Medical Device Design using

Polymer Compounds
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Plastics—more specifically, specially formulated polymer compounds—make

possible a wide range of components used in medical device design, from syringe
bulbs and blood-pressure cuffs to catheters and bags for intravenous (IV) fluids.
Medical tubing includes peristaltic tubing used to pump fluids and multi-lumen
catheters that can be used, for example, to administer multiple IV solutions or drugs
at once. Medical compounds are essential for items used in surgery, including
Yankauer suctioning tools, oxygen masks, and drip chambers. These plastic
compounds are needed for gaskets, cushioning, insulation, bag spouts, caps,
fittings, and luers.

How can Polymers be validated for design inputs?

Because medical compounds are used in these applications that are critical to life
and health, they have specific requirements for biocompatibility, sterilization, and
material physical performance; these qualifications help the devices in which they
are used to gain regulatory approval.  The following article describes some of these
characteristics, which can be used to validate whether a material will be fit for a
specific use.

What is biocompatibility?
To be biocompatible, a material or device must not produce any adverse response in
the human body. Compounds used in medical devices must meet the
biocompatibility requirements of the application for which they are used. Regulatory
agencies typically require the final medical device, which might include several
different types of materials, to be tested for biocompatibility for a specific application.
Although agencies approve the device, not the materials, materials can be tested
ahead of time to validate that they are generally biocompatible.

Standards for measuring biocompatibility include those in the United States

Pharmacopeia (USP), published by the non-governmental organization with the
same name; the European Pharmacopoeia (Ph. Eur.), published by the European
Directorate for the Quality of Medicines and Healthcare (EDQM); the Japanese
Pharmacopoeia (JP), published by the Japanese Pharmaceuticals and Medical
Devices Agency, and others. The globally accepted standard, however, is
the International Organization for Standardization (ISO)’s ISO 10993, “Biological
evaluation of medical devices—Part 1: Evaluation within a risk management
process.”

USP General Chapter <87> “Biological Reactivity Tests, In Vitro,” describes three
tests (agar diffusion, direct contact, and elution) used to determine biological
reactivity of mammalian cell cultures in contact with polymer materials. The tests
look at cytotoxicity (i.e., if and to what extent a material is toxic to cells).

USP General Chapter <88> “Biological Reactivity Tests, In Vivo,” details tests that
can be used to classify materials into one of six classes (I to VI), based on biological
reactivity under certain conditions related to the intended end use. USP Class VI
requires the most comprehensive testing. According to US Pharmacopeia, if the
material is to be exposed to a sterilization process prior to end-use, the tests should
be conducted on specimens preconditioned under the relevant process. PVC
Compound 2222C-85 is an extrusion-grade PVC that is widely used for urological
tubing. It meets all requirements for biomedical Class VI devices.

Are medical compounds latex-free?  

Some people may be severely allergic to the proteins found in natural latex. For
these patients, even a trace amount of latex or latex in even a minor component of a
device can produce a life-threatening reaction. Mexichem Specialty Compounds
medical compounds do not contain latex and are not processed on compounding
lines with any latex materials, so they are latex free.

Do medical compounds contain phthalates?  

Flexible PVC has historically used phthalate-based plasticizers. Due to some
potential health and safety concerns, some ortho-phthalate-based plasticizers have
been eliminated or have had their use restricted in some countries. There are many
plasticizers, however, that are not restricted and can be used safely in PVC. Some
non-phthalate plasticizers are considered acceptable and there is a range
of phthalate-free plasticizers being used in medical PVC compounds. TPEs are an
alternative to PVC that does not use plasticizers at all.
Do medical compounds contain animal by-products?
In the past there was some concern that ingredients based on animal by-products
(e.g., tallow, glycerol, casein) could have a risk of containing an infectious prion
protein that causes TSE (Transmissible Spongiform Encephalopathy). Although
animal-based tallow has been confirmed to be safe against the spread of TSE when
processed properly, some customers wish to eliminate all animal by-products.
Animal-based ingredients can often be replaced with vegetable-sourced or
petroleum-based products to make compounds without any animal by-products.

For more information, Read a Case Study about PVC Compound ‘Animal By-Product
Free’ solutions for Medical and Dental Products.

What are the physical performance requirements for

medical compounds?
In addition to being non-toxic and sterilizable (as discussed previously in this article),
compounds need to have the strength and flexibility appropriate for their intended
use. For example, some uses may require flexible materials (with durometers in the
35-95 Shore A range), while others may require the material to be stiff, but still
pliable (i.e., semi-rigid, with durometers in the 55-70 Shore D range). Other uses
may require a rigid material (typically over 75 Shore D hardness) with good impact
resistance. Compounds used in tubing should have kink resistance, so that the tube
won’t collapse when it is bent. For some uses, water-blush resistance is important,
meaning that there will be no migration of ingredients to the surface of the device
upon contact with water or immersion in water. Applications such as drip chambers
need a compound with high clarity. Compound formulators design materials to have
the best balance of properties for a given application.

What does it mean to be sterilizable?

Medical devices are typically sterilized after they are manufactured to ensure that no
pathogenic organisms are present on their surface. In most cases, compounds used
in these medical devices must be sterilizable. In other words, they must be stable
under sterilization conditions, and the material must not break down, degrade, or
suffer a major loss of physical properties and/or aesthetics.  

Methods of sterilization include autoclaving, which uses saturated steam (i.e., moist
heat sterilization), and gaseous chemical sterilization. Sterilizing by irradiation with
high energy (e.g., electron beam or gamma rays) requires specially designed
compounds to withstand these conditions.

What regulatory standards must medical compounds

meet?
Many countries have a regulatory body that monitors and approves medical devices
according to that country’s specific requirements. In the US, devices are regulated by
the Food and Drug Administration (FDA)’s Center for Devices and Radiological
Health (CDRH). Health Canada’s Therapeutic Products Directorate (TPD) authorizes
devices in Canada under the Canadian Medical Device Regulations (SOR/98-282).
In Japan, the Ministry of Health, Labor and Welfare (MHLW) administers Ministerial
Ordinance 169 for medical devices. In Europe, devices must have a CE mark, which
indicates compliance with the appropriate directives (e.g., the Medical Device
Directive). Most regulations cover the finished medical device, not the materials
going into those devices. However, device makers should consider the
characteristics that will be needed, such as whether the materials are biocompatible
and sterilizable.

Several chemical regulations also affect medical compounds. The Registration,

Evaluation, Authorisation, and Restriction of Chemicals (REACH) is a
comprehensive regulation for the use of chemicals and substances in the European
Union. Additives used in medical compounds in Europe must comply.  

The European Union’s Restriction of Hazardous Substances (RoHS) directive was

originally designed for reducing hazardous materials (e.g., heavy metals such as
lead and mercury) in electrical and electronic equipment.  An updated version (RoHS
2) expanded the scope to include medical devices and additional restricted
substances, including the phthalate plasticizer DEHP, which is widely used in
medical plastics. To comply with RoHS by 2021, medical plastics containing DEHP
will need to be reformulated with alternative plasticizers. 

Other common concerns for medical compounds

What are FDA sanctioned ingredients? The US Food and Drug Administration
(FDA) regulates materials that come in contact with food. The components of a
compound can be approved by FDA for direct or indirect food contact. This approval
is not a requirement for medical devices, but it is often considered an indication of
product purity. 
Drip chambers, tubing caps and connectors benefit from the sparkling clarity, high
thermal stability, and easy mold release of PVC Compound 3006-90.

What are biobased materials? Traditionally, plastic compounds have been made

from petroleum-derived products. Today, some plastic compounds are made instead
with biobased materials. These can include polymers made from renewable
resources as well as biobased additives, including plasticizers, stabilizers, and
lubricants. Biobased materials are considered more sustainable and environmentally
friendly. 

What polymers are used in medical product design

Different types of polymers have been used for many years in medical devices. The
most-used polymer for medical device applications has been PVC, because of its
properties such as versatility, availability, clarity, kink-resistance, and low price. For
enhanced properties such as resilience, abrasion resistance, and chemical
resistance, PVC alloys (e.g., with polyurethane, ethylene vinyl acetate [EVA], and
polyacrylonitrile [pAN]) have been developed.

Thermoplastic elastomer (TPE) compounds have been developed as an alternative

to PVC. TPEs are flexible without containing plasticizers and are used for demanding
medical applications requiring phthalate-free, soft touch, and high elasticity.  

 
Should you require further information with regards Medical
Compounds please contact our sales representative in your
country here.