For manufacturers of medical devices, when looking to manage and reduce risk, many have looked to the ISO 14971 standard as a means of managing the risks associated with the manufacture and processing of their medical device. This standard references and suggests the use of ALARP. As a result ALARP has become widely applied and is the basis for the acceptance by many manufacturers of the low to moderate levels of residual risks which may be associated with the development, processing and use of their medical devices.
However, ALARP is now no longer going to be acceptable (in Europe at least).
Under the incoming European Medical Device Regulations (MDR’s), the requirement for those involved in development and manufacture of Medical Devices is that all risks need to be reduced “as far as possible”.
What is the difference? Well there is quite a significant difference.
Basically ALARP allows a manufacturer to include economic impacts into considerations as to what are acceptable and unacceptable risks. AFAP (as far as possible), does not allow economic impacts to form part of the risk decision making process.
As the European Medical Device Regulations come into legal force across the European area, those manufacturers, which have been using ALARP in the risk management processes will need to change over to AFAP. In some cases, where economic considerations have been part of the risk decision processes, then changes will need to be made to align with the AFAP requirements, otherwise such medical devices may not be legally marketed across the European Market.
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Risk Management.
Current Best Practice. Information & Training Presentation >>>
To explain:
In the 2012 version of ISO 14971, Annex D. D.8, the concept of ALARP is detailed.
“When establishing the risk acceptability policy, the manufacturer might find it convenient to use an as-low-as reasonably-practicable approach”.
The standard then goes on to explain how economic factors can input into the risk decision processes:
“After a particular risk control option has been applied, there are three possible results:
a) the residual risk exceeds the manufacturer’s criterion for risk acceptability;
b) the residual risk is acceptable because it is so small as to be negligible or
c) the residual risk is between the two states specified in a) and b); for these risks the residual risk is acceptable for the option that reduces the risk to the lowest practicable level, bearing in mind the benefits resulting from its acceptance and taking into account the costs of any further reduction.”
The standard specifically, states that the costs associated with further reduction of residual risks can be considered and justification of not taking further risk reduction activities are acceptable if the costs associated with such actions are not justifiable.
ALARP has been frequently legally interpreted, and detailed into various legal acts, along the basis that the “implementation of risk-reducing measures until the cost of further risk reduction is disproportional to the potential risk reducing effect achieved by implementing any additional measure.”
However, the European Medical Device Regulations’ detail that all risks associated with medical devices be reduced as far as possible (AFAP).
Per Article 10, 2 of the Medical Device Regulations (EU MDR 2017 / 745). Manufacturers are required to establish, document, implement and maintain a product safety risk management system. The detailed requirements of the system are listed in the Annex I Chapter I, points 2-9.
ANNEX I
GENERAL SAFETY AND PERFORMANCE REQUIREMENTS CHAPTER I GENERAL REQUIREMENTS
General Requirements. Part 1.
“Devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose. They shall be safe and effective and shall not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art.”
General Requirements. Part 2.
“The requirement in this Annex to reduce risks as far as possible means the reduction of risks as far as possible without adversely affecting the benefit-risk ratio.”
The MDR’s do not allow financial considerations to override the Essential Requirements for the safety and performance of medical devices. If risks are identified via a risk analysis, and risk controls are not implemented, the justification for any non-implementation cannot be based on financial reasons.
In reality, the costs associated with risk controls will always be considered, however, that is not acceptable per the MDR’s. Risk decisions need to remain focused on safety risk benefits.
In order to help manufacturer’s understand the meaning of the “as far as possible” concept, the European Commission published an interpretation of “as far as possible”.
Per the EU Commission, “the phrase as far as possible has led to significant confusion for those involved in placing medical devices on the market. Strict interpretation would create practical problems such as where to stop in reducing risk before a product can be placed on the market. This may restrict patient access to safe and affordable devices.”
The Commission raises concerns that the use of ALARP could result in economic considerations surmounting safety considerations. On the other hand, the reduction of a risk “as far as possible” could be without limits and the resulting devices might no longer be affordable for a larger group of patients.
Recommendation of the Commission: “Although economic considerations will always be relevant in decision-making processes, the safety of the product must not be traded off against business perspectives. For transparency the manufacturer must document the end-point criteria of risk reduction based on his risk policy.”
The clarification provided by the EU Commission, still leaves room for discussion, however, while the extent of the meaning of “as far as possible” still leaves some room for discussion, the focus of risk management and risk mitigation under the MDR’s must be primarily driven by safety concerns, e.g. “risk versus safety” benefits, not “risk versus cost/safety” benefits. Therefore, when a risk is identified, the product developer / manufacturer needs to be able to demonstrate that all practical risk control measures, which reflect “current state of the art” have been implemented and any further risk controls would not further reduce risks.
Medical Device Developers / Manufacturers need to revisit their Risk Management procedures are ensure that:
All risks, including those determined as “negligible” under ISO 14971, have been reduced AFAP, based on the “state of the art”. Note “state of the art” refers to “generally accepted state of the art”, which relates to current best practices in the industry. It does not mean the most advanced or latest technology, just what is widely seen as current best practices.
When making risk reduction decisions, and identifying and implementing risk controls, cost is not part of the decision-making process.
The benefits to the producer / user / society, etc. outweigh the residual risks associated with the device.
Where residual risks remain, addition risk controls would not result in lower risk levels.
Medical Devices.
- Validation. Classification. Regulation. Requirements. Current best practices.
- FDA cGMP’s, EU MDR’s / MDD’s.
- Risk Identification. Documentation. DHR’s. DMR’s.
Current Best Practice. Information & Training Presentation >>>
Risk Management.
- Risk Identification. Risk Evaluation. Risk Mitigation. Risk Control. Etc..
- Requirements. Standards. Etc..
Current Best Practice. Information & Training Presentation >>>
Reference:
Medical Device Regulation MDR 2017 545.
Information & Training. | Medical Devices
The ISO 14971 standard has been developed for those involved in the manufacture of medical devices, however it can be used as guidance in developing and maintaining a risk management process for other products that are not necessarily medical devices.The standard deals with processes for managing risks associated with medical devices. Risks can be related to injury, not only to the patient, but also to the user and other persons. Risks can also be related to damage to property (for example objects, data, other equipment) or the environment.
The 2019 edition cancels and replaces the second edition (ISO 14971:2007), which has been technically revised. The main changes compared to the previous edition are as follows:
– There are newly introduced definitions related to “benefit”, “reasonably foreseeable misuse” and “state of the art”:
Medical Device Validation. Classification. Regulation. Requirements.
FDA cGMP’s, EU MDR’s / MDD’s.
Risk Identification. Documentation. DHR’s. DMR’s.
Information & Training presentation >>>
“benefit”
The positive impact or desirable outcome of the use of a medical device on the health of an individual, or a positive impact on patient management or public health. Benefits can include positive impact on clinical outcome, the patient’s quality of life, outcomes related to diagnosis, positive impact from diagnostic devices on clinical outcomes, or positive impact on public health.
“reasonably foreseeable misuse”
Use of a product or system in a way not intended by the manufacturer , but which can result from readily predictable human behavior. Readily predictable human behavior includes the behavior of all types of users, e.g. lay and professional users. Reasonably foreseeable misuse can be intentional or unintentional.
“state of the art”
The developed stage of technical capability at a given time as regards products, processes and services, based on the relevant consolidated findings of science, technology and experience. The state of the art embodies what is currently and generally accepted as good practice in technology and medicine. The state of the art does not necessarily imply the most technologically advanced solution. The state of the art described here is sometimes referred to as the “generally acknowledged state of the art”.
– More attention is given to the benefits that are expected from the use of the medical device. The term “benefit-risk analysis” has been aligned with terminology used in other widely utilized regulations.
– It is explained that the process described in ISO 14971 can be used for managing risks associated with medical devices, including those related to data and systems security.
– The method for the evaluation of the overall residual risk and the criteria for its acceptability are required to be defined in the risk management plan. The method can include gathering and reviewing data and literature for the medical device and for similar medical devices and similar other products on the market. The criteria for the acceptability of the overall residual risk can be different from the criteria for acceptability of individual risks.
– The requirements to disclose residual risks have been moved and merged into one requirement, after the overall residual risk has been evaluated and judged acceptable.
– The review before commercial distribution of the medical device concerns the execution of the risk management plan. The results of the review are documented as the risk management report.
– The requirements for production and post-production activities have been clarified and restructured. More detail is given on the information to be collected and the actions to be taken when the collected information has been reviewed and determined to be relevant to safety.
Medical Device:
- Validation. Classification. Regulation. Requirements. Current best practices.
- FDA cGMP’s, EU MDR’s / MDD’s.
- Risk Identification. Documentation. DHR’s. DMR’s.
- Information & Training presentation >>>
Risk Management:
- Risk Identification. Risk Evaluation. Risk Mitigation. Risk Control. Etc..
- Requirements. Standards. Current best practices.
- Information & Training presentation >>>
ISO 14971:2019. Medical devices — Application of risk management to medical devices.
Information & Training. | Risk Management.
The ISO 31000, Risk Management Standard was first released in 2009. The standard is not specific to any particular industry or risk setting, but is designed to provide “best practice” guidance in all scenarios where risks can arise. The standard has been subsequently revised to the ISO 31000:2018 standard. This new revision provides a greater emphasis on the involvement of senior management and the integration of risk across the organization.ISO 31000 identifies key principles in risk management.
– Risk needs to be integral within organizational decision making and all processes.– Risk must be considered in a systematic, structured and timely manner.
– Risk decision must be based on the best information available.
– There is a requirement to take human and cultural factors into account. How could risk be impacted by organizational culture, and staff capabilities, perceptions & values.
– Risk is a dynamic activity, the risk management processes must be equally dynamic to remain relevant.
– There is a need to continually improve the risk management processes and use risk management to improve the organization.
– Be transparent and inclusive of all stakeholders. Ensure senior management buy in to the risk management processes, include relevant parties in decisions and communicate to the whole organization to mitigate resistance to change.
– Be tailored to your business. Align risk management decisions to business goals, risk profile and individual internal and external factors.
Based on the principles of risk management, the ISO 31000 standard then details the need for a “Risk Framework”.
In addition to the Risk Framework, the standard details that the next step is to define the Risk Process. The Risk Process, as defined by ISO 31000: 2018, is “multi-step and iterative; designed to identify and analyze risks in the organizational context.”
The key stages in the Risk Process are:
– Communication and Consultation– Definition of the scope, the context both internal and external and the risk criteria.
– Risk Assessment processes (Identification, Analysis, Evaluation), and
– Risk Treatment processes.
– Continual monitoring.
– Recording and reporting of findings.
Information & Training presentation on Risk Management. Risk Processes. Risk Planning. Etc. >>>
Information & Training.
Risk Management.
- Risk Identification. Risk Evaluation. Risk Mitigation. Risk Control. Etc..
- Risk Processes. Risk Planning. Risk Reporting.
- Requirements. Standards. Current best practices.
- Information & Training presentation >>>
Reference:
ISO 31000 2018 International Organization for Standardization
Integrated Risk Management (IRM) entails combining cyber security-based compliance, digital and cyber risk management, and corporate governance into a universal and streamlined approach. This gives businesses the benefit of enterprise-wide visibility into their cyber posture, besides enabling the meaningful automation of their risk management strategies.
In the current digital era, businesses have diverse needs. Likewise, they face a wide range of digital risks. In its purest form, IRM mirrors the dynamic needs of today’s businesses. Security managers and the C-suite shouldn’t be satisfied with regular compliance-driven GRC tools. They need tools that can visualize, integrate, and synthesize the various forms of risk data. This is what integrated risk management is all about.
What Should IRM Entail?
When it comes to integrated risk management, the value of a program always increases as more risk activities come into view. IRM allows corporate executives to make matter-of-fact decisions regarding what risks to mitigate and what to transfer or accept. As you implement an IRM program, there are many risk areas that you should consider. You should also keep in mind that there are interdependencies and interconnections among these risk areas, which are:– Identity risk
– Third-party risk
– Business continuity risk
– Corporate compliance risk
– IT risk
Benefits of IRM to Your Business
Broadens Your Range of Opportunities
With an IRM program in place, it will be easier for you to consider both the negative and positive aspects of risks that your business faces. It also helps you to identify unintended consequences that could lead to more significant problems in the future. Knowing the risks that you face across all aspects of your business creates opportunities for alignment, cost savings, and competitive advantages. In doing so, you’ll be adding value to the company over and above risk mitigation.Makes It Easier to Identify and Mitigate Risks
Typically, risks affect all aspects of your business. A risk can emerge from one part of your operations and affect other components of the company. A one-way strategy, such as GRC, (Governance, Risk, Compliance) can’t address such risks effectively. With IRM, it’s easier to identify and mitigate entity-wide risks. This risk management strategy provides an aggregate view of the risks that you face, besides enabling you to quantify them.Eliminates Surprises
Risks often come as a surprise. If you are caught off-guard, your business will undoubtedly suffer. With IRM, you can limit negative surprises while optimizing gains. It allows you to improve your ability to identify both positive and negative risks and establish suitable responses. By eliminating negative risk surprises, you will be able to avoid the resultant financial losses.Integrated risk management provides a foundation for having informed discussions regarding alternatives and unintentional consequences. Indeed, negative risks won’t stop emerging, but if they do, they won’t have an element of surprise. For instance, if you are setting delivery schedules for your manufacturing firm, you should realize that delays in highway traffic can’t be avoided. To avert resultant risks, you can develop alternative routes and protocols for alerting customers about potential delays.
Minimizes Performance Variability
The risks that some businesses face have little or nothing to do with surprises. Instead, these risks emerge from performance variability. Having an integrated risk management strategy makes it easier for you to gauge the performance of all aspects of your business. On the other hand, a single risk management strategy will only help you to measure the performance of one aspect of your business.Improves Resource Deployment
IRM ensures that you have a wealth of information on risks at your fingertips. This way, it’s easier to assess your organization’s overall resource needs, thus optimizing resource allocation. For instance, an in-depth risk assessment of your company’s infrastructure can help you to determine components that are old and need replacing. Greater focus and emphasis on resources such as money, time, and people, makes those resources more efficient. This is what IRM helps you to achieve.How to Implement IRM Successfully
Here’s what you should do to implement integrated risk management successfully:– Align your company’s business outcomes with its cyber strategy
– Facilitate a risk-engaged and risk-aware culture at your organization
– Integrate risk into all business strategy discussions
– Create employee and stakeholder awareness about your IRM strategy
Implementing an integrated risk management strategy is one of the best decisions that you can make. IRM shouldn’t be separate from other management processes and decisions. Instead, it should get embedded in your corporate culture so that it becomes an integral part of your decision-making processes and day-to-day operations.
It’s crucial to keep in mind that when implementing IRM, your organization should consider all relevant implementation platforms so that you use a platform that suits you best. In the current digital age, threats evolve rapidly, thus the need to implement an integrated risk management strategy that can accommodate constant changes. Even if your business isn’t ready for a full-blown IRM upheaval, you can still take small steps towards improving your risk visibility.
Information & Understanding. | Software Validation.
Activities associated with validating software occur throughout the evolution of the product. There are numerous techniques and tools that may be used in isolation or in combination with each other.Software Technical Review.
Includes techniques such as audits, walk-throughs, inspections. Most of these approaches involve a group meeting to assess a work product. Software technical reviews can be used to examine all the products of the software evolution process. In particular, they are especially applicable and necessary for those products not yet in machine processable form, such as requirements or specifications written in natural language.
Software Validation Information & Understanding.
Software Testing
Software testing is the process of exercising a product to verify that it satisfies specified requirements or to identify differences between expected and actual results.Various levels of testing activities, each with its own specific goals, are widely utilized.
i) Module Testing
Module (or unit) testing is the lowest level of testing and involves the testing of a software module or unit.
(ii) Integration Testing
Integration testing consists of the systematic combination and execution of product components.
iii) System Testing
System testing is the process of testing the integrated hardware and software system to verify that the system meets its specified requirements.
iv) Regression Testing
Regression testing can be defined as the process of executing previously defined test cases on a modified program to assure that the software changes have not adversely affected the program’s previously existing functions. The error-prone nature of software modification demands that regression testing be performed.
Testing Techniques and their Applicability
(i) Functional Testing and AnalysisFunctional testing develops test data based upon documents specifying the behavior of the software. The goal of functional testing is to exercise each aspect of the software’s specified behavior over some subset of its input.
ii) Structural Testing and Analysis
Structural testing develops test data based upon the implementation of the product. Usually this testing occurs on source code.
iii) Error-Orientated Testing and Analysis
Error-oriented testing and analysis techniques are those that focus on the presence or absence of errors in the programming process.
iv) Hybrid Approaches
Combinations of the functional, structural, and error-oriented techniques
v) Integration Strategies
Integration consists of the systematic combination and analysis of product components.
vi) Transaction Flow Analysis
Transaction flow analysis develops test data to execute sequences of tasks that correspond to a transaction, where a “transaction” is defined as a unit of work seen from a system user’s point of view.
vii) Stress Analysis
Stress analysis involves analyzing the behavior of the system when its resources are saturated, in order to assess whether or not the system will continue to satisfy its specifications.
viii) Failure Analysis
Failure analysis is the examination of the product’s reaction to failures of hardware or software.
ix) Concurrency Analysis
Concurrency analysis examines the interaction of tasks being executed simultaneously within the product to insure that the overall specifications are being met.
Proof of Correctness
Proof of correctness is a collection of techniques that apply the formality and rigor of mathematics to the task of proving the consistency between an algorithmic solution and a rigorous, complete specification the intent of the solution.Simulation and Prototyping
Simulation and prototyping are techniques for analyzing the expected behavior of a product.Requirements Tracing
Requirements tracing is a technique for ensuring that the product, as well as the testing of the product, addresses each of its requirements.
Information & Understanding. | Software Validation.
- Agile Development. Extreme Programming. Spiral Validation. Etc..
- Software Validation explained in an easy to understand, visual, format.
- Use to inform yourself on the Validation of Software.
- Information & Understanding >>>
General Principles of Software Validation FDA
EU Commission guidance on stand alone software
ISO/IEC 12207 Systems & Software Engineering – Software Life Cycle Processes
“Introduction to Software Verification and Validation”. Software Engineering Institute. Carnegie Mellon University. Pittsburgh, Pennsylvania
Six Sigma Tools for Process Improvement are significant elements that are essential for your business process improvement. These tools help in identifying the flaws and weaknesses and eliminating them for an error-free result.
If you use the process systematically, it will help in increasing your employees’ productivity and drive profits.
In this post, we will talk about the seven most essential tools that will help in business process improvement:-
Business Process Mapping:
It is the process of recording the activities of the business processes. This tool consists of roles and responsibilities, criteria involved in the process. It gives you a clear picture of each of the operations, such as the job of people within the process and ensures everyone is clear about their roles.Types of Maps:
Flowchart – One of the most popular types of maps. Though it is not so flexible, it is easier to make it quickly. You can draw it with your hands, or in MS Office.
Value stream map – A more intense option to the flowchart. It is used across lean six sigma operations.
SIPOC – (Supplier, Inputs, Processes, Outputs, Customer) diagram – This diagram visually documents your business process from beginning to end.
Swimlane Diagram – It is used in process flow diagrams, that visually differentiates job sharing and responsibilities for sub-processes of a business process.
7 Elements of Waste:
7 Wastes process map will help you achieve the ideal state that you desire for by helping you to identify the waste and eliminate them.Over Production – Building an excess quantity of units or more than the customer needs is sheer waste and produces more cost than required. The solution is to schedule and provide the exact amount that needs to be immediately sold/shipped.
Waiting – Waiting occurs when goods are not moving or being processed. Connecting processes together so that one feeds directly into the next can reduce waiting.
Transporting – Transporting product between processes incurs the cost and doesn’t add value to the product. Mapping the product flows can make it easier to visualize the extra time wasted either done manually or with the machine.
Processing – The waste of excess processing leads to a waste of money and time. If you can invest in smaller, more manageable tools where possible and combining steps will significantly decrease the waste of unnecessary processing.
Inventory – Excess inventory increases cash to spend, produces more handling and storage charges which you may never recover.
Motion – Excess motion is dangerous in terms of safety and health issues as well. For example, motion to accommodate a machine or frame a house; these can be achieved by resetting design, tools, and employees.
Defects – Quality defects lead to rework or scrap the product. It adds up to a massive cost to organizations.
Value Stream Mapping:
Value Stream Mapping (VSM) is a work environment efficiency tool which is constructed to combine material processing steps with information flow, including other related data. It is widely used in lean manufacturing but can be used in any industry.The process map includes all the steps involved in the business process; process map, timeline, and information flow. The timeline appears from the process map and abstracts all the data during the process. The information flow describes how each of these steps cooperates.
VSM helps you create a robust implementation plan that will help to maximize your available resources and also help to ensure that materials and time are used efficiently.
RACI Matrix:
RACI (Responsible, Accountable, Consulted, and Informed) matrix is nothing but a method of nominating each task to the members of the project and so that each of the functions can be done without any repetition.In a RACI Matrix table, left side column consists of the specified tasks, and the top row includes the team member names. The intersection cells have the letter (R, A, C, I) corresponding to what a team member will handle within the assignment. This matrix enables you to recognize the gaps in the team structure and which roles you need to fill.
5S:
This methodology is simple, comprehensive, gives quick impact, and can be universally applied in areas such as production, office, and information systems.Sort – Listing out the tasks in order of high importance to least importance and handle them accordingly.
Straighten – Arrange the items/tasks in such a way that minimizes travel/search wastes for the quick and simple flow of the items to be picked or tasks to be completed first.
Shine – It is the stage where you need to keep the work area intensively clean
Standardize – You can color code, create standard signage format, color scheme, font, and appearance.
Sustain– You should always audit the processes, and there must be controls and measures defined
Cause and Effect Analysis:
This analysis is also known as Fishbone or Ishikawa or X-Y diagram. It is a systematic way to explore different causes leading to an uncertain condition. All the members discuss and analyze the problem condition. The final product of the exercise looks similar to Fishbone.The steps to perform this analysis are:-
– Brainstorm all potential reasons for the problems. Subject Matter Experts and the Black Belt can expedite the brainstorming.
– You can divide the significant causes under various categories
– While brainstorming, you need to shortlist and prioritize the only potential causes.
– Now you can draw the fishbone diagram after you have prepared the categories
– At last, you can figure out the root causes of the problems.
Mistake Proofing (Poke Yoke):
It is a technique to prevent defects and identify defects as soon as possible. The primary use of this process is to eliminate product defects by preventing unintentional human errors.These tools will highly support your business improvement process and are used globally in various industries. However, depending upon the industry and situations, you may utilize them to get an error-free and the best output.
Author Bio:
Jane Thomson is a Content Marketing Manager at GreyCampus with five years rich experience on developing content for professional certification courses like PMP- Project Management Professional, PMI-ACP, Six Sigma, Prince2, and ITIL (Information Technology Infrastructure Library).
Information & Training. | Quality Assurance. Quality Management.
The International Standards Organization (ISO) is the primary international body responsible for development worldwide standards in quality, environmental, safety, regulatory environment. Within the ISO body, technical committees (TC’s) are set-up to focus on specific areas where standards are to be developed. The Technical Committees are staffed by experts in their area, who come from industry, academia, government and non-government bodies from around the world. The TC’s draft new or revised standards, which are then circulated for comment, feedback and recommendation. It takes approximately 3 years to develop a standard from initial draft to final approved publication.
ISO Standards Development (source: ISO International Standards Organization)
There are four principles upon which the ISO base their standards development process. First, the standard must respond to a need in the market, second the standard must be based on global expert opinion, third the standards are developed and progressed through a multi-stakeholder process, i.e. members of the relevant TC must represent the brood range on interested parties, e.g. industry, academia, government, voluntary sectors, etc. and finally the new standard needs to be based on consensus.
Information & Training. | Quality Assurance. Quality Management.
- The Principles of Quality Management
- The Quality Manual
- Quality Standards and Specifications
- The Quality Management System
- Revised requirements of ISO 9001: 2015
- Design Quality – Products & Processes
- Good Manufacturing Practice (GMP)
- Documentation
- CAPA – Corrective And Preventative Action
- Calibration Certification
- Change Management and Control
- Quality Management Training
- Product and Process Validation
- Supplier Quality Assurance
- Audits & Auditing
- Ensuring the Quality Management System is Risk based
- Etc. …. Etc. …. Etc. …
- Information & Training presentation >>>
Information & Training. | Medical Devices
Health care providers typically place endotracheal tubes into a patient’s airway (trachea) to help establish and maintain their airway and to ensure the adequate exchange of oxygen and carbon dioxide. The Vyaire Medical Tri-Flo Subglottic Suction System can be used to remove liquids or semisolids that block an adult patient’s airway when an endotracheal tube is in place.Reason for the Medical Device Recall:
Vyaire Medical Inc recalled the Tri-Flo Subglottic Suction System because there was a risk that the distal soft tip of the catheter may break off and enter the patient’s lungs.
This could result in serious adverse health consequences including choking, wheezing, additional surgery to remove the tip from the patient’s lungs, irritation and reddening of the skin (erythema) of the airways, infections or death.
FDA consideration:
The FDA has identified this recall as a Class 1 recall, which is the most serious form of recall. This is due to the potential serious effects if a device breakage were to occur while in use.
FDA statement >>>
What can we learn from this particular Medical Device Recall:
Unfortunately, Medical Devices can and do fail while in use. How best to prevent? Clearly, all medical devices need to undergo comprehensive design validation which is based on risk assessments which identify the high-risk areas, if indeed a product or component of a product were to fail. Once fully validated, there remains a need to ensure ongoing effective process controls and monitoring of materials and suppliers needs to be in place to ensure no degradation of the product due to lower quality materials getting into the supply chain.
Information & Training.
Medical Device:
- Validation. Classification. Regulation. Requirements. Current best practices.
- FDA cGMP’s. EU MDR’s / MDD’s.
- FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
- FDA Medical Device Classification. The FDA approach to Medical Device Classification.
- EU Medical Device Regulation and Classification (per MDD’s).
- New European Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
- Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
- Quality System requirements to maintain compliant Validations.
- Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
- Medical Device Software Validation.
- Medical Device Design Validation.
- Electronic Signature, Electronic Records.
- Life Cycle Approach to Validation.
- Risk Identification. Documentation. DHR’s. DMR’s.
- Etc. Etc. …
- Information & Training presentation >>>
Unexpected quality, reliability, safety or efficacy outcomes can result in process shutdowns, product recalls, regulatory sanctions, litigation, etc.. Validation seeks to minimize the potential for process or product non-conformance to design and development intent.
Why validate a medical device
Medical Device Process Validation >>>
FDA GMP QSR General Requirements >>>
Process HAZOP Analysis >>>
Device History Record >>>
FDA Regulation of Combination Products >>>
Process Validation. Product Validation >>>
EU Medical Device Regulation MDR 2017 745 >>>
Validation, Regulation, Risk Management, information & training presentation >>>
Information & Training. | Total Quality Management.
Round Robin Brainstorming.
The “Round Robin” Method.
Round Robin Brainstorming is a widely applied and very successful method directed towards problem solving and continuous improvement. In the traditional “free form” brainstorming session, team members are encouraged to suggest ideas, and other team members try to build on these ideas. One of the problems inherent with the “free form” approach, is that the more vocal, more assertive team members can influence the direction of discussion and idea generation down a path which aligns with their own thinking and can result in the team veering away from actually find the true root cause of a problem.For example, consider a team formed to understand why an item of process equipment is experiencing frequent breakdowns. The team may consist of representatives from production, maintenance, quality, engineering, etc.. At the start of the brainstorm session, the team leader explains the rules and asks for suggestions. Immediately, the maintenance person, suggests “procedures not being followed by production”, consequently the brainstorm session may follow a path where ideas are suggested as to how to get the production personnel to “follow procedures”. This may be a valid path to follow, however, in a team with some very strong vocal personalities, and quieter team members, the team leader may find it difficult to get a broad balance of ideas generation.
The “round robin” approach is a modification to the “free form” approach to Brainstorming, which seeks to balance out the relative strengths of personalities within the team.
Brainstroming
Bottleneck Analysis
Benchmarking
FMEA
FTA
HAZOP
PDCA/DMAIC/DMADV
SIPOC
Etc. Etc.
Information & Training presentation >>>
The round robin can be broken down into the following sequential steps:
Step 1: The team leader explains the objectives of the brainstorm session, encourages questions but asks the team members to keep their ideas to themselves.
Step 2: Each member of the team is provided with a blank card for writing ideas onto.
Step 3: The team leader then asks each team member to think about possible ideas and to write one idea onto their blank card.
Step 4: Once each member has written down their idea, they pass their card onto the person next to them, so that all the cards (and ideas) move onto a new person. There is no open discussion at this stage between the team members, so that the ideas are kept relatively concealed.
Step 5: The leader then asks the team members to consider the ideas suggested on the cards they are now holding, and to make further suggestions based on these ideas.
Step 6: Again the cards, now with two suggestions each, are passed onto the next team members. This process is repeated, until team members get exhausted of ideas, or the team feel that sufficient ideas have been generated.
Step 7: The cards are now gathered-up by the team leader and posted-up onto a board for all to see.
Step 8: The team now goes back to the “free form” approach and start to discuss the ideas, combine duplicates, discard those that may be seen as unworkable, prioritize those for further investigation, etc..
Advantages & disadvantages of the “round robin” approach to Brainstorming.
Under the round robin approach, all team members have an equal voice in idea generation, therefore ideas and consequent follow-up discussion is not based on individual assertiveness or individual passion for the topic in question. Sometimes individuals like to think quietly about a problem, and the open discussion format of the “free form” approach can hinder their thinking. The round robin forces a respect for ideas as each team member has to consider the prior single idea suggested and build on this suggestion.A disadvantage of the round robin is that the initial quiet, documentation steps, can work against the fundamental spontaneous nature of Brainstorming, where the focus is to create an open forum, where ideas are spontaneously suggested, often in rapid suggestion, and where a form of comradery can be created which helps build a unified team approach to addressing the problem under consideration.
The “round robin” can also take longer to complete as the initial stages need time and in many work environments, there are tight time resource constraints.
Quality Improvement Techniques
Information & Training. | Total Quality Management Tools and Techniques …
- Continuous improvement utilizing Analytical Techniques.
- Brainstorming
- 5 why’s analysis
- Process Flow Diagrams/Flowcharts/Process Mapping
- Check sheets /Check Lists
- Run charts
- Histograms
- Scatter Diagrams/Scatter Plot
- Cause and Effect/Fishbone/Ishikawa Diagrams
- Identifying sources & causes of variation
- Control/Shewart Charts/DPU Charts
- Cpk and Ppk Analysis
- Pareto Analysis
- Bottleneck Analysis
- Benchmarking
- FMEA
- FTA
- HAZOP
- PDCA/DMAIC/DMADV
- SIPOC
- Etc. Etc.
- Information & Training presentation >>>