Why the serialization of medical devices is important?

To increase the medical device's supply chain integrity more than 40 countries have implemented track and trace laws to regulate products as it moves through the supply chain. The serialization of equipment and its parts by assigning a unique traceable serial number to an individual sealable component is the cornerstone of all the regulations.

Serialization implementation is challenging and has a ripple effect on the entire supply chain process at pharmaceutical manufacturing companies as well as packing partners. Serialization is not about just assigning a number to the product box it leads to the paradigm shift for the industry. Serialization evolves the focus of producing the same product and labeling them with unique data and communicating that data during supply chain operations.

Cost-effective traceability solution

Medical devices have small individual sealable components that are supposed to be assembled at the treatment site. If a single small component goes missing it will put patient treatment at risk or delay. Serialization help to inspect the production and packaging line of medical devices. This will minimize the risk of component loss or poor packing operation and improve the quality and efficiency of medical devices manufacturing industries.

Guaranteed Patient’s Health and safety

Counterfeit product identification is the biggest challenge for medical device manufacturers and suppliers. They harm patient health, damage brand reputation and the original manufacture has to face the loss in business. Serialization provides the ability to authenticate the originality of the product and offers protected supply to the end-users. It enables to track the right product is delivered at the right place and make sure no illegitimate product or device has entered in supply chain lines.

Enhanced inventory control at healthcare centers

Inventory management plays a crucial role in healthcare systems. Surgical equipment is a widely utilized item in the hospitals and needs to constantly keep a decent stock at hand for day to day treatments. Serialization will help optimize inventory control for hospital management and keep track of equipment used for low as well as overstock. As these devices and equipment are expensive their optimized management is necessary to control cost and avoid loss.

Reduced risk of reimbursement fraud

Healthcare programs are always under the risk of fraud and product duplication. Fraudulent billing for the products will burden the legitimate providers and also disrupt the business reputation in the market. Serialization help to track that device was original and what is the actual selling price. So the risk of reimbursement fraud will be minimized and implementation of an efficient trace and tracing strategy through serialization will also help to manage the returnable end expired devices.

Logistics Optimization

Certain sensitive medical devices and equipment require a safe and controlled movement towards a destination. Serialization will help categorize these devices for transportation with care and optimized conditions such as temperature, humidity, etc. Both the manufacturer and suppliers will know that products under which seriation numbers need to take care of while transporting and keep them separate from other devices.

Bottom Line:

The implementation of serialization for medical devices is now declared compulsory for the healthcare industry in more than 40 countries of America, Asia, and Europe. New legislations for pharma serialization are made obligatory for the production and transport of medical drugs and surgical equipment. This strategy will not only help manufacturers and suppliers during the production and supply chain operation to effectively carry out these operations but also it will ensure the patient's health and safety.

She is a Digital Marketing Strategist in a Software House based in the USA and offers Business Intelligent Solutions. She is writing articles and blog posts for the past six years.