When manufacturers seek approval fornew medical devices, they often sub-

mit and cite standards as evidence of thedevice’s safety and efficacy. But currentpaperwork to submit standards data to regulators can be burdensome and long.

As a result, the U.S. Food and DrugAdministration (FDA) is considering revisions to the submission process for standards data for medical devices. FDAofficials detailed a potential update to Form3654, a Standards Data Report, for 510(k)

Mary Logan, JD, CAE, an accomplishedassociation executive, has been select-

ed as AAMI’s new president. During an extensive, nationwide search,

the AAMI Board of Directors sought an individual who would be poised to leadAAMI into a successful future with new andupdated member services and programs, astrong position in medical technology man-agement, and collaborative relationshipswith outside stakeholders throughout theworld.

“Mary Logan is ideally suited to guideAAMI successfully through the transitionfrom our respected long-term leader, MikeMiller,” says Chuck Sidebottom, chair ofAAMI’s Board of Directors and director ofcorporate standards at Medtronics. Miller isretiring at the end of June after nearly 40years of dedicated service to AAMI.

Logan has 20 years of senior manage-ment experience, most recently serving aschief operating officer (COO) of theAmerican Dental Association (ADA) inChicago. As the ADA’s COO, she wasresponsible for the operational managementof the organization. Most of its divisionsreported to her, including the ADA’s wellrespected Standards Area and its large

Science Division.During her tenure, the ADA was namedone of the mostremarkable associa-tions in the UnitedStates in SevenMeasures of Success, a report issued by the American Societyof AssociationExecutives. Loganalso served as the ADA’s general counsel,and as general counsel for the global financeand administrative arm of The UnitedMethodist Church.

“Mary Logan brings a unique combina-tion of skills and talents to AAMI, with herfacilitative style of leadership, a passion forhealthcare and what medical technology cando to improve patients’ lives, knowledge ofthe regulatory and standards arena, and asolid reputation for getting things done,”says Sidebottom.

Logan says she is looking forward tojoining the AAMI team.

“AAMI is a gem of an organization with an inspiring mission and dedicatedmembers.”

To Seek Efficiencies . . .

FDA Outlines Proposed Changes to Standards Form

CONTINUED ON PAGE 10

New AAMI President Named, Begins Job This Month

Vol. 44, No. 4 • April 2009

Association for the Advancement of Medical Instrumentation W W W. A A M I . O R GNews

The Inside Word

“What if these devices have to be used on my

daughter or son?”

Rossiny Jacques

See story page 14

I N S I D E . . .

Compromise Reached on Fire Safety Standard. . . . . . . . . . . . . . . . . page 3

How to Promote YourDepartment’s Value. . . . . . . . . . . . . . . . . page 6

ST79 Webinar Details 2009 Changes . . . . page 8

Biomeds Singled Out for Outstanding Service. . . . . . . . . . . . . . . . page 14

Report Clarifies ElectricalEquipment Standard. . . . . . . . . . . . . . . . page 16

Mary Logan

Barbara Zimmerman, left, and Carol Herman, center,both of FDA, speak with a conference participant duringthe International Standards Conference.

AAMI News is the official newsletter of the Association for the Advancement of Medical Instrumentation (AAMI), a unique alliance of the healthcare professions providingessential information on the development and use ofmedical instrumentation and technology.

AAMI News is a benefit of AAMI membership; nonmembersmay subscribe for $160. Foreign subscriptions cost $195.

ISSN 0739-0270. Copyright © 2009 by AAMI.

Advertising rates and deadlines:Contact Steve Campbell at (703) 525-4890, ext. 241, or e-mail scampbell@aami.org

President: Michael J. Miller, JD

Senior Vice President of Communications, Marketing, and Healthcare Technology Management:Steve Campbell

Director of Publications: Susan Gillespie

AAMI News Editor: Robert King

Communications Assistant: Cindy Kang

1110 N. Glebe Road, Suite 220Arlington, VA 22201-4795(703) 525-4890 (Phone)(703) 276-0793 (General fax)(877) 249-8226 (Publication orders)www.aami.org

ABOUT AAMI NEWS

2/April 2009 www.aami.org AAMI News

N E W S I N B R I E FReport: Healthcare IT Funds May Not Be Enough

New financial incentives in therecently passed economic stimulus

bill will still leave many physicians insmall practices facing significant up-front healthcare information technology(IT) implementation costs, according toa review from Avalere Health, an analytic research firm.

The stimulus package containsroughly $17 billion in incentives forphysicians and hospitals to adopt elec-tronic medical record (EMR) systems.Avalere researchers found that a solo orsmall-group physician practice willspend an estimated $124,000 over thefive-year period of 2011–2015 to adoptEMRs, and will receive up to $44,000 infederal incentive payments.

For more information on the report,visit www.avalerehealth.net.

TMC Career Brochure in Hot Demand

AAMI has distributed more than3,800 copies of a new version of its

popular career brochure in less than a two-month period.

The new brochure—titled ServicingTechnology, Saving Lives: A Career in

Biomedical EquipmentTechnology—was created byAAMI’s TechnologyManagement Council(TMC) to help hospi-tals, manufacturers,schools, and othersrecruit students tothe biomed field.

The brochure includes informationabout the responsibilities of biomedicalequipment technicians (BMETs), theirskills and training requirements, salaryand fringe benefits, and the long-termoutlook for the field.

It also includes testimonials from a number of BMETs who talk aboutwhy they find the field so rewarding.

The brochure also promotes the fact that U.S. News & World Report hasselected the field as a top career choicefor 2009.

To request the brochure, contactPatrick Bernat at pbernat@aami.org.Please include your complete mailingaddress and the number of copies youwould like to receive.

AAMI Dialysis Collection Available as PDF

For the first time, AAMI’s completedialysis standards collection is

available as a single PDF.

The searchable PDF format allowsquick access to all of AAMI’s dialysisstandards. The standards collection isalso available in book and CD format.The individual standards are also available for purchase.

The standards—which addresshome hemodialysis, reprocessing ofhemodialyzers, and recommendedpractices and guidance for dialysis—also continue to be available in printand on CD.

The 2008 edition includes threeupdated standards: RD47 (Reprocessingof hemodialyzers), RD5 (Hemodialysis systems), and RD52(Dialysate for hemodialy-sis, Amendment 1—Annex C: Special considerations for home hemodialysis andAmendment 2—AnnexD: Self-assessment ofcompliance with recom-mendations for dialysatepreparation).

To order AAMI Standards andRecommended Practices: Dialysis, call(877) 249-8226, use the order form onpage 23, or visit http://marketplace.aami.org. The list price is $325 and theAAMI member price is $195. The ordercode is DSBK08-PDF. The source codeis PB.

AAMI News www.aami.org April 2009/3

Amajor hurdle has been overcome in the proposed revisions to

NFPA 99—the National Fire ProtectionAssociation’s safety standard forhealthcare facilities.

The document, which is undergoinga major revision and modernization,establishes criteria to minimize the haz-ards of fire, explosion, and electricity inhealthcare facilities. As a result, thedocument is particularly important tobiomeds.

Recently, the committee responsiblefor updating the standard reached acompromise on a thorny issue overwhether all operating rooms (OR)should be considered wet locations.The committee recommended againstmandating all ORs as wet locations, butreached a compromise that wouldaffect new and renovated ORs.

The compromise helps pave the wayfor possible final approval of the stan-dard. Parties can still file a Notice ofIntent to File a Motion (NITMAM) byApril 3 to amend the draft standard.

All certified NITMAMs will be consid-ered by the NFPA’s membership at itsannual business meeting in June, afterwhich the NFPA’s Standards Councilwill make the final decision on therevised standard. The standard is dueto be published in September 2009 as a2010 edition.

Currently,NFPA 99 is a vol-untary standardto be implement-ed in healthcarefacilities.However, thenewly revisedstandard is writ-ten as a code tobe adopted intolaw, says AlanLipschultz, chair of the medical equip-ment sub committee for NFPA 99 andAAMI’s representative on the commit-tee. “NFPA is inviting localities andstates to adopt NFPA 99 by making it acode, but they all act on their own

timetable,” Lipschultz says.

Wet LocationsIn proposing a resolution to the wet

locations issue, the NFPA’s Health CareFacilities Technical Committee haspotentially resolved one of the mostcontroversial issues about the standard.

A wet location is an area wherepatient care is performed that is nor-mally subject to wet conditions whilepatients are present. Wet locationsshould use ground fault circuit inter-rupters, which will interrupt the power,or isolated power, Lipschultz says.Since one doesn’t want to interruptpower during an operation, inter-rupters aren’t a valid option, and thatleaves isolated power.

In the current version of NFPA 99,each healthcare institution decideswhether an OR is a wet location.However, the revised version requiresisolated power in ORs unless the governing body makes a conscious

Safety Standard Revision . . .

NFPA Report Seeks Compromise on Wet Locations Issue, Faces June Vote

Alan Lipschultz

CONTINUED ON PAGE 4

decision that the ORs are not wet. Manyhospitals already use normal groundedpower in their operating suites.Typically, existing facilities are not sub-ject to new requirements.

“It has never been disputed that wet conditions exist in some, if notmany, ORs during medical procedures,”the committee said in its report. “Thereal question raised . . . was whether allORs must be designed, by code, to com-ply with wet location requirements asdefined by the codes and standards.”

The report noted that the committeedidn’t find a single documentedinstance of electrical problems in ORscaused by the use of grounded systems,nor of problems averted through theuse of isolated power systems.

After weighing the issue, the com-mittee said that mandating all ORs aswet locations would be an unnecessaryhardship on the healthcare industry.However, “compared to the existing

language in NFPA 99, a greater burdenof proof has been placed on the facilityto do anything other than design for awet location,” the report indicates. “Allnew and renovated ORs will berequired to be designed to wet locationstandards, unless the facility, through adetailed evaluation and review, includ-ing user groups, determines that someORs may be deemed as not being wetlocations, and constructed accordingly.”

Routine Safety TestingA proposed change to eliminate a

requirement for routine safety testing ofmedical equipment didn’t receive anycomments, Lipschultz says. The changeeliminates the requirements for routineperiodic testing.

Under the current NFPA 99, biomedsmust conduct routine safety testingevery six months or a year. The pro-posed revision says biomeds wouldn’tneed to do testing except when a deviceis being accepted or following repair,Lipschultz says. “Just because it isn’trequired anymore doesn’t mean youshouldn’t do it,” he adds. “It just meansit is not required.”

A facet of the proposed standard that

generated numerous comments focusedon requirements for manufacturers tosupply technical documentation to theircustomers. The committee originallydecided to eliminate a chapter in thestandard concerning this issue because itwas redundant. But many commentedthat in eliminating that chapter the com-mittee deleted requirements for manufac-turers to supply technical documentationsuch as service manuals. The committeeagreed to incorporate the requirementsinto another chapter of the standard.

For more information about NFPA 99,visit www.nfpa.org.

4/April 2009 www.aami.org AAMI News

NFPA 99 StandardFaces VoteCONTINUED FROM PAGE 3

Want to Learn More?

Alan Lipschultz will be a presen-ter on NFPA 99 during a ses-

sion at AAMI’s 2009 AnnualConference & Expo, which runsfrom June 6–8 in Baltimore, MD. He will discuss changes in theNFPA 99 standard and addressquestions from the audience.

For more information about theconference, or to register, visitwww.aami.org/ac.

T E C H W O R L D

As many healthcare institutions cut back due to the poor economy, it’s moreimportant than ever for clinical engineer-ing departments to promote their value to administrators. In this edition of Tech World, Ken Schwarz—who works in the healthcare sector for FrancisCauffman, an architecture and design firm in Philadelphia—discusses howdepartments can do just that.

Biomedical or clinical engineering(CE) may have been born out of

necessity, but today it has become anintegral part of healthcare. The CEdepartment, whether in-house or out-sourced, faces many challenges.

Most biomedical equipment techni-cians and managers have strong techni-cal backgrounds, but we as a fielddon’t sell our value very well. Thatneeds to change in today’s market.While finding the time to do this maybe difficult, not promoting your depart-ment can harm not only the operationof your department but also the health-care institution.

I have found that you must showpeople what you do for them, and thencontinue to remind them. We have allsaved money on sourcing parts or find-ing a qualified, less expensive vendor,

or even negotiat-ing a service con-tract or chargeswith a serviceengineer from anoriginal equip-ment manufac-turer. This typeof informationshould not justbe filed andstored. It shouldbe compiled and brought to the health-care institution’s attention.

Think about what you accomplishduring your day. How many preven-tive maintenance (PM) inspectionshave been performed and how manyhours did it take? How much did yousave on parts and outside servicestoday? You need to show your “customer” what you do for them andexplain it. Invite administration,department managers, and key users toquarterly or semi-annual meetings. Ithelps to schedule these meetings dur-ing lunch and provide lunch.

Do some preparation and make sure you know your hospital’s mission, value statements, and strategicplan. Open up the presentation with

Tech World features local biomedical societies, personalities, and issues facing

BMETs and clinical engineers.

introductions and a quick PowerPointpresentation (keep it less then 25slides). Remind them of your depart-ment’s mission and key services. Youcan take some of this from your med-ical equipment management plan. Tellyour customer what accomplishmentsand improvements you have made inrecent months. Make the presentationabout them. It’s good to quickly reviewyour performance indicators and whatyou are doing to improve them. Show aslide on your workload, including howmuch equipment you take care of,number of PMs, and repairs. Showthem any projects you have completedor are working on, and don’t forget theslide on cost savings.

The most important part of thesemeetings is interaction. If your cus-tomer is involved with your service(not just using it) they will see thevalue. Ask them what improvementsthey want to see and make sure youreport back to them at the next meeting.

How can you do all of this? If youget organized and collect the data asyou go along, preparation time is mini-mized. Also, once you find the formatthat works best, it becomes easier toupdate the presentation, rather than re-creating it. Although this will takesome time, it’s time well spent.

Set up a process to capture the datayou want to present, and find out whatthe staff wants to learn and under-stand. Frequently, staff sees us onlywhen we are busy running from oneplace to the next. Meetings like this willopen up their eyes. I conducted a meet-ing once where a department managersaid he “didn’t realize all we did.” Thisprocess will also help you with theannual evaluation of your medicalequipment management plan. Youshould have all the data you need.

When other staff members fullyunderstand and appreciate what youdo and how you can help them, youwill develop a better relationship andform a better team.

—Ken Schwarz

How to Promote Your Department’s Value

6/April 2009 www.aami.org AAMI News

Ken Schwarz

With many hospitals facing tougheconomic times, some biomed

departments are under the gun to cutspending and possibly services, but bio-meds should seek to do just the oppo-site, a longtime clinical engineeringleader says.

“Biomed is acost-savingdepartment. Theway that we savemoney in hospi-tals is to get big-ger, not toshrink,” says PatLynch, a biomed-ical support spe-cialist for GlobalMedical Imaging,and a 34-year veteran of the industry.

Lynch—who will be among thespeakers at AAMI’s Annual Conferenceto discuss how biomeds can cope in thiseconomy—says biomeds should consid-er expanding their department’s respon-sibilities to maintain and repair more

equipment. “Historically, most biomedsare only doing the general biomedicalequipment in hospitals. They are notvery involved in the higher-end imag-ing, ultrasound, and equipment thatcosts big dollars to maintain.”

By bringing higher-end equipmentsuch as ultrasounds in-house, biomedscould reduce maintenance and repaircosts. Lynch will illustrate the savingsby showing how a hospital can savemoney on diagnostic imaging mainte-nance. He will also provide tips on howto convince administrators to make thechange by using a chart to demonstrateanticipated savings.

Other session speakers include KeithD. Persinger, senior vice president andchief financial officer for the Universityof Maryland Medical Center, andBritton Berek, director of regulatorycompliance for ARAMARK Healthcare.

While training and travel costs oftenface added scrutiny when the economyis poor, biomeds should emphasize totheir administrators how important

training is for them, Lynch says. “Hospitals need to realize that

training is a true investment in thefuture,” he says. “If a nurse doesn’t go to a nursing conference for two or three years, she is still a nurse andcan still practice nursing. If a biomedengineer doesn’t go to training on newequipment coming out, he will not beable to service that equipment.”

AAMI News www.aami.org April 2009/7

AAMI’s Annual Conference . . .

Biomed Shops Should Leverage Economy to Their Advantage

Here to Help

The Annual Conference sessionon the economy is one of 50

educational sessions that will beoffered during the conference,which will be held in Baltimorefrom June 6–8. To register for theconference, visit www.aami.org/ac.

For more tips on surviving in the poor economy, visitwww.aami.org/economy.

Pat Lynch

8/April 2009 www.aami.org AAMI News

focused on various aspects of steamsterilization and sterility assurance.

One proposed amendment underconsideration this year offers a newsection on risk analysis. “It is recog-nized that the effectiveness of certainprocesses cannot be verified by inspec-tion and testing,” says Cynthia Spry,webinar speaker and co-chair ofAAMI’s Steam Sterilization HospitalPractices Working Group, which isresponsible for ST79 authoring andupdating. “We can’t tell if our product

Potential changes to AAMI’s popularsteam sterilization standard, ST79,

this year include a new section on riskanalysis, a committee leader says.

The first webinar in a five-part serieson ANSI/AAMI ST79, A comprehensiveguide to steam sterilization and sterilityassurance in health care facilities, detailedsome of the 26 potential changes toST79 and provided an overview of thestandard. ST79 is a consolidated revi-sion of several AAMI standards that,prior to being superceded by ST79,

is sterile by lookingat it, and we obvi-ously can’t test ourdevices before wesend them to theoperating room.Therefore perform-ance of the steriliza-tion process is routinelymonitored and equipment maintained.”

Because manufacturers validate steril-ization cycles based on the assumptionthat a device is being processed alone,which is not the usual case in a health-care facility, a facility should perform arisk analysis, Spry adds.

A risk analysis includes a risk assessment, which identifies the sourceof a sterilization failure, estimates thelikelihood that failure will occur, andassesses the consequences of failure. Arisk analysis includes risk management,which determines failures that requireattention, and plans to ensure steriliza-tion failures are controlled.

The ST79 standard has a continuousmaintenance process to keep it current.There are 25 other potential amend-ments to the standard, including newtests for assessing the efficacy of clean-ing, currently under consideration.

These amendments will not be finaluntil AAMI and the American NationalStandards Institute (ANSI) complete theapproval processes later this year. Theamendments are expected to be pub-lished this summer.

Many Amendments Considered for ST79 . . .

Webinar Gives Peek at Potential 2009 Changes

For More on ST79 . . .AAMI offers education courses . . .

You can still register for theremaining webinars in the

series. For information, visitwww.aami.org/meetings/webinars.

AAMI offers the standard . . .ST79, Comprehensive guide tosteam sterilization and sterilityassurance in health care facilitiesLIST PRICE: $220AAMI MEMBER PRICE: $110ORDER CODE: ST79 or ST79-PDF

SOURCE CODE: PB

To order copies, call (877) 249-8226, use the order form on page 23, or visit theMarketplace at http://marketplace.aami.org

10/April 2009 www.aami.org AAMI News

19th Annual AAMI/FDA International Conference on Medical Device Standa

submission of medical devices during a recent session at the AAMI/FDAInternational Conference on MedicalDevice Standards and Regulation. Mostsignificantly, the proposed form con-tains changes to the conformance tablefor some standards, with the goal ofsimplifying the process.

Form 3654 hasa critical role inthe 510(k) sub-mission process,session speakersnoted. “It is real-ly important tomake this work,”said DaveOsborn, managerfor internationalstandards for Philips Healthcare and amember of AAMI’s Board of Directors.

“FDA needs appropriate information,and manufacturers have to provide it ifthey want the process to work quicklyand efficiently.”

Osborn said manufacturers are per-mitted to use standards in submissions,particularly 510(k), as a risk controlmethod. “For a device like an intensivecare unit (ICU) monitor, a manufacturerwill cite anywhere from eight to 20 stan-dards,” he said.

Many industry professionals findForm 3654 hard to use, particularly theconformance table manufacturers mustfill out to show their compliance withstandard sections. “One of the interpre-tations of the original form is that youhave to report in the summary tableevery clause and sub-clause, whichcould be thousands of entries, while infact FDA only needs to know aboutthose few clauses that are not applicableor have been modified,” Osborn said.

In the proposed Form 3654, manufac-turers only have to list certain clausesand sub-clauses. One example of aclause that must be listed is a clause

where some parts of the standardaren’t applicable.

Some of the language in the foot-notes of the existing form also impliesthat all testing has to be completedbefore a manufacturer could send in asubmission, Osborn said. That is inconflict with other FDA guidance. Theproposed form explicitly states thatmanufacturers are permitted to submita promissory note detailing that thetesting will be completed, Osborn said.

Osborn was part of a team of devicemanufacturers that proposed the newform to replace the existing Form 3654.FDA distributed the proposed form toconference participants, and plans todistribute it to various trade groups forcomments. After comments have beenreceived, FDA will consider whether to make the changes, said Carol L.Herman, director of the standards pro-gram for FDA’s Center for Devices andRadiological Health (CDRH). The U.S.Office of Management and Budget willmake the final decision, she added.FDA expects a decision by this fall.

Standards SubmissionForm ChangesCONTINUED FROM PAGE 1

Dave Osborn

AAMI News www.aami.org April 2009/11

The software expert for the U.S. Foodand Drug Administration (FDA)

shared how to determine when yoursoftware product would become a medical device. The session, presentedduring the AAMI/FDA InternationalConference on Medical DeviceStandards and Regulation, also includ-ed insight on security for information technology (IT) networks incorporatingmedical devices.

John Murray, software complianceexpert for FDA, explained how hemakes recommendations for softwaredevice decisions. “The intended use iswhat drives device decisions,” he said.“When we start this process, the firstthing we need to have is a good intend-ed use definition. If you have a productwhere the intended use is to store,transfer, or display data, then that is anIT product. The product can become amedical device if the storage, transfer,or display of that data has some specif-ic ‘intended’ clinical application that

meets the legal definition of a device.”Some examples of device clinical

application or use include calculatingdoses and calculating and controllingtreatment timing.

When FDA determines that a soft-ware product is a medical device, itmust also decide which device class itis. Devices are divided into three class-es based on their risk to patients, withClasses I being the lowest and Class IIIthe highest risk. “For software medical

devices, the idea here is to classify medical device infrastructure IT systemssuch as data acquisition systems in aClass I arena,” Murray said. “Anythingthat has automatic control of the delivery, treatment, or diagnosis of care typically would be in the Class IIIarena. The majority of other productswould fall between these two risk levels, and fall into Class II.”

IT Network SecurityThe session also included a segment

on IT security. Traditional IT security is based on a static approach whereaspects stay in place, said BrianFitzgerald, deputy division director for FDA’s Division of Software andElectronic Engineering. But thisapproach doesn’t work in the medicalfield. Devices and patients move around.

Fitzgerald offered tips for IT security.For example, users may need separatedevice-level and network central account administrations, he said.

ards and Regulation

Brian Fitzgerald speaks about IT network securityduring the International Standards Conference.

Speakers Provide Insight on Regulating Software as a Medical Device

12/April 2009 www.aami.org AAMI News

Manufacturers who sell their prod-ucts overseas must get ready for

some changes to medical device regula-tions in Europe.

In March 2010, a revised version ofthe Medical Device Directive (MDD),which provides the basis for theEuropean Union’s medical device regulatory requirements, will go intoeffect. A session at the AAMI/FDAInternational Conference on MedicalDevice Standards and Regulationdetailed some of the changes.

One of the major changes in theMDD focuses on the labeling of car-cinogenic, mutagenic, or toxic to repro-duction (CMR) substances. There was adebate within Europe about whethersuch substances should be banned, saidRoger Gray, vice president of regulato-ry affairs for Rome-based DonawaConsulting and the session speaker. IfCMRs were banned, it could have hada profound effect on medical devicemanufacturing, Gray said. Di(2-ethyl-hexyl)phthalate (DEHP), a widely used

plasticizer in medical devices, is classi-fied as a CMR in Europe.

Recognizing this concern, theEuropean Parliament, which approvedthe MDD revisions, reached a compro-mise. Rather than banning CMRs out-right, all devices that contain DEHP willhave to be labeled as such when thenew rules take effect in 2010, Gray said.

The MDD revisions also opened theway for the use of electronic labeling—providing instructions to customers bya CD, DVD, or the Internet rather thanpaper copies. Like the current MDD, therevisions don’t allow electronic labeling.But the European Commission hasincluded in its 2009 work programmeetings with stakeholders to addressthe issue, which may lead to a processfor manufacturers to supply informa-tion by non-paper means. “It does giveus hope that we could see guidance totell us that we can use something otherthan paper,” Gray said.

But there may be certain restrictionsfor using alternative means. Gray cited

conditions from a European guidancedocument approved in January 2007 forin vitro diagnostic products. Some con-ditions specify that when makingInstructions for Use (IFU) downloadablefrom a website, the manufacturer mustprovide clear direction to a dedicatedarea of the site and ensure the down-loadable IFU is identical to the paperIFU, Gray said.

For more information on the MDDrevisions, visit the European Commis-sion’s website at http://ec.europa.eu.

Expert Details 2010 Changes to European Device Regulations

International Conference on Medical Device Standards and Regulation

Roger Gray speaks during a session at theAAMI/FDA International Standards Conference.

AAMI members are invited toattend the association’s annual

business meeting on Saturday, June 6,during AAMI’s 2009 AnnualConference & Expo. The meeting willinclude a report on 2008 and 2009activities, and plans for the future.

The annual business meeting will beheld from 4:30 p.m. to 5 p.m. at theSheraton Inner Harbor Hotel inBaltimore, MD, the site of this year’sannual conference.

During the meeting, AAMI memberscan review past, present, and futurepolicies and programs, and pose ques-tions to the AAMI leadership and staff.

AAMI members will also vote toelect two new Nominating Committeemembers and re-elect two members ofAAMI’s Board of Directors. David W.Braeutigam, CBET, and LarryFennigkoh, PhD, have been chosen toserve on AAMI’s NominatingCommittee, which is responsible forrecommending individuals to serve onthe Board of Directors. Charles PhilipCogdill, vice chair, industry, and DavidG. Osborn, director, have been re-nomi-nated to AAMI’s Board of Directors.Both were elected to the board in 2006.

Braeutigam is director of biomedicalengineering at Baylor Health CareSystem in Dallas, TX, and Fennigkoh isa professor of biomedical engineeringat Milwaukee School of Engineering inMilwaukee, WI. Osborn is manager ofinternational standardization at PhilipsHealthcare, and Cogdill is director ofcorporate sterilization and microbiolo-gy for Boston Scientific.

Members who do not plan to attendthis meeting should complete andreturn the proxy card enclosed in thisissue of AAMI News. The proxy cardcan also be completed online atwww.aami.org/private/ProxyCard/proxyform.htm. Under associationbylaws, a minimum number of AAMImembers must either be present at themeeting or submit a proxy card toensure a quorum and to conduct neces-sary association business.

The agenda for the meeting is as follows:I. Call to Order—Chuck

Sidebottom, PE, Chair, AAMI Board of Directors

II. Approval of Minutes of the 2008 Annual Business Meeting—Sidebottom

III. Report from the Chair of theBoard—Sidebottom

IV. Report on AAMI Strategic andBusiness Plans and Goals—Michael J. Miller, JD, AAMI President

V. Report of the Treasurer andFinance Committee—Michael H.Scholla, PhD, AAMI Treasurer

VI. Nominating Committee Report—Sidebottom

VII. Election of Officers andDirectors—Sidebottom

VIII. Old and New BusinessIX. Expression of Appreciation

to OfficersX. Adjournment

AAMI News www.aami.org April 2009/13

AAMI’s Annual Business Meeting to Feature Nominee Elections

The Baltimore Convention Center is the site of thisyear’s AAMI Annual Conference & Expo.

These distinguished speakers will share their insights at AAMI 2009!

Ben Carson, MD, will share the philosophies that have enabled him to rise from a life of poverty in America’sinner cities to become a world-renowned pediatric neurosurgeon (as portrayed in the TV movie, “GiftedHands: The Ben Carson Story”). He will discuss how the keys to a life of satisfaction, accomplishment, andpeace lie in one’s ability to discover his or her potential for excellence. (Sponsored by GE Healthcare)

W. Randolph Chitwood, Jr., MD, will explore the fascinating evolution of robotics being used in surgerytoday. He will outline the tremendous advancements in the technology, as well as the patient outcomes thathave been achieved with surgical robots. He also will provide his unique perspective on what the futureholds for this technology. (Sponsored by PSICOR)

Marc Ringel, MD, will discuss the intelligent use of information technology, focusing on which tasks are bestaccomplished by technology and which tasks are best accomplished by humans. He will describe howclinical information systems can enhance the patient-provider relationship by freeing clinicians to do whatthey, as humans, do best — understand social contexts, values, and ethics.

For details about these and other AAMI 2009 events, visit www.aami.org/ac

www.aami.org/ac

Featured SpeakersFeatured Speakers

The Big PictureRichard Swim will celebrate his 30th

anniversary with Baylor in July. He isour clinical engineering coordinator,managing our clinical engineers andproviding many other services.

During his time working for Baylor,Richard has seen many changes withinBaylor and in healthcare in general.Not only has Richard survived thosechanges, he has thrived. He has all ofthe attributes you would want fromsomeone who works in biomedicalengineering.

The biggest example of how Richardhas adapted is with computers and net-working. Richard understood early onthat computer technology was going tobe a big part of medical equipment,and that understanding this technology

was going to berequired foreffective medicalequipment sup-port. Richard notonly learnedabout personalcomputers andhow to supportthem, he alsolearned aboutnetworking. He was self-educated to alarge extent, but supplemented thatwith formal training. He is the mostknowledgeable in our department withrespect to computers and networking.

Richard realizes that he may notalways have enough information tounderstand the big picture, but heknows that there is a big picture and

that computer technology is part of it. I am truly honored to be able to workwith Richard.

Kenneth E. MaddockCorporate Director, Biomedical

Technology ServicesBaylor Health Care System, Texas

A Strong CommitmentWe were about

to open a newsurgery center,and some peoplefrom our depart-ment offered tohelp. SeniorTechnicianRossiny Jacqueswas one of them.We had less thanfour days to prepare four operatingrooms for surgeries, as well as a 16-bedpost anesthesia care unit/pre-operationarea equipped with a patient monitor-ing network.

Without Rossiny’s hard work anddedication, this might not have beenpossible. He showed up early in themorning and left late at night. Everyday he built new anesthesia machines,electrosurgical units, patient monitors,and a multitude of devices. Not onlydid he work hard to put them together,but he worked harder to test them prop-erly. His reason for the extensive testingwas, “What if these devices have to beused on my daughter or son?”

The center opened in February, andever since it has housed multiple sur-geries. There hasn’t been one issue withthe equipment we set up, and a big rea-son for that is Rossiny’s excellent work.

Ilir KullolliClinical Engineer

Brigham and Women’s Hospital, Boston

Being a MentorHorace Hunter has been the assistant

director of engineering at our hospitalfor roughly 30 years. He started ourprogram here, and actually has theresponsibility for four other hospitals inaddition to the doctors’ offices, clinics,seven dialysis facilities, and four nurs-ing homes we maintain.

He and a few others actually started

Paying Tribute to the Behind-the-Scenes Stars of Technology Management

14/April 2009 www.aami.org AAMI News

National Biomedical/Clinical Engineering Appreciation Week . . .

Richard Swim

Rossiny Jacques

Most patients who walk into a hospital will never meet or even know about abiomedical equipment technician or clinical engineer. Yet, the biomeds who

help purchase, service, and repair medical technology play a vital role in helpingto improve patient safety and controlling healthcare costs.

Next month, AAMI’s Technology Management Council (TMC), hospitals, bio-medical associations, and schools around the country will honor these healthcaretechnology professionals during the 3rd annual National Biomedical/ClinicalEngineering Appreciation Week from May 10–16.

In celebration, AAMI has collected a sample of tributes to individual biomedswho make a difference through their numerous contributions. These stories, sub-mitted by colleagues and supervisors, illustrate the unique contributions that thesemanagers of medical technology make every day.

the GeorgiaBiomedicalInstrumentationSociety. He con-tinues to mentorthe employeesand holds educa-tional work-shops, includingone for middleschool kids toprepare them for the biomed field.

Horace also helped SouthwestGeorgia Technical College start its elec-tronics program, and helped recruitand keep individuals interested in thefield of biomed. He is an individualwho deserves to be recognized in everypossible way.

Christa ShiverClinical Engineer TechnicianJohn D. Archbold Memorial

Hospital, Georgia

Forging PartnershipsJohn Loua, CBET, a senior clinical

engineering technician at The MountSinai Medical Center, New York, effec-tively managed a patient monitoring

hardwareupgrade of eightbedside monitorsand one centralstation in thepediatric inten-sive care unit(PICU).

The PICU hadpatient monitor-ing technologythat was intended for replacementtoward the end of the year. However, atthe beginning of this year, the centralstation needed to be upgraded and thedepartment looked to clinical engineer-ing to suggest an interim solution. Johnresurrected a patient information centerthat the clinical engineering departmentkept from past de-installations.

John worked with the medical com-pany’s technical support to configurethe new central station and ensured itwas compatible with the eight bedsidemonitors.

Izabella GierasARAMARK Healthcare

Director, Clinical Engineering DepartmentMount Sinai Medical Center, New York

AAMI News www.aami.org April 2009/15

How to Celebrate Your Week

National Biomedical/ClinicalEngineering Appreciation Week

is on the horizon, and there aremany ways to celebrate.

AAMI’s Technology ManagementCouncil (TMC) has launched a newweb section—www.aami.org/tmc-connect/promoting.html—featuringhelpful tools for biomeds to cele-brate the week, which runs fromMay 10-16.

The tools include a sample letterthat biomeds can send to state or local elected officialsasking them to formallyrecognize the week.

The web pageincludes a poster thatbiomeds can print ordistribute at their facil-ities. AAMI memberscan request large-sizeposters by e-mailingPatrick Bernat, AAMI director ofhealthcare technology management,at pbernat@aami.org.

Horace Hunter John Loua, CBET

Anew AAMI Technical InformationReport (TIR) provides a bridge

between the second and third editionsof IEC 60601-1.

ANSI/AAMI/IEC TIR62296,Considerations ofunaddressed safetyaspects in the secondedition of IEC 60601-1and proposals for new requirements,includes clarifica-tions on clauses and

requirements within ANSI/AAMIES60601-1, Medical electrical equipment—Part 1: General requirements for basic safety and essential performance, which isthe U.S. adopted version (with nationaldeviations) of IEC 60601-1, 3ed.

“The standard 60601-1 is written toapply across the board to all medicalelectrical equipment. You have a situa-tion where what makes sense in gener-al may not make that much sense whenyou look at a specific piece of equip-ment,” says Mike Schmidt, a medicaldevice safety and standards consultantwho is co-chair of AAMI’s ElectricalSafety Committee, which adopted the

report in the United States. Originallythe report was developed by IECSubcommittee 62A, Working Group 14.

Experts from test houses or “testinglaboratories” that offer certificationservices to the medical industry aremembers of Working Group 14.“Obviously, they are familiar withways of interpreting how a givenrequirement in 60601-1 needs to beapplied,” Schmidt says.

“The TIR explains how to applythose requirements where there is flexibility within certain clauses andrequirements,” Schmidt says. “Where astraight read of the requirement wouldsuggest a more or less stringent inter-pretation, the technical report givesinsight into how you might apply therequirement for a specific device or for a specific application. Essentially,the 60601 series allows you to take adifferent approach with any require-ment as long as you provide an equiva-lent level of safety to that you wouldachieve by straightforward compliancewith the requirement.”

“Some of the recommendationsraised within the TIR are device-specific, but in many cases it talks

about certain types of configurations of equipment,” Schmidt says. “If theequipment has no connection to themain power source because it is battery powered, does the requirementapply and, if so, how?” he says as anexample.

16/April 2009 www.aami.org AAMI News

Report Clarifies Requirements in Electrical Equipment Standard

ANSI/AAMI/IEC TIR62296,Considerations of unaddressedsafety aspects in the second editionof IEC 60601-1 and proposals fornew requirementsLIST PRICE: $95AAMI MEMBER PRICE: $50ORDER CODE: TIR62296 or TIR62296-PDF

ANSI/AAMI ES60601-1, Medicalelectrical equipment—Part 1:General requirements for basicsafety and essential performanceLIST PRICE: $150AAMI MEMBER PRICE: $75ORDER CODE: 6060101, 6060101-PDF,

6060101-CD or 6060101-PE

To order copies, call (877) 249-8226, use the order form on page 23, or visit theMarketplace at http://marketplace.aami.org

SOURCE CODE: PB

Document Control andRecords Management

This 3 day program provides participants with theskills and tools needed for quality improvement andbusiness acuity within their organization. Attendeeswill learn how to use documentation as a tool to facilitate compliance with the Quality System reg-ulation and the ANSI/AAMI/ISO 13485:2003 standard,implement a quality management system using clas-sic systems architecture to establish appropriate linksbetween core processes, and make decisions and usedocumentation and objective evidence for imple-menting change.

This program is designed for professionals that haveresponsibility for making decisions related to the use of documents and records in the areas of changecontrol, quality assurance, design, manufacturing,purchasing, regulatory affairs, FDA inspections, andISO audits. AAMI recommends this course for thosewho have medical device experience and a workingknowledge of the Quality System regulation and theANSI/AAMI/ISO 13485:2003 standard.

For more information, visit www.aami.org orcall (800) 373-3174. Call Virginia Schoenauer at (703) 525-4890, ext. 247 about bringing this coursein-house.

2009 COURSES■ April 29–May 1

San Francisco, CA■ November 16–18

Philadelphia, PA

FEESAAMI Corporateand InstitutionalMembers.........$1685

Individual Members.........$1785

Nonmembers...$2085

GovernmentEmployees.........$585

Document Control andRecords Management

for Medical DevicesNEW COURSE!

AAMI News www.aami.org April 2009/17

C A R E E R C E N T E R

increase our treasury with membershipdues and add credibility to the societyby their experience,” he notes.

Also, during the roundtable,Francoeur hopes that society leaderswill share their ideas on how AAMIand the TMC can continue to strength-en membership benefits and outreachefforts to local biomed associations.

If you have questions or are interest-ed in attending the roundtable, contactPatrick Bernat at pbernat@aami.org.

State and local biomedical associa-tions will have an opportunity this

summer to get together to share ideasand best practices.

AAMI’s Technology ManagementCouncil (TMC) will host the 2nd annu-al Biomed Society Roundtable onSunday, June 7, during AAMI’s AnnualConference & Expo in Baltimore.

“It’s a greatopportunity forindividuals rep-resenting bio-medical societiesto have a nation-al forum to shareideas, concepts,and relationshipsregarding infor-mation that willbe enriching andthought-provoking,” says DaveFrancoeur, the TMC’s vice chair.“Society leaders can learn what othersfrom around the country are doing andshare what’s working for them. By put-ting faces to names, they can also learnwho to reach out to for guidance whensituations arise that others may havealready worked through.”

During the roundtable, society leaders are expected to discuss howsocieties can form certification studygroups, modeled after the successfulexperiences of the ColoradoAssociation of Biomedical EquipmentTechnicians (CABMET).The Coloradosociety is credited with helping toincrease pass rates of the exam.

Society leaders are also expected toshare ideas on how to attract speakersand attendees to meetings, and discusswhat topics are most interesting anduseful to members. “Certified biomed-ical equipment technician (CBET) train-ing is the number one requested topicat California Medical InstrumentationAssociation (CMIA) meetings,” saysJames Knight, a board member ofCMIA’s Central Valley Chapter.

Finding ways to increase societymembership and meeting attendance iscritically important, adds AnthonyCampos, vice president of CMIA’sCentral Valley Chapter. “The more biomed techs who become members

State Biomed Society Leaders to Share Ideas, Network

Dave Francoeur

Are You an Early Bird?You can save $55 by registeringfor AAMI’s Annual Conference by Friday, April 24. To register orlearn more about the conference,visit www.aami.org/ac.

substantially andfundamentallydifferent world. Integration ismore than get-ting data fromdevices intomedical records.It’s about decision supportand control.

No one canargue that the information we are being provided by manufacturers forcomplex systems today is sufficient tofully characterize its operation. And in fairness to manufacturers, in manycases they cannot provide similar information because today’s systemsare too complex. But that doesn’tremove the requirements to come upwith other documentation that is aseffective.

M E M B E R N E W S

Rick Schrenker is a member of the CE-ITCommunity, a collaboration among mem-bers of AAMI, the Healthcare Informationand Management Systems Society(HIMSS), and the American College ofClinical Engineering (ACCE). The coalitionaims to create a unified voice to addressclinical engineering (CE) and informationtechnology (IT) concerns. In this issue ofAAMI News, Schrenker discusses impor-tant issues facing CE-IT convergence,including recent funding in the economicstimulus package for healthcare IT.AAMI News: You are vice-chair of theCE-IT Community’s working group onintegration. What are some challengeswith integrating systems in this multi-vendor environment? Rick Schrenker: From where I sit, whatchallenges me most are not the techni-cal and cultural issues that we areaddressing but rather the implicationsthat derive from moving toward a

AN: How do you hope the CE-ITCommunity will help address thosechallenges?

RS: The community offers a number ofopportunities. It’s a safe place for CEand IT to talk with each other. Successwill be marked by the presence of con-flict as well as cooperation. Not onlydoes the ability to argue indicate thepresence of trust, but it is in the resolu-tion of conflict that stronger relation-ships often emerge.

AN: You currently work as systemsengineering manager for MassachusettsGeneral Hospital. How did you getinvolved with systems engineering?

RS: What a long, strange trip it’s been.It’d be great to say I planned it out, butit would be more truthful to say itevolved out of chasing down interest-ing problems. Early in my career Ialways liked design and development

IN PROFILE

18/April 2009 www.aami.org AAMI News

CE-IT Community Braces for New Challenges

Rich Schrenker

nications manager for Partners Healthcare,a group of hospitals in Boston, MA.

Mohammed M.Kaleem hasjoined HealthHero NetworkInc., a RobertBosch GmbHcompany, as itsdirector of qualityand regulatoryaffairs for NorthAmerica. Thecompany offersproducts and solutions for remote healthmonitoring. Kaleem will be responsible for ensuring that the company is in com-pliance with domestic and internationalquality systems and regulations, amongother duties. He was previously managerof quality systems for Philips Healthcare’sNuclear Medicine Business Unit.

AAMI News www.aami.org April 2009/19

MEMBERS ONTHE MOVE

John Coraluzzi has joined IVTechnologies as vice president of criticalsales in the company’s new critical caredivision. The company specializes ininfusion pumps and replacement parts.Coraluzzi previously worked forMediq/Hill Rom.

Rick Hamptonhas joined theEditorial Boardof AAMI’s peer-reviewed journal,BiomedicalInstrumentation & Technology(BI&T). As amember of theEditorial Board,Hampton will help write and reviewarticles, critique the bi-monthly journal,and develop the content for future edi-tions. Hampton is the wireless commu-

engineering, hardware, and software.When the ability to do that diminishedin clinical engineering, I moved intosoftware development management forour departmental systems. Along theway, I picked up an interest in medicaldevice interoperability, but there wasno way to act on it until I had a clinicalchampion to work with. And then oneday Julian Goldman, MD, an anesthesi-ologist at Massachusetts Generalinvolved in the interoperability amongmedical devices, walked up to me andsaid, “I hear you’ve been involved inIEEE 1073, the standard for medicaldevice communications . . .”

A little bit of research took me to soft-ware engineering, which in turnreminded me how medical device com-panies working on interoperability hadstressed the importance of require-ments engineering. I realized clinicalengineering needed to learn about soft-ware engineering.

AN: How has the introduction of sys-tems affected a biomed’s duties regard-ing repair and maintenance of medicaldevices?

RS: It remains to be seen. A very realquestion is the fact that the creation ofa system results in properties of thesystem that are not present in its con-stituent components (if that were notso, then why create a system in the firstplace?). So do devices need to beinspected as well as a system? Can sys-tem inspection remove the need forindividual device inspection?

We are entering a different worldwhere what was done in the past maynot be appropriate for the future.

AN: The recent economic stimulus pack-age included roughly $19 billion inspending for healthcare IT. Will thishave an impact on the CE-IT integra-tion and, if so, how?

RS: Given the Obama administration’sintent on realizing the electronic medical record system, I have tobelieve that stimulus money will flowto this work. Hopefully it will initiallydo so in the form of funding proof-of-concept and other prototype efforts.

Rick Hampton

Mohammed M. Kaleem

NEW MEMBERSNew Member Organizations

ALBERTA HEALTH SERVICES10409 98th StreetGrande Prairie, AB T8V 2E8, CanadaPHONE: (780) 830-4830CONTACT: Craig SchultzE-MAIL: craig.schult@albertahealthservices.ca

ANNA JACQUES HOSPITAL25 Highland AvenueNewburyport, MA 01950-3894PHONE: (978) 463-1263CONTACT: John De CostaE-MAIL: jdecosta@ajh.org

ATLANTICARE REGIONAL MEDICAL CENTER1925 Pacific AvenueAtlantic City, NJ 08401-6713PHONE: (609) 345-4000 X2705CONTACT: Raymond P. Smitelli, ARMCE-MAIL: rsmitelli@atlanticare.org

BIOSTABLE SCIENCE & ENGINEERING INC.401 Congress Avenue, Suite 2950Austin, TX 78701PHONE: (512) 981-9901CONTACT: Al BeavanE-MAIL: al.beavan@biostable-s-e.com

BUSINESS PROCESS & TECHNOLOGY MGMT., LLC421 N. McAree RoadWaukegan, IL 6085PHONE: (847) 249-1983CONTACT: John M. DeFoggiE-MAIL: john_defoggi@bptm.com

CHEYENNE MEDICAL CENTER3235 Sparks RoadCheyenne, WY 82001-6152PHONE: (307) 633-8121CONTACT: Jason Kinchelow

CLINICAL DYNAMICS CORPORATION10 Capital DriveWallingford, CT 06492-2318PHONE: (203) 269-0090CONTACT: Joseph R. RebotE-MAIL: jrr@clinicaldynamics.com

ELITE BIOMEDICAL INC.1415 Oakland Blvd., Suite 104Walnut Creek, CA 94596PHONE: (925) 210-1814CONTACT: Rachel GeernaertE-MAIL: rachel@elitebiomedical.com

For a complete list of new members, seewww.aami.org/publications/AAMINews/members.html.

NationalStandardsNew PublicationsSee order form on page 23 to orderprint copies, or go to the Marketplaceat www.aami.org to order electronic(pdf) version for immediate download.

ANSI/AAMI/IEC TIR62296,Considerations of unaddressed safe-ty aspects in the second edition ofIEC 60601-1, 1ed. (TIR62296 orTIR62296-PDF; $50/$95)

ReaffirmationsANSI/AAMI/ISO 10993-04:2002/(R)2009, Biological evaluation ofmedical devices, Part 4: Selection oftests for interactions with blood,2ed. Reaffirmed 10 March 2009 as anAmerican National Standard.(1099304 or 1099304-PDF; $45/$90)Identical to ISO 10993-04:2002.

ANSI/AAMI/ISO 10993-16:1997/(R)2009, Biological evaluation ofmedical devices—Part 16: Toxico-kinetic study design for degradationproducts and leachables from medical devices, 1ed. Reaffirmed 5 March 2009 as an AmericanNational Standard. (1099316 or1099316-PDF; $35/$70) Identical toISO 10993-16:1997.

Call for CommentsProposed standards and recommend-

ed practices available for publicreview and comment are listed here,in Standards Monitor Online, and onthe AAMI website at www.aami.org.Drafts can be obtained from AAMI.See order form on page 23 to orderprint copies, or go to the Marketplaceat www.aami.org to order electronic(pdf) version for immediate download.

Comments must be received by thedeadline in order to ensure their con-sideration. A form for submittingcomments is available (in PDF andWORD) at www.aami.org/standards/about.forms.html. Proposed draftsmay remain publicly available after thecomment period closes, but latecomments generally are deferred tothe next review/revision cycle, usually4 to 5 years from approval of the cur-rently proposed draft. Proposals thatare substantially revised as a result ofpublic comment are made availablefor additional public review. Note thatthe final text of a document may differfrom the proposed version.

Comments due by 8 May 2009AAMI/CDV-1 8637 (ISO/DIS 8637),Cardiovascular implants and artifi-cial organs—Haemodialysers,haemodiafilters, haemofilters andhaemoconcentrators, 3ed. (proposedAAMI/American National Standard).This lnternational Standard specifiesrequirements for haemodialysers,haemodiafilters, haemofilters andhaemoconcentrators, hereinafter col-lectively referred to as “the device,”for use in humans. (8637-D, $20/$25;8637-D-PDF, $0/$25)

AAMI/CDV-1 8638 (ISO/DIS 8638),Cardiovascular implants and artifi-cial organs—Extracorporeal bloodcircuit for haemodialysers, haemo-diafilters and haemofilters, 3ed. (proposed AAMI/American NationalStandard). Specifies requirements forthe single-use extracorporeal bloodcircuit (hereafter referred to as “thedevice”) and (integral and non-inte-gral) transducer protectors which areintended for use in haemodialysis,haemodiafiltration and haemofiltration.(8638-D, $20/$25; 8638-D-PDF,$0/$25)

Comments due by 11 May 2009AAMI/CDV-1 60601-2-25 (IEC62D/758/CDV), Medical electricalequipment—Part 2-25: Particularrequirements for the basic safety

and essential performance of elec-trocardiographs, 3ed. (proposedAAMI/American National Standard).Specifies particular basic safety andessential performance requirementsfor electrocardiographs, recording andanalyzing single channel and multi-channel electrocardiographs intendedfor the production of detachable elec-trocardiograms for diagnostic purpos-es. This particular standard alsoapplies to vector cardiographs andmedical electrical equipment for exer-cise testing. Special requirementsconcerning use in ambulances,phono-cardiographs, cardiographicmonitors, polygraphs, telemetering,special tests (for example, His bundleelectrocardiographs, electrocardio-graphs for late potential detection),Holter electrocardiographs, invasiveelectrocardiography etc. are not cov-ered by this particular standard.Medical electrical equipment withmicroelectrodes used directly in thefibres of the heart muscle is alsoexcluded. (601225-D, $20/$25;601225-D-PDF, $0/$25)

New WorkProposalsTo obtain more information, commenton proposed new work, or obtain acommittee membership applicationform, contact the indicated staff per-son by e-mail or phone (ext. 250). Anonline committee membership appli-cation form as well as downloadableversions of the form are availablefrom the Standards section of theAAMI website (www.aami.org).

Approved/Work in ProgressAAMI/ISO 10993-12/Ed.4, Biologicalevaluation of medical devices—Part12: Sample preparation and refer-ence materials, 4ed. Contact:hwoehrle@aami.org

AAMI/ISO 13485:2003/C1/Ed.1,ANSI/AAMI/ISO 13485:2003,Corrigendum 1, 1ed. (beingprocessed as an amendment).Contact: hwoehrle@aami.org

Recently initiated periodicreviewsAAMI EC53/Ed.2, Periodic review ofANSI/AAMI EC53:1995 and A1:1998,ECG cables and leadwires (asamended in 1998)—Decision:Revise document, 2ed. Contact:hchoe@aami.org

AAMI ID26-Reaff/Ed.3, Periodicreview of ANSI/AAMI ID26:2004,Medical electrical equipment, Part 2:Particular requirements for the safe-ty of infusion pumps and controllers,3ed. Contact: jmoyer@aami.org

InternationalStandardsNew PublicationsThe following international standardscan be obtained in the U.S. fromANSI, 25 West 43rd Street, New York,NY 10036 (www.ansi.org). If a PDForder code is provided, electroniccopy also can be purchased from theMarketplace at www.aami.org.

IEC 60601-2-19:2009, Medical electrical equipment—Part 2-19:Particular requirements for basicsafety and essential performance ofbaby incubators, 2ed. InternationalStandard.

IEC 60601-2-2:2009, Medical electrical equipment—Part 2-2:Particular requirements for basicsafety and essential performance ofhigh frequency surgical equipmentand high frequency surgical acces-sories, 5ed. International Standard.

IEC 60601-2-20:2009, Medical electrical equipment—Part 2-20:Particular requirements for basicsafety and essential performance oftransport incubators, 2ed.International Standard.

IEC 60601-2-21:2009, Medical electrical equipment—Part 2-21:Particular requirements for basicsafety and essential performance ofinfant radiant warmers, 2ed.International Standard.

IEC 80601-2-30:2009, Medical electrical equipment—Part 2-30:Particular requirements for basicsafety and essential performance ofautomated type non-invasive sphyg-momanometers, 1ed. InternationalStandard.

ErrataISO 11137-2:2006 (Corrected copy),Sterilization of health care prod-ucts—Radiation—Part 2:Establishing the sterilization dose,

IMPORTANT NOTICE: UnderAAMI’s procedures, public reviewperiods may be set based on whenitems first appear in StandardsMonitor Online or AAMI News,whichever comes first, and lengthcan vary from 30 to 60 daysdepending on various factors. To maximize your review time, we strongly encourage you to subscribe to Standards MonitorOnline (free service), which isissued approximately every other week. To subscribe, go towww.aami.org/standards/smo.html and follow the links to the subscriber sign-up area.

20/April 2009 www.aami.org AAMI News

STANDARDS MONITOR

AAMI News www.aami.org April 2009/21

1ed. International Standard. TechnicalCorrigendum ISO 11137-2:2006/Cor1:2009 issued 2009-2-10.

ISO/TS 11135-2:2008, Sterilizationof health care products—Ethyleneoxide—Part 2: Guidance on theapplication of ISO 11135-1, 2ed.International Technical Specification.(1113502; $50/$95). TechnicalCorrigendum ISO/TS 11135-2:2008/Cor 1:2009 issued 2009-2-9.(Note: Correction already made to theAAMI adopted version.).

AAMI Call forCommentsThe following international drafts canbe obtained from AAMI. See orderform on page 23 to order printcopies, or go to the Marketplace atwww.aami.org to order electronic(pdf) version for immediate download.

Parallel Adoptions (see National Standards Callfor Comments for details)● IEC/CDV-1 60601-2-25 (IEC

62D/758/CDV)● ISO/DIS-1 8637● ISO/DIS-1 8638

Comments due by 8 May 2009ISO/DIS-1 13960 (ISO/DIS 13960),Cardiovascular implants and artifi-cial organs—Plasmafilters, 2ed.(proposed International Standard).Specifies requirements for sterile, sin-gle use plasmafilters, intended for useon humans. (13960-D, $20/$25;13960-D-PDF, $0/$25)

Comments due by 11 May 2009IEC/CDV-1 60601-2-23 (IEC62D/759/CDV), Medical electricalequipment—Part 2-23: Particularrequirements for basic safety andessential performance of transcuta-neous partial pressure monitoringequipment, 3ed. (proposedInternational Standard). This particularstandard specifies the particular basicsafety requirements and essential per-formance, for transcutaneous partialpressure monitoring equipment,whether this ME equipment is standalone or part of a system. It applies totranscutaneous monitors used withadults, children and neonates, and itincludes the use of these devices infoetal monitoring during birth. It does

not apply to haemoglobin saturationoximeters or to devices applied to sur-faces of the body other than the skin(for example conjunctiva, mucosa).(601223-D, $20/$25; 601223-D-PDF,$0/$25)

IEC/CDV-1 60601-2-34 (IEC62D/760/CDV), Medical electricalequipment—Part 2-34: Particularrequirements for the basic safetyand essential performance of inva-sive blood pressure monitoringequipment, 3ed. (proposedInternational Standard). Applies toinvasive blood pressure monitoringequipment. This particular standarddoes not apply to catheter tubing,catheter needles, Luer locks, taps andtap tables. This particular standardalso does not apply to non-invasiveblood pressure monitoring equipment.(601234-D; $20/$25)

IEC/CDV-1 60601-2-49 (IEC62D/761/CDV), Medical electricalequipment—Part 2-49: Particularrequirements for the basic safetyand essential performance of multi-function patient monitoring equip-ment, 2ed. (proposed InternationalStandard). Applies to the safetyrequirements of multifunction patientmonitoring equipment. This standarddoes not specify requirements forindividual monitoring functions.(601249-D, $20/$25; 601249-D-PDF,$0/$25)

New WorkProposalsTo obtain more information, comment on proposed new work, or obtain a committee membershipapplication form, contact the indicat-ed staff person by e-mail or phone(ext. 250). An online committeemembership application form as well as downloadable versions of theform are available from the Standardssection of the AAMI website(www.aami.org).

Approved/Work in ProgressISO 10993-12/Ed.4, Biological evalu-ation of medical devices—Part 12:Sample preparation and referencematerials, 4ed. Contact:hwoehrle@aami.org

ISO 13485:2003/C1/Ed.1, ISO13485:2003, Corrigendum 1, 1ed.(Being processed as an amendment.)Contact: hwoehrle@aami.org

UpcomingMeetingsAAMI Committeesand U.S. TAGsOpen meetings of AAMI committeesand U.S. Technical Advisory Groups(TAGs) are listed here and at the AAMIwebsite (www.aami.org). Agendas foropen meetings are usually availablefrom AAMI Committee Central. (Go towww.aami.org/committeecentral,find the committee or working groupusing “Browse Committees,” andselect the link to the committee’s“Working Documents.”) Note: If youplan to attend a meeting, please senda brief note to the AAMI StandardsDepartment (standards@aami.org)indicating the name and date of themeeting so that staff can contact you in the event of a cancellation.

AAMI/BG, Blood/Gas ExchangeDevice Committee (Open Meeting).07-May-09, 08:00 to 17:00 h. LargeConference Room, AAMI, 1110 N.Glebe Road, Suite 220, Arlington, VA22201-4795, USA. Directions toAAMI, important information aboutbuilding security, and a list of nearbyhotels are available at www.aami.org/about/directions.html. DevelopWorking Draft of ISO 11658 on coat-ings for blood contact equipment.Contact: cbernier@aami.org

AAMI/HE, Human FactorsEngineering Committee (OpenMeeting). 22 to 24-Jun-09, 10:00 to14:00 h. Chicago, IL, USA. Contact:jmoyer@aami.org

AAMI/PC, Cardiac RhythmManagement Device Committee(Open Meeting). 12-May-09, 13:00 to18:00 h. Boston Marriott CopleyPlace, 110 Huntington Avenue,Boston, MA 02116, USA. Contact:jmoyer@aami.org

AAMI/RD, Renal Disease andDetoxification Committee (OpenMeeting). 25-Apr-09, 08:00 to 18:00h (ANNA meeting). Indigo 204 Room,Hilton San Diego Bayfront, 1 ParkBoulevard, San Diego, CA 92101,USA. Status of RD52 and RD62amendments; status NWIP on testingmethodologies for water and NWIP on

ultrapure dialysate; develop US posi-tions on ISO 8637, ISO 8638, and ISO13960 DISs; results of RD52 format-ting revision ballot. Contact:cbernier@aami.org

AAMI/ST, Sterilization StandardsCommittee (U.S. TAG for ISO/TC198) and affiliated working groupsand sub-TAGs (Open Group Meeting).08 to 10-Jun-09 (AAMI AnnualConference and Exposition). BaltimoreMarriott Inner Harbor, Baltimore, MD,USA. Contact: jlewelling@aami.org

AAMI/ST, Sterilization StandardsCommittee (U.S. TAG for ISO/TC198) and affiliated working groupsand sub-TAGs (Open Group Meeting).16 to 18-Nov-09. Arlington, VA, USA.Contact: jlewelling@aami.org

Joint meeting of the U.S. TAGs forIEC/TC 62, IEC/SC 62A, and IEC/SC62D (Open Meeting). 5-May-09,10:00 to 15:00 h. AdvaMed, 701Pennsylvania Avenue, NW, Suite 800,Washington, DC, USA Contact:hwoehrle@aami.org

InternationalCommittees andWorking GroupsCall or write the indicated staff person at AAMI (Attention: StandardsDepartment) for more informationabout upcoming international stan-dards meetings.

IEC/SC 62D/JWG 06, Joint ISO/TC121/SC 1-IEC/SC 62D WG:Respiratory gas monitors (ISO/TC121/SC 1/JWG 06) (Closed Meeting).06 to 08-May-09. Cambridge, MA,USA. Contact: hchoe@aami.org

IEC/SC 62D/MT 17, High frequencysurgical equipment (Closed Meeting).21 to 22-Apr-09. Vancouver, Canada.Discuss revision of IEC 61289-1 and -2. Contact: sbalboni@aami.org

IEC/SC 62D/MT 20, Hemodialysisequipment (Closed Meeting). 26 to28-May-09. Milano, Italy. Contact:cbernier@aami.org

IEC/TC 62, Electrical equipment inmedical practice, affiliated subcom-mittees and working groups (ClosedGroup Meeting). 08 to 19-Jun-09.Brussels, Belgium. Contact:hchoe@aami.org● IEC/TC 62, Electrical Equipment

in Medical Practice (ClosedMeeting). 18-Jun-09. Contact:

22/April 2009 www.aami.org AAMI News

S TA N D A R D S M O N I TO Rhchoe@aami.org

● IEC/TC 62 CAG, Chairman’sAdvisory Group (Closed Meeting).17 to 18-Jun-09.

● IEC/SC 62A, Common Aspects ofElectrical Equipment Used inMedical Practice (ClosedMeeting). 16-Jun-09. Contact:hwoehrle@aami.org● IEC/SC 62A CAG, Chairman’s

Advisory Group (ClosedMeeting). 15-Jun-09. Meeintgon second day starts at 9 am.

● IEC/SC 62A/JWG 07, JointIEC/SC 62A-ISO/TC 215 WG:Application of risk manage-ment to information technology(IT) networks incorporatingmedical devices (ClosedMeeting). 10 to 12-Jun-09.

● IEC/SC 62A/MT 29, Mechanicalhazards (Closed Meeting). 12 to15-Jun-09. MT will decide firstday on exact start/end time forsecond day.

● IEC/SC 62B, Diagnostic imagingequipment (Closed Meeting). 17-Jun-09. Contact: hchoe@aami.org

● IEC/SC 62C, Equipment for radiotherapy, nuclear medicineand radiation dosimetry (ClosedMeeting). 16-Jun-09. Contact:hchoe@aami.org

● IEC/SC 62D, ElectromedicalEquipment (Closed Meeting). 17-

Jun-09. Contact: hchoe@aami.org● IEC/SC 62D CAG, Chairman’s

Advisory Group (ClosedMeeting). 15-Jun-09.

● IEC/SC 62D/MT 18, Therapyequipment (Closed Meeting). 11 to 15-Jun-09. MT will decidefirst day on exact start/end timefor second day.

● IEC/SC 62D/MT 22,Electromedical diagnostic and patient monitoring equip-ment. NOTICE—MEETING CANCELLED (originally sched-uled for 08 to 11-Jun-09).

● CENELEC/TC 62, Electrical equip-ment in medical practice (ClosedMeeting). 19-Jun-09. Contact:hchoe@aami.org

ISO/TC 121 and IEC/SC 62D JointWorking Groups Meeting (ClosedGroup Meeting). 11 to 19-Jun-09.Orebro, Sweden. Contact:hchoe@aami.org● IEC/SC 62A/JWG 06, Joint IEC/SC

62A-ISO/TC 121/SC 3 WG:Medical electrical equipment andsystems for use in home careapplications (ISO/TC 121/SC3/JWG 06) (Closed Meeting). 15 to19-Jun-09 (Tentative date & time).Contact: hwoehrle@aami.org

● IEC/SC 62D/JWG 01, Joint ISO/TC121/SC 3-IEC/SC 62D WG: Critical

care ventilators (ISO/TC 121/SC3/JWG 01) (Closed Meeting). 15 to19-Jun-09 (Tentative date & time).Contact: hchoe@aami.org

● IEC/SC 62D/JWG 02, Joint ISO/TC 121/SC 1-IEC/SC 62D WG:Anaesthesia workstations (ISO/TC 121/SC 1/JWG 01)(Closed Meeting). 11-Jun-09(Tentative date & time). Contact: hchoe@aami.org

● IEC/SC 62D/JWG 05, Joint ISO/TC121/SC 3-IEC/SC 62D WG: Pulseoximeters (ISO/TC 121/SC 3/JWG10) (Closed Meeting). 15 to 19-Jun-09 (Tentative date & time).Contact: hchoe@aami.org

● IEC/SC 62D/JWG 07, Joint IEC/SC62D-ISO/TC 121/SC 3 WG: Non-invasive blood pressure monitor-ing equipment (ISO/TC 121/SC3/JWG 07) (Closed Meeting). 15 to19-Jun-09 (Tentative date & time).Contact: hchoe@aami.org

● IEC/SC 62D/JWG 08, Joint ISO/TC121/SC 3-IEC/SC 62D WG:Clinical thermometers (ISO/TC121/SC 3/JWG 08) (ClosedMeeting). 15 to 19-Jun-09(Tentative date & time). Contact: hchoe@aami.org

ISO/TC 150, Implants for Surgery,affiliated subcommittees and work-ing groups (Closed Group Meeting).

07 to 11-Sep-09. Kyoto, Japan.Contact: cbernier@aami.org● ISO/TC 150/SC 2, Cardiovascular

Implants and ExtracorporealSystems (Closed Meeting). 07 to11-Sep-09. Detailed schedule forSC and its WGs to be announced.Contact: cbernier@aami.org

● ISO/TC 150/SC 6, Active Implants(Closed Meeting). 07 to 11-Sep-09. Detailed schedule for SC andits WGs to be announced. Contact: jmoyer@aami.org

ISO/TC 150/SC 6/JWG 01, JointISO/TC 150/SC 6-IEC/SC 62D WG:Cardiac pacemakers andimplantable defibrillators (IEC/SC62D/JWG 03) (Closed Meeting). 11 to 12-May-09. Boston, MA, USA.Contact: jmoyer@aami.org

ISO/TC 150/SC 6/JWG 02, JointISO/TC 150/SC 6-IEC/SC 62B WG:Effects of magnetic resonance imag-ing on active implantable medicaldevices (IEC/SC 62B/JWG 01)(Closed Meeting). 27 to 29-May-09.Washington, DC, USA. Contact: jmoyer@aami.org

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Requirements and Industry Practice

Corrective andPreventive ActionCorrective andPreventive Action

2009 Course June 22–24.....Arlington, Virginia

This intensive 2.5 day course provides the knowledge and skills to improveimplementation and effectiveness of a corrective and preventive action program while meeting the CAPA requirements of FDA’s Quality Systemregulation. The program includes a workshop to develop core skills toeffectively identify non-compliances, take the proper corrective action or identify potential problems, and take the necessary preventive action.

The program is designed for quality assurance professionals, regulatory affairspersonnel, management and others responsible for CAPA implementation andregulatory compliance.

For more information, visit www.aami.org or call (800) 373-3174. Call VirginiaSchoenauer at (703) 525-4890, ext. 247 about bringing this course in-house.

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AAMI Dialysis Standards PDF (page 2) PDF DSBK08-PDF $195/$325

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AAMI’s Benchmarking Solution (page 9) Online Bench $460/$580

AAMI Standards on CD—Sterilization Edition (page 13) CD-ROM STBKCD $475/$725

AAMI Standards on CD—The Complete Collection (page 15) CD-ROM STDSCD $875/$1095

ANSI/AAMI/IEC TIR62296, Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements (page 16) Print TIR62296 $50/$95

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AAMI News www.aami.org April 2009/23

Vol. 44, No. 4 • April 2009

Association for the Advancement of Medical Instrumentation1110 N. Glebe Road, Suite 220Arlington, VA 22201-4795(703) 525-4890www.aami.org

Non-ProfitOrganizationU.S. Postage

PAIDAlexandria VAPermit No. 285

Quality System Requirements and Industry PracticeApril 20–24 St. Pete Beach, FL

Radiation Sterilization for Medical DevicesApril 28–May 1 Minneapolis, MN

Document Control and Records Management for Medical DevicesApril 29–May 1 San Francisco, CA

Integrating Risk Management into the Quality SystemJune 1–3 Minneapolis, MN

AAMI 2009 Conference & ExpoJune 6–8 Baltimore, MD

Process Validation Requirements and Industry PracticeJune 10–12 Denver, CO

UPCOMING EVENTS

News

ST79 Webinar Gives Peek at Potential 2009 Changes—see page 8.