Professional Issues in BMESocieties, Licensure, Ethics, Forensics/ConsultingChapter 22

Biomedical Engineering Societies

BMES annual mtg, newsletter, annalsIBE joint mtgs, web newsletterAAMI yearly, largely instrumentationIEEE-EMBS yearly, joint, magazines, int.AMIA biannual, magazineRESNA rehabACMsigbio special interest group

Societies, continuedSPIEinternational, bio appsASME, ASCE, AIChEAdvaMed (Advanced Medical Technologies Assn.) www.himanet.com

Standards Settings Groups: Society Based

IEEEASMEAAMIAMA American Medical Assn.AHA American HeartADA American DentalASQC Am. Soc. Quality ControlANSI Am Nat. Stds. Assn.!!!!

Standards Settings Groups: National Groups

NEMA electrical manufacturersNSC safety council (ISTD)NFPA fire protectionNCRP radiation protection

Standards Settings GroupsU.S. Miscellaneous

UL underwriters labOSHA Gov’t. occ. SafetyFCC Federal Communications Comm.JCAHO www.jcaho.org

Major International Groups:

ISO International Standards Organization – 110 countries – ANSI is US rep.IEC International Electrotechnical Commission – electric/electronic standards

Professional LicensureWhy? Required for work involving public safety, certification of requirements, etc. $. Respect. Testimony. Promotions. Future job requirement?

Professional Licensure, Continued

How?BS in an ABET 4yr approved curriculum. - few exceptions (equivalency)Pass FE exam ->Engineering InternSee www.ncees.org for more info & dates

Professional Licensure, Continued

4+ years of responsible engineering work +FE or 12 years responsible workPass Principles & Practice Exam & Presentation of Credentials-> P.E. License (with stamp)

Professional Licensure, Maintenance

Yearly license fees paymentYearly privilege tax paymentContinuing EducationAbiding by rules of conduct (ethical practice!)

Professional Conduct = Preservation of public welfareService only in areas of competenceObjective, truthfulNo conflicts of interestNo bribes, false advertising, etc…IEEE, NSPE, most have code(s), ethicswww.nspe.org/ethics/eh1-code.asp

ForensicsPE almost a necessity.Area of competence?Determine “fault”Document “fault” via investigation, replay, testing, mathematical modelingConvey info to the one who hired youOutcome: fired or continue (50%)

Forensics continuedhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFMDocument, prepare for testimony, answer interrogatories, Rule 26, go or no go!Go to court if necessary (5-10%)

Forensics continuedCharges: 1/1000 annual per hour, plus expenses (hotel, travel, duplicating, services agreed upon, supplies…)Generally write a maximum daily charge into the contractFor you folks: 55,000/1000 = $55/hourLawyer: $150 & upMD: $200 & up, …

Forensics continuedMale assist device: refused.Claim no data/damage low speed – NO!Ventilator -> brain damage (simulation)Air embolism case (simulation)Drapery cord case (communication)Enteral feeder case (case justified?)

ConsultingArea of expertiseNon-disclosureAgree on contract: 1 day, % time, rights, etc.Whatever the market will bear(S&E&…) …