Project 2

ISO13485:2016 specifies requirements for a quality management system for medical devices.

where an organization needs to demonstrate its ability to provide medical devices and related services that consistently satisfy customer and applicable regulatory requirements.

Such organizations are involved in almost each stage of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device.

Lets take in vitro diagnostic medical device, every stage has to be essentially monitored starting from design and development, installation to reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus.

Look at some key aspects of ISO 13485:2016 -

• Risk is defined as the combination of the probability of occurrence of harm and the severity of that harm, what will be the consequence. So, this risk needs to be managed, for this there is risk management system.
• Risk Management is the systematic application of management policies, procedures and practices to the tasks of analysing, evaluating, controlling and monitoring risk. It goes in a loop,
• First, identify – risk needs to be identified to be managed.
• Second step is rate and analyse- there is a probability vs consequence graph that helps in rating the risk. It’s a 3-by-3 graph, indicates the risk as low, moderate or high and accordingly risk is categorised for further analysing. Check the severity and probability of the risk, probability can be explained as how often a person uses the instrument and exposed to the instrument. Severity goes like for how long a person is exposed to that instrument, whether it’s a direct exposure or indirect exposure. So by considering all these, criteria is setup and analyse in the graph.
• Control- by analysing all this, control measurement is taken. Either exposure time can be reduced by keeping 2 to 3 persons in shift or else a protective suit can be worn.
• Evaluate and monitor- after controlling everything, it needs to be monitored whether it is working properly or not.
• Life Cycle of medical device defined as all the phases in the life of a medical device from the initial conception to final decommissioning and disposal.

Stage 1 : Design and development- life cycle of any device starts from the time when it has been planned to make the device, its design is discussed along with all the procedure of development needed.

Stage 2: manufacturing- then after the planning and discussing, finally it is manufactured

Stage 3: use/maintenance- it is fully developed, now the time to use it along with its maintenance so, product is sold to a customer.

Stage 4: end of use- everything has a time limit so as long as it has worked properly, someday it does stop working.

Stage 5: scrap/reuse/disposal- after it stops working, either it go to scrap or some goes for reuse or else some gets disposed. And at this point life ends of a device.

Each step needs to be analysed and prepared for any kind of risk.

• Design and development- only designing and developing the product won’t be enough. There are several steps in between that needs to be maintained.
• First of all working place should be sterilized to make it contamination free.
• Purchase best quality raw material to avoid working problem. One should check before buying.
• Manufacturing should be handled with professional manufacturers who are potential for best result.
• Should pay heed while packing and packaging the product, because there can be chances of breaking down or can be contamination.
• Two-three layer of packaging should be done as a precaution as parts can get damaged during transportation. It should also be labelled properly.
• All the documents of the product have to be available inside the box as one can need anytime. There should not be having any problem during installation and documents should be in user friendly language.

The risk management process does not end with the design and manufacturing process but also includes applicable sterilization, packaging, labelling, storage, handling/ transport, distribution and market surveillance. The manufacturer shall apply risk management from the initial conception until the ultimate decommissioning and disposal of the product. Therefore, the gathering of post- production information is a required part of the process.

Risk assessment is one such tool to identify potential issues. It needs three factors-

• Correction is an action to eliminate a detected nonconformity or it can be an immediate “set right” of occurred problem.

Example- lets take someone is having headache so she took painkiller for temporary relief, this is a correction but what if again after 2 hour the pain starts. Now here corrective action is needed.

• Corrective Action eliminates the cause of nonconformity and to prevent a recurrence. It’s a long-term solution.

Example- as a corrective action for headache, she consulted a doctor and got spectacles.

• Preventive Action- is action that eliminate the cause of a potential nonconformity or other potential undesirable situation (to prevent the occurrence).

Example- during covid, a person has started taking precautions like maintaining distance and hygiene and many more things so this is preventive action. As in he has not been infected by the virus still he started taking precautions beforehand.

• PDCA is one of the elements of quality infrastructure, it stands for PLAN, DO, CHECK, and ACT.

Everything needs planning so to build a medical device and for its risk assessment also plan is needed, its design and type of risk and how will it be managed, the cost-estimation and all, after the perfect preparation of plan its time to implement it.

So “Do” is for implementing the plan and how it should be implemented, the correct way of implementing it.

“check”- now checking of the implemented plan is required, as it will work or not. What’s the probability of getting success and is there any risk, so everything has to be checked.

As all things are ready, so time to “act”, the medical device which is planned to build along with all the steps and measures for risk management are taken now will be applied to build the final product.

PDCA is followed for continual improvement.

• Clause 4 to clause 8 of ISO 13485:2016 are the requirements to be implemented.

Clause 4- Quality Management System (QMS)

Clause 5- Management Responsibility

Clause 6- Resource Management

Clause 7- Product Realization

Clause 8- Measurements, Analysis And Improvement.

• It is generally accepted that the concept of risk has two key components:

— the probability of occurrence of harm and

— the consequences of that harm.

• ISO 14971:2019 Medical devices — Application of risk management to medical devices

The document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.

The requirements of this document are applicable to all phases of the life cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability.

This document specifies a process through which the manufacturer of a medical device can identify hazards associated with the medical device, estimate and evaluate the risks associated with these hazards, control these risks, and monitor the effectiveness of the controls throughout the life cycle of the medical device.

Risk Management Process ISO 14971 requires the manufacturer to establish, document and maintain a risk management process for:

• Reviewing the intended use (intended purpose) of the medical device
• Identification of hazards (known and foreseeable)
• Estimation of the probability of occurrence of harm
• Estimation of the severity of each hazard and its harm
• Evaluation of associated risks (decision making)
• Control of these risks

Monitoring of the effectiveness of these controls throughout the whole life-cycle of a medical device.

Conclusion- The key to successful risk management in medical device design is to start early. As soon as conceptual designs are available, the risk management process can begin. A preliminary hazard analysis can be useful in selecting the concept with the highest level of inherent safety. Later, as the design is developed, design reviews at key points in the development process will allow changes to be made without significantly affecting the project schedule. The further along in the design process that changes are identified, the fewer choices are available to mitigate hazards without significant schedule implications.

Generally, risk management activities will identify opportunities to improve device performance. The benefits of conducting risk analysis during medical device design can be significant and can be used to offset some or all of the cost of implementing risk-mitigating measures.

S.No.	Activity	Risk	Risk Rating	Action/control	Residual rating
1.	Purchase of raw material	Low quality or not working properly	8	Purchasing best quality materials after checking.	2
2.	Manufacturing	Exposure to radiation	9	Control measurements are taken by court or by keeping people in shift.	2
3.	Packing and packaging	Breakage or contamination	9	Double-triple box of packaging	2
4.	Transporting	Parts can get damage	8	Choosing Safe transportation way	3
5.	Installation	Wire misplace	9	Appoint good technician	2