“Medical devices” is a term used for a wide range of equipment from a simple wooden tongue depressor to a computerized, highly sophisticated medical equipment. There are different international classifications systems for these devices. In all systems, safety is the biggest concern. There are some safety and performance-related regulations in place and manufacturers and suppliers have to follow these regulations. This is where medical device consultants in UK can help them.
A medical device is an apparatus, instrument, machine, implement, appliance, implant, software or any other article manufactured to be used by human beings. More than one device can be combined and used together to serve a purpose.
The device can use for:
- Prevent, diagnose, treat, monitor or alleviate diseases
- Prevent, diagnose, treat, monitor or compensate for an injury
- Investigate, replace, modify or support a physiological process
- Support or sustain life
- Collect information for medical use by examining a specimen derived from the body of the patient.
Keep in mind that an accessory is not a medical device. However, if an accessory is specially manufactured to be used with a medical device (parent medical device), both the accessory and the device should go through the same inspection, safety check and other procedures.
In Vitro device is a medical device used for diagnostic and monitoring purposes. Sample collection devices, calibrators, reagents, control materials and other apparatus or instruments are examples of these devices. There are separate regulations for In Vitro devices. Which devices are considered to be medical devices, this varies from jurisdiction to jurisdiction. In general, the following are considered to be medical devices:
- A device that aids handicapped/disabled people
- A device used for the diagnosis/treatment of injuries and diseases
- Medical device spare parts
- A device incorporating human tissues
These regulations make use of some terms having restricted meanings. For example, there are precise definitions for manufacturers, vendors, distributors, and retailers. However, there can be different definitions for these terms in different countries. The list of definitions coming with regulation also consists of definitions for other important terms such as effectiveness, performance and more.
Medical Device Safety
There are several essential elements involved in the optimum assurance of the safety of medical devices:
- You cannot guarantee absolute safety.
- Safety is a risk management issue.
- Align safety with the performance/effectiveness of the device.
- Consider the entire life-span of the medical device.
- It is a shared responsibility of stakeholders.
Safety And Risk Management
No device is 100% free from risks. Each device has a certain degree of risk that can cause problems in certain circumstances. Sometimes, it takes the extensive market experience to detect a problem a medical device can cause. For example, an implant can cause a problem that was not predicted when it was implanted. These failures occur due to conditions unique to certain patients. Sometimes, failure can be random or unpredictable.
The current approach to the safety devices estimates the potential of the device becoming hazardous. A hazard is an adverse event that can be a source of danger. The device can cause some safety problem or harm. This estimation of risks is called risk assessment. Risk measurement estimates the combination of:
- The hazard
- Likelihood of its occurrence
- The severity
- Overall impact
Risk assessment consists of risk analysis and risk evaluation. In risk analysis, possible hazards are identified. Risk evaluation is the estimation of the risk of each hazard. Risk assessment is pretty complex and based on computation, evidence, experience, or even guesswork. There are some factors that influence risk assessment. These factors include economic conditions, cultural background, political climates and even personal perceptions.
It is important to follow all the rules and regulations in place. So, find medical device consultants in UK and get help.