Staying Connected - June 2012

The impact of RoHS, WEEE and REACH on Medical Cables and Connectors

The majority of OEMs that Affinity manufactures cable assemblies for operate globally and ship products into European Union member countries.  Because of this, most of the products that Affinity manufactures are, or will, be required to comply with RoHS and REACH directives.



There is no standard logo
to show RoHS compliance

RoHS – Restriction of Hazardous Substances Directive

Adopted in February 2003 by the European Union, Directive 2002/95/EC (Restriction of Hazardous Substances Directive) took effect on July 1st, 2006.  The directive restricts the use of six hazardous materials in the manufacture of electronic and electrical equipment.  Medical devices were excluded from the original RoHS directive.  In 2011, the European Union adopted “RoHS Recast” which eliminates the exemption for most medical devices in July 2014.

Restricted Substances

Compared to REACH, which is discussed later, the RoHS directive is relatively simple and only restricts the use of six substances:

  • Lead (Pb)
  • Mercury (Hg)
  • Cadmium (Cd)
  • Hexavalent chromium (Cr6+)
  • Polybrominated biphenyls (PBB)
  • Polybrominated diphenyl ether (PBDE)

PBB and PBDE are often referred to as brominated flame retardants (BFR).  These substances are commonly used as flame retardants for plastic materials.

Maximum Concentrations

For RoHS compliance, the maximum permitted concentration of listed substances is 0.1% or 1,000 parts per million for all but cadmium.  For cadmium, the maximum permitted concentration is 0.01% or 100 parts per million.  The restriction is for any “homogeneous material,” meaning any substance that can even theoretically be separated.

RoHS requires that every component that can be identified as a homogeneous material must be below the maximum concentration.  As an example, if a device includes a solder connection and the solder contains more than 0.1% of lead, the entire device would be considered non-compliant under the RoHS directive.

Lead

The first restriction often thought of in relation to RoHS is the restriction on the use of lead.  Lead has been a common substance used in the manufacture of electronic and electrical devices, both in electronic components and in solder.


A typical symbol that designates
a product as lead-free


Except where customers specify leaded
solder, Affinity transitioned to lead-free
solder in 2008

Excluding products where the customer continues to specify leaded solder, Affinity transitioned to lead-free solder in early 2008.  “Except for a much higher cost, we don’t see a difference in manufacturing with lead-free solder,” said Affinity Manager of Manufacturing, Kevin Kom.  “Our ongoing solder training to IPC 610 and 620 has been done with lead-free solder for the past four years.”

Cadmium

Copper alloy conductors are often used for cable applications where greater flex life or tensile strength is required.  To increase performance a small amount of cadmium has been commonly used with copper and other substances. While the amount of cadmium in these alloys was typically about 1%, that is far in excess of the .01% permitted to be RoHS compliant.

RoHS compliant copper alloys have become available with various combinations of beryllium, tin, phosphorus, chromium, and iron which offer nearly the same performance as non-compliant alloys that contained cadmium.

Brominated Flame Retardants (BFR)

Brominated flame retardants are prohibited by RoHS and are typically not a concern for medical cables.  The addition of flame retardants typically causes the cable jacket to fail biocompatibility and cytotoxicity requirements.  Because of this, the resins used in medical cable jackets do not include flame retardants.

WEEE – Waste from Electrical and Electronic Equipment Directive

The European Union Directive 2002/96/EC was adopted together with RoHS in February 2003.  WEEE - Waste Electrical and Electronic Equipment Directive sets collection, recycling and recovery targets for electrical goods in order to reduce the amount of toxic electronic waste.


The WEEE symbol called
out by EN 50419 used to
designate the device should
not be discarded in normal
waste stream


The WEEE waste hierarchy chart –
graphically illustrates the best to worst
end-of-life options for electronic products

The WEEE directive is made up of ten reporting categories, with category 8 being medical devices.  The directive sets collection, recycling and recovery targets for electronic and electrical products.  WEEE makes the manufacturer or distributor of electronic equipment responsible for meeting recovery targets.

The WEEE directive promotes reuse, with section 18 of the directive stating: “Where appropriate, priority should be given to the reuse of WEEE and its components, subassemblies and consumables.”  Designing and manufacturing long-lasting, robust medical cables is one of the core competencies of the Affinity engineering team and aligns well within the scope of WEEE.


The flag of the European Union

REACH - Registration, Evaluation, Authorization and Restriction of Chemicals

REACH - was approved by the European Parliament on December 13 2006 and was formally adopted shortly thereafter.  It became effective June 1, 2007 with implementation scheduled to be phased in over eleven years.

Headquartered in Helsinki, Finland, the European Chemicals Agency (ECHA) was founded in 2007.   The Agency manages the technical, scientific and administrative aspects of REACH.  It manages the databases necessary to operate the system, co-ordinates the evaluation of chemicals and offers a searchable public database of chemical substances.

The Agency has set three major deadlines for the registration of chemicals. In general the registration deadline is determined by the amount of the substance manufactured or imported by a company or individual.

Quantity Registration Deadline
1,000 tons or more per year December 1, 2010
100 tons or more per year June 1, 2013
1 ton or more per year June 1, 2018

Because of the potential negative impact on human health or the environment, REACH also addresses the use of “substances of very high concern” (SVHC).  Beginning June 1, 2011, the European Chemicals Agency must be notified of the presence of SVHC substances in articles if the total quantity used or imported is more than one ton per year and the amount of the substance is greater than 0.1% of the weight of the article.

Bis(2-ethylhexyl) phthalate - DEHP

Un-plasticized polyvinyl chloride (PVC) is hard and brittle at room temperature.  DEHP is the most commonly used plasticizer added to increase the flexibility PVC.  It is also referred to as a phthalate.  Medical devices that may contain DEHP-plasticized PVC include: bags, tubing, catheters, and, some medical cables.

PVC is one of the materials commonly used as a jacket for lower cost medical cables and leadwires.  PVC is not as durable as thermoplastic rubbers or urethanes and is often used for limited use cables or disposable leadwires.

Medical grade PVC resins are available that do not contain DEHP and that meet both RoHS and REACH requirements.  As our OEM partners request or change specifications, Affinity is transitioning components that containd DEHP to RoHS and REACH compliant materials.

Substances of Very High Concern – SVHC

As of June 18th, 2012, the list of SVHCs contained 84 “candidate” substances.  Manufacturers or importers of articles containing more than 0.1% by weight of any listed item must provide their customers adequate information on the safe use and disposal of the substance or article which contains the substance.  Beginning June 1, 2011, manufacturers and importers also had to notify the European Chemicals Agency of the quantities of SVHCs used in their articles.

The list is referred to as the "candidate" list because all substances placed on it are candidates for inclusion in Annex XIV of REACH. If a substance is added to Annex XIV, it is given a "latest application date" and a "sunset date".  The sunset date is the date after which the substance cannot be used or imported into the EU without specific authorization from the ECHA.

The Affinity engineering team has analyzed the list of SVHC substances and except for DEHP none are known to be used in cables or connectors manufactured by Affinity.

Summary

For device manufactures operating globally, complying with RoHS, WEEE and REACH is a necessity.  If your current cables to not meet these requirements, the Affinity engineering team would be happy to offer a compliant alternative.  For additional information, please contact us at +1 949-477-9495 or via email to customercare2@affinitymedical.com.

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Lunch and Learn – An Affinity Educational Program
at Your Facility


Affinity’s Lunch and Learn programs are another way we try stay connected with our customers and friends.  Choose from one of our three programs and gain additional insight and perspective about custom medical cable assemblies and connectors.

Our programs last about forty-five minutes, with the time divided between learning and lunch.  Affinity will provide lunch for your group.  There is no cost or obligation, except that we require a group of at least four and a meeting room with a digital projector.  Each attendee will receive a copy of the training material.

  • Off-The-Shelf or Custom Medical Connectors – A discussion of three connector options: off-the-shelf, custom or hybrid.  We’ll discuss the advantages and disadvantages of each including performance, cost and availability.  Samples of each will be shared and discussed.
  • ANSI/AAMI EC53 Compliance – Establishing the basis for medical cable and leadwire specifications.  We’ll discuss the standard, its intent, and how it can be applied to medical cable and connector design.
  • Strain Reliefs – A discussion of how strain reliefs affect both electrical and mechanical performance of medical cables.  We’ll show samples of off-the-shelf and custom strain reliefs and discuss the advantages and disadvantages of each.

Lunch and Learn sessions are offered free of charge and are conducted by Bob Frank, Hank Mancini, or Jim Itkin.  Each have over 20 years experience in medical devices including medical cable assemblies and medical connectors.

For more information or to schedule a Lunch and Learn session for your team, contact Hank Mancini at 949-477-9495 or email to hmancini@affinitymedical.com.

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Meet Stephanie Abatangelo – Junior Buyer



Stephanie Abatangelo
– new Junior Buyer

Stephanie Abatangelo is one of the newest Affinity team members joining the company in April as a Junior Buyer.

After taking a three-year break to be a stay-at-home mother, Stephanie wanted to go back to work.  She found Affinity’s add for a Junior Buyer on Craig’s list, applied and after several interviews was offered the position by Sue Alessi, Affinity’s Materials Supervisor.

Prior to having children, Stephanie worked for Urban Decay, a local cosmetics company as a senior buyer.  “During my five years at Urban Decay, I purchased just about everything - components, bulk powders, packaging and labeling,” said Stephanie.  “I learned a lot at Urban Decay and really enjoyed purchasing.”  Before that, she worked in the Men’s Department at Nordstrom’s where she met her husband.


Affinity Buyer/Planner
Karena Bejarano training Stephanie

When asked what attracted her to the company, Stephanie replied, “I was impressed with the sincerity of everyone I met at Affinity.  I was looking for a company that I could grow with and the position at Affinity seemed to be in-line with my goals.  And, since starting at Affinity, everyone here has been very helpful and welcoming,” said Stephanie.

Asked about the challenges of her job so far, Stephanie commented, “My biggest challenges so far have been understanding all of our part numbers and just not having enough time in the day.  I look forward to having a better understanding of all aspects of the company so that I can contribute more.  I am a people person and enjoy working with our suppliers.  I also enjoy the fast pace of purchasing.”

Stephanie grew up on Orange County, California and graduated from California State University Fullerton with a Bachelor of Science degree in Child Development.

Stephanie and her husband Frank live in Anaheim Hills, about twenty miles from Affinity.  They have been married for nearly 10 years and have two children, a 7 year old son, Jude and a 3 ½ year old daughter, Charlie.

Asked about what she does away from work, Stephanie said “I love photography!  My husband bought me a camera about five years ago and I love capturing our family’s special moments.  I always have my camera with me at family gatherings and outings.  I enjoy sharing my photos with everyone in our family.”  Stephanie also said she enjoys spending time with her family and volunteering at church.

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Announcements, Information and Trivia


Word Trivia

“Stewardesses” – is the longest word that can be typed with only the left hand

“Dreamt” – is the only English word that ends in “mt”

Quick Brown Fox – The sentence “The quick brown fox jumps over the lazy dog” uses every letter of the alphabet!

“Aegilops” - a genus of plants generally known as goatgrasse, is the longest English word with its letters arranged in alphabetical order


“MOW” “SWIMS” AND “SIS” are three English words that when written with uppercase letters read the same when viewed inverted 180 degrees

“Lollipop” – is the longest word that can be typed with only the right hand

“Folk” and “Folks” are both plural English words without singular forms

Fiddledeedee – is one of the two longest English words (the other is fickleheaded) containing only letters from the first half of the alphabet

Deeded is one of the few English words that is normally typed with just one finger