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March 16, 2016
FDA safety communication: Olympus Duodenoscope Models TJF-160F and TJF-160VF reprocessing instructions validated
Olympus Corporation of the Americas (Olympus) has issued updated, validated manual reprocessing instructions for the TJF-160F and TJF-160VF
duodenoscope models (160 F/VF duodenoscope models) to replace those provided in the original device labeling. The FDA reviewed the updated
reprocessing instructions and the validation data and determined that they meet the Agency's expectations.
As noted in the FDA's February 2015 Safety Communication, the complex design of duodenoscopes may impede effective reprocessing.
Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. 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. If these residual
fluids contain microbial contamination, subsequent patients may be exposed to serious infections.
The FDA continues to closely evaluate the association between reprocessed endoscopes and the transmission of infectious agents. Visit the
Infections Associated with Reprocessed Duodenoscopes webpage for a listing of actions the Agency has taken on this issue. The Agency will
continue to provide updates as appropriate.
FDA recommends that facilities using Olympus' 160 F/VF duodenoscope models train staff on the updated instructions and implement them as soon
as possible.
Olympus sent a letter dated March 14, 2016 to healthcare facilities and other users of the 160 F/VF duodenoscope models outlining the updated,
validated reprocessing instructions. An updated reprocessing manual and one box of MAJ-1534 brushes (3 brushes per box) required for the
updated cleaning procedure accompanies Olympus' Customer Notification Letter. See the FDA Safety Communication for additional details
regarding cleaning procedures.
Read the MedWatch safety alert.
New data shows infection rates still too high in U.S. hospitals
Though hospitals are making strides in avoiding central line-associated blood stream infections (CLABSIs) and catheter-associated urinary tract
infections (CAUTIs), a report shows patients are still experiencing these serious, and sometimes fatal, infections too frequently.
The report, Health Care-Associated Infections, is the first in a series of five in-depth reports analyzing current health care safety trends in the United
States, as revealed by infection data collected by The Leapfrog Group, a Washington, D.C.-based organization representing consumers, employers
and other purchasers aiming to improve health care safety and quality, and assembled and analyzed by Castlight.
“We’re in the midst of Patient Safety Awareness Week (March 13-19) and there’s no better time than right now to stress the importance of
transparent, safe care at hospitals,” said Leah Binder, president and CEO of Leapfrog. “The good news is that a record number of hospitals make
their infection rates public, which shows commendable transparency and candor within the hospital industry. The bad news is there are still too many
infections.”
Key findings include:
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At the majority of hospitals (75 percent), the central line infection rate was too high – Only 25 percent of hospitals met The Leapfrog
Group’s target standardized infection ratio (SIR) of zero for CLABSI. Sixty-seven percent of hospitals had an SIR between zero and 1.0,
while a small, but significant minority of hospitals (8 percent) had an SIR of above 1.0.
Only 25 percent of hospitals met Leapfrog’s urinary tract infection standard – The Leapfrog Group's standard for CAUTI is that the rate of
infections is close to zero. CAUTI is considered the most common type of healthcare-acquired infections.
Infection rates vary by state of residence, choice of hospital and metropolitan area – On average, New Hampshire had the safest hospitals,
with 67 percent reporting a CLABSI rate of zero. Alternatively, Rhode Island and Maryland showed the most urgent need to improve, with
no hospitals reporting a CLABSI rate of zero. What’s more, hospital infection rates vary significantly within communities.
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Infection rates are declining, but more transparency and quality improvement are needed – Public reporting through Leapfrog has helped
galvanize a decline in CLABSI rates. For example, the percentage of hospitals reporting a CLABSI rate of zero has steadily increased from
18.8 percent in 2013 to 25 percent in 2015. However, nationwide, three quarters of hospitals still do not meet Leapfrog’s standards.
The report is the first in a series of five reports examining key quality and safety measures at hospitals nationwide based on data from the 2015
Leapfrog Hospital Survey of more than 1,500 U.S. hospitals and analysis provided by Castlight Health. Future publications in the report series will be
available at www.leapfroggroup.org/HospitalSurveyReport.
Visit Leapfrog for the 2015 report.
CDC recommends doctors avoid prescribing opioids for chronic pain
To combat the nation's deadly prescription painkiller epidemic, the Centers for Disease Control and Prevention on Tuesday issued its first set of
guidelines on dispensing the addictive medications, urging doctors to avoid providing them for chronic pain.
The agency said the risks from prescribing opiates, a class of morphine-like painkillers, far outweigh the benefits for most patients with long-term
pain, except for those receiving cancer treatment or end-of-life care. When the drugs are necessary, the CDC advises doctors prescribe the lowest
possible dose for the shortest amount of time.
About 40 Americans die each day from overdosing on prescription painkillers, according to the CDC. In 2013, an estimated 1.9 million people
abused or were dependent on prescription opiates.
The guidelines are intended for primary care physicians, who prescribe nearly half of opiates, including drugs such as Vicodin and OxyContin.
Doctors aren't legally obligated to follow the recommendations, which are intended for adult patients.
The CDC hopes the guidelines will help doctors determine when to begin or continue opiates for chronic pain, which type of painkiller to choose, how
long to administer the drugs and how to weigh their risks.
The recommendations are "a game changer" that doctors are likely to follow, said Andrew Kolodny, executive director of Physicians for Responsible
Opioid Prescribing. "For the first time, the federal government is communicating clearly that the widespread practice of treating common pain
conditions with long-term opioids is inappropriate," Kolodny said. "The CDC is making it perfectly clear that medical practice needs to change
because we’re harming pain patients and fueling a public health crisis."
When the benefits of prescription opiates outweigh the risks, doctors should talk to patients about their treatment goals and when they will stop using
the drugs. Due to a high risk of overdose, physicians should avoid prescribing opiates at the same time as benzodiazepines, such as anti-anxiety
drugs Valium and Xanax. Doctors also should prescribe immediate-release opiates, rather than extended-relief tablets that are more likely to be
abused.
Patients with acute pain, such as that caused by an injury, usually need prescription opiates for only three days. Prescribing the drugs for more than
seven days is rarely needed, he said.
If patients abuse opiates, doctors should help them get treatment supported by strong medical evidence, such as the therapies buprenorphine or
methadone, which block or partly block the effects of opiates.
The CDC's hard line on opiates is a major shift from conventional wisdom about relieving pain.
Visit USA Today for the article.
RNs begin 7-day strike at Kaiser's LA flagship hospital
Registered nurses at Kaiser Permanente's flagship Los Angeles Medical Center began a seven-day strike from March 15-March 22, with a focus on
improving staffing to protect patient care and achieving economic gains to retain experienced RNs and boost recruitment of new nurses.
The walkout affects 1,200 RNs, members of the California Nurses Association/National Nurses United who are seeking their first CNA collective
bargaining contract.
"Kaiser LAMC prides itself on being the tertiary flagship center for the Southern California region and has expanded services here in the past few
years, but it is hard to provide quality care while we are constantly short staffed," said Joel Briones, a coronary care unit RN at LAMC. "Our patients
deserve better. With billions in profits, the nurses are insisting Kaiser settle a contract that reflects our role as patient advocates for the region."
LAMC is the hub for specialty services such as Transcatheter Aortic Valve Implantation, a procedure for high-risk patients and is the regional highrisk center for young children with cancer. Nurses are calling on Kaiser to invest in this regional specialty center and settling a fair contract with
strong patient care provisions similar to what Kaiser has previously agreed in the CNA contract for 18,000 nurses in California.
Despite making over $14.4 billion in profit over the past six years, Kaiser has frozen wages for nurses at the region's tertiary center.
Visit PR Newswire for the release.
FDA Recall: Abbott Vascular has recalled the MitraClip Clip Delivery System due to an issue with the delivery system deployment process
Abbott Vascular has received reports of cases where the Clip Delivery System could not be detached from the Clip due to a malfunction of the
device. These cases resulted in open heart surgery to retrieve the delivery system. Abbott Vascular is therefore recalling the MitraClip Delivery
System to provide updated instructions and training for healthcare providers who use the device.
The use of affected products may cause serious adverse health consequences, including serious patient injury or death. Currently there are 3,534
devices on the market, with nine reports of this malfunction. There has been 1 death.
Visit FDA for the recall notice.
McKesson InterQual Connect creates connected ecosystem for medical review and authorization
InterQual Connect,introduced by McKesson, uses cloud connectivity to offer payers and providers an efficient workflow to automate medical review
and authorization. And it works with the same care management systems and InterQual Criteria they already use, making it cost-effective to
implement and deploy.
Today the total cost of an authorization is between $35 and $100 when faxes, denials, appeals, and other aspects are considered, according to
McKesson research. Fully 13 hours of nursing time per physician per week is spent on pre-authorization, and 13% of physicians and their patients,
wait over a week for an authorization, according to a Health Affairs study. An American Medical Association survey found reducing or eliminating the
pain around pre-authorization is an important priority for 78% of physicians.
By fully automating the authorization process, redundancy-where both payers and providers perform medical reviews-can be eliminated. Now payers
can use InterQual Connect's secure connectivity and data exchange to receive the medical review and clinical information from their network
providers, and send back notification or authorization, without ever leaving their existing systems. Often this can be done without ever needing to
manually touch the request. This helps eliminate duplicate processes and manual work, enabling users to reduce administrative costs, speed
authorizations, and ensure appropriate care.
For more information, visit www.InterQualConnect.com.
Bristol-Myers bucks trend toward precision medicine
Bristol-Myers Squibb Co. has sprinted to an early lead in the race to sell a new class of cancer treatment by bucking the trend toward precision
medicine.
For years, drug companies tried to sell medicines to as many patients as possible. More recently, under pressure from health insurers aiming to
improve the odds a costly drug will work, many pharmaceutical companies have been pairing their new therapies with diagnostic tests identifying
patients best suited for the treatment.
Merck & Co., Bristol’s chief cancer-drug competitor, has pursued such a “precision medicine” approach while selling its new lung-cancer drug, which
harnesses the immune system to attack tumors. But in selling its similar therapy, Bristol has outflanked Merck partly by sticking to the old, massmarketing approach.
Bristol says doctors have been prescribing its drug, Opdivo, to more than 60% of new, lung-cancer patients in the U.S. who are eligible for the
treatment, with the rest receiving a variety of other treatments including Merck’s product.
A key reason, according to Bristol officials and doctors: Many oncologists don’t have time to run the diagnostic test that must be used with Merck’s
drug, Keytruda, which screens tumors for a protein called PD-L1 that signals the drug might work.
The issue: Cancer doctors, particularly those seeing patients in busy community practices rather than research centers, see so many patients with
various types of cancer they prefer the ease and speed of prescribing a drug without having to order a test, wait for the results and then review the
matter with patients before writing a prescription.
A spokeswoman for Quest Diagnostics Inc., a lab-services company that offers the test to determine eligibility for Keytruda, says it is typically
ordered by hospital-based oncologists. Quest usually takes about three to five days after receiving a biopsied tumor specimen to perform the
analysis and report results back to the doctor. Medicare, one of the biggest payers for such patients, pays about $89 a patient for the test, Quest
said.
Unlike longtime treatments that strike cancer directly, immunotherapies unshackle the patient’s immune system so it can do the fighting. Analysts
say the drugs’ world-wide sales have risen faster than expected, and Leerink Partners’ Seamus Fernandez projects sales could top $23 billion in
2020.
Bristol’s Yervoy, the first of the new wave of immunotherapies, was approved in 2011 to treat advanced skin cancer. It was followed in 2014 by
Merck’s Keytruda and Bristol’s Opdivo, each of which is now approved to treat lung and skin cancer.
Last year, Bristol reported $2.1 billion in global sales of the drugs, compared with Merck’s $566 million.
Health insurers and others have encouraged the targeting of drugs to patients most likely to benefit as a way to control costs and improve treatment.
From the earliest days of designing the lung-cancer studies for Keytruda, Merck bet that the diagnostic test would help doctors determine which
patients would benefit and which wouldn’t. It enrolled in the trials only patients who tested positive for the PD-L1 protein, and the company believed
this would result in a speedier trial with more robust results that could chip away at Bristol’s head start in lung cancer.
The Food and Drug Administration approved Opdivo for sale for a form of lung cancer seven months before approving use of Merck’s
immunotherapy in lung cancer. The agency specified Merck’s drug should be given only to patients who tested positive for the PD-L1 protein, which
wasn’t required of Bristol’s treatment.
As it developed Opdivo, Bristol worked on a PD-L1 diagnostic test to complement use of its drug, but the company also saw in early clinical trial
results that some patients lacking high levels of the protein still benefited from the drug.
Bristol’s bet paid off. When the FDA approved Opdivo, it also approved a complementary PD-L1 test for the drug, but said Opdivo could be used
regardless of a patient’s PD-L1 status.
Currently, both Opdivo and Keytruda are approved for use only in patients who failed to respond to other drugs. Both companies are aiming to get
the FDA to approve their drugs as first-line treatments, meaning they can be prescribed before other drugs are tried.
Visit the Wall Street Journal for the story.
Suture Ease showcases the versatile crossbow laparoscopic fascial closure device
Suture Ease Inc., developer of devices to enhance the efficacy, efficiency and safety of minimally invasive surgery, will be exhibiting at the annual
Society of Gastrointestinal and Endoscopic Surgeons meeting (SAGES 2016), being held in Boston from March 16-18. At the meeting, Suture Ease
will be showcasing the CrossBow Fascial Closure System, the second generation of its laparoscopic closure technology.
Suture Ease’s CrossBow makes it easier for a surgeon to perform reliable and reproducible fascial closure during minimally invasive surgery.
CrossBow’s unique closure mechanism is designed to minimize complications and costs associated with port-site herniation.
The CrossBow Fascial Closure System comprises a guide and proprietary suture passer. Like the SecurusDL, no grasper is required and the
device’s intuitive guide operation, enhanced snare loops and controlled tissue “bite” help enable easy suture placement and retrieval.
Additionally, it facilitates multiple stitch patterns, offering broad versatility to accommodate a variety of patient anatomies and surgical disciplines,
including gynecology, bariatric, general surgery and urology procedures.
For more information, visit: www.suturease.com.