Safety Lancet

Introducing HTL-STREFA

HTL-STREFA S.A., based in Poland, is a global leader in the design, development, and manufacture of specialized medical devices, particularly in the fields of diabetes and capillary blood sampling. Operating as a subsidiary of the MTD (Medical Technology and Devices) Group, the company holds a prominent position in the global medical industry thanks to its significant innovations in producing safe medical equipment, including the invention of the “Safety Lancet” product category.

With advanced manufacturing facilities in Łęczyca, Ozorków, and Bydgoszcz, Poland, and distribution offices in Poland and the United States, HTL-STREFA consistently delivers high-quality products that meet stringent international standards. The company emphasizes close collaboration with customers and end-users, continually developing safe, practical, and innovative products that cater to diverse global market needs.

HTL-STREFA Product Classification

HTL-STREFA offers a wide range of medical devices under proprietary brands like Droplet and Drop Safe. The company’s products are primarily categorized into three main areas:

• Safety Lancets: HTL-STREFA Safety Lancets are single-use devices for capillary blood sampling, used in diagnostic tests such as blood glucose, cholesterol, hemoglobin, and other clinical analyses. Classified as IVD (In Vitro Diagnostic Devices), their safe design minimizes the risk of needle-stick injury and reuse. Key features of HTL-STREFA Safety Lancets include:
  • Self-destructing mechanism: Prevents reuse for enhanced safety.
  • Silicone-coated needles: Reduces pain and improves patient comfort during puncture.
  • Adjustable penetration depth: Suitable for various skin types and sampling needs (e.g., 1.5 mm for sensitive skin up to 2.0 mm for larger samples).
  • Various types: Includes models like Acti-Lance Lite (28G, 1.5 mm for sensitive skin), Acti-Lance Universal (23G, 1.8 mm for general tests), and Acti-Lance Special (17G, 2.0 mm for neonatal heel sticks).
• Pen Needles: These are medical devices specifically designed for injecting diabetic medications, including insulin, using injection pens. Classified as Therapeutic Medical Devices, their ergonomic design and ease of use have made them a top-selling choice in global markets. In Iran, Droplet brand pen needles are known as “Hemo Fine” and are highly regarded by patients and healthcare professionals for their quality and efficacy.
• Safety and Immunization Products: This category includes safety needles and other injection devices designed to reduce the risk of injury to healthcare professionals and patients. These products are especially crucial in situations requiring frequent injections, as they mitigate the risk of infection transmission and injuries from unsafe needles, ensuring the health of both parties.

Risk Classification and Standards

HTL-STREFA Safety Lancets are classified as Class II medical devices according to FDA and EU MDR standards. This classification reflects their diagnostic application in sampling and the need for specific controls to ensure their safety and effectiveness. These lancets are designed and manufactured in compliance with international standard ISO 13485 and bear the CE mark, indicating conformity with European Union safety and performance requirements. Furthermore, these products are supplied sterile and for single-use to minimize the risk of contamination and infection.

Vision and Commitment

As a leading medical device company, HTL-STREFA demonstrates its commitment to “Simplifying Healthcare.” By focusing on innovation, safety, and patient comfort, the company designs products that meet the specialized needs of healthcare professionals while providing a safe and pain-free experience for patients.

Types of Safety Lancets

1. Acti-Lance Safety Lancets

The Acti-Lance series is designed for various diagnostic applications, from home testing to clinical screening, and is known for its simple activation mechanism and high safety. It includes the following types:

• Acti-Lance Lite 1.5 mm (28G)
  • Description: A safety lancet with a fine needle (1.5 mm diameter) specifically designed for sampling from sensitive skin.
  • Application: Used in blood glucose, cholesterol, and other low-blood-volume diagnostic tests. These features make it suitable for children and diabetic patients.
  • Features: The needle is silicone-coated to reduce pain and discomfort. Acti-Lance Lite also features a self-destructing mechanism. This lancet is supplied sterile and for single-use.
• Acti-Lance Universal 1.8 mm (23G)
  • Description: A standard safety lancet with a 1.8 mm (23G) needle, designed for sampling from normal skin with a moderate blood volume.
  • Application: Used for routine tests such as blood glucose measurement, hemoglobin level checks, and metabolic disease screening in adults.
  • Features: Notable features include easy activation with minimal pressure, precise needle beveling, sterile conditions, and compliance with international standards like ISO 15197.
• Acti-Lance Special 2.0 mm (17G)
  • Description: A safety lancet with a 2.0 mm (17G) needle, designed for high-blood-volume sampling and used in cases such as neonatal heel sticks.
  • Application: Specifically developed for screening newborns for metabolic diseases like PKU or hypothyroidism.
  • Features: Safe design to reduce tissue damage, sterile packaging, and a precise activation mechanism that ensures accuracy and safety of the sampling process.

2. Medlance Safety Lancets

The Medlance series is suitable for clinical and home use due to its ergonomic design and variety of models. The Medlance Plus Extra (21G, 2.4 mm) model, specifically designed for thicker skin or high blood volume requirements, is still available in the global market. Medlance Safety Lancets include the following types:

• Medlance Plus SuperLite 1.2 mm (30G)
  • Description: With a 1.2 mm (30G) diameter, this is an ultra-fine safety lancet designed for blood sampling with minimal pain for sensitive skin.
  • Application: Used for blood glucose testing in home or clinical settings. Due to its special design, it’s an ideal choice for children or diabetic patients requiring frequent testing.
  • Features: Electropolished needle with silicone coating to reduce friction and pain, contact activation mechanism for increased accuracy and safety, and sterile, single-use conditions.
• Medlance Plus Lite 1.5 mm (25)
  • Description: This product, with a 1.5 mm diameter and 25-count packaging, is a safety lancet equipped with an ultra-fine needle designed for low-blood-volume sampling in glucose tests or diagnostic assays.
  • Application: Ideal for common tests such as blood glucose measurement, cholesterol, and coagulation tests in individuals with sensitive skin.
  • Features: Electropolished needle with silicone coating allows for quick and less painful penetration, and its dual-spring design increases the speed and accuracy of sampling. All lancets are supplied sterile.
• Medlance Plus Universal 1.8 mm (21G)
  • Description: With a 1.8 mm (21G) needle, this is a standard safety lancet designed for sampling from normal skin with sufficient blood volume.
  • Application: Used for blood glucose tests, hemoglobin measurement, and metabolic screening in adults.
  • Features: Precise needle beveling, advanced safety mechanism, guaranteed sterile conditions, and compliance with international standard ISO 15197, optimizing the accuracy and safety of the sampling process.
• Medlance Plus Extra 2.4 mm (21G)
  • Description: This is a safety lancet with a 21-gauge needle and a 2.4 mm penetration depth, designed for sampling from thicker skin and tests requiring higher blood volume (more than 10 microliters). This model is offered under the Medlance Plus Extra brand and is still available in the market.
  • Application: Its primary use includes diagnostic tests such as hematology assays, metabolic screening, and other tests requiring a larger blood sample.
  • Features: Electropolished needle with linear guidance to reduce vibration and pain, self-destructing mechanism, dual-spring design for quick penetration, sterility, and gamma sterilization with a protective cap.
• Medlance Plus Special 0.8 mm Width, 2.0 mm Depth (Blade)
  • Description: This is a safety lancet with a blade of 0.8 mm width and 2.0 mm depth, designed for high-blood-volume sampling. It is used for collecting blood from neonatal heels or adult fingers.
  • Application: An ideal option for screening newborns for metabolic diseases like PKU or hypothyroidism. Also used in adult tests requiring high-volume blood samples.
  • Features: Medlance Plus Special, with its ultra-sharp blade, allows for quick healing and is supplied in sterile packaging.

3. Droplet Safety Lancets

The Droplet series is designed for home and clinical use, focusing on comfort and accuracy in sampling. Droplet Safety Lancets include:

• Droplet Personal Lancets (30G, 1.6 mm)
  • Description: The Droplet safety lancet, sized 30G with a 1.6 mm depth, is an ideal choice for blood glucose testing with minimal discomfort.
  • Application: Home or clinical blood glucose testing for diabetic patients.
  • Features: This ultra-fine lancet features Extra Thin Wall technology, which reduces pain and skin damage. This safety lancet is sterile and single-use, and its compact packaging and compatibility with most blood glucose meters make it easy and reliable to use.
• Droplet Micro Lancets (33G, 1.2 mm)
  • Description: This product is a safety lancet with the thinnest needle, designed for sampling with minimal pain and low blood volume.
  • Application: These lancets are suitable for blood glucose testing or diagnostic assays in individuals with very sensitive skin, such as children.
  • Features: Ultra-fine needle, maximum pain reduction, sterility, and single-use, making it safe and practical for patients in pain-sensitive or infection-prone groups.
• Droplet Neonatal Lancets (High Flow, 1.5 mm)
  • Description: A safety lancet with a specific blade or needle for high-blood-volume sampling from neonatal heels, designed for screening newborns for metabolic diseases.
  • Application: With its safe design and reduced tissue damage, this lancet minimizes sampling discomfort for newborns.
  • Features: Sterility, high-quality blade or needle, and full compatibility with neonatal sampling needs. This product is specifically developed to ensure accuracy and safety in the neonatal screening process.

4. DropSafe Safety Lancets

The DropSafe series is designed for clinical applications with a focus on advanced safety and easy activation. Some Medlance models (like Extra) are offered under this brand.

• DropSafe Safety Lancets (28G, 1.8 mm)
  • Description: This product is a standard safety lancet designed for sampling from normal skin with a moderate blood volume.
  • Application: Used for blood glucose testing, hemoglobin measurement, or metabolic screening in adults.
  • Features: Advanced safety mechanism, precisely beveled needle, sterile conditions, and low-pressure activation, making it safe, accurate, and hassle-free to use.

5. Other Safety Lancets (Less Common Models)

Other safety lancets include:

• Medisafe Solo Safety Lancets (Variable specifications, typically 28G or 23G, 1.6 to 2.0 mm)
  • Description: These single-use lancets have a safe and simple design. Although less common in Iran, they are used in European markets, especially in healthcare facilities where personnel and patient safety are a priority.
  • Application: Primarily used in clinical settings for diagnostic tests like blood glucose.
  • Features: Silicone-coated needle for reduced pain, self-destructing mechanism, and gamma sterilization process to ensure hygiene. Additionally, its two-step activation system minimizes the likelihood of unintended injuries.

Commitment to Quality and Conclusion

HTL-STREFA is committed to quality, producing safety lancets that combine safety, accuracy, and patient comfort. Utilizing advanced technologies, these products not only simplify the blood sampling process but also serve as effective tools in screening programs and diabetes management. Each lancet is meticulously designed to fully meet clinical needs and provide a pain-free and reliable experience for patients.