By: Ashish Siddhapura - Marketing
The medical device industry is characterised by its use of flashy marketing language. When purchasing blood collection tubes, labs and healthcare facilities often encounter claims that sound impressive but lack real evidence.
Let's expose five common marketing claims and show buyers what evidence they should actually seek before making a purchase.
1. Imported Quality
The Claim:
Many manufacturers promote their tubes as having "imported quality." This suggests that making them overseas guarantees better performance.
The Reality:
Import status doesn't guarantee quality. A tube made overseas could still fail to meet international standards or suffer from uneven anticoagulant concentrations.
What truly matters is whether the product holds the right certifications, not where it was manufactured. A locally made tube with the correct certifications will work better than an imported tube that lacks them. Don't be misled if a product is "Made in India" but the company uses imported terminologies to market it; always verify the actual credentials.
What buyer should ask:
Does the manufacturer hold ISO 13485 certification for a medical device quality system?
Have these tubes undergone Validation in your laboratory according to CLSI guidelines?
2. Tube Should Have Click-lock Sound
The Claim:
Some manufacturers and buyers claim that blood collection tubes should produce a “click-lock sound” when the closure is attached, suggesting this indicates proper sealing and quality.
The Reality:
Blood collection tubes do not require a click-lock sound for proper sealing. The closure system relies on pressure and mechanical fit, not an audible click. Many high-quality seals are perfect without any sound. The “click-lock” expectation often comes from confusion with other medical devices that use click mechanisms. The click-lock sound is something present due to the cap design, but it is not a quality indicator. Staff who are not properly trained may focus on the click-lock sound as a quality check, but this is misleading. Proper testing should focus on what the company actually validated: leakage test, breakage test, and spillage test. These are the real performance metrics that determine tube quality, not an audible click.
What buyer should ask:
What validated tests are conducted?
3. Type of Sterility
The Claim:
Manufacturers claim their tubes are “Sterile” without specifying the type of sterility or the sterilisation method used.
The Reality:
Blood collection tubes are sterilised using only two methods in the industry. Gamma Irradiation and E-Beam. This is standard and acceptable since the tube interior comes into direct contact with blood, not sterile medical instruments. The confusion arises when customers expect “completely sterile” products or when manufacturers fail to specify which method was used. Many companies use Sterile A, Sterile, Sterile EO on the labels, which is not suitable for Blood Collection Tubes.
What buyer should ask:
Which sterilisation method was used – Gamma or E-Beam sterilisation?
What is the sterility assurance level (SAL)? (Standard SAL 10⁻⁶)
Is sterility validated according to the ISO 11137 standard?
Can you provide the sterilisation certification showing the method used?
Will you be able to do a sterility test if asked for?
4. Premium Material
The Claim:
Manufacturers frequently promote “premium PET”, “medical grade rubber”, and “high quality additives”. These claims can be relevant but only when tied to performance outcomes.
The Reality:
The material itself is not the end goal. The goal is sample integrity. Poor-quality plastic or stoppers can contribute to additive contamination, leakage, breakage or hemolysis.
What buyer should ask:
What material is the tube made from?
What tests are performed for chemical compatibility?
What is the tube’s break resistance and leak-proof performance?
Do you have a suitable TDS & MSDS for all the products?
5. International Standards
The Claim:
Many manufacturers claim their blood collection tubes meet international standards, implying superior quality and reliability. However, the claim often lacks details about which standards are being followed and whether they are relevant to the product itself.
The Reality:
Not all certifications guarantee product performance. A manufacturer may comply with certain quality standards but not product-specific standards for blood collection tubes. Buyers should always ask for documentation and verify exactly which standards the product meets.
What buyer should ask:
Which standards are being claimed?
Can the manufacturer provide current certifications?
Does the product meet biocompatibility and sterility requirements?
Additional questions for the buyer should be asked before purchasing the blood collection tubes.
1. Can you provide batch consistency data?
2. How is vacuum retention validated?
3. What is the tube’s validated shelf life?
4. Can you provide stability study reports?
5. Can you provide a Certificate of Analysis (COA)?
6. What quality checks are performed before release?
7. How is product traceability maintained?
8. Has the product undergone biocompatibility testing?
9. Can you provide a comparison report?
10. What is the tube breakage rate?