Introduction: Understanding Leachables in Medical Devices
When designing and using medical devices, keeping patients safe is always the top priority. One hidden risk that many people overlook is the presence of leachables in medical devices. These are chemicals that can slowly move from the materials of the device into the body, which can affect patient health and how well the device works.
At ResolveMass Laboratories Inc., we offer expert Extractables and Leachables (E&L) testing. Our advanced methods help detect even tiny amounts of harmful chemicals before they cause problems. In this case study, we’ll show how we identify and reduce these substances to protect patients and meet strict safety rules.
Read more about how we protect patients through EL Testing and Patient Safety.
What Are Leachables in Medical Devices?
Leachables are chemicals that escape from parts of a medical device—such as plastic tubes, adhesives, or surface coatings—and enter a patient’s body or a drug product during actual use. They can come from leftover materials used during production, sterilization chemicals, or even the device packaging. Over time, these substances may accumulate in the body or interact with drugs in harmful ways. If not detected early, they can affect patient safety, product performance, and regulatory approval.
Over time, even small amounts of these chemicals can build up or react with the body. That’s why it’s so important to find and remove them early during testing.
Why Testing for Leachables in Medical Devices Is Important
Health and Safety Risks
Some leachables can cause serious health issues like irritation, cancer, or damage to organs, depending on how much enters the body. Their effects can vary based on the patient’s age, health condition, and duration of exposure. In some cases, even low levels of toxic leachables can trigger allergic reactions or long-term complications.
Impact on Drug and Device Performance
These chemicals may change how a drug works or make the device less effective. This could result in treatment failure or other complications. For example, they might cause the drug to break down faster or lose its potency over time. In some situations, this can lead to repeated treatments, increased healthcare costs, or harm to the patient.
Meeting Regulatory Standards
Rules like ISO 10993 and guidance from the FDA require detailed testing of extractables and leachables. Without proper testing, a device may fail approval or face costly recalls. Regulatory agencies expect clear evidence that all potential risks have been identified and addressed. Failing to meet these requirements can delay product launches and damage a company’s reputation in the market.
Dive deeper with our Extractables and Leachables Testing Services.
Case Study: Solving Leachables Issues in a Complex Device
Client Challenge
A global medical device company came to us when chemical spikes showed up during stability testing of an inhalation device. These unexpected results raised concerns about leachables in medical devices that could affect the safety and quality of the product.
Project Goal
The client needed help to:
- Identify unknown chemical compounds,
- Find where they were coming from,
- Check if they were harmful,
- Recommend changes to reduce or eliminate the leachables.
Phase 1: Finding the Leachables
Advanced Testing Methods
We used a mix of powerful tools to look for leachables:
- GC-MS to find volatile compounds,
- LC-MS/MS for non-volatile chemicals,
- ICP-MS for metals,
- SPME to collect trace chemicals from complex samples.
Each method was customized for this inhalation device as part of our tailored EL testing process.
Our lab followed the guidance of Custom EL Testing Services to tailor a method specific to this device configuration.
What We Found
We discovered over 12 leachables above the safety threshold. They mostly came from plastic tubing, glue layers, and printed markings on the device. Two chemicals were unknown at first, but further testing confirmed what they were and if they posed a risk. These findings allowed us to map each leachable to its source within the device’s materials. Understanding the origin of these chemicals helped us create a targeted plan to reduce or eliminate them.
Phase 2: Health Risk and Toxicology Review
Working with toxicology experts, we followed safety guidelines like:
- Threshold of Toxicological Concern (TTC),
- Permitted Daily Exposure (PDE),
- Cumulative exposure models.
Most chemicals were within safe limits. However, one compound—an aromatic amine—exceeded acceptable levels and needed to be addressed immediately.
Learn more about our risk-driven approach in E&L Testing Case Study
Phase 3: Reducing Leachables in Medical Devices
Material Improvements
- We replaced the adhesive with a safer, low-leach material.
- Printed labels were removed and replaced with safer, non-printed alternatives.
Better Manufacturing Processes
- Added a heat-curing step to remove leftover chemicals in plastics.
- Improved cleaning of tools and equipment to prevent unwanted residues.
These changes helped lower chemical migration and made the device safer and more reliable.
Explore our comprehensive offerings in Extractable and Leachable EL Services
Results: Faster Approval and Safer Devices
After changes were made, all leachables dropped below the risk threshold. The device met ISO 10993‑18 and FDA testing standards. As a result, the product was approved within six months, saving time and cost for the manufacturer while protecting patients.
Read how this success saved our client time and cost at Cost of Extractables and Leachables Testing
Key Takeaways from the Case Study
Start Testing Early
Early E&L testing helps spot problems before they lead to redesigns or delays. It allows manufacturers to identify potential risks during the early stages of product development, saving time and resources. By catching leachables early, teams can make informed material choices and avoid costly rework or failed regulatory submissions.
Use Custom Testing for Each Device
Each medical device is different. A tailored testing plan provides clearer, more reliable results. Standardized testing may miss device-specific risks, especially with unique materials or delivery methods. Customizing the approach ensures that the testing truly reflects real-world use and exposure scenarios.
Stay Ready for Regulations
Accurate reports and proper documentation are essential to meet global regulatory expectations. Agencies like the FDA and international bodies require detailed, science-based justifications for material safety. Staying prepared with up-to-date data not only speeds up approval but also builds confidence with regulators and stakeholders.
FAQs About Leachables in Medical Devices
Leachables are identified through a specialized process called Extractables & Leachables (E&L) testing. This involves using advanced tools like GC-MS, LC-MS/MS, and ICP-MS to analyze samples under conditions that mimic real-life usage. These methods help pinpoint even trace levels of harmful substances.
E&L testing ensures that medical devices are safe, effective, and compliant with regulatory standards. It helps prevent harmful exposures, reduces the risk of product recalls, and supports faster regulatory approval. Without this testing, patient safety and product reliability could be compromised.
Key standards include ISO 10993-18, USP <1663> and <1664>, and various FDA guidance documents. These regulations provide clear frameworks for how to assess, document, and limit the risk of extractables and leachables in medical products. Compliance with these is essential for market approval.
Yes, ResolveMass Laboratories has deep expertise in E&L testing for inhalation and nasal delivery systems. These types of devices have unique requirements due to the direct exposure to sensitive lung tissues. Our team is equipped to handle their specific challenges with custom testing protocols.
Leachables can be reduced by selecting safer materials, optimizing manufacturing steps, and improving cleaning or sterilization processes. Regular E&L testing throughout development also helps catch potential issues early. These steps together ensure better safety and smoother regulatory clearance.
Absolutely. ResolveMass Laboratories offers personalized consultations and detailed quotes based on your product and compliance goals. Whether you’re in early development or preparing for submission, our experts are ready to guide you every step of the way.
Conclusion: ResolveMass Leads the Way in Managing Leachables in Medical Devices
At ResolveMass Laboratories Inc., we use science and experience to help companies find and control leachables in medical devices. This case study shows that careful testing and smart changes can remove risks before devices ever reach patients. By working with us, you can be confident that your medical products are safe, compliant, and ready for approval.
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