Staying Connected - March 2008

Design Verification and Validation of Medical Cable Assemblies

Design verification and validation of medical devices is required by regulatory bodies to help ensure that newly developed products perform as expected.  The 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.”

Additionally, “Validation [820.30(g)] means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.”

One of the services that Affinity Medical offers to its customers is reporting of Design Verification Testing and Validation activities.  Design verification confirms that the product meets all requirements established during design input.  Design validation ensures that the device will operate correctly for its intended application. 


Verification and validation
plan documented in protocols

Validation and Verification -
Part of Our Development Process

At Affinity, we include design verification and validation as an integral part of our new product development process.   As we work with our customers to establish specifications we understand that we will need the means to verify these requirements.  Considering validation and verification from the beginning of a project allows time to plan these activities and acquire or build test devices or equipment necessary to perform verification and validation testing.

By establishing regularly scheduled design reviews and project status meetings, we assist our customers to establish, confirm, and document product specifications.  Reviewing the design, product specifications and requirements on a regular basis generally means that there are no surprises and the project proceeds on schedule.

Verification and Validation Protocols

Good planning helps ensure verification and validation activities do not slow down or hinder new product deployment.  Planning entails writing Verification and Validation Protocols.  Each Protocol should include well defined steps, leading to confirmation of the design.  At Affinity, our protocols typically consist of:

  • Purpose – States the purpose of the Protocol.  Verification confirms that design outputs match design input requirements.  Validation confirms the device meets specifications established and documented in the development process.
  • 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:
    • Environmental requirements
    • Cleaning, disinfecting, and chemical resistance requirements
    • Electrical requirements
    • Mechanical requirements
    • Labeling and packaging requirements
  • Reference Documents –documents containing the specifications, the test plan, drawings, and referenced standards.
  • 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 testing, and 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.
  • Test Data – includes the test results, the 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/Summary – Confirms that the product tested exhibits compliance to customer specifications and referenced standards and detailing any area of non-compliance.

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


Preparing samples for
dielectric withstand testing
and test data recorded on pad


Numbered validation samples

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 production first article parts are produced.

Depending upon the nature of the product, pre-conditioning may be required as part of the test plan.  Pre-conditioning may include sterilization or cleaning.  For products subject to ETO sterilization, AAMI/ANSI EC53 requires 10 sterilization cycles which can add several weeks to the testing schedule.

Once any pre-conditioning is complete, electrical and mechanical testing can begin.  Two aspects of mechanical testing, mate/un-mate and flex testing, typically take the greatest amount of hours.  If the test plan calls for a number of samples to be flex tested to failure, weeks of lab time may be required.  Similarly, if the number of mate and un-mate cycles and the sample size is large, many hours may be required.  At Affinity, we typically perform all mate and un-mate testing by hand because it more accurately reflects how medical cable assemblies and connectors will be used.


Validation testing for
dielectric withstand

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

Summary

Verification and validation helps ensure the functionality and manufacturability of newly developed products.  Affinity Medical includes complete reporting of design verification testing and validation activities as a part of our new product development process.  Let Affinity not only help design and develop your new medical cable assembly but save you time and resources by completing verification and validation requirements. For more information, contact Affinity Customer Care at 949-477-9495 or email to customercare2@affinitymed.com.

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Meet Sue Alessi, Affinity Medical Buyer and Production Planner


Sue Alessi – always smiling

Sue Alessi joined Affinity Medical Technologies six years ago in the duel position of Production Planner and Materials Buyer.  Her previous professional experience in injection molding, materials management and master scheduling in the corporate medical manufacturing industry made Sue a welcome and valuable addition to the Affinity Medical team. 

With a Bachelor of Arts degree in Business Management from Northern Michigan University, Sue first entered the business world as a retail buyer.  At one time, Sue, who is 6’3”, considered starting her own tall women’s retail apparel business but an interesting career opportunity triggered her move to California.  While working for Tyco Healthcare in Southern California, Sue received extensive on the job training in JIT, team building and other aspects of production planning.  Sue’s past experiences help make her more effective planning and buying for Affinity Medical. 

At Affinity, Sue works closely not only with the production team, but with Engineering, Quality and Sales/Customer Care.  In fact, she is instrumental in almost every aspect of the production process for Affinity Medical’s cable assemblies.  Sue works hard to buy raw materials and components at the lowest possible price, which helps Affinity keep price increases to a minimum.  She also works hard to maintain correct inventory levels, schedules production work orders and manages several Vendor Managed Inventory (VMI) programs for Affinity customers.  Sue also supervises two cable cutters and assists them in their career development with on-the-job training to improve their skills, allowing them to accept more responsibilities. 


Sue at Affinity 10th
Anniversary picnic

Sue is always willing to do her best to help meet or exceed the customer’s expectations.  When asked what she likes most about her position at Affinity Medical Sue replied, ”I enjoy the small company environment and the great team that I work with.  We are all working together for one goal: to achieve customer satisfaction.  When orders are finished on time and cables meet our high quality standards, the entire team can see the immediate results of our efforts.”

An avid gardener, Sue enjoys swimming and spending time outdoors. She and her husband Adam are the proud “young” grandparents of a beautiful baby grandson, Antonio who they visit as much as possible along with their extended families.   Sue and Adam also like to step out to dine and dance at their favorite local restaurant in Mission Viejo, California whose owners are long time family friends. 

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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 safety pin connector

Affinity manufactures EP 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.


Example of “Distal”
printed on wire

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@affinitymed.com

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Announcements and Information

"Hoppy" Easter, Happy Spring!

Easter is the time for springtime festivals, school holidays, and a time to welcome back the tulips, the crocuses and the daffodils. It is a time of chocolate bunnies, marshmallow chicks and colored eggs.


The Flowers
of Spring

Easter is a movable Christian holy day because it falls on different dates dependant on lunar cycles. Easter falls at some point between late March and late April each year.  In 2008 Easter is celebrated in the United States on March 23rd, the 4th Sunday in March.  Many countries celebrate Easter Monday as a holiday.  Greek Orthodox Easter will be celebrated Sunday April 27th.  Enjoy Easter with your family and friends whatever day you choose to celebrate.

 


Suzann Sitka and Candy Golding
the Affinity Customer Care team

Affinity Customer Care - Hours of Operation

Affinity Medical Technologies customer care specialists are available from 7:00 A.M. until 4:00 P.M. Pacific time.

You may reach us by phone at 949-477-9495 or email to customercare2@affinitymed.com.

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Affinity Medical Technologies

1732 Reynolds Ave
Irvine, CA 92614  USA
Phone: 949-477-9495
Fax: 949-477-9499
Email: CustomerCare2@affinitymed.com
Website: www.affinitymed.com