AAS News Fall 2008

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    P R E S I D E N S M E S S A G EDr. Herb Chen

    I know that the start of the academic year brought many new activities into all of our lives. I am hapreport that the AAS committees have been quite busy carrying out several exciting initiatives.

    I would like to formally thank the faculty members and registrants who made our Fall Courses asuccess. More than 170 surgeons and trainees participated in the 4th Annual Career Development C(CDC) and the 19th Annual Fundamentals of Surgical Research Course (FSRC). We have remuch positive feedback on the courses from the attendees, and future plans may include increasinOutcomes Research training portion of the courses. I would like to congratulate the CDC Co-ChairsEric Kimchiand Peter Nelson; the FSRC Director, Dr.Anees Chagpar; and the Co-Chairs of theEducation Committee, Drs. Lillian Kao and Carla Pugh, for putting together a talented group of speTanks to all of the speakers for taking time out of their busy schedules to help the AAS accomplish itsof furthering the development of young academic surgeons.

    Abstract selection has been completed under the guidance of AAS Recorder Dr. Daniel Albo and SocUniversity Surgeons (SUS) Publications Chair Dr. George Yang. We are excited that we had another ryear for abstract submissions! Overall, 776 abstracts were submitted to the Academic Surgical Co

    (ASC) meeting, which represents an 18% increase compared to submissions for the 2007 meeting! Tisabstracts included 62 international submissionsa 300% increase. Tanks to all the AAS memberssubmitted abstracts! More details are provided in the Recorders report.

    AAS Secretary Dr. Scott LeMaire has done an extraordinary job organizing the quarterly newsletterkeeping our Association on track. In this issue, he will inform you of the growing collaboration betwee

    AAS and the Royal Australasian College of Surgeons, including its Younger Fellows Committee.

    Over the past 9 months, the AAS Councilors have been working to reorganize our election process soimprove its effi ciency while maintaining fa irness and the spirit of inclusiveness on which our organizis based. AAS Councilor Dr. Rebecca Minter will update you about the upcoming 2009 CommElection process.

    Under the leadership of Chair Dr. Nipun Merchant, the AAS Membership Committee has beenrecruiting new AAS members. Impressively, the committee has enlisted 108 international members 23 different countries. In Dr. Merchants report, he will summarize the committees efforts to inmembership from other underrepresented groups.

    Dr. ara Breslin is the new AAS representative to the Association of Women Surgeons (AWS). Shprovide details about the upcoming AWS dinner, which will be on Wednesday, February 4, 2009, thevening of the ASC meeting.

    I am proud to announce that the AAS Foundation, under the leadership of Dr. Dana Anderson, hasworking hard to establish a financial core to support our many AAS faculty and resident research scholar

    I am also happy to report that the AAS Foundation will soon fund and manage one of our ongoing resresearch scholarships.

    In addition, the AAS is holding discussions with the Association for Surgical Education, the Surgical OutClub, and several other organizations to formalize relationships with our organization by increasingrepresentation on the AAS Executive Council. We hope that these new partnerships will maximizeffectiveness of all the involved organizations.

    I look forward to seeing each of you at the 4th Annual ASC Meetingat Sanibel Harbour Resort &Fort Myers, Florida, in February 2009! Happy Holidays!

    Herb

    ASSOCIAION FOR ACADEMIC SURGERY FALL 2

    N

    D. He Chen

    I N H I S I S S U E

    Presidents Message

    1

    Update on the2009 ASC Meeting

    2

    udent Research Award Winners

    2

    Secretarys ReportOur Expanding Relationshipwith the Royal Australasian

    College of Surgeons

    3

    New Process forCommittee Elections

    4

    Information &echnology Review

    Regulation of Medical Devices

    5

    MembershipCommittee Initiatives

    7

    ssociation of Women Surgeons

    7

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    D. Dal Ao

    P RO G R A M F I N A L I Z E D F OR H E4 H A N N U A L A S C M E E I N G

    Dr. Daniel Albo, AAS Recorder and Program Committee Chair

    As we look forward to the 4th Annual ASC Meeting, we are excited about what promises to be our

    successful meeting to date. Tis year, for the first time, the AAS and SUS Program Committees

    functioned as a joint Program Committee. Te team spirit and camaraderie that have permeated a

    Program Committees activities this year are a powerful indicator of the synergism shown by our

    societies, the AAS and SUS, as we share our common goal of advancing academic surgery.

    As the Chair of the joint ASC Program Committee, I would like to thank all the committees me

    for their selfless dedication and work. Tis year, they reviewed nearly 800 abstractsa record nu

    With their invaluable help, Program Committee Co-Chair Dr. George Yang and I have put toge

    scientific program that represents a cross-section of our scientific community. o enhance dialogue a

    like-minded investigators, the program is organized in thematic units that range from the basic scien

    clinical outcomes, from education to translational research. For the first time, the abstract-submission p

    included keywords, which streamlined abstract review and allowed investigators to select the thematic

    to which they wished to be assigned. We hope that the scientific program will foster incisive discussion a

    investigators from all walks of academic life.

    In addition, a variety of other exciting sessions will be held during the ASC meeting. At the Founders Le

    the AAS keynote speaker will be one of the preeminent surgeons of our time, Dr. John Niederhuber, D

    of the National Cancer Institute. Te Association for Women Surgeons dinner session, organized by D

    Breslin, will feature Drs. Coleen Brophy, Julie Freischlag, and Rosemary Kozar, who will speak about

    Advice I Wish Id Been Given. In addition, the Committee on Issues and the Committee on Educatio

    hold dynamic sessions entitled Partnering with IndustryMoving Discoveries from the Bench to the Be

    and Surgical Education in the Internet Era, respectively. Building on last years success, the State-of-t

    Lectures will showcase cutting-edge advances in academic surgery. Tis years distinguished speake

    include Drs. Raphael Pollock, Layton Rikkers, Patricia Donahoe, and Gary Dunnington. Tis event w

    followed by the Clinical opics session on Te Glass Ceiling: Does It Still Exist for Women and Min

    in Academic Surgery? for which the speakers will be Drs. Omaida Velazquez, Selwyn Vickers, and

    Bickel. And, of course, our President, Dr. Herb Chen, will deliver the AAS presidential address: Episo

    Te Return of the Surgeon, which promises to be a truly memorable event.

    Tis year, the AAS will present several awards during the ASC meeting:

    BES MANUSCRIP BY A NEW MEMBER OF HE AAS

    Manuscripts written by a new AAS member as the first or senior author and submitt

    January 7, 2009, will be reviewed by a subcommittee of the AAS Program Committee, whic

    select the best paper. Te winner will be announced at the business meeting. He or she will r

    $500, a certificate, and a lis ting in next years program. Resident research-award papers are exc

    from this competition.

    BES MANUSCRIP OVERALL

    Manuscripts submitted by January 7, 2009, will be reviewed by another subcommittee of the AAS Pr

    Committee, which will select the best paper. Te winner will be announced at the business meetin

    or she will receive $500, a certificate, and a listing in next years program. Resident research-award

    and the winning manuscript written by a new member are excluded from this competition.

    BES ORAL PRESENAION BY A NEW MEMBER OF HE AAS

    Tis competition will involve the top 10 abstracts scored by the AAS Program Committee and se

    for oral presentation. Each presentation will be rated by a subcommittee of the AAS Program Comm

    Te winner will be announced at the business meeting. He or she will receive $250, a certificate,

    listing in next years program.

    BES QUICKSHO PRESENAION BY A NEW MEMBER OF HE A AS

    Each presentation will be scored by a subcommittee of AAS Program Committee. Te winne

    be announced at the business meeting. He or she wil l receive $250, a certificate, and a listing i

    years program. Contin

    Catuat oh AAS 2009 SteRa Awad

    Wie!

    1S PLACE

    Phillips B. HarringtonUniversity of FloridaCollege of Medicine

    2ND PLACE

    Joseph G. CromptonJohns Hopkins University

    School of Medicine

    3RD PLACE

    John C. McAuliffeUniversity of exas at Houston

    School of Medicine

    4H PLACENathan . MorrellStanford UniversitySchool of Medicine

    5H PLACE

    Inga GurevichAlbert Einstein College

    of Medicine

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    BES QUICKSHO PRESENAION BY AN AAS MEDICAL SUDEN

    Tis competition will involve the top 10 abstracts scored by the AAS Program Committee. Te w

    will be chosen by members of the AAS Executive Council and announced at the business m

    He or she will receive $250, a certificate, and a listing in next years program.

    AAS RESEARCH RESIDEN AWARDS

    Te winners will be announced at the business meeting, and will receive $500, a certificate, and a

    in next years program.

    All AAS members are invited to submit a manuscript to theJournal of Surgical Research. Manuscripts sub

    by 11:59 PM CS on Friday, January 9, 2009, will be ensured an expedited review. Manuscripts submithis journal by ASC presenters have traditionally had high acceptance rates.

    We are looking forward to a terrific meeting in February. I hope to see you in beautiful Fort Myers!

    S E C R E A R Y S R E P O R:OUR EXPANDING RELAIONSHIP WI H

    HE ROYAL AUSRA LA SIAN COLLEGE OF SURGEONSDr. Scott LeMaire

    Over the past 2 years, the AAS has intensified its efforts to develop mutually beneficial relationships with

    international surgical societies. Tus far, this broad initiative has resulted in a highly successful Fundamen

    Surgical Research and Career Development Course, given in Sierra Leone in partnership with the West A

    College of Surgeons. It has also led to the first International Visiting Professorship exchanges between th

    and both the aiwan Surgical Association and the Royal Australasian College of Surgeons (RACS) an

    substantial increase in the number of international AAS members. Tese successes are due to the treme

    efforts of our Immediate Past-President, Dr. Fiemu Nwariaku; our President, Dr. Herb Chen; the ad hoc

    Affairs Committee, led by Co-Chairs Drs. Benedict Nwomeh and Evan Nadler; the Issues Committee, hea

    Co-Chairs Drs. Carlton Barnett and Cataldo Doria; the Membership Committee, led by Dr. Nipun Mer

    and several other AAS members who volunteered to serve as faculty abroad. Te success of these pro

    has led to further developments in our international programs that will be featured in future editions o

    newsletter. Te intent of the current report is to update you about our expanding relationship with the RA

    Te RACS is the overarching governing body for surgeryrepresenting all surgical specialtiesin Au

    and New Zealand (ANZ). In addition to serving the interests of ANZ surgeons (much as the AmCollege of Surgeons does in the United States), the RACS is also directly responsible for postgraduate su

    training (like the Surgery Residency Review Committee of the Accreditation Council for Graduate M

    Education) and for certification (like the American Board of Surgery). Te designation FRACS spec

    denotes successful completion of training and passing of the certification examination; fellowship

    RACS is mandatory for surgeons practicing in ANZ. Te AAS and RACS are currently working togeth

    two evolving initiatives, the RACS Younger Fellows Committee/AAS Leadership Exchange and the upc

    inaugural ANZ Developing a Career in Academic Surgery Course.

    HE RACS YOUNGER FELLOWS COMMIEE/AAS LEADERSHIP EXCHANGE

    RACS Fellows who are within their first 10 years of fellowship are considered younger fellows; the

    Younger Fellows Committee serves their interests and assures representation within the College. Each ye

    Younger Fellows Forum is convened by the RACS Younger Fellows Committee immediately before the Annual Scientific Congress. Te purpose of the Younger Fellows Forum is to discuss policy issues of par

    relevance to young surgeonssuch as those related to training, certification, industry relations, etc.

    ultimately to generate a series of specific recommendations that are brought to the RACS Council, t

    ensuring that young surgeons in ANZ have a voice in the RACS. Te Younger Fellows Committee and th

    have developed a Leadership Exchange in order to foster an international alliance involving the future lea

    surgery. o this end, the Younger Fellows Committee has secured funding from Johnson & Johnson Med

    support an AAS members visit to the Younger Fellows Forum and the RACS Annual Scientific Congre

    call for applications on page 4). Te primary focus of the visit will be to participate in discussions conc

    important policy issues with young surgeons in the RACS. Similarly, one member of the Younger F

    Committee will receive support to attend the Academic Surgical Congress as our guest.Contin

    Al AAS mebea ivid o sui mauri o h

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    T AAS ad RACSa uey ki

    he n to

    evvi iitativ,h RACS Yue

    F Ci/AAS Lehip

    Exa ad hi iagualANZ Devi

    Cae in Aec

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    D. S LMai

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    HE INAUGURAL ANZ DEVELOPING A CAREER IN ACADEMIC SURGERY COURSE

    On the heels of the successful course given in Sierra Leone earlier this year, the AAS and the RACS Sec

    Academic Surgery will present the Developing a Career in Academic Surgery Course on May 5, 2009, immed

    before the RACS Annual Scientific Congress in Brisbane. As in the Sierra Leone course, the curriculum

    ANZ course draws from the content of both AAS fall courses. Te faculty, comprising speakers from bo

    AAS and RACS, will deliver presentations that focus on the practical aspects of conducting surgical resea

    well as career development issues of particular relevance to ANZ surgeons.

    We hope that these initiatives will strengthen the relationship between the AAS and RACS and will l

    additional opportunities for international collaboration among the members of both societies.

    Cal F Aat!For the RACS Younger Fellows Committee/ AAS Leadership Exchange

    Te AAS and the Younger Fellows Committee of the Royal Australasian College of Surgeons (RAC

    are pleased to announce the 2009 Leadership Exchange. Te recipient of the second annual AA

    International Visiting Professorship Award will receive support to travel to Brisbane, Australia, t

    attend the RACS Younger Fellows Forum on May 2-4, the inaugural Developing a Career in Academ

    Surgery Course on May 5, and the RACS Annual Scientific Congress on May 6-9, 2009. Te Exchang

    is made possible, in part, by the generous support that the Younger Fellows Committee has obtaine

    from Johnson & Johnson Medical. Because the Younger Fellows Forum focuses entirely on policissues, applicants for the Leadership Exchange should have a strong interest in policy issues that affe

    young surgeons in the United States and abroad. Instructions for applying for the award are availab

    on the AAS website; applications must be submitted by December 15, 2008.

    N E W P R O C E S S F O R C OM M I E E E L E C I ODr. Rebecca Minter, Councilor

    Over the past several years, membership in the AAS has grown significantly. At the same time, we have ob

    a great increase in the number of enthusiastic members vying for committee positions. Tis growth is rema

    but has led to some logistical issues with respect to carrying out the elections. o remedy this problem

    Councilors have been working with the Executive Council and the Information and echnology Comto identify ways in which the election process might be streamlined in the future. o that end, a num

    improvements will be implemented for the 2009 elections, as outlined below.

    Nominations for all committees will be solicited online beginning December 15, 2008.1.

    Members are2. stronglyencouraged to participate in the online nomination process so as to facilitate a sm

    election process during the business meeting.

    Members will be asked to nominate themselves for up to three committees only.3.

    Statements of interest will be strictly limited to 100 words or less.4.

    Statements must be submitted online before 11:59 PM CS on January 15, 2009, so that they c5.

    complied and posted on the AAS website before the ASC meeting. Te statements will also be printfor the annual business meeting. Active members and resident members will be listed separately, an

    statements will be aligned with the names on the preprinted ballots.

    Preprinted ballots will be used for voting, and a few blanks will be left at the bottom of the bal6.

    accommodate any nominations from the floor.

    Only7. self-nominations will be allowed from the floor, and no statement will be made; thus, it is

    candidates advantage to participate in the online nomination process.

    We sincerely hope that this process will facilitate the flow of the business meeting while allowing a ll inte

    members to put their names forward for the committees on which they would like to serve. We look fo

    to the continued growth of the AAS, and we hope that these changes will both encourage that growt

    streamline the election process.

    D. Rb Mie

    2008 INERNAIONAL

    VISIING PROFESSORSHIP

    AWARDfor the

    AIWAN SURGICAL

    ASSOCIAION

    Te AAS Executive Committeewould like to congratulate Dr.ipun Merchant for receiving

    e AAS International Visitingofessorship Award for the

    aiwan Surgical Association.

    r. Merchant will be attendinge 68th Annual Meeting of theaiwan Surgical Association

    aipei in March 2009. Inchange, a representative ofe aiwan Surgical A ssociationwill attend the 2009 ASCeeting in Fort Myers, Florida.he International Visiting

    ofessorship Award wassigned to further foster the

    ASs international relations andhighlight the work being done

    y academic surgeons from otheruntries. We look forward toelcoming our colleagues fromound the world at our nextSC meeting.

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    I N F O R M A I ON & E C H N OL O G Y R E V I E WR E G U L A I ON O F M E D IC A L D E V I C E SDr. John Anderson, Information and echnology Committee

    QUESION: I want to use a new device in clinical research or practice. What are the pot

    regulatory implications?

    Te Center for Devices and Radiological Health (CDRH) is the branch of the Food and Drug Administ

    (FDA) charged with regulating devices to ensure safety and effi cacy. Te regulations are outlined in the

    of Federal Regulations (CFR) itle 21, Parts 8001299. Institutional review boards (IRBs) are respofor reviewing, approving, and monitoring biomedical and behavioral research involving humans an

    guided by CFR itle 45, Part 46. In research involving the investigation of medical devices, there are di

    tiers of applicable regulatory requirements, based on the potential for harm that use of the device

    pose to research participants. Research involving current FDA-approved devices may be subject to addi

    regulatory requirements if the research includes clinical evaluation of certain modifications or new int

    uses of legally marketed devices. Although research involving investigational devices obviously requ

    review by the IRB and FDA (directly or indirectly), notification is also required for clinical use of an

    unapproved device, even if the primary intent is not research. In addition to FDA and IRB approval, sp

    and investigators have further responsibilities for using investigational devices, including monitori

    compliance and adverse events, making periodic reports, issuing proper labels, and ensuring quality c

    and research integrity. An investigator who develops his or her own device takes on the obligations o

    the sponsor and the investigator.

    What are the regulations when using new devices in clinical research?

    All clinical research that involves medical devices requires an Investigational Device Exemption (IDE)

    exception to the requirement for an IDE. An IDE permits investigational devices to be shipped for

    clinical evaluations on human subjects. Te IDE exempts the device from certain requirements man

    by the Food, Drug, and Cosmetic Act that would otherwise normally apply to devices in comm

    distribution. Tis allows the device to be used in clinical studies aimed to collect safety and effi cacy d

    support a Premarket Approval (PMA) or a Premarket Notification [510(k)] application. Te federal regul

    concerning IDEs are contained in CFR itle 21, Part 812.

    Unless exempt from IDE regulations (see below), the IRB must make a determination to categorize the

    as posing either a Nonsignificant Risk or a Significant Risk. Significant-Risk devices require submissionIDE application to the FDA. Te initial assessment of the risk is made by the sponsor, who is also respo

    for providing enough details to allow the IRB to assess the risk. Te FDA authorizes the IRB to ma

    assessment of Significant Risk versus Nonsignificant Risk. However, the FDA has the ultimate authori

    may later disagree with the IRBs decision. Te sponsor can contact the FDA directly for further guida

    desired. Te FDA provides a guide to risk determination on its website (www.fda.gov):

    Te risk determination should be based on the proposed use of a device in an investigation, and

    not on the device alone. In deciding if a study poses a Significant Risk, an IRB must consider

    the nature of the harm that may result from use of the device. Studies where the potential harm

    to subjects could be life-threatening, could result in permanent impairment of a body function

    or permanent damage to body structure, or could necessitate medical or surgical intervention to

    preclude permanent impairment of a body function or permanent damage to body structure shouldbe considered Significant Risk.

    When is an IDE required?

    An IDE is required for:

    An unapproved device classified as a Significant-Risk Device.1.

    A legally marketed device for a new indication that may pose a significant risk: for example, the use2.

    approved metallic stent for a new indication.

    Contin

    DEADLINEIS APPROACHING

    FOR HE AAS RESEARCH

    FELLOWSHIP AWARD

    Applications dueDecember 1, 2008

    Te AAS Research Fellowship

    ward, given to eligible residents or

    lows who have completed at least

    years of postgraduate training

    a surgical discipline, provides

    e winner with an opportunityspend 2 years in full-time

    search or clinical studies with

    AAS member. Applicants must

    candidate or active members of

    e AAS, and the mentor must be

    active member of the AAS. Te

    ward of $15,000 per year for 2

    ars may be used for salary support

    for the direct-cost expenditures

    the research. Te award is to be

    pended solely for the purpose of

    e sponsored research. Funding

    r the award will begin July 1,

    09. Te deadline for RECEIP

    applications is 11:59 PM CS

    n December 1, 2008. Finalists

    will be invited for interviews

    the 2009 ASC Meeting in

    ort Myers, Florida.

    D. Jhn Aen

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    A formal IDE is not required for the following Exceptions:

    Nonsignificant-Risk devices: Abbreviated Requirements 21 CFR 812.2(b). Tis category is regar1.

    equivalent to having an IDE.

    Exempt categories: Tere are seven exempt categories (21 CFR 812), the most common of whi2.

    listed below:

    a) Research involving legally marketed devices that are used in accordance with the labeled indic

    [or that meet criteria or a classification that would exempt the device from 510(k) status (see the M

    Device Exemptions 510(k) link below)].

    b) Diagnostic devices, labeled appropriately for research only [21 CFR 809.10(c)], provided thresearch (i) is noninvasive, (ii) does not require an invasive sampling procedure that presents sign

    risk, (iii) does not, by design or intention, introduce energy into a subject, and (iv) is not use

    diagnostic procedure without confirmation of the diagnosis by means of another, medically estab

    diagnostic product or procedure.

    c) A device undergoing consumer preference testing, testing of a modification, or testing of a combi

    of two or more devices in commercial distribution, if the testing is not for the purpose of determ

    safety or effectiveness and does not put subjects at risk.

    What are the regulations for using new devices for medical treatment?

    Te off-label use of FDA-approved devices for the provision of medical care is acceptable without notifi

    of the IRB or the FDA, although additional local/institutional requirements may apply. In contrast, offuse of unapproved investigational devices (use outside of an approved clinical study) requires involvem

    the sponsor, IRB, and FDA. Te FDA recognizes that there may be circumstances under which a healt

    provider may wish to use an unapproved device to save the life of a patient or to help a patient suffering

    serious disease or condition for which no other alternative therapy exists. Early/expanded access mecha

    (of which there are four main types) provide this alternative. However, they all have specific criteri

    require involvement with the sponsor, local IRB, and FDA. Importantly, these mechanisms are for pro

    medical care, not for conducting research.

    A special case exists for Humanitarian Use Devices, which require a special Humanitarian Device Exem

    (HDE). Tis provision is designed to encourage the development of devices for treating diseases or cond

    that affect fewer than 4000 individuals per year in the United States. Te mechanism exists for treatme

    research, but it still requires IRB review, approval, and monitoring.

    Summary

    All research involving medical devices requires IRB approval. Significant-Risk devices require an IDE

    being used in a research investigation. Off-label use of unapproved devices, even for medical treatmen

    requires involvement of the sponsor, IRB, and FDA.

    References

    1 Device AdviceEarly Expanded Access. www.fda.gov/cdrh/devadvice/ide/early.shtml.

    2 FDA > CDRH > CFR itle 21 Database Search. www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/

    CFRSearch.cfm?CFRPart=812&showFR=1&subpartNode=21:8.0.1.1.9.1.

    3 FDA > CDRH > Medical Device Exemptions 510(k) and GMP Requirements.

    www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm?GMPPart=868#start.

    4 HHS-Registration of an Institutional Review Board (IRB) or Independent Ethics Committee (IEC).

    www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.

    5 Humanitarian Device Exemption: Overview. www.fda.gov/cdrh/devadvice/hde.html.

    6 US FDA/CDRH: Device Advice. www.fda.gov/cdrh/devadvice/index.html.

    7 US FDA/CDRH: Guidance on IDE Policies and Procedures. www.fda.gov/cdrh/ode/idepolcy.html.

    GLOSSARY OF

    REGULAORY ERMS

    edical Device

    medical device is defined, in part,

    any health care product that does

    t achieve its primary intended

    urposes by chemical action or by

    ing metabolized.

    emarket Approval (PMA)Te most stringent device approval

    plication required by the FDA.

    volves scientific and regulatory

    view to evaluate the safety and

    ffi cacy of Class III devices, ie, those

    at support or sustain human life,

    e of substantial importance in

    eventing impairment of human

    alth, or which present a potential,

    nreasonable risk of illness or injury.

    emarket Notification [510(k)]Application to the FDA to

    monstrate that a device is

    ubstantially equivalent to

    , at least as safe and effective as)

    already marketed device not

    bject to a PMA.

    esearch

    stematic investigation, including

    search development, testing, and

    aluation, designed to develop or

    ntribute to general knowledge.

    gnificant-Risk Device

    device that presents a potential

    rious risk to the health, safety, or

    elfare of a subject and (1) is an

    mplant; or (2) is used in supporting

    sustaining human life; or (3)

    of substantial importance in

    agnosing, curing, mitigating

    treating disease, or otherwise

    events impairment of human

    alth; or (4) otherwise presents atential serious risk to the health,

    fety, or welfare of a subject [21

    FR 812.3(m)].

    Vsi u i aWWW.AASURG.ORG

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    D. a Bin

    D. Niun Mea

    Cuey, uazatn ay

    3,000 mebe suad etst!

    o an m abuAWS tivit ad a

    tuit h AWS bsi

    WWW.WOMENSURGEONS.ORG

    M E M B E R S HI P C OM M I E E I N I I A I V E SDr. Nipun Merchant, Chair of the Membership Committee

    Since its founding in 1967, the Association for Academic Surgery (AAS) has continued to provide a f

    that offers programs designed to facilitate the development of young surgeons and surgical scient

    investigators and educators. Te success of these objectives has resulted in the tremendous growth of th

    over the years. Currently, our organization has nearly 3,000 member surgeons and scientists!

    As our reputation grows, we are receiving increased international recognition. Terefore, a major initiat

    the Membership Committee has been to increase international membership. We now have 108 interna

    members from 23 different countries.

    In keeping with the AASs mission to stimulate young surgeons and surgical scientists to pursue c

    in academic surgery, another major initiative of the Membership Committee has been to recruit m

    students and surgical residents as members. By establishing a new medical student membership cat

    we have gained 61 new medical student members in 2008 alone! By engaging these motivated individu

    the activities of the Association and providing them with a forum for interaction and guidance, we can

    ensure that the future of our Association will be in good hands. Candidate membership for junior su

    residents also continues to grow at a steady pace, and these members are serving as ad hoc members on

    all of the Associations committees.

    Te Institutional Representative Program continues to be successful, and the terms of the representative

    been expanded so that they can continue their recruitment efforts. We are making great strides to ensurwe have an institutional representative at every academic medical center in the United States. We a

    expanding this program to international academic centers.

    It has been most exciting and fulfilling to witness the steady growth of the AAS and its reput

    Tis progress is doing a great deal to further our profession and to increase the opportunities for our me

    to succeed in their careers.

    A S S O C I A I O N O F W O M E N S U R G E O N SDr. ara Breslin, Representative to the AWS

    Te Association of Women Surgeons (AWS) was founded in 1981, when Patricia Numann, MD, FACS, ifemale surgeons to attend a breakfast at the October meeting of the American College of Surgeons (

    Realizing that they shared many common experiences, interests, and concerns, the women decided to

    informally on an annual basis. For the next few years, these Wednesday morning breakfasts at the AC

    meeting provided the first significant contact that many female residents or newly practicing female surgeo

    with more professionally advanced female surgeons. As attendance at these informal gatherings grew, it b

    apparent that the group needed a more formal structure to address their common professional concerns.

    Incorporated in 1986, the AWS currently has 1600 members. In 1995, it was recognized by the ACS,

    created a governorship position for the AWS. Te AWS fosters professional development through its annu

    Meeting, which is held concurrently with the ACS Clinical Congress. Other AWS activities include spons

    of a visiting professorship program, publication of Pocket Mentor (a residents commonsense guide to su

    residency), involvement in a research grant program, and participation in a networking event at the AcaSurgical Congress. In partnership with the American Journal of Surgery,AWS members developed a se

    articles that describe the many interest areas and varieties of practice that comprise surgery. Althoug

    series is aimed primarily toward trainees and students, it is also a valuable resource for any surgeon w

    considering a change in his or her career or who is involved in a mentoring relationship. Trough its

    educational, networking, and professional-development programs, the AWS seeks to inspire, encourag

    enable women surgeons to realize their professional and personal goals. o learn more about AWS activiti

    grant opportunities or to obtain a copy of the recently updated and improved Pocket Mentor (available f

    price of postage), please see the AWS website www.womensurgeons.org.

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