A-to-Z of Medical Equipment and Devices

by

Gp Capt (Dr) Sanjeev Sood,

MD, PGDHHM, M Phil (HHSM) Hospital and Health Systems Administrator Air Force Hospital, Chandigarh

This article defines and explains the various technical terms and key issues related to the field of biomedical devices and biomedical engineering, and clarifies the terms sometimes used interchangeably. What is a medical equipment/ device? Medical equipment, device, apparatus, instrument and appliance are regulatory terms, precisely defined in laws of different countries. However, they are often used interchangeably and are applied variously in different contexts The Global Harmonization Task Force has proposed the following harmonized definition for medical devices (GHTF document SG1/N029R11 refers). Medical device means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purposes of diagnosing, monitoring and treating patients. It thus includes everything from highly sophisticated computerized medical equipment down to simple wooden tongue depressors from crutches, catheters,tubes,needles,syringes,dressing materials ,hernia meshes, joint prosthesis, bone cements, nails and rods used in orthopedics, heart valves, patches and stents used in intervention cardiology, or wearable or implant devices like intraocular lenses, dental, breast or cochlear implants. The term medical appliance generally covers that equipment used manually for nursing care and patient comfort such as, crutches, wheel chair and sputum

mug etc. Instruments imply surgical instruments such as forceps and scissors. The equipment having a display (analogue or digital) to record physiological values, are also referred to as instruments e.g., BP instrument. Besides, there are other categories of equipment- hospital textiles, linen, flooring, gas pipes, stretchers, and furniture. Each one of these items should meet certain safety and regulatory standards. There are several basic types of medical equipment and device:

Diagnostic equipment includes medical imaging machines, used to aid in diagnosis. Examples are ultrasound and MRI machines, PET and CT scanners, and x-ray machines. Therapeutic equipment includes infusion pumps, medical lasers and LASIK surgical machines. Life support equipment is used to maintain a patient's bodily function. This includes medical ventilators, anesthetic machines, heart-lung machines, ECMO, and dialysis machines. Medical monitors allow medical staff to measure a patient's medical state. Monitors may measure patient vital signs and other parameters including ECG, EEG, blood pressure, and dissolved gases in the blood. Medical laboratory equipment automates or helps analyze blood, urine and genes.

Diagnostic Medical Equipment may also be used in the home for certain purposes, e.g. for the control of diabetes mellitus. What is GHTF? The Global Harmonization Task Force provides guidance to regulatory authorities in the development of regulatory schemes for medical devices. The goal of GHTF is to develop common regulations for medical devices to promote world trade. For exact information on given product, manufacturer/vendor need to understand the regulations and definitions of terms in those countries where they expect to market their product.

How are medical devices classified?

Under schedule M-III, medical devices will be divided into four classes according to their risk level--A, B, C and D. -Class A includes low-risk devices such as thermometers and tongue depressors. -Class B includes low-to moderate-risk devices such as hypodermic needles -Class C includes moderate-to high-risk devices such as lung ventilators and bone fixation plates -Class D includes high-risk devices such as heart valves and implantable defibrillators Higher-risk devices will require more regulations and a more stringent conformity assessment. What is an electro- medical equipment? The medical devices powered by electricity are called electro-medical equipment or systems. These are covered under the IEC 60601-1 and recent IEC 62363 standard and its family of standards, which are voluntary standards and not regulations, unless specifically included in a country's regulatory system. Medical devices that are not powered by electricity or not powered at all are not covered by IEC 60601-1. How is a medical device different from drugs? Drugs are pharmaceutical products that achieve their primary intended action in or on the human body by pharmacological, immunological or metabolic means. The intended primary mode of action of a medical device on the human body, in contrast with that of medicinal products, is not metabolic, immunological, or pharmacological. However, the MoH and FW, GoI, may also classify certain items as drugs (like condoms, stents and hypodermic needles and syringes) under specific gazette notifications under Drugs and Cosmetics Act and Rules.

The medical equipment comprises of several technologies and components. E.g., what is an amplifier, sensor and transducer? Amplifier is an electronic device that strengthens the signals as it passes along a communication channel. Physical variables associated with biomedical systems are measured by a group of sensors known as physical sensors. Sensors for these variables, whether they are measuring biomedical systems, bodily functions or other systems, are essentially the same. A transducer is a probe that converts one from of energy into another form, thus collecting physiological information into comprehensible form. E.g., an ultrasound transducer generates acoustic waves by converting magnetic, thermal, and electrical energy into mechanical energy. The most efficient technique for medical ultrasound uses the piezoelectric effect, which was first demonstrated in 1880 by Jacques and Pierre Curie.

What is the procedure for grant of license for manufacturing of medical devices in India? The manufacturer of notified sterile medical devices shall apply to the state licensing authority on a prescribed form (Form 27) along with requisite fees, detailed product information in the form and manner as prescribed in the said rules along with a copy to the office of DCGI. For a new product, a technical committee shall scrutinize the application and recommend necessary certification process. The state licensing authority after joint verification and inspection would forward the license to Central License Approving Authority (CLAA).The retailers of these medical devices shall also obtain an appropriate license marketing of the product from the state authority. How can a company register for import of medical device in India? The company has to furnish the following details to DCGI for the purpose of import of devices and follow the procedure for registration and import license as prescribed under the Drugs and Cosmetics Rules- applicant details , product information, regulatory status, master file (details of good manufacturing practices employed by the manufacturer to ensure quality of the device), devices

containing medicinal product, post market surveillance, undertaking of conformity with respect to product standards, safety and effectiveness requirements and quality systems in the country of origin. Thus, the process of registration is quite comprehensive. What are the safety issues related to biomedical equipment? The cases of medical equipment failure, underperformance or malfunction leading to unintended harm to the patient or operator are not uncommon in hospitals world over. Reports of neonates getting burnt in incubators, burns during electro cautery, radiation overdose, ventilators or defibrillators not functioning at critical moments and patients dying due to power failure in hospitals are not uncommon. The biomedical/clinical engineers ensure medical device safety for the patient, operator and equipment itself by robust design, proper installation, and strict compliance to safety and performance standards and by carrying out preventive maintenance. What is the certification process for medical devices? The medical devices have to go through a process of rigorous testing, analysis and conformance to various predetermined safety and performance standards during different stages of design and usage that are known as certification, such as IEC 60601-1. Whereas, calibration is the act of checking and adjusting the accuracy of measuring instruments and validating is authentication of a process, such as software development (21 CFR Part 11). What is the current status and future prospects of medical device industry in India? The medical device industry in India is estimated to be worth Rs 15,000 cr (USD 3.3 billion) and growing rapidly at 12-15 per cent per year. It is estimated to reach US$ 5 billion by 2012. Since almost 75-80 per cent of the medical equipment is imported, it is a key area for forging partnerships across borders. In addition to this, engineering excellence, cost-effective labor, increasing emphasis on intellectual property rights and most importantly a fast growing domestic market makes India an ideal manufacturing base. This opportunity has attracted foreign

medical equipment makers to float Indian subsidiaries -- 30 of them received import clearances in 2007 alone. What is the current status of regulation of medical devices in India? The medical devices are covered under the1982 Amendments to Drugs and Cosmetics Act, 1940 and do not cover modern definition of medical devices. The DCGI has notified about 15 products using drug approach. The proposed Indian Medical Devices Safety Bill -2008 harmonized with GHTF recommendations and based on European 3rd party conformity assessment system, is stuck in the Law Ministry as of now. There is also a proposal by stakeholders to set up a Medical Device Regulatory Authority for regulation of medical devices. What is Biomedical Engineering? Biomedical Engineering is an important vital interdisciplinary field. Biomedical engineers are involved in many medical ventures. They are involved in the design, development, maintenance and utilization of materials, devices (such as pacemakers, lithotripsy, etc.) and techniques (such as signal processing, artificial intelligence, etc.) for clinical research and use; and serve as members of the health care delivery team (clinical engineering, medical informatics, rehabilitation engineering, etc.) seeking new solutions for difficult heath care problems confronting our society. Who is a clinical engineer and how are they different from Biomedical Engineers? A clinical engineer is a professional who supports and advances patient care by applying engineering and managerial skills to healthcare technology as per American College of Clinical Engineers (ACCE) Definition, 1992 .As clinical medicine has become increasingly dependent on more sophisticated technology and the complex equipment associated with it, the clinical engineer, as the name implies, has become the bridge between modern medicine and equally modern engineering. Biomedical engineers apply electrical, mechanical, chemical, optical, and other engineering principles to understand, modify, or control biologic (i.e., human and animal) systems, as well as design and manufacture products that can monitor physiologic functions and assist in the diagnosis and treatment of patients. When biomedical engineers work within a hospital or clinic and involved with patient care and safety, they are more appropriately called clinical engineers, so as to involve them in delivery of patient care Clinical engineers make significant

contribution in improving the quality of life of patients suffering from a wide array of diseases. In UK, they all come under the umbrella of medical physicist. A biomedical equipment technician (BMET) is a vital component of the healthcare delivery system. Employed primarily by hospitals, BMETs are the people responsible for maintaining a facility's medical equipment. What is eHealth and who is medical informaticians? E-health is the combined use in the health sector of electronic communication ,information and communication technology (digital data transmitted, stored , retrieved electronically, electronic medical records and Hospital Information Systems) for clinical, education and administrative purposes, so as to make health care delivery more efficient, accessible and affordable, both at the local site and at a distance. Practitioners of eHealth are generally referred to as medical informaticians. What are the opportunities available to Clinical and Biomedical Engineers? Many opportunities are available to biomedical engineers. Medical device companies-private testing laboratories, Government research laboratories regulatory agencies (FDA,DCGI) ;hospitals as clinical engineering, laboratory manager (Catheter, Radiology, etc.);compliance and certification engineer; consulting as a healthcare consultant (Accenture, Rigel );design (IDEO, Patni);academiaresearch and development and teaching in institutes. What are the emerging new areas in Biomedical Engineering? Some of the emerging areas are computer assisted surgery (MIS), cellular and tissue engineering, molecular medicine, nanotechnology, rehabilitation and orthopedics, robotics and virtual human beings.
Gp Capt (Dr) Sanjeev Sood is a Hospital Administrator and NABH empanelled Assessor based in Chandigarh. He has also undergone Advanced Clinical Engineers Workshop organized by ACCE at SCTIMST, Thiruvanthapuram and been a guest faculty with International Clinical Engineering Workshop recently held at COE, Pune .Email-doc_ssood@yahoo.com