BUYERS' GUIDE FOR MEDICAL DEVICES

Download Buyers' guide 2011-2012 for European medical devices

Laptop Cardiovascular Ultrasound System for using in space

GE Healthcare announced that NASA has selected the company’s Vivid q cardiovascular ultrasound system for use by its human research program aboard the International Space Station (ISS).


The laptop-sized device will be used to study the effects of long term space flight on astronauts’ bodies. GE also announced that the Vivid q might be used in underwater space simulation in addition to its use on the ISS.

Click below to read more :
Laptop Cardiovascular Ultrasound System  for using in space

WORKING OF MAGNETIC RESONANCE IMAGING SCANNER - VIDEOS

These videos explains the working of MRI Scanner.

Download The Consumer and Portable Medical Applications Guide

The Consumer and Portable Medical Guide from TI features technical and product information for a variety of medical applications, including: heart rate/fitness monitoring systems, blood glucose and other diagnostic meters, blood pressure monitors, digital thermometers, and portable medical devices.

The guide contains the full range of building blocks from analog signal chain and power management to signal processing, wireless connectivity and logic devices. Find product articles, design examples, component and application-functional block diagrams and information about development tools and evaluation modules.

Download this medical applications guide.

PULSE OXIMETER - BLOCK DIAGRAM

Click here to see the design considerations of Pulse oximeter.

Reference : Texas Instruments

HOME MEDICAL EQUIPMENT

Home medical equipment is a category of devices used for patients whose care is being managed from a home or other private facility managed by a nonprofessional caregiver or family member. It is often referred to as "durable" medical equipment (DME) as it is intended to withstand repeated use by non-professionals or the patient, and is appropriate for use in the home.

Medical supplies of an expendable nature, such as bandages, rubber gloves and irrigating kits are not considered by Medicare to be DME.

Within the US medical and insurance industries, the following acronyms are used to describe home medical equipment:

DME: Durable Medical Equipment
HME: Home Medical Equipment
DMEPOS: Durable Medical Equipment, Prosthetics, Orthotics and Supplies.

TYPES

Air ioniser
Air purifier
Artificial limb
Breast protheses
Cannula
Commodes
Crutch
Diabetic shoes
Dynamic splint
Enteral nutrition
Infusion pump
Nasal cannula
Nebulizer
Orthosis
Oxygen concentrator
Patient lift
Positive airway pressure (CPAP)
Prosthesis
Respiratory Assist Devices
Seat Lift
Walkers
Wheelchair

GETTING HOME MEDICAL EQUIPMENTS

For most home medical equipment, a patient must have a doctor's prescription for the equipment needed; this is not always true for minor HME such as walkers or canes.

The physician may then recommend a supplier for the home medical equipment, or the patient will have to research this on their own. HME / DMEPOS suppliers are located throughout the country; for suppliers of oxygen and other critical medical equipment, Medicare rules require the supplier to only serve patients within a fixed distance, to ensure their ability to deliver supplies and maintain equipment in a timely fashion. For most areas of the US this results in a great number of local HME / DMEPOS suppliers available to the patient in their immediate area.

INSURANCE

Home medical equipment is typically covered by patient's healthcare insurance, including Medicare (Part B). In order to properly code home medical equipment for billing, the Healthcare Common Procedure Coding System HCPCS is utilized.

As of 2007, under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, providers of HME/DMEPOS will be required to become third-party accredited to standards regulated by the Centers for Medicare and Medicaid Services (CMS) in order to continue eligibility under Medicare Part B. This effort aims to standardize and improve the quality of service to patients provided by home medical equipment suppliers.

There is no established typical size for HME / DMEPOS suppliers. Supply companies include very large organizations such as WalGreens and Invacare, to smaller local companies operated by sole proprietors or families. A new evolution in the Home Medical Equipment arena is the advent of internet retailers such as US Medical Aid who are operating with extremely low margins and cutting the ultimate cost for end consumers. In all cases, however, strict rules and laws governing HME / DMEPOS suppliers apply.

Once a patient or caregiver selects an appropriate HME / DMEPOS supplier, he/she presents the supplier with the prescription and patient's insurance information. HME / DMEPOS suppliers maintain an inventory of products and equipment, so fulfillment of the prescription is rapid, much like a Pharmacy.

The HME / DMEPOS supplier is obligated to perform certain functions when providing home medical equipment. These include:
Proper delivery and setup of the equipment
Ensuring the home environment is suitable and safe for proper usage of the equipment
Training the patient, family and caregivers on the proper usage and maintenance of the equipment
Providing 24-hour contact information in the event of equipment malfunction or other emergency
Informing the patient and/or caregiver of their rights and responsibilities
Providing periodic maintenance services (e.g., refilling oxygen, servicing equipment, etc.)
Notifying the patient or caregiver of any changes in insurance

All HME / DMEPOS suppliers are reqquired to comply with Health Insurance Portability and Accountability Act (HIPAA) to protect patients' confidentiality and records.

DURABLE MEDICAL EQUIPMENT

Durable medical equipment is a term of art used to describe certain Medicare benefits, that is, whether Medicare may pay for the item. The item is defined by Title XVIII the Social Security Act:

(n) The term “durable medical equipment” includes iron lungs, oxygen tents, hospital beds, and wheelchairs (which may include a power-operated vehicle that may be appropriately used as a wheelchair, but only where the use of such a vehicle is determined to be necessary on the basis of the individual's medical and physical condition and the vehicle meets such safety requirements as the Secretary may prescribe) used in the patient's home (including an institution used as his home other than an institution that meets the requirements of subsection (e)(1) of this section or section 1819(a)(1)), whether furnished on a rental basis or purchased, and includes blood-testing strips and blood glucose monitors for individuals with diabetes without regard to whether the individual has Type I or Type II diabetes or to the individual's use of insulin (as determined under standards established by the Secretary in consultation with the appropriate organizations); except that such term does not include such equipment furnished by a supplier who has used, for the demonstration and use of specific equipment, an individual who has not met such minimum training standards as the Secretary may establish with respect to the demonstration and use of such specific equipment. With respect to a seat-lift chair, such term includes only the seat-lift mechanism and does not include the chair/

CLASSIFICATION OF MEDICAL DEVICES

EUROPEAN DEFINITION OF MEDICAL DEVICES

COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices defines a ‘medical device’ as:

any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:

— diagnosis, prevention, monitoring, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
— investigation, replacement or modification of the anatomy or of a physiological process,
— control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means

The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medical devices in the UK under European legislation. Medical devices must not be mistaken with medicinal products.

USA DEFINITION
(BY FOOD & DRUG ADMINISTRATION)

A medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.

as defined by the Federal Food, Drug, and Cosmetic Act, 21 United States Code [321] (h).


CLASSIFICATION OF MEDICAL DEVICES

United States

The Food and Drug Administration has recognized three classes of medical devices based on the level of control necessary to assure the safety and effectiveness of the device. The classification procedures are described in the Code of Federal Regulations, Title 21, part 820 (usually known as 21 CFR 820).

Class I: General Controls

Class I devices present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. These devices are subject only to general controls. General controls cover such issues as manufacturer registration with the FDA, good manufacturing techniques, proper branding and labelling, notification of the FDA before marketing the device, and general reporting procedures. (Most Class I devices are exempt from the good manufacturing practices and/or the FDA notification regulations.) These controls are deemed sufficient to provide reasonable assurance of the safety and effectiveness of the device; or the device is not life-supporting or life-sustaining and does not present a reasonable source of injury through normal usage. Devices in this category include tongue depressors, bedpans, elastic bandages, examination gloves, and hand-held surgical instruments and other similar types of common equipment.

Class II: General Controls with Special Controls

Class II devices are those for which general controls alone are insufficient to assure safety and effectiveness, and additional existing methods are available to provide such assurances. Therefore, Class II devices are also subject to special controls in addition to the general controls of Class I devices. Special controls may include special labeling requirements, mandatory performance standards, and postmarket surveillance. Devices in Class II are held to a higher level of assurance than Class I devices that they will perform as indicated and will not cause injury or harm to patient or user. Devices in this class are typically non-invasive and include x-ray machines, PACS, powered wheelchairs, infusion pumps, surgical drapes, surgical needles and suture material, and acupuncture needles.

Class III: General Controls and Premarket Approval

A Class III device is one for which insufficient information exists to assure safety and effectiveness solely through the general or special controls sufficient for Class I or Class II devices. Such a device needs premarket approval, a scientific review to ensure the device's safety and effectiveness, in addition to the general controls of Class I. Class III devices are described as those for which "insufficient information exists to determine that general controls are sufficient to provide reasonable assurance of its safety and effectiveness or that application of special controls ... would provide such assurance and if, in addition, the device is life-supporting or life-sustaining, or for a use which is of substantial importance in preventing impairment of human health, or if the device presents a potential unreasonable risk of illness or injury."

Examples of Class III devices which require a premarket approval include replacement heart valves, silicone gel-filled breast implants, implanted cerebral stimulators, implantable pacemaker pulse generators and endosseous (intra-bone) implants (with the exception of root-form endosseous dental implants which were recently reclassified as Class II).

European Union and European Economic Area

The classification of medical devices in the European Union is outlined in Annex IX of DIR 93/42/EEC. There are basically four classes, ranging from low risk to high risk.

Class I
Class IIa
Class IIb
Class III

The authorisation of medical devices is guaranteed by a Certificate of Conformity. This certificate is issued by the manufacturer itself, but for products in classe II until III, it should be backed by a so-called Notified Body, i.e. a test organisation accredited to the validate the compliance of the device with the council directive. Medical devices that pertain to class I (on condition they do not need to be sterilised or are not used to measure a function) can be put on the market purely by self-certification.

The European classification depends on rules that involve the medical device's duration of body contact, its invasive character, its use of an energy source, its effect on the central circulation or nervous system, its diagnostic impact or its incorporation of a medicinal product.

Certified medical devices should have the CE mark on the packaging, insert leaflets, etc.. These packagings should also show harmonised pictograms and ISO standardised logo's to indicate essential features such as instructions for use, expiry date, manufacturer, sterile, don't reuse, etc...

MEDICAL EQUIPMENT

Medical equipment is designed to aid in the diagnosis, monitoring or treatment of medical conditions. These devices are usually designed with rigorous safety standards.

There are several basic types:

1.)DIAGNOSTIC EQUIPMENT

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.


(ULTRASOUND SCANNER)


(MRI SCANNER)


(PET MACHINE)


(CT SCANNER)


(DIGITAL X-RAY MACHINE)


2.)THERAPEUTIC EQUIPMENTS

Therapeutic equipment includes infusion pumps, medical lasers and LASIK surgical machines.


(INFUSION PUMPS)


(SYRINGE PUMPS)


(MEDICAL LASER)


(LASIK SURGERY)

3.)LIFE SAVING EQUIPMENTS

Life support equipment is used maintain a patient's bodily function. These include medical ventilators, heart-lung machines, ECMO, and dialysis machines.


(PATIENT VENTILATORS)


(HEART LUNG MACHINE)


(HEMODIALYSIS MACHINE)

4.)MEDICAL MONITORS

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.


(VITAL SIGNS MONITOR)


5.)MEDICAL/CLINICAL LAB EQUIPMENTS

Medical laboratory equipment automates or help analyze blood, urine and genes.


(CLINICAL CHEMISTRY ANALYZERS)


(URINE ANALYZER)