Transcript 7100 Software Test System

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!