Staying Connected - February 2012

Design Verification and Validation of Medical Cable Assemblies

Design Verification Testing confirms that a product meets the specifications and requirements established when a product is designed.  Design validation confirms that the product functions according to design inputs when manufactured using normal production processes.



U.S. Code of Federal
Regulations requires verification
and validation for medical devices

Design verification of medical devices is required by regulatory bodies to help ensure that newly developed products perform as expected.  The U.S. Code of Federal Regulations (CFR) states “Each manufacturer shall establish and maintain procedures for verifying the device design. Design verification [820.30(f)] shall confirm that the design output meets the design input requirements.”

Design Controls

Design controls required for medical devices include design verification and, when output cannot be confirmed by subsequent testing, design validation.  These activities should be considered and included as part of the new product development process.

Considering validation and verification requirements at the beginning of a project allocates and schedules time to:

  • Adequately plan and document verification and validation activities
  • Identify resources necessary to perform verification and validation activities
  • Execute the test plan
  • Evaluate and report test results

Storage, handling and shipping
requirements may be part of
Verification and Validation testing

Verification and Validation Protocols

Good planning helps ensure verification and validation activities do not slow down or delay new product deployment. An important part of planning is writing a Verification and Validation Protocol appropriate for the product being developed.  The Protocol should include well defined steps, leading to confirmation of the design. 

A typical verification and validation protocol will include:

  • Procedure number and product description – A unique number which identifies the protocol and the name of the product being tested

  • Purpose – States the purpose of the Protocol.  Verification confirms that design outputs match design input requirements.  Validation confirms that the product functions as intended when manufactured using normal production processes.

  • Scope – Describes what will be tested, how many will be tested (sample size), and who will perform the testing.  Typical testing for medical cables will include:
    • Cleaning, disinfecting, sterilization and chemical resistance requirements
    • Electrical requirements
    • Mechanical requirements
    • Labeling and packaging requirements
    • Storage, handling and shipping requirements
  • Reference Documents –documents containing the specifications, the test plan, drawings, and referenced standards.

  • Responsibilities – who will be responsible for preparing the test protocol and report, who will manufacture the parts to be tested, who will perform testing and who will complete the test report.
  • Test Plan – Defines the various tests to be performed to confirm the product will perform as required and expected.  The plan will outline each type of test, the appropriate regulatory and industry standards, the sample size for each test element, and the acceptance criteria.
  • Test Methods – Describes in detail how each test will be performed, what equipment is needed to perform testing, what data will be collected, and what criteria must be met to confirm the design.

    If any pre-conditioning (such as sterilization) or testing will be out-sourced, those activities should be identified so that resources can be identified and scheduled well in advance.
  • Test Data – includes test results, individuals performing the tests, and equipment listing along with model numbers and calibration data.  Data from each test is included, generally in table form.  This is often accompanied by photographs or diagrams of the test set-up and apparatus. 
  • Results and Summary – Confirms that the product tested complies with customer specifications and referenced standards and details any area of non-compliance.

Once verification and validation protocols are reviewed and approved by the customer, they become part of the Device History File along with subsequent test results and summary.



Preconditioning cables using various
cleaning solutions prior to performing
mechanical and electrical testing

Testing

Quality System Regulations specify “production parts, or equivalent” be used for validation.  With proper planning, test protocols will be approved and ready to implement when first article parts are produced.

Pre-Conditioning

Depending upon the nature of the product, pre-conditioning may be required as part of the test plan.  Pre-conditioning may include cleaning or sterilization.  Cleaning and disinfection agents commonly used to pre-condition connectors or cable assemblies often include:

  • Sodium hypochlorite (10% bleach solution)
  • Glutaraldehyde solutions
  • Green soap

If the cable assembly or connector is not designed to have an ingress protection rating of X6 or higher, preconditioning is commonly done by wiping.  ANSI/AAMI EC53 specifics 15 cycles: wiping with the cleaning agent, followed by a rinse wiping and followed by wiping to dry.  The specified number of cycles is repeated for each cleaning or disinfection agent.

For products requiring many sterilization cycles prior to testing, weeks or even months may be needed to complete the pre-conditioning process.


Sterilization preconditioning
is often out-sourced


Cables numbered for
validation testing

Once any required pre-conditioning is complete, testing can begin.



Flex testing is typically performed to
a specified number of cycles, but
also may be performed to failure

Mechanical Testing

For medical cable assemblies, and depending upon the application, mechanical testing may follow ANSI/AAMI EC53 and may include:

  • Flex life testing – cable material to any terminations
  • Tensile strength – cable to any terminations
  • Tensile strength of cable material or any leadwire material
  • Mate/Un-mate – of any connectors
  • Connector retention force

Electrical Testing



Defibrillation withstand testing is a
common requirement for
medical cable assemblies

Depending upon the application, electrical testing of medical cable assemblies and may include:

  • Dielectric withstand wire to wire
  • Dielectric withstand wire to shield
  • Sink current
  • Defibrillation withstand
  • Triboelectric noise
  • Cable and contact resistance

In addition to recording data, it is important for those performing tests to include notes and comments describing any unexpected or extraordinary results. 

Reporting

The final stage of verification and validation activities is preparing a summary of test results and a full report.  The summary typically confirms that the test protocol was executed and that the product tested meets the applicable requirements while the full report typically contains all test data.

Once the report has been reviewed and accepted by all parties it is included in the Device History File.

Summary

Verification and validation testing helps ensure the functionality and manufacturability of newly developed products.  The Affinity engineering team has the experience and expertise to help design and develop your new medical cable assembly, connector or interface.  We can also save you time and resources by completing verification and validation activities.   For more information, contact Affinity customer care at 949-477-9495 or email to customercare2@affinitymed.com.

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Meet Roberto Henker – Representing Affinity in Germany



Roberto Henker

With Germany and the surrounding German speaking areas of Europe representing a significant market for medical devices, Affinity is proud to have Roberto Henker representing the company.

Roberto is employed by Affinity’s business partner, MPS Terminal located in Feldkirchen-Westerham, Germany.  “We have known and respected Roberto for over eight years and are very happy to have him working for MPS-Terminal representing Affinity,” said Affinity President and CEO, Mary Phillipp.  “He understands the unique demands of medical device manufactures and has an excellent technical background.”

Roberto grew up in the countryside around the Ore Mountains in eastern Germany.  As a child, he enjoyed music and sports.  Roberto studied radio and television engineering in school and worked in the field as a service engineer for ten years before returning to school to earn a Bachelor’s degree.

After earning his degree, Roberto worked for Rutronik, one of the largest distributors of electronic components in Europe, for ten years.  After two years working as inside sales, Roberto was promoted to Sales Engineer and oversaw a client base representing 12 million Euros per year.

Mary and Affinity’s Director of Engineering, Bob Frank, got to know Roberto while he worked for Hypertac/Hypertronics where he was responsible for growing the company’s presence in the medical market.  “Working on mutual projects we got to know Roberto very well,” said Bob.  “He has a lot of experience working with medical device manufactures and we are glad that he is part of the Affinity team.”


Andrea, Gary, Tracy and Roberto

Asked about why he was interested in representing Affinity, Roberto replied, “I have always respected Mary and Bob and the way Affinity approaches business.  I believe our customers are our valued partners as Mary and Bob do.”

Roberto and his family live in the countryside in Allgau Germany, a region in south-west Bavaria.  His wife, Andrea, and two children, Tracy (7) and Gary (10) love the mountains and hiking.  Roberto says, “Andrea does a wonderful job of managing our family which keeps me free to concentrate on my job during the day.  We have wonderful children.  Both Tracy and Gary are very good in school.  They both like music and singing and are very active children.”

When asked what his hobbies were, Roberto replied, “I like country music and enjoy wearing western clothing.  I have cowboy boots and several Stetson hats.  I also love dark chocolate and old malt whisky!  Of course I also enjoy a delicious steak as well Asian cooking and sushi.  I like to meet ingenious people and enjoy discussing business as a way to learn from each other!”

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Cables for Electrophysiology

One area of expertise for Affinity Medical is the design and manufacturing of cables for electrophysiology.


Example of 10-lead EP cable

Din 42802-2 style protected pin connector



Affinity produces both device to
patient and device to device cables

Affinity manufactures custom electrophysiology cables to our customer’s specifications, however most feature DIN 42802-2 safety pins for connection to the interface panel and the customer specified catheter connection on the opposite end.  Designations may be printed on the safety shield or on the wire itself.

In addition to cables to connect catheters to the interface panel, Affinity also designs and manufactures adapter cables and cables to connect system components.

For more information or samples of EP cables produced by Affinity contact Customer Care at 949-477-9495 or email to customercare2@affinitymedical.com

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Announcements, Information and Trivia



Canada’s Maple Leaf Flag


Mexico’s Flag

February Trivia

Flag Day - National Flag of Canada Day, also known as jour du drapeau national du Canada, is celebrated on February 15th and was established in 1995.  The Maple Leaf flag, the National Flag of Canada, was proclaimed thirty years earlier by Her Majesty Queen Elizabeth II, to take effect on February 15, 1965.

Flag Day - Dia de la Bandera is celebrated February 24th in Mexico and celebrates the flag of Mexico.  The civic holiday was implemented by President Lazaro Cardenas in 1937.

Leap Year Day – The Egyptians seemed to be the first to recognize that the solar year and the calendar year did not exactly match.  The reason is that it takes the Earth almost six hours longer than a calendar year of 365 days to circle the Sun.  In order to keep the calendar year from getting out of sync with the solar year, an occasional extra day was added to the calendar.


February 29th, 2012
is Leap Year Day

 

 


The Romans were the first to designate February 29th as a leap year day.  However, the 16th century Gregorian calendar was the first to include a leap year day only in years evenly divisible by four.  Even this, was not accurate enough to keep our calendar synchronized to the solar year.

Two other corrections were added.  Years evenly divisible by 100 are not a leap year, but years evenly divisible by 400 are!  Got that? – 2000 was a leap year, but 1900 was not!