standards final

• ISO31/1000
• international bureau of weights & measures
• national institute of standards
• reference laboratory
• measurement device

application of math & physics to biological and medical problems

• patient/user safety
• protection of environment
• know one's own limitations
• confidentiality
• continuing education
• conflict of interest
• fairness/credit

• research
• development
• evaluation
• marketing
• manufacturing
• procurement
• utilization
• disposal

• a reference
• desirable attributes of a product, process, or system
• define safety, protection of environment, conflict of interest; professional practice
• legal protection

• national or international standards (NRC/NIST)
• 1⁰ standard (national level)
• reference standards/transfer standards
• working standards
• client test equipment, shop/level standards, 2⁰ standards

• condition of receive & return
• date/env of calibration
• expiration
• standards/equip'ts used
• certificate of traceability

• identify risks inherent to device, eliminate/reduce risk, provide protection against those risks, provide info related to risks that remain
• not compromise clinical safety condition
• conforms to safety principles
• performance over life time
• transport & storage requirements
• material compatible
• safe sterilization method
• software performance validation
• appropriate training manuals

• control manufacture process
• ISO9000-2003 (General QA) ~ ISO13485 (Medical QA) ~ 21CFR820 (Quality System Requirements)
• ISO14971-2000 (Risk Management)

general, many types of equipments e.g. CISPR.11

• device specific
• e.g. AAMI EC12-1991

• technical requirements & test methods
• CSA-Z32-99 (electrical safety & essential electrical system in health care facilities) e.g. backup power requirements
• IEC 60601-2: Particular requirements for safety
• IEC 60601-1: General req'ts for basic safety & essential performance

• derived by standard organizations
• not part of gov't body
• not created by treaty
• most standards
• IEC, ANSI, CISPR

• notified bodies:
• - CSA (Canadian Standards Assoc)
• - Underwriters Laboratory (U.S. version of CSA)
• associations:
• - AAMI (Association for the Advancement of Medical Instrumentation)
• - ANSI (American National Standards Institute)
• - ISO (International Standard Organization)
• - ECRI

• scope (disclaimer, what is covered & not)
• purpose (intended or desired result)
• definitions
• requirements
• test methods (how requirements verified)
• appendixes

• self certification, regulatory body right to audit
• third party certification, gives certificate
• diff jurisdiction, diff certification requirements
• CSA Certification Program: certifies process & device (>1)
• CSA Special Inspection Program: certifies 1 particular device (only 1)

• ensures measurement, test, and process-control equip'ts & materials are calibrated and maintained w/in tolerance limits sufficient for individual tasks to meet regulatory & quality requirements
• ensures control of environmental conditions to get accurate results

high current (mA), low density, transcutaneous

low current (uA), high density, introduced to heart

• P = I²R --> burns tissue
• evokes action potential
• heart fibrillation
• current threshold for macroshock

• 1 mA: threshold of perception
• 5 mA: max harmless current
• 10-20 mA: can't let go, sustained muscular contraction
• 50 mA: pain, faint, exhaustion
• 100-300 mA: ventricular fibrillation start
• 6 A: temporary respiratory paralysis, burns, myocardial contraction

inherent flow of current from an energized cct to conductors

• drain leakage currents
• create short cct in case of fault
• min. unwanted noise

electrical system in which no cct conductor is connected directly to ground

• no spark at ground fault
• SF fault to ground no shock occurs
• fault does not affect operation of device

• line isolation monitoring system
• displays current that would flow if there's direct fault to ground to the equipotential grounding system
• impedance measuring device
• indicate degree of isolation from ground to isolated portion
• trig at ~2mA

• Ground Fault Circuit Interrupter
• interrupts power if I_leak >= 5 mA or when I_in >> I_out
• protection against macroshock
• not for OR use b/c power shuts down

• if long distance to panel can have voltage drop
• green-yellow wire insulation
• ensure all same length

• proper ID: color, label, PISS (pin index safety system), DISS (diameter index safety system)
• storage & transportation of gas containers: valve protection cap, chains
• leaks: fire hazard
• oil/grease free environment: high pressure O₂ + oil/grease = burning/explosion hazard
• sparks: explosion hazard
• ventilation: accumulation of gases in enclosed areas
• relieve valve location & air intake
• cryogenic burns
• shock-waves: no 1/4 turn valves with high pressure systems
• dust contamination

process to find answers in engineering design, design improvement, and troubleshooting

• brainstorming
• reverse engineering
• decision tree
• PMI
• SWOT
• Critical Path / Gantt

• troubleshooting flowchart
• fault tree analysis
• half-split analysis
• identical systems analysis

• clinical considerations
• documentation
• incident reporting

• R_rayleigh = h {1.22 x lambda / (2 x NA) }
• distance between peaks of 2 light spreads
• point spread function, defines the design of the lens
• higher resolution have higher R_rayleigh

• 1. problem definition: understand/verify problem
• 2. background research
• 3. high level approach: problem isolation
• 4. idea generation: possible causes
• 5. idea formulation: test & measurement methods
• 6. idea evaluation and implementation: test & measure
• 7. verification/validation: follow-up document

• summary of device and intended use
• general operational specifications/initial requirements
• functional specifications: performance
• non-functional specifications: safety & standard compliance
• packaging & cost

• method for developing creative solutions to problems
• encourages lateral & creative thinking
• no criticism
• choose best solution with decision making tools
• individual or group

• adopt ideas from similar systems, processes, or problems and modify to suit our needs
• consider intellectual property issues & give credit where it's due

• 1. assign value/cost to outcomes
• 2. assign probability to each branch according to effort
• 3. calculate value to next higher level
• 4. select path with highest value

• Plus-Minus-Interesting
• plus: pros
• minus: cons
• interesting: implications & possible outcomes for taking action

• Strength: what it does well
• weakness: what it does less well
• opportunity: what current trends favour it ssuccess?
• threats: what obstacles exist to its success?

• Planning of an activity/project
• sub-dividing problems into more manageable tasks
• resource assignment
• budgeting
• determine critical paths & tasks

• typically provided by manufacturer in manual under troubleshooting section
• lists problems, provides typical possible causes and corresponding remedies

• start with system block diagram or flowchart
• define input & faulty output
• split diagram into half or at a convenient boundary
• continue to split until problem is isolated & part, code, or process can be replaced

• 2 identical systems are available & 1 works
• troubleshoot by swapping suspicious components

• know the equipment: patient/user, function, env't
• resources: manual, manufacture, databases, ECP
• back to basics: common faults (age, user error, misuse, power interruption), replaceable parts, analysis
• communication: documentation (logbook, ECP)

• 21CFR803
• report if caused or contributed to death or serious injury
• submit annual report, event file, incident report w/in 5, 10, and 30 days
• reporting procedures must be developed, implemented, and maintained

• initial response: secure the scene, stop dmg spread, know seq of events
• gather incident info
• remedial action
• coroner's inquests: if death unexpected, will be investigated
• internal communication and documentation: report to supervisor
• external communication: FDA, Health Canada

• scientific/clinical investigations
• technical feasibility
• device classifications
• market assessment / requirements
• risk assessment
• knowledge of basic properties and functional requirements
• competitive analysis
• customer service plan
• regulatory and clinical strategy
• develop business case

• product definition
• intellectual property generation & strategy
• requirements
• high-lvl product and process design
• product design, verification and validation
• process development
• supply-chain development
• clinical studies/trials and regulatory submissions/approval
• product certification
• risk assessment & mitigation
• develop & update business plan
• commercialization strategy & marketing plans
• design transfer design

• pilot production
• production
• market rollout
• distribution channel management
• maintenance and service
• continuous improvement programs
• pos-market clinical studies
• market feedback
• disposal

• encourage safety & effectiveness
• encourage a systematic, structured, and documented process
• encourage customer based development
• encourage continuous improvement
• enforce risk management development & operation
• enforce planning and evidence-based development, manufacturing, and operation
• enforce definition and verification/validation of requirements
• encourage proactive organizations

• proactive: keeps changing design, start slow, but less problems in the future
• reactive: high productivity in the beginning, lots problems later

• 1: cost of preventing defect before it occurs
• 10: cost of correcting a defect before it reaches the customer
• 100: cost of correcting after it reaches the customer

• Regulatory: HBFB, FDA, MDD, etc
• Electrical: IEC60601, degree of protection against electrical shock, types B, BF, CF
• Electrical: IEC60601, type of protection against shock, class I (relaxed insulation), class II (enhanced insulation)
• Laser: eye safety, aversion response, wavelength and output power, class I, II, IIA, IIIa, IIIb, and IV (old); 1, 1M, 2, 2M, 3R, 3B, and 4

• ISO13485 - design controls
• Canada - I (no need), II, III, IV
• U.S. - I (only need for software), II, III
• EU - I, IIa, IIb, III

• Rule-Based Classification
• active device: source of nrg other than human body or gravity
• active diagnostic device: info for the purpose of detection or monitoring
• active therapeutic device: supports, modifies, replaces, restores
• invasive device: contact with eye or penetrate
• Particular rules apply to particular devices.

• Substantial Equivalence: same intended use AND tech characteristics OR same intended use AND FDA does not raise new questions of safety & effectiveness
• Class I: general controls, min potential for harm
• Class II: special controls, general controls insufficient
• Class III: premarket approval, special controls insufficient

• labelling
• medical device reporting
• investigational device exception (IDE): get this for pre-approved device before allowed to get clinical test data
• market clearance
• premarket approval of medical devices
• QSR (quality system regulation)
• medical device classification and groups

• management responsibility
• ID & traceability
• document control
• customer-supplied product
• tool control
• non-conforming material (lock up so nobody uses it)
• quality records
• corrective & preventive action
• handling, storage & packaging
• quality system
• design control
• purchasing
• contract review
• testing
• labelling
• internal audits: "say what you do, do what you say"
• training
• statistical analysis
• servicing

• ensure safety & efficacy through controlled design process
• ensure successful & efficient implementation
• U.S. 21CFR820.30 required for classes II, III
• Canada ISO13485 section 4.4 required for classes III, IV

• 
• output feeds into input
• separate overlapping phases
• risk management is a 'separate' parallel process
• documentation part of design process
• not realistic b/c design process not linear but iterative
• usually limited on time

DHF (design history file) contains DMR (device master record, everything needed to know about service & manufacturing device) + DHR (device history record, this is what i did, materials that i used)

• design control: planning, input/output, verification & validation, hazard analysis, review
• documentation & documentation control
• corrective/preventive action
• consistency of process
• management commitment
• proactive rather than reactive