The Impact of Regulations on Medical Device Design
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1 The Impact of Regulations on Medical Device Design Richard C. Fries, PE, CRE Manager, Corporate Reliability Engineering Baxter Healthcare Round Lake, Illinois
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The Impact of Regulations on Medical Device Design. Richard C. Fries, PE, CRE Manager, Corporate Reliability Engineering Baxter Healthcare Round Lake, Illinois. Extra Activities for Regulated Industries. Develop and maintain a Quality System Product Documentation Design History File - PowerPoint PPT Presentation
Transcript of The Impact of Regulations on Medical Device Design
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The Impact of Regulations onMedical Device Design
Richard C. Fries, PE, CREManager, Corporate Reliability EngineeringBaxter HealthcareRound Lake, Illinois
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Extra Activities for Regulated Industries
Develop and maintain a Quality SystemProduct Documentation
Design History FileTechnical File
Product submissionsTesting certificationsExtra time for:
SubmissionsAnswer questions from regulatorsRe-submissions
Audits
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The Typical Road to Market for a Non-Medical Device
Generate a new idea for a productDesign the productTest the productManufacture the productShip the product
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The Typical Road to Market for a Medical Device
Generate a new idea for a productDesign the productTest the productSubmit data to the regulatory agencyWaitManufacture the productShip the product
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Timing of Product Development
Establish a window of opportunity to sell the product
Determine the amount of time to manufacture the product
Determine the amount of time for regulatory approval
Determine the amount of time to test the product Determine the amount of time to design the
product Determine the amount of time to specify the
product Start the development cycle
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Types of Regulations
ProcessISO 9000 familyAudits by Notified Bodies
ProductFood and Drug Administration (FDA)Medical Device Directive (MDD)Individual country requirements (Canada, Australia,
Japan, Russia)City of Los AngelesOther standards required for certain productsEnvironmental standards
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Process Regulations
Basis for product regulationsRequires the company to show an
experienced quality system in placeISO 9000 family used as the gold standardFor companies with design capabilities,
ISO 9001 is the foundationFor medical device companies, ISO 13485
is beginning to be accepted
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ISO 9001
Management responsibility Quality system Contract review Design control Document and data control Purchasing Control of customer supplied product Product identification and traceability Process control Inspection and testing
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ISO 9001
Control of inspection, measuring, and test equipment Inspection and test status
Control of non-conforming product Corrective and preventive action Handling, storage, packaging, preservation, and
delivery Control of quality records Internal quality audits Training Servicing Statistical techniques
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Design Control
Design and development planningOrganizational and technical interfacesDesign inputDesign outputDesign reviewVerificationValidationDesign changes
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Product Regulations
United StatesFDA
EuropeMedical Device Directive
Other CountriesAustraliaCanadaJapanRussia
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Food and Drug Administration
Quality systemTesting to prove the safety and efficacy of
your productSubmission material dependent on the
type of product you are makingParticular attention to softwareMDRsRecallsAudits
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Food and Drug Administration
Safety and efficacy:
Requirement verification
Risk analysis
Environmental testing
Clinical testing
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Food and Drug Administration
Submissions:
Class I Little regulation
Class II 510(k)
Class III PMA
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FDA 2004 User Fees
Large business:
510(k) $ 3,480
PMA $206,811 180 day supplement $ 44,464 Real-time supplement $ 14,890
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FDA 2004 User Fees
Small business:
510(k) $ 2,784
PMA $ 78,588 180 day supplement $ 16,896 Real-time supplement $ 5,658
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Food and Drug Administration
Software: Based on an bad experience in Canada FDA doesn’t understand it Therefore, they over-regulate it All current regulations are in draft form Software in a device is the same level as the
device Excess documentation required Auditors free to regulate according to their own
principles
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Food and Drug Administration
MDRs and Recalls: MDR: a report sent to the FDA detailing
the circumstances of your device killing or causing serious injury to a patientThe FDA also gets a report from the hospital
or clinic where the situation occurred
Recall: a detailed plan for making design changes in all your devices currently in the field
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Food and Drug Administration
Audits:
General
Triggered by submissions
Triggered by field failures
Triggered by unsolicited information
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Medical Device Directive
Required for selling a product in Europe
Product must contain a CE markMust have a quality systemProduct must meet a list of essential
requirementsCertificates for all testing
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Medical Device Directive Process
Analyze the device to determine which directive is applicable
Identify the applicable Essentials Requirements List
Identify any corresponding Harmonized standards
Confirm that the device meets the Essential requirements/Harmonized Standards and document the evidence
Classify the device
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Medical Device Directive Process
Decide on the appropriate conformity assessment procedure
Identify and choose a notified bodyObtain conformity certifications for
the deviceEstablish a Declaration of ConformityApply for the CE mark
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Medical Device Directive
Three directives:
Active Implantable Medical Devices Directive (AIMDD)
Medical Devices Directive (MDD)
In Vitro Diagnostic Medical Devices Directive (IVDMDD)
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Essentials Requirements List
Essential Requirement A or N/a Standards Activity Test Clause Pass/Fail Document Location1. The device must be designedand manufactured in such a waythat when used under theconditions and for the purposesintended, they will notcompromise the clinicalcondition or the safety ofpatients, users, and whereapplicable, other persons. Therisks associated with devicesmust be reduced to an acceptablelevel compatible with a highlevel of protection for health andsafety.
A Internal Risk analysis
Safety review
Design History File
Design History File
2. The solutions adopted by themanufacturer for the design andconstruction of the devices mustcomply with safety principlesand also take into account thegenerally acknowledged state ofthe art.
A Internal Specificationreviews
Design reviews
Safety review
Design History File
Design History File
Design History File
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Declaration of Conformance
Every device, other than a custom-made or clinical investigation device, must be covered by a declaration of conformity
Document that states you have met all the essential requirements for your device
Must include the serial numbers or batch numbers of the products it covers
Signed by a member of Senior Management
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The CE Mark
XXXX
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Difference Between FDA and MDD
FDA:A submission must be sent to the FDA for
each product to be marketedMust wait for approval
MDD:A company may qualify for self-certification
to MDD for their products. These are checked during scheduled audits.
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Other Product Regulations
CountriesJapanAustraliaChinaRussia
Type of Device StandardsAlarmsSoftware
Environmental StandardsEMCTemperature/HumidityShipping
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Audits
1-4 people in your spaces for 3 days to several months
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Audits
Will cover in detail your process and products
Auditors will “dig-in” in they find the hint of a problem
Major discrepancies will shut you down until they are fixed
Legal and/or punitive steps may be taken
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Newest of the Regulations
HIPAA
Health Insurance Portability and Accountability Act
Main components are Privacy and Security
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Protected Health Information (PHI)
PHI is health Information that:1) is created or received by a health care provider, health plan, employer, or health
care clearinghouse, and2) relates to the past, present, or future
physical or mental health or condition of an individual, the provisions of health care to an individual, or the past, present, or future payment for the provision of health care to an individual, and i) that identifies the individual or ii) with respect to which there is a reasonable basis to believe the information can be used to identify the individual.
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Protected Health Information (PHI)
Any health information that can be identified to a person
It includes information about treatment and care
PHI can include:NameDatesRecord numberSocial security numberFull face photoAny other unique identifying information
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De-Identification
Patient information from which identifiers have been deleted, redacted, or blocked, so that remaining information cannot reasonably be used to identify a person. Identifiers to be deleted include:
Name Social security number Address Telephone number Birth date Admission date FAX numbers E-mail addresses Medical record numbers Health plan beneficiary numbers Account numbers Certification/license numbers Full face photos.
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Civil Penalties for Non-Compliance
$100 for each violation
Total of $25,000 for all violations of an identical requirement in a calendar year
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Criminal Penalties for Wrongful
Obtainment/Disclosure of PHI Not more than $50,000
and/or not more than 1 year impisonment
Not more than $100,000 and/or not more than 5 years imprisonment if the offense is “under false pretenses”
Not more than $250,000 and/or not more than 10 years imprisonment for the intent to sell, use for commercial advantage, personal gain, or malicious harm Protected Health Information
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HIPAA Philosophy
What I see here,What I hear
here, When I leave
here,Remains here!
