In a recent article, we described how the new EU Medical Devices Regulation and revisions to ISO 10993-18, the international standard related to the chemical characterization of materials, were affecting the way in which medical manufacturers source and process polymers. There is another development underway in Indonesia and some other majority-Muslim countries that will also impact material selection, albeit through a different prism. A law in Indonesia stipulates that all imported, distributed and traded products, including medical devices, will need to be halal-certified by 2019, according to Jacqueline Anim, Principal Material Engineer and Subject Matter Expert at Ethicon (Cincinnati, OH), part of the Johnson & Johnson (JNJ) family of companies.
Products that carry the Halal certificate have been processed according to rules established by the Islamic Council. Certification is mainly applied to meat and other food products such as milk, canned food and additives, but it can also apply to medical devices, as will be the case in Indonesia per Law no. 33, which was passed in October 2014. Until it goes into effect next year, compliance is voluntary.
Medical device OEMs and their suppliers need to have this on their radar, says Anim, because “the region is a potential growth area for the marketing and sale” of medical products. Manufacturers need to be able to answer questions such as, “Do you have animal-derived raw materials in your product?” If the answer is yes, added Anim, the question then becomes, “Is the animal-derived raw material obtained in a manner that is consistent with halal certification or was it produced in a halal-certified manufacturing facility?”
The concept of halal applies to a wide range of goods and services used in a Muslim’s daily life, explains USA Halal Chamber of Commerce Inc. Muslim consumers choose products because it is in compliance with the process and procedure as defined by Islamic Law (Sharia). Industry and producers of goods and services are often not aware of these requirements. Subsequently, they overlook the needs of this segment of our population, according to USA Halal Chamber of Commerce.
Moving away from ingredients derived from traditional animal sources is a trend that transcends Muslim beliefs, added Anim, who will be discussing the evolution of medical materials during a conference session at PLASTEC/MD&M Minneapolis later this month.
During the session, Anim said that she hopes “to bring into focus the exponential advances that medical materials are making to integrate today’s medical solutions with future patient care.” That future, she stresses, will be animal free.
“Ingredients such as mold-release products and additives historically have been sourced from animal tallow, but they are now available from vegetable-based materials. Some of the material innovations that were not possible a decade ago are now feasible, as vendors such as Trinseo, for example, have switched to animal-free raw materials over concerns of bovine spongiform encephalopathy, commonly known as mad-cow disease. This is what is referred to as ‘kosher manufacturing’ practices. Technologies that do contain animal-based substances must undergo extensive scrutiny,” added Anim, more so than vegetable-based alternatives.
In that context, Indonesia’s halal law is one more brick in the wall of a larger trend. “As article 4 of the bill states, ‘products that enter, circulate and trade in the territory of Indonesia must be halal certified.’ If a supplier of plastics or a medtech OEM has the intention of doing business in that region, he must comply with the law,” stresses Anim. “This means that raw materials and the manufacturing process must be backed by a Halal Assurance System (HAS) and the ‘halal’ or ‘non-halal’ certificate must be placed on the product in a noticeable and readable format that cannot be erased or removed. Other countries in the region that embrace halal certification include India, Bangladesh, the Philippines and Pakistan, to name just a few,” said Anim. Malaysia’s Department of Islamic Development is expected to introduce halal certification for medical devices—the first of its kind—later this year, according to Thomson Reuters.
Anim will discuss a range of issues related to trends and innovation in the medical materials space during the Technical Solutions conference track in room 211B at the co-located Medical Design & Manufacturing (MD&M) and PLASTEC Minneapolis event on Oct. 31 and Nov. 1. She is scheduled to speak at 8:30 AM on Oct. 31.