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Rub­ber and plas­tics in med­ical technology 

31.08.2022   | Tobias Bettels

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Rub­ber and plas­tic have become indis­pens­able in med­ical tech­nol­o­gy. Thanks to their flex­i­ble prop­er­ties, they are ide­al for use in doc­tors’ offices, hos­pi­tals and care facil­i­ties. They are unbreak­able, easy to clean, do not absorb odors and have a low aller­gy risk. How­ev­er, the devel­op­ment of med­ical rub­ber and plas­tic solu­tions is chal­leng­ing because they are sub­ject to strict reg­u­la­tions and high qual­i­ty requirements.

Areas of appli­ca­tion for plas­tics and elastomers

The prop­er­ties of plas­tics and elas­tomers can be flex­i­bly adapt­ed to the area of appli­ca­tion by adding addi­tives. Depend­ing on their com­po­si­tion, their char­ac­ter­is­tics are stronger or weak­er. This makes them attrac­tive for the med­ical sec­tor, which is char­ac­ter­ized by high require­ments. A mate­r­i­al that can be flex­i­bly tai­lored to a spe­cif­ic ster­il­iza­tion process, for exam­ple, is of great val­ue here.

At the same time, it should be not­ed that sin­gle-use prod­ucts are fre­quent­ly used in med­i­cine, which are sup­plied ster­il­ized and dis­posed of after use. Price there­fore plays a major role. Dis­pos­able syringes, for exam­ple, which are ordered by the thou­sands by hos­pi­tals, must not have high unit costs.

Nev­er­the­less, the qual­i­ty require­ments of the med­ical indus­try still apply. To achieve this bal­anc­ing act, flex­i­ble mate­ri­als are need­ed whose char­ac­ter­is­tics can be pre­cise­ly modified.

There are many areas of appli­ca­tion for elas­tomers and plas­tics in med­ical tech­nol­o­gy. Exam­ples include:

  • Dis­pos­able syringes
  • Tubes for wound drainage
  • Cov­ers for med­ical devices
  • Breath­ing masks
  • Spat­u­las
  • Dis­pos­able gloves
  • Han­dles for sur­gi­cal instruments
  • Ram­ming pro­tec­tion for patient beds

In addi­tion, the mate­ri­als are used in elec­tron­ic com­po­nents installed in med­ical devices. For example:

  • Hoses
  • Valves
  • Diaphragms
  • O‑rings
  • Cas­ing

Dis­pos­able gloves and syringes as an appli­ca­tion area for polymers

Spe­cial require­ments for rub­ber and plas­tic products

Med­ical tech­nol­o­gy places high demands on rub­ber and plas­tic prod­ucts, because defects can have seri­ous con­se­quences for the health and life of patients. The spe­cif­ic require­ments depend on whether and how the prod­uct comes into con­tact with the body.

  • The high­est require­ments apply to implants and pros­the­ses that remain in the body for a long time and are dif­fi­cult to replace. These include arti­fi­cial joints and hearts, as well as com­po­nents installed in heart or brain pacemakers.
  • Reg­u­la­tions are some­what less strin­gent (but still high) for med­ical devices that come into con­tact with the human organ­ism only tem­porar­i­ly. This group includes res­pi­ra­to­ry masks, sur­gi­cal instru­ments, ban­dages and wound drains.
  • Periph­er­al devices make up the third cat­e­go­ry. These are med­ical prod­ucts that do not have direct con­tact with the human body, such as trans­port box­es, elec­tron­ic com­po­nents in pumps or the ram pro­tec­tion on patient beds. Com­pared to the first two cat­e­gories, the require­ments for them are rel­a­tive­ly low, but still high­er than in many non-med­ical areas.

All med­ical devices that come into direct con­tact with patients are required to be bio­com­pat­i­ble. This means that they must not have any neg­a­tive effects on the organ­ism and must be free of harm­ful sub­stances or side effects. The exact spec­i­fi­ca­tions of bio­com­pat­i­bil­i­ty are defined in ISO 10993.

It should be not­ed that bio­com­pat­i­bil­i­ty can also affect periph­er­al devices, in the form of indi­rect rela­tion­ships. This is the case, for exam­ple, with plas­tic bags for blood prod­ucts. Although the bag itself does not come into con­tact with the human body, its con­tents do. The plas­tic must not con­t­a­m­i­nate the blood bag. So here, too, bio­com­pat­i­bil­i­ty is an absolute must.

Mate­r­i­al selec­tion in med­ical technology

Med­ical tech­nol­o­gy is char­ac­ter­ized by a wide range of require­ments. Here, plas­tics and elas­tomers are exposed to var­i­ous chem­i­cals, clean­ing agents and sol­vents and must meet high qual­i­ty stan­dards. All these fac­tors have a direct influ­ence on mate­r­i­al selec­tion.

The ster­il­iza­tion process in par­tic­u­lar presents med­ical device man­u­fac­tur­ers with chal­lenges, as it expos­es the mate­r­i­al to unusu­al stress­es. Depend­ing on the type of ster­il­iza­tion, med­ical equip­ment must with­stand high tem­per­a­tures, radi­a­tion or con­tact with cer­tain gas­es with­out chang­ing its char­ac­ter­is­tics. These addi­tion­al require­ments must be con­sid­ered in mate­r­i­al selec­tion and lim­it options.

Among oth­ers, the fol­low­ing fac­tors influ­ence mate­r­i­al selec­tion in med­ical technology:

  • Tem­per­a­ture (This pri­mar­i­ly con­cerns resis­tance to high tem­per­a­tures that occur dur­ing clean­ing and sterilization). 
  • Media con­tact (Clean­ing agents and sol­vents are pri­mar­i­ly impor­tant, but ingre­di­ents of med­ica­tions can also be relevant).
  • Bio­com­pat­i­bil­i­ty or implant suit­abil­i­ty (This places even high­er demands on mate­ri­als and requires long-term safe­ty studies). 
  • Clean­ing and ster­il­iza­tion process (This includes resis­tance to radi­a­tion and UV light).
  • Prod­uct life and ser­vice life
  • FDA approval and cer­ti­fi­ca­tion accord­ing to ISO 13485 (qual­i­ty man­age­ment for med­ical products)
  • Clean­room suit­abil­i­ty (This relates less to the prod­uct itself than to pack­ag­ing and logis­tics, but can also have an impact on mate­r­i­al selection).
  • Sta­t­ic and dynam­ic loads (main­ly in med­ical devices)
  • Pres­ence of sliding/friction appli­ca­tions (For exam­ple, in hoses and pumps)

Typ­i­cal mate­ri­als in the med­ical industry

Unfor­tu­nate­ly, there is no uni­ver­sal mate­r­i­al that cov­ers all the require­ments of med­ical tech­nol­o­gy. The choice of mate­r­i­al always depends on the area of appli­ca­tion. Despite the high require­ments, some mate­ri­als have estab­lished them­selves that are used par­tic­u­lar­ly frequently. 
Verschiedene Polymere /blog/materialauswahl-bei-der-gummiproduktion/

Var­i­ous mate­ri­als for med­ical technology

Sil­i­cone

Sil­i­cone is a bio­com­pat­i­ble high-per­for­mance rub­ber that is char­ac­ter­ized by its out­stand­ing resis­tance to aging, weath­er­ing and tem­per­a­ture. It is insen­si­tive to alco­hol and can with­stand tem­per­a­tures up to 250 to 300 °C (depend­ing on the com­pound), so it can be eas­i­ly ster­il­ized. Thanks to its resis­tance, sil­i­cone is often used for func­tion­al com­po­nents that must not fail.

EPDM

EPDM is a tough, durable syn­thet­ic rub­ber used in var­i­ous med­ical prod­ucts. It is insen­si­tive to water (steam), alco­hol, acids as well as alka­line sol­vents. Clean­ing and ster­il­iza­tion are there­fore no prob­lem. In its basic form, the mate­r­i­al is not bio­com­pat­i­ble. How­ev­er, this prop­er­ty can be achieved by addi­tives. EPDM is very resis­tant and there­fore an excel­lent all-round mate­r­i­al for med­ical technology.

Poly­eth­yl­ene

Poly­eth­yl­ene (PE), the most wide­ly used plas­tic in the world, has sev­er­al char­ac­ter­is­tics that make it attrac­tive to the med­ical indus­try. It is resis­tant to acids and alka­lis, bio­com­pat­i­ble, wear-resis­tant and rel­a­tive­ly inex­pen­sive. PE is used for pack­ag­ing and syringes.

Polypropy­lene

Polypropy­lene (PP) is sim­i­lar to poly­eth­yl­ene in terms of dis­tri­b­u­tion as well as chem­i­cal and mechan­i­cal prop­er­ties. The mate­r­i­al is robust, resis­tant to clean­ing agents and dis­in­fec­tants and with­stands high tem­per­a­tures. PP is often used for pack­ag­ing, hous­ings and syringes.

Poly­styrene

Poly­styrene (PS) is par­tic­u­lar­ly inter­est­ing for the med­ical indus­try because of its opti­cal prop­er­ties. The mate­r­i­al has a high trans­paren­cy and is there­fore well suit­ed as a glass sub­sti­tute. Among oth­er things, PS is used for bot­tles, mea­sur­ing beakers and Petri dishes.

PVC

PVC is a robust, durable mate­r­i­al that is very easy to process and extreme­ly inex­pen­sive. In med­ical tech­nol­o­gy, it is used for hoses, catheters and dis­pos­able gloves, among oth­er things. Since PVC is very hard, plas­ti­ciz­ers are often added to the mate­r­i­al, which in the past caused health con­cerns. In the mean­time, how­ev­er, these addi­tives are DEHP-free (di(2‑ethylhexyl) phtha­late) and there­fore very suit­able for med­ical use.

Con­clu­sion

Plas­tics and elas­tomers have become stan­dard mate­ri­als in med­ical tech­nol­o­gy. They are light­weight, robust, harm­less to health and rel­a­tive­ly inex­pen­sive. In addi­tion, their mate­r­i­al prop­er­ties can be flex­i­bly adapt­ed to the area of appli­ca­tion. How­ev­er, it is impor­tant to care­ful­ly spec­i­fy the prod­uct require­ments. Par­tic­u­lar­ly in the med­ical indus­try, it can be dif­fi­cult to find a mate­r­i­al that opti­mal­ly meets all spec­i­fi­ca­tions, giv­en the high qual­i­ty require­ments. If in doubt, it is there­fore advis­able to con­sult mate­r­i­al experts who are famil­iar with the pit­falls of the industry.

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Author: Tobias Bettels

Tobias Bet­tels is a sales rep­re­sen­ta­tive at Jäger. The state-cer­ti­fied busi­ness econ­o­mist has more than 20 years of expe­ri­ence in plas­tics sales and worked in med­ical tech­nol­o­gy for eight years.

t.bettels@jaeger-gk.de | +49 5115358238

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