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Radiology has found itself in a central role in all modern medicine for any diagnosis or treatment. From X-rays and CT scans to fluoroscopy and cath-lab interventions, the use of ionizing radiation is inevitable. But with its merit also comes a silent risk concerning the radiation exposure both to healthcare professionals and to the patients themselves. Thus, radiation protection gear such as lead aprons, thyroid shields, gonadal protectors, and lead-free aprons is a must-have in any hospital setting.
Alarmingly, however, a new threat has entered the healthcare system in India: Imitation or substandard radiation protection gear. Counterfeits may superficially resemble the certified ones, yet fail to shield against harmful radiation. Their use endangers not only the safety of medical personnel and patients but also erodes trust in hospital systems and compromises regulatory compliance.
Why one must have awareness?
While there are strict guidelines from regulatory bodies such as the Atomic Energy Regulatory Board (AERB), many Indian hospitals and diagnostic centers sometimes use non-compliant or fake radiation equipment. Offending products may lack the necessary shielding layers, contain lead-equivalent materials, or fail quality tests, yet they are marketed as cheaper alternatives. Here’s why awareness is essential:
Risk of radiation: While individual risks may seem low, the continued exposure to even small amounts of scatter radiation can create a cumulative increase in risk for cancer and cataracts, and for infertility, thyroid problems, and damage to the bone marrow. The use of such ineffective gear makes these risks even worse.
The medical staff are the most vulnerable: Radiologists, surgeons, cath-lab teams, and technicians who work around radiation-emitting devices spend most of their time in a day, sometimes hours. Protection gear serves as their first line of defense, and if it fails, their health is at stake.
Legal and regulatory liabilities: A hospital that has been found using counterfeit radiation-protective gear would be liable to suffer extreme punishment, including suspension of its license, legal action, or even closure. Regulatory audits have increasingly targeted equipment authenticity.
Damage to the reputation of an institution: For healthcare providers, trust from patients is everything. Using low-quality protective gear can damage reputations and bring public backlash, adversely affecting NABH accreditations.
How to verify radiation protection equipment?
Hospital administrators, radiology departments, and procurement heads must keep their eyes open and ensure that the radiation protection gear they buy conforms to all regulatory and safety benchmarks. Here are key checks to verify a product's authenticity:
Check for AERB and BIS compliance
Ensure they are certified by AERB (Atomic Energy Regulatory Board) and follow BIS (Bureau of Indian Standards) guidelines. Genuine manufacturers usually provide certificates of conformity or batch-wise test reports; such documents should be available at the time of purchase.
Ask for lead equivalence reports
Radiation protection equipment should at least offer 0.25 mm to 0.50 mm lead equivalence, depending on its use; always ask for attenuation test results from certified laboratories as proof of the claimed protection level.
Look for serial numbers and traceability
Reputed manufacturers embed barcodes or RFID tags on their aprons for inventory tracking and verification. If your gear has no unique identification or traceability, it’s a red flag.
Demand manufacturer credentials
Is the company ISO 13485 certified for medical devices? Are they registered with government medical procurement platforms like GeM or approved by large hospital chains? Ensure the brand has credibility and an established presence in radiation safety.
Check quality and finish
It has even stitching, a high-quality outer fabric, a design that focuses on ergonomics, and clear labeling. An apron that is very light and poorly stitched could indicate that it does not have a proper shielding material inside it. Check the innermost lining for cracks, which could suggest that the materials are fake or degraded.
Ask for product warranty
If a manufacturer provides a warranty of 2 to 5 years on its protective equipment, it is likely to be a trusted manufacturer. Façade or gray market products seldom offer such guarantees, leaving the users vulnerable without post-sale assistance.
Choose a well-reputed provider
Cutting costs when it comes to radiation protection can cost lives. Hospitals must invest in high-quality gear manufactured by certified, reputable companies with a proven track record of safety in medical imaging.
Here’s what makes a provider trustworthy:
Proven expertise in radiation safety: Choose companies that specialize in radiology or radiation safety and have dedicated R&D teams. Choose providers who have decades of experience and offer a complete portfolio of AERB-approved protective gear, from lead-free aprons to patient shields and radiation monitoring devices.
Who to choose for trusted radiation protection gear?
Proficient in radiological safety: Radiation security should be one of the specializations of a radiology company manned by an R&D team. Choose companies that have decades of experience and the full range of protective gear from AERB-approved lead-free aprons to patient shields and radiation monitoring devices.
Full testing and certification
A manufacturer who conducts serious quality-control checks offers testing documents for all batch products. Additionally, the products are tested not only for protection against radiation but also for comfort, durability, and ergonomics of design.
After-sales support and accessory tracking
Seek providers who equip inventory tracking, like inspection logs and, oftentimes, yearly tests, within the facility. Some manufacturers have even gone a step further by establishing digital apps for accessory lifecycle management, replacements, and compliance - a wise investment in overall hospital safety.
Affidavits and use in the best institutions
If some big hospitals, teaching institutions, and diagnostic chains have this high brand loyalty, it's because that brand has gone through all their due diligence. One can look for direct customer feedback, use at radiology colleges, and presence at events organized by the radiological society.
Here's what you need to remember before buying or wearing any radiation protection or safety equipment:
Authentication before purchase: Never skip any certification and test report. Cross-check all with AERB guidelines.
Cheap knock-offs beware: If a price seems too good to be true, it probably is. Products in this range may have excluded essential shielding material in their construction.
Only certified brands: Carry out business with ISO-certified brands, which have a healthcare pedigree and global safety standards.
Conclusion
Radiation safety cannot be compromised, especially in a sector as sensitive as healthcare. The danger posed by fake radiation protection gear in hospitals across India is no longer a regulatory or procedural issue - it's a public health issue. Each time a health worker steps into the radiology suite while wearing a fake apron, he becomes a potential victim. Every time a phony thyroid collar is worn, someone's future is endangered.
Awareness, education, and responsible purchasing can save lives in health care.
(Author is president - Trivitron Healthcare)
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