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The RoundupA compilation of items about healthcare technology news,regulations, and AAMI initiativesJoin the AAMI 2018Fun RunAAMI will host its first FunRun & Walk on June 3during the association’s 2018Conference & Expo in LongBeach, CA, to raise funds forthe AAMI FoundationScholarship Program. Thisfun, noncompetitive eventprovides attendees with anon-the-move networkingexperience that also helpsraise money for the nextgeneration of health technology professionals. All levelsof fitness are encouraged toparticipate.The AAMI FoundationScholarship Program, whichwas created in 2009, providesfinancial support to studentswho are pursuing an education in a healthcaretechnology–related discipline. Every year, the AAMI84Foundation awards thousands of dollars to studentsaspiring to become biomedical equipment technicians,clinical engineers, and healthsystems engineers. Thesescholarships expand accessto students who havedemonstrated academicexcellence, technical aptitude, and a commitment tohealthcare technology andpatient safety.For more information andto register, visit www.aami.org/funrun.FDA Sets Barfor Clinical DataGeneratedOutside U.S.Reflecting the increasingglobalization of clinical trialsand the evolution of standards protecting trialparticipants, the Food andDrug Administration (FDA)has issued a final ruleupdating how the agency willevaluate clinical data submitted from medical deviceinvestigations conductedoutside of the United States.Beginning next year, suchinvestigations will need toconform to good clinicalpractice (GCP) standards—abar typically set for U.S.based studies.“FDA will accept data fromwell-designed, well-conducted clinical investigationsconducted [outside theUnited States] as support foran investigational deviceexemption (IDE) or devicemarketing application orsubmission if the investigations were conducted inaccordance with GCP,supporting information isprovided as applicable, andFDA is able to validate thedata from the investigationthrough an onsite inspection, if necessary,” the FDAwrote in the final rule.Under the new rule, studysponsors seeking a devicemarketing application or IDEwill need to submit astatement attesting that thestudy meets GCP guidelines,along with supportinginformation, or provide anexplanation as to why GCPstandards weren’t followed.If GCP standards can’t beBiomedical Instrumentation & Technology March/April 2018met for an investigation,then study sponsors canapply to the FDA for a waiveron a case-by-case basis.AAMI Board toWelcome TwoNew DirectorsThe AAMI NominatingCommittee has selected twohealthcare technology leadersto serve on the association’sBoard of Directors: MichaelC. McNeil, a global productsecurity and services officer atPhilips Healthcare, andWalter M. Rosebrough Jr.,president and CEO ofSTERIS Corporation.The Board is made up of 18to 19 representatives who areresponsible for reviewing,revising, and approvingstrategic and business plans,establishing and approvingpolicies, and providingguidance on strategic issuesaffecting the association. TheWalter Rosebrough Jr.

The RoundupGeorge McNeilofficial election of McNeil andRosebrough will occur at theassociation’s annual businessmeeting, which will be heldduring the AAMI 2018Conference & Expo in LongBeach, CA, on June 2. Theirthree-year terms will beginimmediately thereafter.“The nominees are exceptional leaders in our industry,and we are pleased to havethem join us in helping chartthe strategic course of theorganization,” said AAMIBoard Chair Phil Cogdill,senior director of quality,sterilization, and microbiology at Medtronic. “Ourcommunity is known for itsleadership in advancing thesafe use of health technology,and I look forward to thefresh perspectives andvaluable insight these newmembers will bring.”E.U. ProposesUnion-WideHealth TechnologyAssessmentsIn a regulatory moveintended to speed up accessto new health technologies,the European Union hasannounced plans to overhaulits evaluation through theuse of joint clinicalJoint clinical assessments are intended to break down health technology barriers across the European Union.assessments within its 28constituent countries. Theplan would reduce theoverlapping, and sometimescompeting requirements,that manufacturers facewhen their products areevaluated in individual E.U.member countries.Currently, health innovators that have cleared E.U.regulatory hurdles must alsosubmit clinical evidence toindividual regulators, such asGermany’s Institute forQuality and Efficiency orFrance’s Haute Autorité deSanté. The proposed Regulation on Health TechnologyAssessment would allowunion-wide pooling ofresources and expertise toavoid “duplications in theassessment of the identicalproducts,” said VytenisAndriukaitis, Europeancommissioner for health andfood safety, in a statement.The proposal could havefar-reaching effects on theE.U. and world economy, asthe healthcare industry isresponsible for 10% of theunion’s gross domesticproduct, according to theEuropean Commission.feature will allow patients toreceive alerts when lab resultsare ready, integrate information from different hospitalApple to BringHealth Records tothe iPhoneApple, Inc., has announced anew iPhone feature thatintegrates medical recordsinto the phone’s healthtracking app. The feature isavailable in a beta version ofthe iPhone’s 11.3 operatingsystem for patients ofApple-partnered healthcaresystems. The medical recordsMedical records in the iPhone’shealth app are organized in atimeline view to make them easierto understand.Biomedical Instrumentation & Technology March/April 201885

The RoundupThe blood vessel grafts acted and appeared similar to real blood vessels sixmonths after implantation in baboons. Photo courtesy of the University ofMinnesota.Tranquillo, who led thestudy. “In the future,thousands of the labgrown vessels could bemade from a small skinbiopsy from one donorand then stored on theshelf for when they areneeded by patients.”Once implanted in thebody, the grafts take onthe biological tissue of therecipient. The finalproduct, described in arecent Science Translational Medicine coverstory, looks like anendogenous blood vessel,self-heals when pricked,and does not generate animmune response. Thenext step is seeking FDAapproval for a clinical trialin children with pediatricheart defects, according tothe researchers.systems, and view their healthinformation more easily.Apple is currently testingthe feature with majorhospitals, including JohnsHopkins Medicine, MedStarHealth, and Penn Medicine.Apple said it expects theaddition of more healthcareinstitutions in the comingmonths.“We’ve worked closely withthe health community tocreate an experience everyone has wanted for years—toview medical records easilyand securely right on youriPhone,” said Jeff Williams,Apple’s chief operatingofficer. “By empoweringcustomers to see their overallhealth, we hope to helpconsumers better understandtheir health and help themlead healthier lives.”Engineers GrowReady-to-ImplantTubes to ReplaceBlood Vessel86Biomedical Instrumentation & Technology March/April 2018Engineers at the Universityof Minnesota (UM) successfully tested lab-grown bloodvessel grafts in baboons in apreclinical trial. These graftswere created using humanskin cells placed into agel-like protein that’s used inblood clotting. The skin cellsbuild out a scaffold ofcollagen and other proteins.After the cells are washedaway, the graft consists ofnonliving but biologicallybased materials that othercells can eventually callhome.“We harnessed the body’snormal wound healingsystem in this process bystarting with skin cells in afibrin gel, which is nature’sstarting point for healing,”said UM Biomedical Engineering Professor Robertstandards-setting role in theworld of health technology.”ANSI is a nonprofitorganization that promotes,facilitates, and safeguardsthe integrity of the voluntarystandardization and conformity assessment system.AAMI was accredited byANSI as a National Standards Organization in 1977and published its firstANSI-recognized AmericanNational Standard in 1978.Eleven other individualswere elected to the ANSIBoard as directors-at-largefor terms beginning in 2018.AAMI PresidentNamed to ANSIBoard of DirectorsAAMI President and CEORobert Jensen has beennamed a director-at-large bythe American NationalStandards Institute (ANSI)Board of Directors. Jensen,who was nominated to fill avacated position, started hisone-year term at the beginning of 2018.“I am deeply honored tohave been selected as anANSI director-at-large andlook forward to working withthe rest of the Board towardadvancing ANSI’s significantand valuable mission,”Jensen said. “Standards are afundamental component ofpromoting quality and safetyin a multitude of industries,and AAMI is proud of itsRobert JensenACI Awards FirstCertificationsto IndustrialSterilizationProfessionalsFollowing the inauguraltesting period this pastDecember, 23 dedicatedprofessionals have earned theright to be called CertifiedIndustrial SterilizationSpecialists (CISS) from theAAMI Credentials Institute(ACI). Of these, 15 alsoearned credentials in ethylene oxide sterilization(CISS-EO), six in radiation

The Roundupsterilization (CISS-RAD), andtwo in moist heat sterilization (CISS-MH). Half adozen earned multipledesignations.“In the past, we had to baseperceived competency onthings like a résumé orself-proclamation. Now thatthe CISS certification isavailable, it will allow peopleto demonstrate their truetechnical knowledge,” saidClark Houghtling, vicepresident of businessdevelopment and technicalaffairs at Cosmed Group,who helped develop the CISSexam. “Obtaining thiscertification could be one ofthe factors that gives an edgeto a job applicant and, at thesame time, will allow aprospective employer toensure that they are getting ahighly qualified individual.”The next testing windowfor ACI’s CISS exam runsfrom May 1–15, and applications must be received byApril 13. More informationabout the CISS credentialand other ACI certificationsis available at www.aami.org/aci.Trends andTechnologies forHealth Leaders toWatch Out ForHospital leaders are taskedwith keeping an eye on thelatest technologies andtrends. While some ideasturn into the “next big thing,”others may ultimately land asa dud. ECRI Institute’s latestC-Suite Watch List reporthighlights several newtechnologies and patient caredevelopments that healthcareleaders should monitor.Topping this year’s list istelehealth options, such assmartphone apps, that helptreat patients with opioidaddiction. Other trendsinclude direct-to-consumergenetic testing; patientrooms that can change basedon acuity; insertable cardiacmonitors; use of virtualreality to reduce discomfortduring pediatric procedures;noninvasive, nonpharmacologic devices to treatAlzheimer’s Disease; use ofmicroneedles for blooddraws; neonatal magneticresonance imaging scanners;brain tumor treatment usinginternal, implanted radiation(brachytherapy); and “microhospitals” that straddle theline between full-service andurgent care facilities.“Not all of our Top 10topics are technologies orinfrastructure changes thatwe recommend at this timeand, perhaps, neither shouldyou,” the report reads.“Often, hype precedesevidence, and healthcareleaders need to understandhow to address the hype.”BiomedicalInstrumentationTextbook GetsUpdateStudents, recent grads, orhardened veterans who wantto brush up on their biomedbasics now have a newresource to learn the fundamentals of healthcaretechnology. AAMI is nowoffering an updated, secondedition of the Introduction toBiomedical Instrumentationtextbook, written by BarbaraL. Christe, the programdirector of healthcareengineering technologymanagement and an associate professor with theEngineering TechnologyDepartment at PurdueSchool of Engineering &Technology at IndianaUniversity–PurdueUniversity Indianapolis. Thebook provides accessibleinformation to those lookingto develop a career as abiomedical equipmenttechnician.This introductory textbookincorporates the most recentchanges in healthcare, regulations,standards, and technology.“This fully updatedsecond edition providesreaders with all they need tounderstand the use ofmedical technology inpatient care,” Christe said.“It is designed for readerswith a fundamental understanding of anatomy,physiology, and medicalterminology, as well aselectronic concepts.”The update, which is thefirst since 2009, incorporatesthe most recent changes inhealthcare, regulations,standards, and technologyand includes new sectionson device testing and theinterface of medical deviceswith electronic medicalrecords. The book is available for purchase throughthe AAMI Store at www.aami.org/store.South Korea toStreamline Approvalof Cutting-EdgeDevicesGovernment officials andmedical technology companies in South Korea havereached an agreement tohelp speed up the release of“novel medical devices withan immediate value tosociety” when the success ofthe device “hinges onentering the market aheadof competitors,” according toa report by the Korea Herald.Under the agreement, anew “value-based evaluationtrack” will be established toevaluate which technologiesshould gain fast-trackapproval. The system willweigh the benefits to society,as well as clinical evidenceagainst potential safetyconcerns, according to thereport. Technologies thatpass this value-basedevaluation will be given aclinical usage period ofthree to five years beforebeing evaluated again.Medical devices representan approximately 5-billionindustry in South Korea,according to the International Trade Administration,with the United Statessupplying nearly half ofimports. nBiomedical Instrumentation & Technology March/April 201887

Did You See?Did You See?The AAMI Foundation developed a video highlighting the need to implement continuouselectronic monitoring to prevent opioid overdose deaths for hospitalized patients.Watch it at www.aami.org/opioidsAAMI’s computerized maintenance management system guide canhelp your team make the most of these crucial systems.You can get the latest healthcaretechnology news, career resources,standards information, and moredelivered to your inbox with AAMI’se-newsletters.Sign up at www.aami.org/enewslettersGet it at www.aami.org/CMMSguideMarilyn Neder Flack, the guiding forcebehind the AAMI Foundation’s patient safetyinitiatives, is retiring at the end of March.Read about her work at www.aami.org/Foundation MarilynThe AAMI 2018 Conference & Expo inLong Beach, CA, is fast approaching.Register now at www.aami.org/AC88Biomedical Instrumentation & Technology March/April 2018

Community CloseupsTen Questions With Stephanie DomasWhat’s the most pressing issue you see inmedical device cybersecurity today?Maintaining medical devices once they enter ahealth delivery organization (HDO). Securemedical devices are now hitting the market,which is fantastic. But cybersecurity changesevery day, and maintaining devices is necessary to stay secure. Traditional informationtechnology security tools often can’t be usedon many medical devices, and with so manymakes and models—each with differentconfiguration, capabilities, and softwareupdating mechanisms—it takes a small armyto track and maintain all of them.medical devices. I want to make sure patientsget treatment from medical devices that aresafe and secure.What’s a common mistake devicemanufacturers make in their products?Not using the right expert for the job. I’ve seentoo many times where a smart softwareengineer was put in charge of designing andimplementing critical security features in asystem. They may be incredibly talented withsoftware, but they haven’t been trained incybersecurity.What do you enjoy outside of work?How did you first get involved in medicaldevice cybersecurity?Previously, I was on a cybersecurity researchteam for a defense contractor. My area ofexpertise is x86 embedded systems, and thegoal was to research the next frontiers incybersecurity. Gradually, my curiosity shiftedfrom wondering about cybersecurity five yearsout to wondering what we can do now. Istarted to look at the state of cybersecurity andsaw a growing need for increased cybersecurity in medical devices.Maintaining our small hobby farm, where wehave a horse, donkeys, sheep, chickens, andcats.Do you have any advice for people who areconsidering cybersecurity as a career?If you want to make a positive impact on theworld, love solving puzzles, and continuouslylearn, then cybersecurity is the field for you! Itis one of the most versatile jobs. Almost everycompany, regardless of their end product orservice, has a need for cybersecurity.If you could go anywhere in Ohio for a day,where would we find you?Outside of cybersecurity, what’s a causethat you’re very passionate about?In a log cabin in the woods with my family,roasting marshmallows and sipping hotchocolate.Animal rescue, particularly cats. I foster catsfor a local shelter.You recently began a new job at MedSec—tell us about it!I recently joined MedSec as its vice presidentof research. My role is to partner with HDOsand medical device manufacturers to developservices and products that meet the needs ofthe community for the cybersecurity ofStephanie Domas is vicepresident of research at MedSecin Columbus, OH, where sheleads the development ofservices and products to improvethe cybersecurity of healthtechnology. Domas is a memberof several medical devicecybersecurity standards workinggroups, a registered professionalengineer, a certified ethicalhacker, and an adjunct facultymember at The Ohio StateUniversity.What is the worst advice that you neverfollowed?“Just go with the flow.” I like to challenge andbe challenged.Ice cream or gelato?Ice cream! Just plain old vanilla.nBiomedical Instrumentation & Technology March/April 201889

Community CloseupsPeopleAreSayingA sample of comments from AAMI’s social media sites“Patient care is a 24/7 requirement; equipment carefor our clinicians should be as well.”—Darrell Chiasson, AAMI Community group on LinkedIn.Chiasson is a program director of healthcare technologymanagement at Universal Health Services, Inc., in Sarasota, FL.“Being a staff-level biomed is one of the mostrewarding jobs you could ever have. You interactwith the clinical team, the patients, and the public.You are making a positive difference in people’slives on the frontlines. It can also be a tough anddemanding job, but it is an honorable career.”—Donald Armstrong, AAMIBlog. Armstrong works forStanford Health Care in California. He is a member ofAAMI’s Technology Management Council and theBI&T Editorial Board.“It is very important that biomedical professionals havemanagement tools for the development of their roles.”—Gas Latam Mexico, a biomedical company based inGuadalajara, Mexico, sharing its thoughts on AAMI’scomputerized maintenance management system manualon Facebook (translated from Spanish).“We should look beyond the medical device ortechnology—and our vital role in supporting its safeand effective use—and recognize the person.”—Mark Heston, AAMIBlog. Heston is director of servicewith GE Healthcare and a member of AAMI’s TechnologyManagement Council.Join theConversation.www.twitter.com/aami connectwww.facebook.com/aamiconnectSearch for the AAMI Community in groups90http://aamiblog.orgBiomedical Instrumentation & Technology March/April 2018.connect.aami.org/home

NEW!Updated and ImprovedThe new version of ST79 is a must-have standard for anyhealthcare facility that uses steam sterilization. Easierto use with reorganized content and color diagrams, itcovers every step in the process and can apply to a widearray of facilities where sterile products are reprocessed,stored, and used.New features include guidance on the use of ultrasoniccleaners, new text on following manufacturers’instructions, and an annex on alternatives to cooling asterile processing department (SPD).This best-selling standard is an indispensable tool forany SPD. Use it to help you stay in compliance withaccrediting bodies.For complete details and to order,visit www.aami.org/ST79.www.aami.orgAdvancing Safety in Health Technology

SEWING UPSOLUTIONSThe Role ofSoftware Patch Managementin Effective CybersecurityChris Hayhurst92Biomedical Instrumentation & Technology March/April 2018

Cover StoryWith cyberattacks on the rise and a growing appreciation for the threats posed to patients, effectivepatch management is more important than ever.The news came in the form of a securitybulletin on March 14, 2017. “This securityupdate resolves vulnerabilities in MicrosoftWindows,” MS17-010 began. “The mostsevere of the vulnerabilities could allowremote code execution if an attacker sendsspecially crafted messages to a MicrosoftServer Message Block 1.0 (SMBv1) server.”1This Windows flaw, it lat

Symantec Cambridge, MA Mention of any commercial product, process, or service by trade name, trademark, manufacturer, or otherwise in BI&T does not constitute or imply an endorsement or recommendation by AAMI. The views and opinions of the authors in BI&T do not state or reflect the opinion of AAMI. POSTMASTER: Send address