Question

1. There are about 10 stages in the Life Cycle Management of Medical Device. Can you name 4 points and briefly explain each point?

2. The management of medical equipment is a risk-based management program. Please start with the manufacturer’s design to meet intended use, risk assessment, acceptance testing, use, maintenance to the stages of post-market surveillance, and reporting to equipment condemnation. Briefly describe the features of the safety management mechanism at each stage.

Answer 1

Solution 1.

STAGES OF THE MEDICAL DEVICE LIFE CYCLE :-

The life cycle of a medical device can be divided into six distinct parts, with unique regulatory requirements that apply in each phase:

1. Concept: In the concept phase, the medical device exists only as an idea. Each medical device begins as an idea for solving a medical problem that someone has in an easier, cheaper or more effective way. In the concept stage, a medical device developer may begin to initially define the product, explore funding options and potential routes to market and begin to establish early requirements for the device.

2. Planning: The planning stage for medical devices is characterized by the collection of user needs and the translation of those needs into technical requirements for the final product. Here, engineers may start building prototypes, establishing a regulatory strategy, classifying the risk of the device, building a design file and broadening the project planto market the device.

3. Design: Once requirements have been established the medical device enters the design phase. Here, engineers will iterate on the product design, collect feedback from users, perform design verification and validation and begin to draft technical documentation. The product may be ready for brand development, and it could also be time to start developing a manufacturing process that will enable mass production.

4. Validation: In the validation phase of the product life cycle, medical device companies conduct clinical validation activities to verify that the device is safe and effective. The product will be labeled and regulatory submissions will be made so that the product can be marketed in the desired areas.

5. Launch: Once a medical device company gains approval to market a medical device, the product enters the launch phase of its life cycle. The product will be sold to healthcare providers, hospitals and clinics, and the manufacturer will provide training and support that enables effective use of the product.

6. Post Market: Once a medical device has entered the marketplace, it also enters the post-market stage of its life cycle. Post marketsurveillance activities will be conducted to ensure that adverse events that involve the medical device are reported, clinical follow-up studies may be conducted and the manufacturer can still address complaints or adverse events and make improvements to the product. If the product is successful, it may be launched into new markets.

Solution 2.

Safety management systems have six elements:

• A safety plan
• Policies, procedures and processes.
• Training and induction.
• Monitoring.
• Supervision.
• Reporting.

1. Safety plan

A safety plan is a strategic action plan that forms part of the business plan. It analyses the current and prospective risk for a company and charts how the risks will be eradicated and controlled over a calendar period (the safety plan must have a budget).

This plan will ensure that there is a governance structure within your company that ensures every worker clearly understands their safety obligations (and how to comply) and is accountable to carry out those obligations.

2. Policies, procedures and processes

Policies, procedures and processes include all safety paper infrastructures within your company. This paperwork will describe all safety behaviour, expectations, record-keeping, incident reporting, and incident notification documentation.

3. Training and induction

Depending on the nature of your workplace (whether it is low-risk or high-risk), everyone who enters your workplace should receivetraining and induction on:

• The rules of your company;
• The rules of the site; and
• The rules of the location they are visiting.

The training content will depend on the level of risk the person is exposed to.

4. Monitoring

Your obligations to monitor your workplace depend on circumstances and need. Always consider the level of risk. The higher the risk, the more frequent and detailed the monitoring needs to be.

Other times when monitoring will be necessary include:

• To ensure that all risk has been covered by a new risk assessment that has been carried out due to a change in process, e.g. the installation of new workstations; and
• When an investigation takes place following an incident.

5. Supervision

The only way to ensure your workers are carrying out their safety obligations is to have adequate supervision.

The level of supervision required in your workplace will increase if the level of safety control put in place to reduce a risk is low, i.e. the less effective the control measure used, the higher the level of supervision necessary.

6. Reporting

The governance structure of your company needs safety reporting at all levels, not just at board level.