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The Impact of Regulations on Medical Device Design Richard C. Fries, PE, CRE Manager, Reliability Engineering Datex-Ohmeda Madison, Wisconsin Extra Activities for Regulated Industries Develop and maintain a Quality System Product Documentation Design History File Technical File Product submissions Testing certifications Extra time for: Submissions Answer questions from regulators Re-submissions Audits The Typical Road to Market for a NonMedical Device Generate a new idea for a product Design the product Test the product Manufacture the product Ship the product The Typical Road to Market for a Medical Device Generate a new idea for a product Design the product Test the product Submit data to the regulatory agency Wait Manufacture the product Ship the product 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 Types of Regulations Process ISO 9000 family Audits by Notified Bodies Product Food and Drug Administration (FDA) Medical Device Directive (MDD) Individual country requirements (Canada, Australia, Japan, Russia) City of Los Angeles Other standards required for certain products Environmental standards Process Regulations Basis for product regulations Requires the company to show an experienced quality system in place ISO 9000 family used as the gold standard For companies with design capabilities, ISO 9001 is the foundation For medical device companies, ISO 13485 is beginning to be accepted 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 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 Design Control Design and development planning Organizational and technical interfaces Design input Design output Design review Verification Validation Design changes Product Regulations United States FDA Europe Medical Device Directive Other Countries Australia Canada Japan Russia Food and Drug Administration Quality system Testing to prove the safety and efficacy of your product Submission material dependent on the type of product you are making Particular attention to software MDRs Recalls Audits Food and Drug Administration Safety and efficacy: Requirement verification Risk analysis Environmental testing Clinical testing Food and Drug Administration Submissions: Class I Little regulation Class II 510(k) Class III PMA FDA 2004 User Fees Large business: 510(k) $ PMA 180 day supplement Real-time supplement $206,811 $ 44,464 $ 14,890 3,480 FDA 2004 User Fees Small business: 510(k) $ PMA 180 day supplement Real-time supplement $ 78,588 $ 16,896 $ 5,658 2,784 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 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 patient The 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 Food and Drug Administration Audits: General Triggered by submissions Triggered by field failures Triggered by unsolicited information Medical Device Directive Required for selling a product in Europe Product must contain a CE mark Must have a quality system Product must meet a list of essential requirements Certificates for all testing 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 Medical Device Directive Process Decide on the appropriate conformity assessment procedure Identify and choose a notified body Obtain conformity certifications for the device Establish a Declaration of Conformity Apply for the CE mark Medical Device Directive Three directives: Active Implantable Medical Devices Directive (AIMDD) Medical Devices Directive (MDD) In Vitro Diagnostic Medical Devices Directive (IVDMDD) Essentials Requirements List Essential Requirement 1. The device must be designed and manufactured in such a way that when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, users, and where applicable, other persons. The risks associated with devices must be reduced to an acceptable level compatible with a high level of protection for health and safety. 2. The solutions adopted by the manufacturer for the design and construction of the devices must comply with safety principles and also take into account the generally acknowledged state of the art. A or N/a A A Standards Internal Internal Activity Risk analysis Test Clause Pass/Fail Document Location Design History File Safety review Design History File Specification reviews Design History File Design reviews Design History File Safety review Design History File 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 The CE Mark XXXX Difference Between FDA and MDD FDA: A submission must be sent to the FDA for each product to be marketed Must wait for approval MDD: A company may qualify for self-certification to MDD for their products. These are checked during scheduled audits. Other Product Regulations Countries Japan Australia China Russia Type of Device Alarms Software Environmental EMC Temperature/Humidity Shipping Audits 1-4 people in your spaces for 3 days to several months 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 Newest of the Regulations HIPAA Health Insurance Portability and Accountability Act Main components are Privacy and Security 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, and 2) 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. Protected Health Information (PHI) Any health information that can be identified to a person It includes information about treatment and care PHI can include: Name Dates Record number Social security number Full face photo Any other unique identifying information 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. Civil Penalties for Non-Compliance $100 for each violation Total of $25,000 for all violations of an identical requirement in a calendar year 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 HIPAA Philosophy What I see here, What I hear here, When I leave here, Remains here!