31, 2016
Why is a hospital machine tied to superbugs still in use?
When going in for a medical procedure, you probably want to be certain the doctor's instruments are clean. Following a recent turnabout by the U.S.
Food and Drug Administration, that certainty may be a little harder to come by. Six months ago, the regulator said a machine tied to a deadly
superbug outbreak should be taken off the market “as soon as possible” to protect public health. Twice. But the machine, which uses water,
disinfectant, and sound waves to clean certain surgical instruments, remains in use for some of those instruments after FDA officials backed down.
And no one is saying precisely why.
The FDA ordered Custom Ultrasonics Inc. to take its 2,800 System 83 Plus machines out of service. The automated washing machines are used
across the U.S. to clean endoscopes and specialized type of endoscope known as a duodenoscope.
The use of Custom Ultrasonics equipment was one of several factors that "likely contributed" to dangerous infections spread by inadequately
cleaned duodenoscopes, according to a report issued this year by Senate Democratic staff investigating the incidents.
Up to 350 patients may have been infected at dozens of hospitals since 2010, according to separate documents released in April by the House
Committee on Oversight and Government Reform. Not all outbreaks occurred at hospitals using Custom Ultrasonics machines, and the company
has previously denied in court filings that its machines are unsafe or contributed to patient injury or death.
In its November 2015 correspondence with the company demanding a recall, the FDA raised concerns about the device's compatibility with
disinfectants, whether it works with duodenoscopes, and whether it properly eliminates microorganisms from water. In pulling back that recall
demand, the regulator now says it’s working with the company to ensure that the machines "are validated in a timely manner," according to agency
spokeswoman Deborah Kotz.
"Validated" means the company has to prove the devices work as advertised. In the meantime, the machines can still be used to clean instruments
including most endoscopes—just not duodenoscopes, she said. The reversal was “based on information provided by the company,” Kotz said,
without elaborating. "We have nothing more to share on this at this time.”
With the new FDA position, Custom Ultrasonics said in a notice posted on its website that it will send hospitals a label to affix to the washers. The
label warns medical staff not to use the machines to clean duodenoscopes. Robert Blanchard, director of product management and sales for Custom
Ultrasonics, said in an e-mail that the company declined to comment on the FDA letters.
The FDA's scrutiny of Custom Ultrasonics predates the recent outbreaks. Inspections as far back as 1991 found “significant violations” of federal
rules meant to ensure quality manufacturing and timely reporting of patient harm, according to a 2006 complaint filed by federal prosecutors in
Philadelphia. Similar violations were evident in inspections in 1992, 1995, 2005, and 2006, according to the lawsuit.
Thirteen patients tested positive for hepatitis C after being treated with endoscopes cleaned by Custom Ultrasonics' System 83 Plus machine,
according to court filings (over a period of time that wasn't specified). The company learned of the infections in 2004 and was required by law to
report them to the FDA within 30 days, prosecutors said, but didn't do so for more than two years.
The government lawsuit led to a consent decree in January 2007 that remains in force, and was the legal basis for the latest recall. (Custom
Ultrasonics didn't admit any wrongdoing as part of the agreement.) Under its terms, the company was initially barred from making or selling the
devices. A few months later, however, the FDA found that it was complying with the decree and allowed it to resume operations on a limited basis.
But in 2012, the FDA ordered a recall of the System 83 Plus devices because of "recurring violations" of the law and consent decree, according to
the agency's recent directive to the company. After another inspection, the FDA reiterated its recall order, and wrote that the company must pay
damages under the consent decree. In April 2015, the regulator found that the company hadn't validated several aspects of its machine, including
water filtration, compatibility with disinfectants, and that it fully cleans duodenoscopes, the same issues (PDF) raised in the most recent recall.
Two bluntly worded letters dated Nov. 12, 2015 (PDF) and Jan. 29, 2016 indicated that, given the company's "lengthy regulatory history," merely
trying to fix the machines wouldn't suffice. The first letter instructed the company to recall all of them, at its own expense, and figure out how
hospitals could "transition from the System 83 Plus as soon as possible." The second letter said the company’s response to the first letter was
insufficient because it only offered to correct the machines “rather than to remove those devices from use.” The agency wrote, in bold text, "FDA
orders Custom Ultrasonics to immediately recall all System 83 Plus devices by removing them from use.”
FDA officials called the company's response “inadequate” eight times in an eight page letter. The regulator threatened to impose a daily fine starting
on Feb. 8 if Custom Ultrasonics didn’t comply. Then, some weeks later, the FDA backed off.
The tenor of the two letters made the agency's turnaround puzzling, said Mark Duro, director of sterile processing operations at New England Baptist
Hospital in Boston. “In the 20 years that I’ve been in the business, I’ve never seen a recall get changed like that,” said Duro. His hospital doesn't use
Custom Ultrasonics equipment, but he said he remembers when the FDA determined in 2009 that a similar machine wasn't cleared for use because
it didn't work as advertised. That time, the agency didn’t back down. “We were forced to buy new devices,” Duro said.
It’s not clear how many hospitals are still using Custom Ultrasonics devices. Nine out of 16 U.S. hospitals that had superbug cases linked
to duodenoscopes were identified in the Senate staff report as using Custom Ultrasonics machines to clean them. Only one of the hospitals, Hartford
Hospital in Connecticut, said it “immediately” replaced the machines with other models after the recall.
Four hospitals where (according to the report) an estimated 86 patients were infected with superbugs declined to answer whether Custom machines
were still being used to clean their endoscopes, which is still permitted under the FDA's current ruling. They include New York Presbyterian/Weill
Cornell Medical Center in New York; UMass Memorial Hospital, in Worcester, MA; Advocate Lutheran General Hospital, in Park Ridge, IL; and
Carolinas Medical Center in Charlotte, NC.
Two hospitals—UCLA Medical Center in Los Angeles and Massachusetts General Hospital in Boston—said they are in the process of switching to
other vendors. Both said they have already put stricter measures in place for the hard-to-clean duodenoscopes linked to the outbreaks.
Visit Bloomberg for the article.
Class I Recall: Medtronic Respiratory and Monitoring Solutions recalls battery pack used on patient monitors due to potential fire risk
Medtronic Respiratory & Monitoring Solutions is recalling the battery packs due to a manufacturing defect that causes an increase in temperature
within battery that may cause a fire in the system monitor. The FDA has identified this as a Class I recall, the most serious type of recall. Use of
these devices may cause serious injuries or death.
The Capnostream 20 and Capnostream 20p are used to monitor vital signs and levels of oxygen and carbon dioxide in neonatal, pediatric, and adult
patients. The patient monitors and battery packs are used in hospitals or during patient transport.
The recall is for the battery pack used on Capnostream 20 and Capnostream 20p Patient Monitors, with model numbers 016400 and 010520 and
manufactured between April 1, 2014 - February 3, 2016.
Devices recalled in the U.S.: 9,817 battery packs nationwide, including Washington D.C. New batteries will be provided free of charge once the
acknowledgment and receipt form are received.
Visit FDA for the recall.
Recent scientific article proves enhanced terminal room disinfection leads to decreased HAI rates
A recent scientific article in the American Journal of Infection Control by researchers reviews the compendium of clinical evidence on and discusses
the effectiveness of UV devices for terminal room decontamination.
According to the “Effectiveness of ultraviolet devices and hydrogen peroxide systems for terminal room decontamination: Focus on clinical trials”
(Anderson, et al, 2016), two key findings were reported to validate the use and efficacy of no touch UV disinfection robots, such as Tru-D SmartUVC.
Further, the researchers stressed the importance of well-controlled, large-scale, randomized, clinical trials versus small-scale before-and-after
studies that lack monitoring of other infection prevention practices when comparing and contrasting such devices.
Among the key findings in the article, researchers concluded that, "improved terminal cleaning of rooms leads to a decreased rate of individual
patient colonization and infection," and likewise, "improved terminal cleaning of rooms leads to a decreased facility-wide rate of colonization and
infection." Meaning, health care environments have a direct impact on patient care and outcomes.
The study continues to report that of the six hierarchies of research methods, randomized, clinical trials that remove any and all confounding factors
have the greatest bearing on determining effectiveness of UV devices. In the UV disinfection space, Tru-D is the only device validated by a
randomized, clinical trial.
Tru-D was the only UV device of its kind chosen for the first-ever, randomized, clinical trial on UV disinfection due to its patented Sensor360
technology that removes any chance of human error in the disinfection process. The Benefits of Enhanced Terminal Room Disinfection (BETR-D)
study, which was funded by the Centers for Disease Control and Prevention and presented in abstract form at IDWeek 2015, proved that enhanced
terminal room cleaning strategies decreased the cumulative incidence of multidrug-resistant organisms by up to 30 percent, and the largest
decreases were seen when Tru-D was added to the standard protocols. Final results are undergoing peer-review and expected to be published in
the near future.
For more information and links to independent studies, visit www.Tru-D.com.
Senator calls for investigation of Purdue Pharma following Times story
A U.S. senator has called for federal investigations of OxyContin’s manufacturer in response to a Los Angeles Times report that found the bestselling
painkiller wears off early in many patients, exposing them to increased risk of addiction.
Sen. Edward J. Markey, a Massachusetts Democrat whose state has been hit hard by prescription drug abuse, urged the Justice Department, the
Food and Drug Administration and the Federal Trade Commission to launch probes of drugmaker Purdue Pharma.
OxyContin’s main selling point is that it lasts 12 hours. The Times investigation published this month found that when the effects don't last, patients
can suffer symptoms of narcotic withdrawal, including intense craving for the drug, and experience a cycle of agony and relief that experts say
promotes addiction.
The newspaper found that Purdue had evidence of the problem for more than two decades, but continued to insist the drug lasted 12 hours, in part,
to protect its revenue. OxyContin’s market dominance and premium price hinge on its 12-hour duration. Purdue instructed doctors who complained
about the drug’s duration to prescribe stronger, but not more frequent, doses. Research shows that patients taking high doses of opioids are at
greater risk of an overdose and death.
“These are serious allegations,” Markey wrote of The Times’ findings in a letter to Atty. Gen. Loretta Lynch. “They raise questions about ongoing
deception by Purdue, harm to the public, continued costs to the United States, and the availability of further judicial recourse against Purdue…”
In a separate letter to the heads of the FDA and FTC, Markey called OxyContin “a leading culprit in the current opioid and heroin overdose epidemic”
and said the agencies should “proactively warn prescribers, patients, and the general public” about problems the newspaper identified with the drug.
Purdue, a family-owned Connecticut company that has collected more than $31 billion from OxyContin sales, rejected The Times’ findings. The
company noted that the FDA approved OxyContin as a 12-hour drug. A spokesman for the company did not immediately reply to a request for
comment on Markey’s call for investigations.
The FDA, FTC and Justice Department did not immediately reply to requests for comment.
An FDA spokeswoman previously told The Times that the agency “will revise labeling as necessary to improve proper prescribing and treatment,” but
also placed responsibility with doctors.
OxyContin is widely blamed for triggering the prescription drug epidemic. Purdue launched the drug in 1996 with an aggressive marketing campaign
to primary care doctors that presented the painkiller as appropriate treatment for backaches and knee pain. Purdue and three company executives
pleaded guilty in 2007 to federal charges of drug misbranding for what the company acknowledged was an attempt to downplay OxyContin's risk of
addiction. They were ordered to pay $635 million.
Markey has been an outspoken critic of the role of pharmaceutical companies and the FDA in the opioid crisis. In January, he temporarily blocked
the nomination of Dr. Robert Califf as FDA commissioner to protest the agency’s approval process for opioids, including its August decision to
approve OxyContin for use in children as young as 11. Califf was later confirmed.
The Times report concerned an issue that went largely unnoticed in the scrutiny of OxyContin: the drug’s duration. Purdue’s clinical trials
demonstrated the problem. In the first test on patients, for example, OxyContin wore off early in about half of participants.
In his letter to Lynch, Markey wrote that “if warranted” the Justice Department should try to recoup “taxpayer dollars that federal healthcare programs
may have needlessly and unnecessarily spent on OxyContin prescriptions.”
Visit the Los Angeles Times for the story.
FDA approves new diagnostic imaging agent to detect recurrent prostate cancer
The U.S. Food and Drug Administration approved Axumin, a radioactive diagnostic agent for injection. Axumin is indicated for positron emission
tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated prostate specific antigen (PSA) levels following
prior treatment.
Prostate cancer is the second leading cause of death from cancer in U.S. men. In patients with suspected cancer recurrence after primary treatment,
accurate staging is an important objective in improving management and outcomes.
Two studies evaluated the safety and efficacy of Axumin for imaging prostate cancer in patients with recurrent disease. The first compared 105
Axumin scans in men with suspected recurrence of prostate cancer to the histopathology (the study of tissue changes caused by disease) obtained
by prostate biopsy and by biopsies of suspicious imaged lesions. Radiologists onsite read the scans initially; subsequently, three independent
radiologists read the same scans in a blinded study.
The second study evaluated the agreement between 96 Axumin and C11 choline (an approved PET scan imaging test) scans in patients with
median PSA values of 1.44 ng/mL. Radiologists on-site read the scans, and the same three independent radiologists who read the scans in the first
study read the Axumin scans in this second blinded study. The results of the independent scan readings were generally consistent with one another,
and confirmed the results of the onsite scan readings. Both studies supported the safety and efficacy of Axumin for imaging prostate cancer in men
with elevated PSA levels following prior treatment.
Axumin is marketed by Blue Earth Diagnostics, Ltd., Oxford, United Kingdom.
Visit the FDA for the announcement.
Low-sodium diet may increase heart disease risk for those without high blood pressure
Across the United States, roughly 80 million adults are at greater risk for heart disease and stroke because of high blood pressure, also known as
hypertension. But while nearly all Americans consume more salt than they should, exacerbating their risk, not everyone should switch to a low-salt
diet.
A team of researchers from McMaster University’s School of Medicine, found that while lowering salt intake is key to keeping those with high blood
pressure in check, cutting out too much salt could put them at greater risk of cardiovascular disease and death.
“These are extremely important findings for those who are suffering from hypertension pressure who also consume high sodium diets,” said the
study’s lead author Andrew Mente, researcher and professor of clinical epidemiology and biostatistics at McMaster’s School of Medicine, in a
statement. “While our data highlights the importance of reducing high salt intake in people with hypertension, it does not support reducing salt intake
to low levels.”
For the new study, published in the journal The Lancet, researchers analyzed the health data of 133,118 participants, 63,559 of whom were
diagnosed with hypertension and 69,559 who did not test positive for hypertension. They compared average and high sodium intake to see if there
was a link between high sodium intake and heart attack, stroke, and death. Those who were on low-sodium diets were more likely to experience
heart attacks, strokes, and death than those who consumed moderate amounts of sodium in their diets.
The findings reveal that the only people who should be worrying about reducing sodium in their diet are salty-food fiends with high blood pressure.
Some people’s bodies are more sensitive to the effects of sodium than others. However, consuming too much sodium leads to fluid retention and
high blood pressure. Those who are sodium sensitive or who have a history of heart problems or hypertension in their family, may want to reduce the
amount of salt, but also need to make sure they’re consuming the right amount.
Once you go below 2,300 milligrams of sodium per day, there are no benefits to the heart, but instead the potential for harm. When the body is cut
off from a sufficient supply of sodium, it struggles to regulate the water consumption of its cells, causing them to swell up. Eventually fatigue will set
in, followed by nausea, confusion, muscle weakness, and cramps.
According to the Mayo Clinic, many people aren’t aware of how much sodium they consume each day. A single teaspoon of table salt, which is a
blend of sodium and chloride, has 2,325 milligrams of sodium. Meanwhile, the Dietary Guidelines for Americans recommends keeping sodium intake
to 2,300 milligrams a day or less. Sodium and chloride are two electrolytes that help maintain fluid balance, nerve impulses, and help the body
absorb glucose, amino acids, and water, ultimately regulating the body’s blood pressure.
Visit Medical Daily for the study.
Don’t miss this chance to tell how your team stands out! Nominate your team for the Healthcare Purchasing News 2016 Supply Chain
Department of the Year
Prestige, recognition, reputation, status. These words typically describe the accomplishments of the HPN Supply Chain Department of the Year.
Don't miss your opportunity to join the top departments that have earned this distinction from HPN and are part of our Hall of Fame. But the deadline
is approaching. Last Chance. This Friday June 3.
Healthcare Purchasing News announces our 13th Annual Supply Chain Department of the Year award, which emphasizes the expanded focus and
greater importance these key contributors provide to the delivery of quality patient care.
Nominate your team today by providing evidence-based anecdotal details of achievements and accomplishments in the following 4 areas:
Process Innovation - How the department approaches day-to-day operations for internal customers that highlights and reinforces its importance to
the organization. This includes how cohesively department staff members communicate, cooperate and work together for their customers and may
involve the use of information technology and performance improvement measures to achieve efficiency and increase productivity.
Customer service - How the department directly facilitates and manages product evaluations, contracting, purchasing, distribution, inventory
management and clinical consulting for internal customers, including the operating room, nursing floors, and other clinical specialty areas, such as
laboratory, radiology and outpatient services. Also highlight how the department's influence with doctors and nurses impacts the delivery of highquality care for external customers - the patients and community at large.
Financial/Operational Cost Savings - How specifically the department has reduced non-labor and labor expenses to maintain a healthy bottom line
for the organization, including increased productivity, improved service levels and fewer errors, as well as use of IT, value analysis/management and
compliance credentialing.
Comprehensive Strategic Planning - How the department efficiently and intelligently works with partners along the supply chain continuum,
including raw materials suppliers, manufacturers, distributors, group purchasing organizations, service companies (such as consulting firms and
waste management firms) to assist their internal customers within the individual hospital or multiple facilities within the health system for the benefit
of patients.
Document and submit your accomplishments by midnight Friday, June 3, to Editor, Healthcare Purchasing News, 2477 Stickney Point Rd., Suite
315B, Sarasota, FL 34231; Fax: (941) 927-9588 or email: [email protected].
For all the guidelines visit www.hpnonline.com/Nominate/SCMDOY.html.
For past submissions visit the HPN Hall of Fame at www.hpnonline.com/hall-of-fame/index.html.