켐론FDA코리아

FDA는 의료기기 사용자들이 확인할 수 있도록 천연고무라텍스와 관련 있는 Medical Products에 대한 Labeling을
다음과 같이 공표하였다

천연고무라텍스 프로틴(natural rubber latex proteins)에 앨러지를 갖고 있는 사람이 천연고무라텍스를 함유한
Medical products를 접촉할 경우 생명까지 위협할 수 있는 심각한 결과를 초래할 수 있다.

하지만, 몇몇 Medical products의 생산자들은 제품과 제품 포장에 "천연고무라텍스, 건성천연고무, 또는 천연고무라텍스의
합성물질이 사용되지 않았다"라고 사용자들이 확인할 수 있도록 Labeling하고 있다. 그러나 이런 Labeling은 과학적인
증명자료가 없으며 또한 오염사고에 관련한 내용도 누락되어있는 경우가 있다.

앞으로 "latex-free" 또는 "does not contain latex(라텍스를 함유하지 않음)"과 같은 Labeling을 사용하면 안되고,
"Not made with natural rubber latex(천연고무라텍스로 만들어지지 않음)"또는 The is not made with natural rubber latex.
(제품 또는 part의 이름에 천연고무라텍스로 만들어지지 않았다라고 기재)”라고 Labeling 할 수 있다.

FDA는 천연고무라텍스 또는 천연고무라텍스의 합성물질을 원료를 사용한 Medical products의 원료와 제품포장재의 경우
사용을 규제하며, 대표적인 제품 대상은 반창고, 일회용밴드, 수액백, 의료용기저귀 등이 해당된다.

FDA Issues Final Guidance on Recommendations for Labeling Products Not Made with Natural Rubber Latex ‏

Today the Food and Drug Administration (FDA) issued a final guidance, “Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is Not Made with Natural Rubber Latex.”

Contact with medical products containing natural rubber latex can cause a severe, life-threatening, allergic reaction (anaphylaxis) in people allergic to natural rubber latex proteins. Some manufacturers of medical products include statements in their labeling meant to inform users that natural rubber latex, dry natural rubber, or synthetic derivatives of natural rubber latex were not used in the manufacture of a medical product, its container and/or packaging. These labels are not supported by scientific evidence and do not address the potential for accidental contamination with natural rubber latex during or after manufacturing.

Manufacturers should stop using statements such as “latex-free” or “does not contain latex” and instead use the recommended labeling statements, “Not made with natural rubber latex” or “The is not made with natural rubber latex.” These labels can help FDA staff, health care professionals, patients, and consumers easily identify medical devices and packaging that are not made with natural rubber latex.

The final guidance applies to all FDA regulated medical products for which:

• natural rubber latex or synthetic derivatives of natural rubber latex were not used 
   as materials in their manufacture; and
• any  packaging or container was not made with natural rubber latex or synthetic derivatives of natural rubber latex.

Examples of medical products that may be affected include: 

• adhesive bandages
•  medical diapers
•  condoms
•  medical gloves
• stoppers on vials
• syringe tip caps
• sanitary napkins
• braces/splints
• crutches
• medical tape
• wheelchair seat/tire/brake
• blood-pressure monitoring cuffs
• catheters
• IV bags
• disposable syringes
• enema tips
• molding for orthopedics
 
If you have any questions regarding this guidance, please contact CDRH’s Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov, 1-800-638-2041, or 301-796-7100.

Food and Drug Administration
Center for Devices and Radiological Health