Introduction: Waste Medical Devices
As per the Ministry of Health and Family Welfare, the medical devices are controlled and regulated under the Drugs and Cosmetics Act, 1940, and for better regulatory provisions, the Medical Device Rules, 2017, came into play for the manufacturing, sale, import, and distribution of the medical devices as per the risk based criteria formulated under the Drugs and Cosmetics Act, 1940.
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Most of the medical substances, equipment, and devices are dealt with under the biomedical waste management rules; however, there is no mention of the mandatory or EPR responsibilities for the waste Medical Devices.
Regulations For Waste Medical Devices
According to the current regulation, the Drugs and Cosmetics Act of 1940, which also deals with medical devices, medical devices such as an MRI machine, which falls under drugs, do not include any chemical entity and are a technology, a radiation and electronic-based technology.
In January 2022, the Ministry of Health and Family Welfare issued the Medical Device Amendment Rules, 2022, to extend the submission of ISO 13485 compliance for medical device registration. ISO 13485 is an international quality standard for the Medical Device Industry for quality management systems.
Through the E-Waste Management Rules, in May 2022, medical devices (except all implanted and infected products) were brought within the E-Waste Management Rules and the Medical Device Management was put on the PIBOs, so the involving of the businesses of manufacturing, recycling, production, importers, refurbishes, and so on came under this rule. The EPR mechanism makes the Producer of Electrical or Electronic equipment a recycling target for the product being manufactured by it, ensuring environmentally sound e-waste management.
And the infected medical devices can be treated through the biomedical waste treatment mechanism upon their expiration; however, there is no clear specification regarding that from the regulatory point of view.
The Classification Of Medical Devices Into Five Categories Is Done For Quality Management Purposes:
- Consumables and Disposables, including needles and syringes, etc.
- Diagnostic imaging, including MRI, X-rays, ultrasounds, etc.
- The dental products including Dentures, braces etc.
- Orthopedic and prosthetics including knee implantation, artificial joints.
- The patient aids including hearing aids and pacemakers, etc.
The Medical Device includes the substances that are being used for the in-vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag and can be along with the anticoagulant, and It includes the substances such as mechanical contraceptives including condoms, intrauterine devices, tubal rings, disinfectants and insecticides; and some special which are used for the internal and external diagnosis, treatment, mitigation or prevention of diseases or other disorders in human beings and animals, the wastes generated from it is managed according to the Bio medical waste management rules
We can say, Medical devices includes all such instruments, apparatus, appliances, implant material and other articles whether its being used alone or in combination even the software or such accessory being used for human beings or animals by the pharmacological or metabolic, immunological means, and that assist in its functioning including
- For diagnosis, prevention, monitoring, treatment or alleviation of disorder or disease.
- Diagnosis, treatment, monitoring, alleviation or assisting for the disability or injury.
- Investigation, modification, replacement and support with the anatomy of physiological processes.
- Sustenance and support of life.
- Medical devices disinfection and
- Conception control
As Per The Bio Medical Waste Rules Following Are The Steps Being Followed For Different Categories Of Waste Medical And Devices
|S. No.||Waste Category||Disposal mechanism|
|1||Human anatomy (tissues, organs, body parts)||Deep burial or incineration|
|2||Animal tissues, organs, body parts, etc.||Deep burial or incineration|
|3||Biotech. Or microbiology waste||Incineration/microwaving/autoclaving|
|4||Sharp waste(MEDICAL WASTE), (needles, blades, syringes, glass, scalpels etc.||Disinfection, chemical treatment or Microwaving or mutilation, shredding|
|5||Cytotoxic drugs||Disposal in secured landfill, incineration|
|6||Blood fluids, cotton dressings, plaster cast, beddings||Microwaving or incineration|
|7||Wastes such as tubings, catheters, intravenous sets||Disinfection by chemical treatment, microwaving and mutilation|
|8||Lab liquid waste||Disinfection by chemical treatment|
|9||Incineration of any biomedical waste||Dispose of in municipal landfill|
|10||Chemical waste||Solids should be discharged into landfill drains|
Regulatory Bodies Authorizations FOR DIFFERENT Categories OF Medical Devices
The medical Devices Rules, 2017 lays down the classification of the above mentioned medical devices on the following grounds such as
|Moderate low||Class B|
|Moderate High||Class C|
|High risk||Class D|
The Medical Devices Rules, 2017 (MDR-2017) govern medical devices and IVDs (in-vitro diagnostics), categorizing them as Class A, B, C, and D, with Class A and B being low- to moderate-risk devices regulated by state licensing authorities and Class C and D being high-risk devices regulated by the Central Regulatory Authority.
Medical devices are governed and regulated by the ministry of family welfare through CDSCO, and promotion, manufacture, and production are dealt with by the Ministry of Chemicals and Fertilizers, Department of Pharmaceuticals.
However, a few other aspects, such as pricing, availability of raw materials, standardization, consumer affairs, etc., are being regulated by the following:
|1||Price control||National Pharmaceutical Pricing Authority|
|2||Environmental Clearance||Ministry of Environment, Forest and Climate Change|
|3||M2M technology, healthcare sensor, remote monitoring devices, precision medicine, nano medicine||Department of Telecommunication|
|4||Labeling Requirement||Department of Consumer Affairs|
|5||Taxation and other related issues||Department of Revenue|
|6||Establishment of Industries and Factories||Department of heavy Industries|
|7||Raw materials like protein||Department of Animal Husbandry|
|8||Trade and promotion||Department for Promotion of Industry and Internal Trade|
|9||Device standardization||Bureau of Indian Standards|
|10||Quality aspects||Quality Council of India|
|11||X-ray equipment etc||Atomic Energy Regulatory Board|
EPR regulation for Waste medical devices
The E-waste Regulation 2022 has a broad definition of what constitutes electrical waste, which includes items like medical equipment, mobile phones, screens, computers, gaming consoles, refrigerators, air conditioners, microwave ovens, coffeemakers, toys, and batteries.
The government has only notified 37 categories of medical devices; however, there are four types of medical devices, namely
- Medical equipment
- Medical implants
- Medical disposables
- Medical furnitures
According to MDR 2017, clinical research and standards for medical devices are required, along with perpetual license validity, regulation by notified bodies, the processing and approval of applications, a quality management system, and a timetable for the process.
A Framework Of Regulations For Handling E-Waste
The 1948 Factories Act, as amended to the present: This Act includes a list of various contaminants that result from the production or recycling of electronic components.
The Environmental Protection Rules 1986, as amended, are as follows: There isn't a direct standard that can address pollution from the recycling of electronics manufacturing industries. However, some Pollution Control Board (PCB) facilities fall under the electroplating classification entry and must adhere to the effluent disposal standards outlined in Schedule 1 of these regulations.
The Hazardous Waste (Management and Handling) Rules of 1989 (as amended in 2003): Schedule 2 of this act can be applied for the disposal of e-waste. Electrical and electronic assemblies not suitable for direct re-use but suitable for recycling (for EXIM) are listed in Schedule 3 at SI. No. B1110 and Schedule 3 entry at SI. No. A1180, respectively.
E-waste (Management and Handling) Regulation 2022: Every producer, consumer, or bulk consumer engaged in the production, sale, purchase, or processing of electrical and electronic equipment or components as defined in the schedule is subject to these regulations. The producer will be in charge of managing e-waste throughout its entire life cycle. This rule's guiding principle is "Extended Producer Responsibility."
E-waste management and control can be accomplished through the use of extended producer responsibility. The manufacturers of electrical and electronic equipment, such as big and small home appliances, computers, toys, sporting goods, and medical devices, are responsible for gathering any e-waste produced during manufacturing and must direct it toward recycling or disposal. In accordance with the concept of "Extended Producer Responsibility," they will set up collection centers for electronic waste produced by "end of life" products and make sure that this waste is directed to a registered refurbisher, dismantler, or recycler. They must make sure that every piece of electrical and electronic equipment has a special serial number or individual identification code so that it can be tracked in the e-waste management system. Additionally, they must arrange and finance a system to cover the costs associated with managing e-waste produced by the "end of life" of their own products and any historical waste still in existence on the day the regulations take effect. To make it easier for consumers to return their e-waste, producers must also give them the contact information of dealers and authorized collection centers.
Dealers are required to set up a system for collecting e-waste, which includes giving customers a box, bin, or clearly marked area to deposit their waste in and making sure it is transported safely back to the producer or the designated collection facility. Dealers, refurbishers, dismantlers, and recyclers must register with the SPCB or CPCB, depending on which one applies, and they must make sure that the storage, transport, dismantling, and refurbishing of e-waste is permitted.
Each and every stakeholder is required to register with the relevant SPCB or Pollution Control Committee (PCC), keep track of the e-waste they handle, and submit annual reports in Form 3 to the respective SPCB or PCC. Consumers and bulk consumers are responsible for making sure that their e-waste is deposited with dealers or authorized collection facilities. They may also use the producers' pick-up or take-back services. Any individual or group operating a collection center is required by the Rules to obtain permission from the relevant SPCB or PCC. They must guarantee the storage system is safe and the transportation to the producer, refurbisher, or registered recycler is safe in order to ensure e-waste management in an environmentally responsible manner.
According to the regulations, manufacturers are responsible for the secure disposal of electronic products under the concept of "Extended Producer Responsibility." Manufacturers must return the goods when they reach the end of their useful lives. Additionally, it aims to encourage environmentally friendly electronic product designs that reduce the use of dangerous chemicals like lead and mercury.
In order to prevent potential harm to the environment and public health, manufacturers are also responsible for setting up collection centers to oversee the process and making sure that only registered recyclers or dismantlers handle hazardous products. Instead of selling their electronic waste to nearby wholesale scrap yards, large clients like banks, multinational corporations, and other large businesses would have to deposit it at authorized collection centers. They would also be required to submit yearly reports on the amount of e-waste they have disposed of.
Additionally, producers are now in charge of organizing the collection of the e-waste produced by their obsolete products.
In the production of electrical and electronic equipment, hazardous substances must be used less frequently (RoHS). Every manufacturer of electrical and electronic equipment must make sure that their new products don't contain Lead, Mercury, Cadmium, Hexavalent Chromium, Polybrominated Biphenyls (PBB), or Polybrominated Diphenyl Ethers (PBDE). Within three years of the new e-waste rules' implementation (in May 2022) would be reached such a reduction in the use of hazardous substances. The product information booklet is required by the rule to include comprehensive information on the components of the equipment. Additionally, only RoHS- compliant electrical and electronic equipment would be allowed for import or market placement.
The EPR for waste Medical Devices Proposed Rules under the Environment (Protection) Act of 1986
The MoEF has proposed to notify specific rules on e-waste under the Environment (Protection) Act of 1986 in light of the exponential growth in the generation of e-waste. The key components of the proposed rules are as follows:
The rules have incorporated the idea of Extended Producer Responsibility (EPR).
The proposed regulations would fix producers' accountability for the collection of end-of-life products and for ensuring that such wastes are directed for safe handling at the post-consumer stage of the product life cycle. Additionally, producers must arrange and finance a system to cover the costs associated with the environmentally sound management of e-waste produced from the "end of life" of their own products as well as the historical waste present as of the date these regulations take effect.
Producers may appoint organizations as needed to set up an efficient take-back system for all electrical and electronic equipment when it is no longer needed.
The authority to take enforcement action when rules are not followed belongs to the State Pollution Control Boards or Committees in charge of granting authorization, ensuring that the conditions of authorization are followed, and keeping an eye on compliance with registration requirements. The Central Pollution Control Board (CPCB) monitors compliance with the requirements established for granting registration. Producers, dismantlers, recyclers, and collection facilities must submit annual reports in accordance with the e-waste rules and apply for registration with the relevant State Pollution Control Board (SPCB). Annual reports must be submitted by SPCBs to the CPCB. A yearly report on the management of e-waste will be submitted by CPCB after information from all SPCBs has been combined.
The rules also allow the State Pollution Control Board (SPCB) or the relevant Pollution Control Committee (PCC) to grant authorization and registration to a person's or agency engaged in the collection, dismantling, or recycling of e-waste, provided that the applicant has the necessary facilities to handle e-waste safely. This is to guarantee that e-waste is managed in an environmentally responsible way.
Collection centers that are run by individuals, groups of people, or organizations must obtain permission from the relevant State Pollution Control Boards (SPCBs) or Committees before filing annual returns detailing the e-waste they have collected.
Dismantlers and recyclers must submit an annual report detailing the e-waste they handled as well as request authorization and registration from the relevant State Pollution Control Board.
Extended Producers Responsibility (EPR)
The Extended Producer Responsibility (EPR) principle, which is being used to manage the nation's e-waste, seeks to give producers complete accountability for the collection of end-of-life electronics and their secure disposal. They would need to guarantee that recyclers, dismantlers, or refurbishers will recycle the polluting products in an eco-friendly manner. Producers and dealers would be obligated to collect e-waste by giving customers a container, bin, or designated area to dispose of their electronic waste. It has been suggested that large municipal organizations should assume control of the task of acquiring e-waste directly from consumers for delivery to a recycler. For the government to guarantee compliance, every recycler and dismantler would also need to register.
The viability of such a measure has not yet been tested in India, and it would be challenging to track electronic goods that may be sold multiple times by different customers after being used for a while. For instance, it might be impossible for an Indian manufacturer to keep track of a piece of electrical or electronic equipment that he or she sold to a customer in the south of our nation, who might then dispose of it to someone else who lives in a different, far-off region.
The Ministry of MSME has stated that because the consumers may be spread out across the nation and unknown to the producers, it may not be practically feasible for the producers to collect the e-waste generated at the end of the lives of the electrical and electronic products.
The Hazardous Waste (Management, Handling, and Trans-boundary Movement) Rules 2008 (as amended in 2016): A list of the types of e-waste that can be imported with prior informed consent can be found in Part-A of Schedule III (Basic No. 1180). The list of e-waste that can be imported and exported without obtaining prior informed consent is found in Schedule III, Part B (Basic No. 1110).
What are the Responsibility of Medical Device Producers, Importers, Retailers, Manufacturers, and Dealers?
The following are the responsibilities of the producers of the medical devices that need to be followed while the product is brought to the market for sale.
- Implementation of the EPR norms provided by the government bodies.
- Collection of the Manufactured, Produced, imported e-waste and delivering them to the authorized collection centers, Dismantlers, or Recycling centers.
- Creation of the awareness programs for the handling of the waste devices and the treatment procedures that are being offered by them for the product they are selling.
- Describe and facilitate the availability of, as well as collection and treatment facilities for, the products via direct or indirect communication, and inform collection points for various waste products of the recycling facilities that are available to them.
- Describing the detailed information for the dealing of the hazardous materials including the electronics and the handling processes of the same and the different devices and components and process of safe dismantling process of them.
- The appropriate labeling in indelible form that indicates the safe handling of the medical devices and means to end up a waste process.
- Process to recycle and use of their recycled products.
- The record regarding the waste generation from the device must be prepared by the producers.
What Are The Responsibilities Of The Waste Medical Device Collection Centres?
The collection centers of the waste medical devices must follow the following guidelines:
- The collection centers must have to maintain the record of the received, handled, stored, and transported waste products and the records of the receiver of the waste generated products, refurbished wastes.
- The devices which are handled through batteries must be handled separately through the authorized Recyclers of the Battery waste.
- The proper labeling of the various products must be covered and secured properly.
- The surety of the safe transportation of the devices and timely delivery of the chemical or hazardous equipped devices is must.
- Every category of waste must be collected and labeled, no matter the existing branding of the devices by the Collection Centers.
- The Producers ensured returnable devices and its components as per their database have to be refunded directly.
- Proper management shall be made ensuring no further damage to the collected devices.
- The maximum capacity must be specified.
- The Producer (PIBOs) must ensure the EPR authorization and ensure collection of their products with the specified quantity per year, however, there could be a contract of the Producer (PIBOs) and collection points.
What are Responsibilities of the Refurbishers
The refurbisher and service centers shall provide their services for the authorized or permitted database, and the reselling shall be done in an authorized manner by the authorized refurbishers.
What are the Responsibilities of PROs
The PROs must deal with the importer, manufacturer, producer, and retailers, as well as collect accounts and data, manage the finances and expenses of dismantlers, recyclers, collection centers, and other entities, and provide training to workers in recyclers and other entities. ensuring the safety of producers, importers, dismantlers, recyclers, and landfills and environmentally sound operations of the same, as well as monitoring and management of the entire waste management process.
With the surge in demand for Medical Devices since COVID 19, there is a demand for new regulation of the different categories of waste Medical Devices for the Medical Device Industry in India. There is no classification in the BIS standard for medical device risk assessment, and there is still no regulation in the BIS standard for various critical medical Devices.
Through the segregation of the waste Medical Devices at the Collection Centers, and the involvement of these bodies in the management of different categories of waste. However, the biomedical waste management rules are followed for the Waste Medical Devices which are chemically compounded.
In order to ensure the safe management of waste Medical Devices, it is essential that it be done in an organized manner with enough resources and sustainable recycling technologies.
Following the Mayapuri radiation leak incident, the Delhi government issued instructions and warnings to all heads of medical facilities using radioactive supplies and equipment for their safe disposal, in accordance with the recommendations of the Atomic Energy Regulatory Board (AERB) under the Atomic Energy (Safe Disposal of Radioactive Wastes) Rules, 1987, and the Atomic Energy (Radiation Protection) Rules, 2004, both of which were promulgated. The rules establishing specific guidelines for medical exposure, potential exposure, self-monitoring, quality control, and even the selection of radiation workers and radiological safety officers already exist under the AERB directives.
This portion of the site is for informational purposes only. The content is not legal advice. The statements and opinions are the expression of author, not corpseed, and have not been evaluated by corpseed for accuracy, completeness, or changes in the law.
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