Why Hospitals Prefer Refurbished Medical Equipment & the Regulatory Challenges

Introduction

Healthcare is among the most significant industries to any nation and in India, it is expanding at an alarming speed. As the population grows, people become more conscious about their health, and the government supports such programs as Ayushman Bharat, the need to have the latest medical facilities has never been as high.

However, as the demand is increasing, hospitals, particularly the mid-size and smaller healthcare providers usually find it hard to contend with the high prices of new medical equipment. That is where the refurbished medical equipment comes in the picture. Recycled equipments enable hospitals to obtain the latest technological devices like MRI machines, CT scanners, cath labs, ultrasound, and X-ray units at a small fraction of the price of original equipments.

Nonetheless, not all things are so easy with the importation and use of refurbished devices. These equipment are classified as hazardous and other waste and their importation needs MOEF&CC approval. In addition to the benefits, hospitals have regulatory issues of obtaining these machines.

This paper discusses the reasons why hospitals choose refurbished medical equipment and cost benefits, regulatory landscape, MOEF regulations and the overall issues of safety, quality and compliance.

Why Hospitals like Refurbished Medical Equipment

• Cost Savings
  High end medical equipment such as MRI scanners or cath lab will cost [?]5-15 crore with refurbishing costing 30-60 per cent of that cost. In smaller hospitals, particularly in the tier-2 and tier-3 cities, this disparity can even dictate whether they will be able to afford such equipment or not.
• Availability of High-tech Technology
  Refurbished does not imply old-fashioned. A large percentage of refurbished machines are those that are 5-7 years old and still have modern diagnostic features. Hospitals gain access to the luxurious brands (GE, Siemens, Philips, Toshiba) at low prices.
• Faster ROI (Return on Investment)
  Hospitals break-even sooner as there is low initial investment since they can provide diagnostic and treatment services at reasonable prices.
• Patient Affordability
  Low-cost medical machinery implies that the hospitals will be able to reduce the cost of diagnostic tests, and healthcare will be discussed more often.
• Environmental Benefits
  Refurbishment prolongs the life of machines, decreasing the e-waste and the production of medical waste. This is sustainable in terms of recycle and reusing technology instead of dumping it.

Refurbished Medical Equipment Regulatory Issues

Although the advantages are not disputable, the policy of refurbished equipment in India is rather problematic on the regulatory level.

• MOEF Permission Requirement
  According to Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016 used or refurbished medical equipment is one of the activities that is regarded as a restriction. The hospitals or importers are required to seek a prior approval of MOEF&CC (Hazardous Substances Management Division).
• Quality & Safety Concerns
  Not every refurbished machine complies with the international standards of safety. Unsafe and faulty equipment might be installed in hospitals without stringent certification.
• Spare Parts/After- Sales Services
  There are a lot of refurbished equipment importers who fail to guarantee after-sales service. The parts may not be easily available particularly when the manufacturer of the original product has stopped the model.
• Customs & Port Delays
  Clearance can take a long time to be granted by the Customs even with permission by MOEF when the documents are not completed or are not matched. A lot of shipments are in ports, and it translates to the loss of money by hospitals.
• India has no Standardized refurbishing guidelines
  Refurbishing to standards (ISO 13485) is performed in such countries as the EU and USA. India does not have a standard refurbishing structure, which sets questions regarding the quality assurance.

MOEF&CC Requirements for Import of Used Medical Devices

The process of importation of refurbished equipment revolves around the MOEF&CC permission. The most important requirements are listed below:

Documents to be submitted to MOEF Permission

• Importer Import Export Code (IEC).
• Application Letter to the Division of HSM of MOEF&CC, the Joint Secretary.
• Company profile having PAN, GST as well as registration certificates.
• Buyer (hospital/clinic) purchase order/ Letter of Intent (LOI).
• Details of the Equipment: Make, model, year of manufacture, serial number. Manufacturer/refurbisher certificate of refurbishment.
• Quality Assurance Certificates: Validation of working condition. Radiation safety certificate (where necessary).
• Service/ Spare Part Undertaking: Importer should guarantee the presence of spare parts and post sales services.
• Waste Management Form: That the parts that cannot be used will be disposed of according to the Hazardous Waste Management Rules.
• End-User Details: Name and address of the hospital/clinic on which equipment will be installed.

Application Process

• The application is made by the importer to MOEF&CC.
• HSM Division examines documents and might require clarification.
• Permission (NOC) is granted to particular equipment and quantity.
• Importer submits MOEF permission to clearance to Customs in port.

Fees

• Government Fee: NIL
• (MOEF is not a paying body when it comes to permission, but the whole process has to be documented.)

Impact on Human Life

The importation of used medical equipment without any control or regulation is hazardous.

• Patient Safety
  Devices that fail to work or are poorly refurbished are prone to giving false diagnosis which results in inappropriate treatments. Radiation generating devices such as CT and X-ray machines may be very dangerous health wise when not certified accordingly.
• Healthcare Worker Safety
  Those technicians/doctors who operate defective machines are prone to risks such as electricity shocks or radiations.
• Public Health Confidence
  When hospitals regularly supply un-safe refurbished equipment, it destroys the confidence of patients in the healthcare system.
• Environmental Risks
  Devices prevent the effective disposal of e-waste that pollute soil and groundwater.

The importance of Checking Imports

• Stops India as a dumping ground of outdated world medical equipment.
• Assures responsibility through import and use monitoring.
• Encourages sustainable healthcare development through moderating affordability and safety.

Key Challenges Going Forward

• Standardization of Refurbishing Norms in India.
• Better liaisons between MOEF, Customs and Health Ministry.
• Finding the compromise between safety and affordability, making sure that hospitals have access to affordable equipment without risking the health of patients.

Conclusion

Second hand medical equipment has turned out to be a lifeline to Indian hospitals that are in need of offering contemporary healthcare services at low prices. The benefits of reduced costs, quicker ROI and increased access to patients are indisputable.

Meanwhile, regulatory vigilance plays a crucial role. The obligatory license by MOEF guarantees that the refurbished imports are environmental friendly, maintainable and safe. The hospitals have to go through these regulatory hurdles with full documentation to exclude delays or fines.

In the long run, India has to establish a powerful ecosystem of refurbishing, and with quality standards, yet it has to keep the MOEF checks in place to protect the patients and the environment.

Affordability and compliance Refurbished medical equipment can bridge the health disparity gap in India as it offers more advanced equipment to millions of patients throughout the nation.