Medical device technology involves regulatory control over risk management, classification, manufacturing process and safety assurance of medical devices. Have a look over exquisite medical device industry. Enjoy and Cheers!
What is Medical Device ?
- Medical Device is any instrument, apparatus, appliance, material or other article, including the software
- It is intended to be used for human beings for the purpose of:
- Treatment or alleviation of disease, or compensation for an injury or handicap.
- Investigation, replacement, modification, or support of the anatomy or of a physiological process,
- It does not achieve its principal intended action by pharmacological, immunological or metabolic means.
What are the Factors that may affect risk levels associated with medical devices ?
- Design: Device design should incorporate the principles of inherent safety.
- Manufacture: Manufacturing processes must be well planned and under control and includes Validated process to ensure conforming output and reduce the compromise to safety.
- Intended Use: This is the objective intent of the manufacturer on how the device will be used. The intended use will define the “scope” of use, and, in particular, places where the device is not intended for use.
- User experience, education, and training: It Define the anticipated user and Identify the expected user’s skill level
- Home use devices should be simple to operate
- Complex devices may require higher levels of training
- Device should not compromise : The clinical condition and safety of patients including Safety or health of users.
- Acceptable risks: The Risks are acceptable when weighed against patient benefits and also Compatible with a high level of health and safety.
- An example of Risk/benefit analysis :
- X-rays are inherently dangerous,
- X-ray machines have a benefit in diagnosis.
- The benefit of imaging outweighs the exposure risk.
How Assurance of Medical device safety is entertained ?
- Absolute safety cannot be guaranteed
- Risk management issues and measures taken to minimize risks.
- It is Closely aligned with device effectiveness / performance.
- Considered throughout the life span of the device.
- Shared responsibility among the stakeholders.
What are Medical Devices Regulatory Controls ?
- Regulators ensure public health and safety :Regulations try to match the level of control with the risk. The overarching goal is appropriate control commensurate with risk!
- The methods to approach regulatory controls differ by geographic market
- Controls follow the market, not the manufacturing location: Product marketed in the EU and manufactured in the US must follow EU regulations
What are Globally Accepted Strategy for Regulatory Practices ?
- It is the Set of essential principles of medical device safety and performance (essential requirements)
- It involves Risk based approach that is Risk based CLASSIFICATION of Medical devices which means Level of regulation based on level of risk.
- It Includes:
- Conformity assessment to ensure compliance with the Essential requirements.
- Standards – devices, processes and quality systems.
- Vigilance / post market surveillance.
What is the General Classification of Medical Devices ?
- The manufacturer determines the device class following the rules rules of regulatory body.
- Determine if the device is invasive or not; An invasive device, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body.
- Determine if the device is active; An active device depends on a source of electrical energy (or any source of power other than that directly generated by the human body or gravity) and acts by converting this energy.
- Determine if any special rules apply.
- When multiple rules could lead to different classification, use the highest risk class.
- For example: The brief outline classification of medical devices in the European Union (EU) is outlined in Annex IX of the Council Directive 93/42/EEC is give below:
- Class I: Low risk (Eg. Surgical retractors, tongue suppressors…)
- Class II a: Low – Moderate risk (Eg. Hypodermic needles, suction equipment…)
- Class II b: Moderate – High risk (ventilators, Bone fixation plates…)
- Class III: High risk (Eg. Heart valves, implantable defibrillators)
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