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Regulation and Standards Chapter 17 1 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 2 The Typical Road to Market for a Non-Medical Device Generate a new idea for a product Design the product Test the product Manufacture the product Ship the product 3 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 4 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 5 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 6 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 7 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 8 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 9 Design Control Design and development planning Organizational and technical interfaces Design input Design output Design review Verification Validation Design changes 10 Product Regulations Europe Medical Device Directive Other Countries Australia Canada Japan Russia United States FDA 11 The various Medical Device Directives define a medical device as: "any instrument, appliance, apparatus, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: diagnosis, prevention, monitoring, treatment or alleviation of disease diagnosis, monitoring, alleviation of or compensation for an injury or handicap investigation, replacement or modification of the anatomy or of a physiological process control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means." 12 Medical Device Directive 3 divisions: AIMDD, MDD, IVMDD 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 13 Medical Device Directive Three directives: Active Implantable Medical Devices Directive (AIMDD) Medical Devices Directive (MDD) In Vitro Diagnostic Medical Devices Directive (IVDMDD) 14 Medical Device Directive Process Analyze the device to determine which directive is applicable Identify the applicable Essentials Requirements List (safety, risk, performance, …) Identify any corresponding Harmonized standards Confirm that the device meets the Essential requirements/Harmonized Standards and document the evidence Classify the device 15 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 16 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 17 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 18 The CE Mark XXXX 19 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. 20 Other Product Regulations Countries Japan Australia China Russia Type of Device Standards Alarms Software Environmental Standards EMC Temperature/Humidity Shipping 21 Audits 1-4 people in your spaces for 3 days to several months 22 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 23 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 (see chapter 16…) 24 Food and Drug Administration Safety and efficacy: Requirement verification Risk analysis Environmental testing Clinical testing 25 Food and Drug Administration Submissions: Class I Little regulation Class II 510(k) Class III PMA 26 FDA 2004 User Fees Large business: 510(k) $ 3,480 PMA 180 day supplement Real-time supplement $206,811 $ 44,464 $ 14,890 27 FDA 2004 User Fees Small business: 510(k) $ 2,784 PMA 180 day supplement Real-time supplement $ 78,588 $ 16,896 $ 5,658 28 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 29 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 30 Food and Drug Administration Audits: General Triggered by submissions Triggered by field failures Triggered by unsolicited information 31 Newest of the Regulations (US) HIPAA Health Insurance Portability and Accountability Act Main components are Privacy and Security 32 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 dentifies the individual or ii) with respect to which there is a reasonable basis to believe the information can be used to identify the individual. 33 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 34 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. 35 Civil Penalties for NonCompliance $100 for each violation Total of $25,000 for all violations of an identical requirement in a calendar year 36 Obtainment/Disclosure of PHI Not more than $50,000 and/or not more than 1 year imprisonment 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 37 HIPAA Philosophy What I see here, What I hear here, When I leave here, Remains here! 38 Other US Standards Groups: AAMI ANSI ASQC ASTM IEEE IES IPC NEMA NFPA OSHA UL 39 Rest of World British Standards Institute European Committee for Normalization European Committee for Electronic Standards TickIT International Committee on Radio Interference Canadian Standards IEEE ISO (9000, 9001, 13485, 13488, 14000) JSA 40 Trends: Harmonization of Regulations & Standards Attempts at defining Medical Informatics and the structures of medical records Computerization 41
