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 Non- Medical 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 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 ILittle regulation »Class II510(k) »Class IIIPMA

FDA 2004 User Fees *Large business: *510(k)$ 3,480 *PMA$206,811 »180 day supplement$ 44,464 »Real-time supplement$ 14,890

FDA 2004 User Fees *Small business: *510(k)$ 2,784 *PMA$ 78,588 »180 day supplement$ 16,896 »Real-time supplement$ 5,658

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

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 » 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!