Staying Connected - October 2013

Design Verification and Validation of Medical Cable Assemblies



Verification and validation is required
by U.S. Code of Federal Regulations
for medical devices

Design Verification Testing confirms that once manufactured, a product meets the original specifications and requirements established during the product development process.  Design validation confirms that the product functions according to design inputs when manufactured using normal production processes.

Design verification of medical devices is required.  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.”

Required 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.

It is important to consider validation and verification requirements at the beginning of a project in order to allocate sufficient time to:

  • Adequately plan and document verification and validation requirements
  • Identify resources necessary to perform verification and validation activities
  • Execute the test plan
  • Evaluate, report and, if appropriate, approve the test results

Verification and Validation Protocols



Packaging, storage, handling and shipping
requirements are commonly included
in Verification and Validation testing


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, product name 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:
    • Mechanical requirements
    • Electrical requirements
    • Cleaning, disinfecting, sterilization and chemical resistance 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 will be used to perform testing, what data will be collected, and what criteria must be met to confirm the design.

  • Test Data – includes test results, names of individuals performing the tests, and equipment used for testing including model numbers and calibration data.  Data from each test is included, generally in table form and 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” are to be used for validation.  With proper planning, test protocols will be approved and ready to implement when first article parts are produced.

Pre-Conditioning prior to Testing

Depending upon the nature of the product, pre-conditioning may be required as part of the test plan.  Pre-conditioning may include cleaning, disinfecting 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 “hand soap”
  • Cidex (Phthalaldehyde)
  • Isopropyl alcohol

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 by wiping and followed by wiping to dry.  The specified number of cycles is repeated for each cleaning or disinfection agent.

For products requiring a high number of sterilization cycles prior to testing, weeks may be needed to complete the pre-conditioning process.


Affinity lab technician David Moreno
placing cables into autoclave chamber
for sterilization pre-conditioning

Cables numbered to facilitate
record keeping of test results

Once all required pre-conditioning is complete and documented, execution of the testing portion of the protocol can begin.

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

Affinity engineering technician
Eric Yamane performs mate-unmate
cycling of connectors by hand

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

Electrical Testing

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


Defibrillation withstand testing
is a common requirement for
medical cable assemblies


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

The Test Report

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 medical interconnect devices.  The Affinity engineering team has the experience and expertise to help design and develop your new medical cable assembly, connector or interface.

The Affinity team may also save you time and resources by completing verification and validation activities on your behalf.   For more information, contact Affinity customer care at 949-477-9495 or email to customercare2@affinitymed.com.

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Meet Jessy Vivar– Affinity Manufacturing Associate


Jessy Vivar,
Affinity Production Associate


While Jessy has only worked at Affinity for two years, he is already on his fourth position in manufacturing, evidence of his interest in learning and growing.

Jessy joined Affinity after graduating from Oceanview High School in Huntington Beach, California.  He said “I wanted a job that was more challenging and interesting than working in fast food.  My cousin worked for Affinity and told me that the company was hiring.  I interviewed with Jerry Ruiz and was happy to be offered a job in production.”

Jessy started in workcell 22 on second shift, manufacturing electrophysiology cables.  He said the most difficult thing to learn was proper soldering techniques.  “I had good teachers both in the workcell and in our formal IPC training, but that was the one aspect of my job that I really had to concentrate on becoming skillful at.”

While assigned to work cell 19, the Cell Champion job became open.  Jessy applied and was promoted to the position.  “We had such good people in the workcell that being a Cell Champion was not difficult.  My responsibilities included making sure that everyone knew exactly what product we were manufacturing, understood the work instructions and that all the tools, fixtures and test equipment needed were available.”

Being interested in learning more and advancing in the company, Jessy applied for and was offered a position as a mold machine operator.  “I started on mold machine number two which produces the high-volume “tails” used on many of the other cables we manufacture.  After gaining experience on that machine I had the opportunity to train and run mold machine number seven, one of our new Arburg presses.  For difficult to mold jobs, I really liked the precision and amount of control the Arburg press offered.”



Angel Vargas showing Jessy
features of a surface grinder in
Affinity’s maintenance shop


Recently Jessy moved into maintenance, wanting to learn even more.  “I love to learn and working with Angel in maintenance gives me even more opportunities to learn.”

Jessy’s wife Beatriz also works at Affinity as a manufacturing associate in workcell 25.  “I see my wife because we both work on second shift, but we don’t work together,” said Jessy.  Asked if there was anything he liked specifically about working at Affinity, Jessy commented, “I really like the family atmosphere.  Everyone gets along well and the work environment is really good.”

Jessy and Beatriz live in nearby Huntington Beach and have a two year old son, Daniel.  When not working, Jessy enjoys spending time with his family.  He also likes hunting and paintball!

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Cables for Electrophysiology Procedures


Example of a 24-lead catheter
interface cable

Din 42802-2 style protected
pin connector

One area in which the Affinity Medical team is very experienced is designing and manufacturing cable assemblies used in Electrophysiology procedures.


Affinity designs and manufactures
both device to patient and device
to device cable assemblies


Affinity manufactures custom electrophysiology cables for OEM device makers.  Our engineering team is available to assist OEMs with design, material selection and establishing specifications.  Many cable assemblies incorporate DIN 42802-2 safety pins for connection to the pin-box panel and customer specified catheter connection on the opposite end.  For proper identification, designations may be printed on the safety shield or on the leadwire jacket.

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

For more information regarding how the Affinity engineering team can assist with your EP cable requirements, contact Affinity Customer Care at +1 949.477.9495 or email to customercare2@affinitymedical.com

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Announcements, Information and Trivia

October Trivia

The 8th Month? – October derives its name from the Latin word “octo” meaning eight.  October was the eight month of the old Roman calendar while it is the tenth month of the year in the Gregorian calendar which we use today.





Oktoberfest – Oktoberfest is the world’s largest fair!  It is held annually in Munich, Germany running 16 days from late September to early October.  During the fair, more than six million people participate from around the world.

Eid-al-Adha – عيد الأضحى Many Muslims observe Eid-al-Adha, also known as the “Feast of Sacrifice,” commemorates the prophet Ibrahim's willingness to sacrifice his young and only firstborn son in obedience to a command from God.  Eid-Al-Adha also marks the end of the annual holy pilgrimage to Mecca.

United Nations Day – October 23th is celebrated as the anniversary of the Charter of the United Nations.  In 1971 the United Nations General Assembly adopted a resolution  declaring that United Nations Day shall be an international holiday and recommended that it should be observed as a public holiday by all United Nations member states.

Daylight Savings Time Ends – For much of Europe, Daylight Savings Time ends on Sunday, October 27th.  For the United States, Canada and those countries in the western hemisphere that adopt Daylight Savings Time, it ends Sunday, November 3rd.