Device advancementsLeading the charge to reduce the spread of infections inhealthcare settingsIn March 2010, BD launched a new surveillance system that generates realtimeinformation designed to reduce the spread of infections. The BD ProtectInfection Surveillance and Data Management System is a portfolio of healthcaremanagement software solutions that tracks infections and helps prevent theirtransmission at three levels – from patient to patient, between patients andhealthcare workers, and from community sources to healthcare settings.The software provides real-time tracking and analysis of potential infection-relatedevents to improve infection prevention workflow, communications and responsetime. Robust report capability enables analysis of infection rates, evaluation ofpatient risk factors, monitoring of preventive processes, and measurement ofprogress toward infection prevention and patient safety goals.The Centers for Disease Control and Prevention (CDC) has identified healthcareassociatedinfections (HAIs) as one of the top 10 causes of death in the UnitedStates. Designed by CDC-trained epidemiologists, the BD Protect system addressesmultiple issues confronting healthcare administrators and public health officers,including the transmission of multidrug-resistant organisms in healthcare settingsand escalating costs related to HAIs.The portfolio includes three modules. BD Protect Infection Prevention targetsreduction of HAIs in patients. BD Protect <strong>Healthcare</strong> Worker Safety monitorsemployee vaccinations, testing, in-service education, injuries and illnessesto protect both employees and patients. BD Protect Syndromic Surveillancecontinuously analyzes emergency department patient data for reportable diseasesand symptoms that could signal a possible community outbreak. It also can be usedat a health department to collect and analyze community-wide data from multiplehospitals.Diagnostics advancesImproved Group BStreptococcus diagnostics fornewborn healthIn June 2010, BD received 510(k)clearance from the FDA to market theBD MAXTM GBS Assay for Group BStreptococcus (GBS) on the BD MAXSystem.GBS remains one of the leading causesof morbidity and mortality amongnewborns, with maternal colonizationserving as a major risk factor for earlyonset GBS disease. However, GBS ispreventable with antibiotics duringlabor, which prevents transmissionfrom mother to infant. The CDCrecommends universal prenatalscreening for GBS colonization andintrapartum chemoprophylaxis forcolonized mothers in order to preventtransmission to infants. The currentstandard of care for preventing neonatalGBS disease is screening pregnantwomen at 35 to 37 weeks of gestationusing culture methods, which arelimited by sensitivity, turnaroundtime and the need for highly trainedtechnologists to interpret the results.The BD MAX GBS assay on the BDMAX System represents a significantadvance in neonatal healthcare bystreamlining the GBS screening processand addressing the limitations ofcurrent culture methods by providingrapid, objective results. With no visualinterpretation required, the BD MAXGBS assay identifies GBS in just overan hour, which can help ensure thatcolonization status is available in thecase of preterm delivery. By automatingsample lysis through polymerase chainreaction detection, the BD MAX Systemoffers walkaway convenience for up to24 samples in approximately two and ahalf hours.36 | <strong>California</strong> <strong>Biomedical</strong> <strong>Industry</strong> 2011 Report
Researcher profileDr. Samuel So addresses an epidemic of a preventable disease<strong>California</strong> Hapatitis B & CFiguresUp to 5.3 million Americans – 2 percentof the U.S. population – are living withchronic HBV or HCV.Viral hepatitis is the fourth leadinginfectious cause of death.<strong>California</strong> is home to about 40 percent(or 6.7 million) of the nation’s AsianAmerican population and 150,000people of Pacific Islander ancestry.San Francisco and Santa Claracounties experience some of thehighest rates of chronic HBV and livercancer in the United States.Unaware that they have been infectedwith hepatitis B, one of 10 Asians andPacific Islanders lives with the chronicinfection — the leading cause of livercancer.Liver failure from chronic hepatitis C isone of the most common reasons forliver transplants in the United States.In 2007 alone, HBV and HCV-relatedhospitalization costs in <strong>California</strong>totaled $2 billion.Samuel So, MD, FACS, Director of theAsian Liver Center, Director of theLiver Cancer Program, and the LiuHac Minh Professor of Surgery at theStanford University School of Medicine,was recruited to <strong>California</strong> as a livertransplant surgeon, an ambition he hadworked hard to fulfill. Yet he was notfar into his practice in the Golden Statewhen he found his true calling.“We were spending hundreds ofthousands of dollars to save one life[through a liver transplant],” he said,“when we could spend far less to savethousands and thousands of lives.”He explained that the preponderanceof his transplant patients had chronichepatitis B virus (HBV), an infection forwhich there has been a safe, effective,and inexpensive vaccine for morethan 30 years. And, yet, an estimated800,000 to 1.4 million Americans havechronic hepatitis B. Approximately onein 10 Americans of Asian and PacificIslander descent have chronic HBVinfection as compared to one in 1,000 ofwhite Americans.One challenge to stemming thespread of HBV is that many peopleare symptom free and do not knowthey have the disease until they havesignificant liver damage. Anotherchallenge, especially in the U.S., isthat neither at-risk groups nor theirhealthcare providers recognize that theyshould be screened and vaccinated forHBV.The at-risk groups include individualsborn in countries with high incidencesof HBV and hepatitis C (HCV), andanyone who might be exposed tocontaminated blood by handlingneedles or other sharp objects. Thesecond group includes healthcareproviders, tattoo artists or clients, andillegal drug users. Individuals born inthe U.S. before 1990, when HBV vaccinewas added to the infant immunizationschedule, and whose mothers wereborn in another country, also should bescreened, So said.Screening for the disease requires asimple blood test, “like the one theRed Cross uses before accepting blooddonations,” So said. In fact, beingturned away at the Blood Mobile ismany patients’ first indication that theyhave a hepatitis infection. If the bloodtest comes back negative, the patientshould be vaccinated. If the test comesback positive, the patient should bescreened periodically for changes in hisor her liver health. People with chronicHBV should also protect their livers bynot drinking alcohol and take measuresto ensure that they do not infect others.To raise awareness of HBV and livercancer, especially among the AsianAmerican communities in the Bay Area,So founded and became director of theAsian Liver Center at Stanford Schoolof Medicine in 1996. The center focuseson outreach and education, researchand advocacy, and it is reaching wideraudiences every year. For instance,the center’s Jade Ribbon Campaign isworking with Asian communities thelength of <strong>California</strong> as well as across thecountry and around the world.The center is drawing on the energyand creativity of youth members withprograms such as the Jade RibbonYouth Council (JRYC), which movesHBV awareness and discussion intohomes, churches and other gatheringplaces. One cultural factor in the fightagainst HBV is that having the diseaseis a stigma in Asian countries. Youngfamily members who have accurateinformation and a passion to makea difference in the health of theircommunities can change perceptionsand behaviors, So said.On the policy front, So has been anactive supporter of state legislation thatwould help eradicate the disease here.He has worked with AssemblywomanFiona Ma in drafting a couple ofHBV-related bills. Ma, who herselfhas chronic HBV, in 2008 introduced<strong>California</strong> <strong>Biomedical</strong> <strong>Industry</strong> 2011 Report | 37