Shipping medical equipment is a sub-set of the global shipping industry that requires specialized expertise. Whether it’s laboratory testing devices or large, diagnostic scanners, these machines can contain fragile gauges, lenses, mirrors, computer chips and other delicate internal items. Careful shipping is essential to maintain the integrity and functionality of the equipment since any damage in transit may have serious implications.
In this guide, we will delve into the nuances of global shipping of medical devices and equipment – from packing to shipping to regulatory compliance.
Types of Medical Equipment
Medical equipment encompasses a wide range of items, each serving specific functions in healthcare settings.
- Items like inhalers, home pregnancy tests, and blood pressure and glucose monitors for large-scale consumer use.
- Diagnostic equipment includes X-ray machines, MRI scanners, and ultrasound systems, essential for diagnosing medical conditions.
- Therapeutic equipment such as ventilators, infusion pumps, and defibrillators aid in patient treatment and management.
- Lab equipment such as centrifuges, autoclaves, incubators and microscopes might be used in testing and research labs.
Understanding the diverse categories of medical equipment is essential for determining appropriate global shipping methods and requirements.
Requirements for Medical Device Shipping
Shippers of medical devices and equipment have goals that are much the same as any other company: deliver goods on time, accurately and in good condition. But many requirements apply uniquely to this class of products. Let’s review what those are.
Regulatory Compliance
Medical devices are subject to a heightened degree of oversight due to the connection to human health. And this oversight impacts logistical activities. Regulatory bodies such as the Food and Drug Administration (FDA) in the United States and the European Commission (EC) impose stringent standards for the shipping of medical devices and equipment. Compliance is imperative to ensure patient safety and legal adherence.
Standards may include specifications for packaging materials, labeling requirements, and documentation procedures. Adhering to regulatory standards not only safeguards patients but also protects healthcare providers from legal repercussions.
The FDA is the prime regulatory body in the U.S. Importers and manufacturers must be registered with the FDA, and the product must have an FDA Device Listing Number and FDA Premarket 510K Number. If the medical device emits any radiation, then FDA would require additional information (FDA 2877 Form with FDA Accession Number).
In the U.S., one of the logistical complications that can occur is that items can clear Customs but not be fully cleared by the FDA.
For instance, Dimerco recently handled a shipment of needles and insulin syringes into the Port of Savannah that were made in China. The FDA decided to put those items on hold pending inspection. Since it can take the FDA 6-7 days to look at a container, the Dimerco team drayed the container to a nearby bonded warehouse where goods were unloaded and the container was returned. There was no option to deliver the container to the customer since their location was 300 miles from the port. The FDA stipulates that shipments pending inspection must remain within 50 miles of the port.
Such medical device shipping situations can get even more complicated if only one SKU requires inspection out of a container with 25 different items. It helps to work with a freight forwarder that can pull and deliver the cleared items and then make special arrangements for the product pending inspection.
Temperature Control
Some medical equipment and devices may require temperature control. For instance, Dimerco ships diabetic test kits with a strict 65–75 degree Fahrenheit range.
Depending on the product and the requirement, you can choose to ship in active or passive containers. Active containers have electrically controlled cooling and heating systems. Passive containers are insulated boxes or containers with no active temperature control. An experienced freight forwarder can guide you through the process of choosing what container and cooling/heating method is best for your medical devices.
Note that product integrity extends well beyond just the global shipping leg. Subsequent drayage, warehousing and final delivery must also adhere to cold chain requirements.
Systems Tracking and Traceability
Look at an RFQ for global shipping services from any medical device company and you’ll see a tight requirement for systemic traceability. Should quality issues arise, the manufacturer will want to look back at the historical record – for ship times, delivery times, temperature logs and other measures.
If a regulatory audit is conducted, the company needs shipping and logistics partners that can provide the needed data quickly and accurately.
Product Packaging
Proper packaging is paramount to protect medical equipment from damage during transit.
Often, larger equipment is packaged with care at the manufacturing facility. Shock-absorbent materials such as foam inserts and bubble wrap may be used to cushion against in-transit bumps and vibrations. Additionally, clear labeling, including handling instructions and identification of fragile components, will be placed on crates to ensure careful handling by logistics personnel.
When it comes to large-scale medical equipment, these ultra-sensitive devices should be carefully monitored in transit for any sudden shock or tilting of the product that could negatively impact machine performance. Your freight forwarder may use monitoring devices, like shock watches, to measure impacts and “tip and tell” indicators to measure any in-transit tilting. The same types of measures are used for shipping multi-million dollar semiconductor capital equipment.
Ship-Time Adherence
Obviously, every company wants its products shipped and delivered on time. But the urgency of on-time shipping is more acute in medical device shipping – for a variety of reasons.
- Shipments can be in response to an urgent shortage, such as with masks and testing kits during Covid.
- Some customers specify time-definite air freight shipping if they would otherwise be late shipping to a major customer, like Medicaid.
- Products may have ship-time requirements related to product integrity. For instance, products shipped with dry ice can’t afford a delay that would push beyond the 96-hour cooling life of dry ice. In another example, Dimerco handles medical devices for air export out of the West Coast that originate in a Texas sterilization facility. Since sterilization is good for only 7–10 days, shipments must be carefully monitored to ensure final delivery within the allowed window.
Smooth Customs Process
Customs delays can slow down the supply chain for vital medical equipment and supplies, so it’s a particular concern for manufacturers and their customers. It’s important to work with a forwarder and customs broker that can ensure adherence to customs procedures. Accurate and complete documentation, including commercial invoices, certificates of origin, and import permits are needed to reduce the risk of Customs delays or penalties.
Your medical device must be properly classified for proper labeling to ensure customs clearance, risk management, and safe handling. In the U.S., the FDA has segmented medical devices into three classifications: Class I, II, and III. The FDA regulates each medical device depending on its risk to the user or patient. The higher the risk, the higher the classification. You can determine your classification by going directly to the classification database run under the FDA.
What to Look for in a Logistics Partner for Medical Device Shipping
When seeking a partner for shipping medical devices and equipment, consider the following characteristics. Some are pretty obvious, but others may not be.
- Proven experience. You want to work with a partner that understands the regulatory and compliance requirements of your products. This is a not a “learn on the job” task. The risks are too high.
- Quality certifications. In medical device shipping, some products have life and death implications. For that reason, manufacturers don’t like risk. They will trade a slightly lower rate for guaranteed, high-quality service every time. Quality certifications like ISO, and GDP (Good Distribution Practices) provide third-party validation that the provider has met rigid quality standards and has the systems and processes to deliver consistent quality service.
- Security program certification. Look for CTPAT-certified or AEO-certified providers that have a demonstrated ability to ensure a safe, secure supply chain during the shipping process. In addition, these certifications can simplify customs and cut clearance time. For high-value items, look for a provider that is TAPA-certified or equivalent. TAPA stands for Transported Asset Protection Association, which has established standards and operating practices to reduce cargo theft.
- Experience shipping from Asia. A large percentage of medical products originate in China and Taiwan. Don’t discount the advantage of having a shipping partner with a strong presence and expertise coordinating product shipments at origin. For example, the Chinese government has its own requirements for medical device inspection and approval of exports. An Asia-based provider like Dimerco has on-the-ground experts that know the customs process in China and Taiwan and can help avoid and troubleshoot delays.
- 24/7 customer service desk. When it comes to shipping medical devices, customers don’t want to wait for answers. In fact, in their RFQs for shipping services, many such companies set rapid response-time requirements for service inquiries.
- Integrated logistics services. The rigid requirements for medical equipment shipping – from temperature control to tracking – become much more difficult if products move among a series of different 3PL providers for origin trucking, global shipping, warehouse services, and final delivery. Use of a single provider to coordinate all services on a single global operating system streamlines and simplifies the process and provides a single point of accountability for shipping these regulated products.
Additional Resources on Shipping Requirements for Medical Products
- Food and Drug Administration (FDA) – fda.gov
- European Commission – ec.europa.eu
- International Air Transport Association (IATA) – iata.org
- World Health Organization (WHO) – who.int
Professional, Compliant Shipping of Medical Devices Ultimately Impacts Quality of Care
Shipping medical equipment requires careful attention to regulatory standards, packaging requirements, ship-time constraints, handling and storage guidelines, and customs procedures. By adhering to critical shipping requirements, healthcare providers can ensure the safe and timely delivery of vital equipment, ultimately contributing to improved patient outcomes and quality of care.
Got a challenge with medical device shipping? Contact the experts at Dimerco Express group today to start a conversation.
