Staying Connected - August 2007

Medical Cable Cleaning and Sterilization Considerations

One factor that should be considered when designing medical cables is how they will perform after being cleaned or sterilized.

As commonly used, all medical cables will require periodic cleaning.  Depending upon the use and the user’s protocol some will be cleaned only occasionally, while others will be cleaned after each use, and some may require disinfection or sterilization.


Common
Glutaraldehyde
Disinfectant

Typical - Non Critical Classification

Based on Spalding and EPA classifications, medical cables and leadwires are generally classified as non critical when considering disinfection or sterilization.  Medical cables and wires typically only touch intact skin and do not come in contact with mucous membranes.  Non critical devices typically require cleaning and low-level disinfection.  When cables or wires come in contact with non-intact skin or mucous membranes high level disinfection is required. 

Cable cleaning can be a simple wipe down with whatever cleaning solution is used in the clinical setting.  This is often a standard hospital disinfectant such as a bleach solution or glutaraldehyde (Cidex).  Both are effective when properly used in killing vegetative bacteria, fungi, and lipid viruses.

Minimum Standards Defined

Minimum standards for cleaning and disinfection of ECG Cables and Leadwires are established by ANSI/AAMI EC53.  Section 4.3.1 details cleaning and disinfection requirements:  “The trunk cable and patient leadwires shall be capable of being cleaned and disinfected 15 times with the following materials per 5.3.1:

  • green soap – or alcohol-free hand soap
  • 2% glutaraldehyde solution (such as Cidex)
  • Sodium hypochlorite (bleach) solution 10% in water

Alcohol based solutions or other solvent based cleaners have not been recommended for cleaning medical cables because they may dry out the cable or wire jacket causing it to become brittle and shorten the life of the product.  However, engineered plastics such as Santoprene® offer good to excellent resistance to isopropyl alcohol or alcohol based cleaners.

Most common “hospital” cleaning solutions and disinfectants can be used to clean and disinfect medical cables and wires when used at the manufacturers recommended dilution.  When used in higher strengths than the manufacturer recommends, cables and wires can be damaged.


Wiping with disinfectant or cleaner

Do not soak cables

Unless the cable assembly, including connectors, is specifically designed and manufactured to an IP (Ingress Protection) rating of 67 or higher, it should not cleaned or disinfected by submersion in a liquid.

Sterilization

EC53, Section 4.4.1 covers Ethylene oxide (EtO) sterilization requirements:  “The trunk cable and patient leadwires shall be capable of being subjected to EO sterilization 10 times according to section 5.4.1.”

In addition to EtO sterilization, some cables materials can be sterilized by Autoclave, but none are recommended for radiation sterilization.  Both Gamma and E-beam sterilization can cause serious degradation of the polymers (plastics) used in the manufacture of medical cables.

Summary

Cleaning, disinfection, and sterilization requirements need to be considered at an early stage of medical cable and wire development.  At Affinity Medical Technologies we design and manufacture medical cables to our customers’ specifications.  Customers will often specify cleaning, disinfection, and sterilization requirements.  Our engineers can assist selecting and specifying materials to meet those requirements.  Once specifications are established we assist with design validation testing and reporting.

 

Meet Candy Golding – Customer Care Supervisor


Candy

Everyone at Affinity Medical Technologies knows Candy Golding.  During her eight years at Affinity, Candy has shared her knowledge, time and skills with all members of the Affinity Medical team.  She draws from extensive previous professional experience in manufacturing, technical administration, supervision and customer service while completing her daily activities at Affinity Medical. 

Whether she is attending to the special needs of her customers, interacting with engineering, QA, production planning, MIS and shipping for customer related issues or special projects, supervising the customer care department as well as managing the front office, Candy is quick to volunteer her assistance.  She never refuses to answer questions from co-workers, assist vendors or take customer inquiries.  Candy is always ready to help resolve pressing issues immediately and thoroughly despite her very busy schedule. As Customer Care Supervisor, Candy Golding is somewhat involved with every department at Affinity Medical Technologies. Her philosophy is: “If I accept it, I own it.”  Candy also has the uncanny ability to be able to identify every part made by Affinity.  If the part exists, you can bet she knows it!  

You might say Candy Golding wears many “hats” at Affinity Medical Technologies.  However, her main focus is and always will be the customer. She has been known to go more than the extra mile to provide world class customer service to each and every external and internal customer.

An example of Candy’s dedication to customers started when Candy answered a phone call from a customer Friday after closing time. The customer had an emergency situation and needed product Saturday morning. Since the other employees had already left for the weekend, Candy gathered up the parts, loaded them into her car and drove some 40 miles in rush hour traffic to LAX airport in time to make sure the order got sent that night.  Candy’s customers truly appreciate and frequently acknowledge her efforts.  When asked what she enjoys most about her job, Candy said: “I consider myself part of the customer’s team and do whatever it takes to help them achieve success. When the customer wins, Affinity wins.” 


Candy goes above and
beyond for Affinity customers

In her free time away from Affinity Medical, Candy is a proud “Mom” to her pets; an active little dog named Pujo, a growing aquatic turtle, Spike and Herman the desert turtle. She has toured several countries in Europe and traveled to Africa on a photo safari. With a Bachelor’s degree in physical education, Candy enjoys tennis and other team sports in addition to reading mystery novels and weekly visits with her Aunt Doll. 

 

Cable Management Systems


Common “jumble” of Cables

Hospital patients are often monitored simultaneously for multiple physiological parameters; most commonly ECG, blood pressure, and oxygen saturation. This generally means that there are three or more cables connected between monitors and the patient.  Add to this an IV line and possibly an oxygen line there can be a “tangle of wires” as one nurse described it.

One option to reduce the number of lines running to the patient is to use a cable management system where one cable carries two or more signals from sensors on the patient to the monitor.  The typical configuration is one trunk cable with multiple monitor connectors on one end and multiple sensor connectors on the distal end.


Example of Trifurcated Cable

Affinity Medical Technologies has developed and manufactured a number of variations of cable management systems including bifurcated and trifurcated versions.

Depending upon the nature of signals to be carried, the raw cable material may be simple, meaning a number of conductors within an outer jacket or complex meaning there are multiple discrete cables, typically shielded or isolated, within the outer jacket; “cables within a cable.”

The Affinity Medical engineering team can assist with design of cable management systems.  Contacting us early in your product development cycle allows you to take maximum advantage of our experience and expertise in cable design.

If you would like to see a sample of a bifurcated or trifurcated cable management system, contact Affinity Medical Customer Care at 949-477-9495 or email to customercare2@affinitymed.com.

 

Announcements and Information


The Affinity team will enjoy a
Monday September 3rd off!

Labor Day is a federal holiday in the United States that takes place on the first Monday in September.  The holiday began in 1882, originating from a desire by the Central Labor Union to create a day off for working men and women.  It is still celebrated mainly as a day of rest and relaxation.  Also, this holiday symbolically marks the end of summer.  We hope you enjoy your day off


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.

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Affinity Medical Technologies

1732 Reynolds Ave
Irvine, CA 92614  USA
Phone: 949-477-9495
Fax: 949-477-9499
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