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July 29, 2016   Download print version

FDA halts blood collection in South Florida

New crop of robots to vie for space in operating room

Household MRSA controlled through treatment compliance, patient education

Cancer found in ancient human ancestor's foot

CareFusion Recalls AVEA Ventilator Due to an Electrical Issue Which May Cause an Unexpected Shutdown

Jump Technologies, Inc. debuts new JumpStock OR Module at AHRMM

Many well-known hospitals fail to score 5 stars in Medicare’s new ratings


Daily Update Archives


Self Study Series:
August 2016

Quality assurance for low-temperature sterilizers
by Susan Flynn, BESc, CSPDT

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FDA halts blood collection in South Florida

FDA is requesting that blood collection facilities in Miami-Dade and Broward counties cease collecting blood immediately in consideration of the possibility of an emerging local Zika virus (ZIKV) outbreak.

FDA requests that blood collection facilities located in the identified areas “cease collecting blood immediately” until the blood collection facilities “implement testing of each individual unit of blood collected in the two counties with an available investigational donor screening test for Zika virus RNA, or until the blood establishments implement the use of an approved or investigational pathogen inactivation technology.”

Further, FDA recommends that blood collection facilities in nearby counties, including Palm Beach, Hendry, Collier and Monroe, cease collecting blood as soon as possible and implement testing as described above. 

For blood collection facilities located outside of the identified areas, FDA suggests that donors who have traveled to Miami-Dade and Broward Counties during the previous four weeks be deferred from donating. Although not stated in today’s communication, AABB recommends that donors who have traveled to an area with active ZIKV transmission be deferred for four weeks following the departure from that area.

FDA is aware that implementation of these measures will result in additional questions and is planning to provide updates as more information becomes available. Those with questions may contact AABB is working with FDA to address questions about this ongoing situation.

Additional ResourcesThe Centers for Disease Control and Prevention maintains an up-to-date web page listing areas with active mosquito-borne transmission of Zika virus.

AABB will update the Tracking Zika Travel Notices table so blood establishments will know the date of this notice as a reference for management of post-donation information, donor eligibility, product suitability and product recall.

AABB Association Bulletin #16-04, “Zika, Dengue, and Chikungunya Viruses,” which is quoted above, focuses on recommendations for members whose collection activities are NOT in locations currently listed on the CDC’s Zika-Affected Areas web page. Recommendations are included for screening donors for travel to Zika-affected areas using Zika Additional Questions and pre-donation and postdonation screening

AABB earlier this month applauded the U.S. Department of Health and Human Services’ plan to spend up to $330 million to advance development of pathogen reduction technologies that could protect the nation’s blood supply from bacteria, parasites, Zika and many other viruses, and other pathogens.

Last month the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) announced that the Biomedical Advanced Research and Development Authority (BARDA), had committed up to $180.5 million to Cerus Corporation of Concord, California to advance its INTERCEPT system for the treatment of red blood cells; and up to $169.3 million to Terumo BCT Technologies of Lakewood, Colorado to further develop its Mirasol system for platelets.

Currently, all blood undergoes two different screening tests to detect many pathogens: serologic (antibody) tests and Nucleic Acid Tests (NAT). If the pathogen reduction process proves effective for removing impurities, it could change how blood is screened, and even who can donate.

Visit AABB for the announcements.

New crop of robots to vie for space in operating room

Even though many doctors see need for improvement, surgical robots are poised for big gains in operating rooms around the world. Within five years, one in three U.S. surgeries — more than double current levels — is expected to be performed with robotic systems, with surgeons sitting at computer consoles guiding mechanical arms. Companies developing new robots also plan to expand their use in India, China and other emerging markets.

Robotic surgery has been long dominated by pioneer Intuitive Surgical Inc., which has more than 3,600 of its da Vinci machines in hospitals worldwide and said last week the number of procedures that used them jumped by 16 percent in the second quarter compared to a year earlier.

The anticipated future growth — and perceived weaknesses of the current generation of robots— is attracting deep-pocketed rivals, including Medtronic Inc. and a startup backed by Johnson & Johnson and Google. Developers of the next wave aim to make the robots less expensive, more nimble and capable of performing more types of procedures, company executives and surgeons told Reuters.

Although surgical robots run an average of $1.5 million and entail ongoing maintenance expenses, insurers pay no more for surgeries that utilize the systems than for other types of minimally-invasive procedures, such as laparoscopy.

Still, most top U.S. hospitals for cancer treatment, urology, gynecology and gastroenterology have made the investment. The robots are featured prominently in hospital marketing campaigns aimed at attracting patients, and new doctors are routinely trained in their use.

Doctors say they reduce fatigue and give them greater precision. But robot-assisted surgery can take more of the surgeon's time than traditional procedures, reducing the number of operations doctors can perform.

To gain an edge, new robots will need to outperform laparoscopic surgery, said Dr. Dmitry Oleynikov, who heads a robotics task force for the Society of American Gastrointestinal and Endoscopic Surgeons.

New systems also will need to be priced low enough to entice hospitals and outpatient surgical centers that have not yet invested in a da Vinci, as well as convince those with established robotic programs to consider a second vendor or switching suppliers altogether.

Intuitive said it too is looking to improve technology at a reasonable cost, but newcomers will face the same challenges.

Device maker Medtronic has said it expects to launch its surgical robot before mid-2018 and will start in India. Others developing surgical robots include TransEnterix Inc. and Canada's Titan Medical Inc.

An RBC Capital Markets survey found that U.S. surgeons expect about 35 percent of operations will involve robots in five years, up from 15 percent today.

J&J, which hopes to be second to market with a product from Verb, has said it sees robotics as a multibillion-dollar market opportunity.

Visit Voice of America for the story.

Household MRSA controlled through treatment compliance, patient education

A new study found that following basic hygienic practices and complying with protocols for Methicillin-Resistant Staphylococcus aureus (MRSA) decolonization reduces the time to clearance of the bacteria more quickly than a treatment regimen of antibiotic ointment and antiseptic body wash.

The findings, published in Infection Control & Hospital Epidemiology, the journal of the Society for Healthcare Epidemiology of America, demonstrate the importance of educating patients in hygienic practices, in addition to encouraging adherence to decolonization protocols in the treatment of MRSA.

"MRSA is particularly dangerous because it can colonize in others without causing infection; and those in close contact, such as family members, are more likely to transmit MRSA to each other," said Valerie Cluzet, MD, an instructor in the division of Infectious Diseases at the Perelman School of Medicine at the University of Pennsylvania, and lead author of the study. "As a result, household members could be an ongoing source of MRSA, leading to recurring infections."

The three-arm non-blinded randomized control trial was conducted at five academic medical centers in southeastern Pennsylvania among members of 223 households. It compared three different interventions: education on personal and household hygiene; education with treatment and reminders with daily phone calls and text messages; and education with treatment, but no reminders.

Researchers observed no significant difference in time to clearance of MRSA between the group that received only education and the groups of patients that received antibiotic treatment. However, secondary analyses found that the biggest impact on decolonization was compliance to treatment (>100%). When patients followed the antibiotic treatment guidance, the bacteria were cleared more quickly (23 days) compared with non-compliant households (27 days).

Based on these findings, the researchers recommend clinicians emphasize to patients the importance of compliance with decolonization treatment for successfully clearing MRSA, and spend time educating patients with MRSA about its transmission and measures to control it. Practices such as washing linens regularly, wiping down high-touch surfaces, avoiding sharing personal hygiene items, and practicing hand hygiene can reduce household spread.

Visit Medical Xpress for the report.  

Study: Single-day EHR rollout doesn’t appear to affect outcomes

Implementation or replacement of electronic health records (EHRs) may be disruptive, inconvenient and confusing. It may slow down clinicians and even cause some minor mistakes. But it doesn’t appear to cause additional deaths, adverse events or hospital readmissions, a new study suggests.

“Despite concerns that implementation of EHRs might adversely impact patient care during the acute transition period, we found no overall negative association of such implementation on short-term inpatient mortality, adverse safety events or readmissions in the Medicare population across 17 U.S. hospitals,” said the study, which appeared in the BMJ.

“Our findings should be reassuring to hospitals and physicians who are considering or planning the implementation of EHRs,” wrote the Boston-based research team, from Harvard, Brigham and Women’s Hospital, Beth Israel Deaconess Medical Center and Massachusetts General Hospital.

The researchers examined readmission, patient mortality and rates of adverse patient safety events in Medicare inpatients at 17 hospitals that implemented or replaced EHRs in a big bang-style rollout in 2011 and 2012.

“There’s a well-documented ‘weekend effect’ and ‘July effect'” on patient safety,” Barnett said. In other words, more errors happen when hospitals reduce staff on weekends and in July, when new classes of residents typically start. Barnett said that he his Boston colleagues expected vendor changes to be at least as difficult for hospitals to manage.

Surprisingly, there was not a significant difference on those three metrics in the 90 days before and after the EHR go-live, according to their analysis of Medicare data at those hospitals.

The study said that implementation of EHRs would have a negative association with short-term patient outcomes owing to disruptions in clinical workflow. Contrary to that hypothesis, the researchers  found that before and after a discrete “go live” date for EHR implementation across 17 hospitals, there was no evidence of a significant or consistent negative association between EHR implementation and short term mortality, readmissions, or adverse events.

Visit MedCity News for the article.


Cancer found in ancient human ancestor's foot

The aggressive tumour was found in a 1.7 million-year-old toe from an ancient human ancestor. The toe belonged to one of the early hominins, either Homo ergaster or Paranthropus robustus.

The researchers said the findings clearly show cancer is not a disease of modern society, as some people claim.

Tumours have been detected in remains before - a Croatian Neandertal who walked the Earth around 120,000 years ago was one of the oldest.

The new discovery was made in a toe bone from Swartkrans cave in the Cradle of Humankind World Heritage Site near Johannesburg.

Data, published in the South African Journal of Science, showed the metatarsal had osteosarcoma - a rare and deadly form of bone cancer.

Despite cancers being detected in a wide range of species, some people believe the disease is a uniquely modern problem.

Edward Odes, one of the researchers at the University of the Witwatersrand, said: "Modern medicine tends to assume that cancers and tumours in humans are diseases caused by modern lifestyles and environments. Our studies show the origins of these diseases occurred in our ancient relatives millions of years before modern industrial societies existed."

Dr Patrick Randolph-Quinney, from the University of Central Lancashire, told the BBC News website: "The idea that cancers are recent has come out of work on Egyptian mummies where they failed to find evidence of cancers in X-rays, which has skewed our reasoning on this."

However, he added that modern lifestyles do increase the risk of some tumours: "The rise of colorectal cancer with a Western diet, liver cancers from alcohol consumption, lung cancer and smoking are all diseases of modernity.

"There's lots of different causes of cancer and they change through history - if you were a chimney sweep in London you were likely to get lung cancer - a lot is context dependent with new diets and new toxins."

Hannah Birkett, from the Bone Cancer Research Trust, commented: "This discovery is really exciting for osteosarcoma and the field of primary bone cancer research as a whole.

"Modern lifestyles and environmental factors loom large in people's perceptions of the cause of cancer and this finding reconfirms the importance of considering other factors such as bone growth.

Visit the BBC for the story.


CareFusion recalls AVEA Ventilator due to an electrical issue which may cause an unexpected shutdown

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.

  • Manufacturing Dates: November 13, 2016 to January 4, 2016

  • Distribution Dates: to December 16, 2016 to February 15, 2016

  • Devices Recalled in the U.S. 501 units distributed nationwide

The AVEA ventilator is intended for continuous breathing support for infants, children and adults. The ventilator is only used in hospitals and other health care facilities.

CareFusion is recalling the AVEA Ventilator because of a faulty fuse on the ventilators' alarm board, which may cause the ventilator to unexpectedly shut down. If the ventilator shuts down, a patient may not receive necessary oxygen. The use of affected product may cause serious adverse health consequences, including death.

Visit FDA for the recall

Jump Technologies, Inc. debuts new JumpStock OR Module at AHRMM

Jump Technologies, Inc. announced their new JumpStock OR Module will be unveiled at the 2016 Association for Healthcare Resource & Materials Management (AHRMM) conference and exhibition.

With this enhancement to JumpStock inventory management, Jump Technologies continues to expand its portfolio of cloud-based mobile solutions that may reduce labor, reduce costs, and enable more automated and accurate supply management.

With disparate systems, manual processes and incomplete functionality from legacy technology, OR staff members face challenges including poor visibility to supplies, limited system integration and data sharing, and difficulty tracking and managing items inventoried in the OR. The lack of visibility to inventory inside the hospital and within the OR cause overstocking issues as well as stock-outs.

Jump Technologies has designed simple interfaces to connect JumpStock with a hospital’s OR scheduling and preference card systems, powerfully integrating current on-hand inventory, on-order inventory and safety stock with scheduled procedures and physician preference cards.

The JumpStock OR Module helps build accurate supply forecasts needed for one OR suite, multiple suites or an entire organization, within a specified time period. In just a few clicks, an OR team member can order required supplies based on forecast.

Using JumpStock to manage inventory provides ongoing, accurate data about supply usage, building greater predictability in the OR. By forecasting supply requirements for scheduled procedures, the JumpStock OR module helps to decrease or eliminate stock-outs, overstocking and waste – and in turn,

reduce rescheduled procedures, helping to build clinical confidence.

Attendees of the AHRMM16 conference can see the new JumpStock OR Module at the Jump Technologies booth (#1020), August 1-2, 2016, along with other cloud-based supply management.

 Visit Jump for more information.


Many well-known hospitals fail to score 5 stars in Medicare’s new ratings

The federal government released its first overall hospital quality rating on Wednesday, slapping average or below average scores on many of the nation’s best-known hospitals while awarding top scores to many unheralded ones.

The Centers for Medicare & Medicaid Services rated 3,617 hospitals on a one- to five-star scale, angering the hospital industry, which has been pressing the Obama administration and Congress to block the ratings. Hospitals argue the ratings will make places that treat the toughest cases look bad, but Medicare has held firm, saying that consumers need a simple way to objectively gauge quality.

Just 102 hospitals received the top rating of five stars, and few are those considered as the nation’s best by private ratings sources such as U.S. News & World Report or viewed as the most elite within the medical profession.

Medicare awarded five stars to relatively obscure hospitals and a notable number of hospitals that specialized in just a few types of surgery, such as knee replacements.

Medicare awarded the lowest rating of one star to 129 hospitals. Five hospitals in Washington, D.C., received just one star, including George Washington University Hospital and Georgetown University Hospital, both of which teach medical residents. Nine hospitals in Brooklyn, four hospitals in Las Vegas and three hospitals in Miami received only one star.

Some premiere medical centers received the second highest rating of four stars, including Stanford Health Care in California, Massachusetts General Hospital in Boston, Duke University Hospital in Durham, N.C., New York-Presbyterian Hospital and NYU Langone Medical Center in Manhattan, the Cleveland Clinic in Ohio, and Penn Presbyterian Medical Center in Philadelphia. In total, 927 hospitals received four stars.

Medicare gave its below average score of two-star ratings to 707 hospitals.

Nearly half the hospitals — 1,752 — received an average rating of three stars. Another 1,042 hospitals were not rated, including all hospitals in Maryland.

Medicare based the star ratings on 64 individual measures that are published on its Hospital Compare website, including death and infection rates and patient reviews. Medicare noted that specialized and “cutting-edge care,” such as the latest techniques to battle cancer, are not reflected in the ratings.

The government said in a statement that it has been using the same type of rating system for other medical facilities, such as nursing homes and dialysis centers, and found them useful to consumers and patients. Those ratings have shown, Medicare said, “that publicly available data drives improvement, better reporting, and more open access to quality information for our Medicare beneficiaries.”

A preliminary analysis Medicare released last week found hospitals that treated large numbers of low-income patients tended to do worse, as did teaching hospitals.

Visit Kaiser for the report.