Showing posts with label GMP. Show all posts
Showing posts with label GMP. Show all posts
Sunday, August 26, 2012
Recall Management
The overall process of medical device involves the manufacturer, the FDA and the public (users, retailers). The following image depicts the actions of all parties involved in the recall process.
Source: GAO analysis of FDA information
Device Recalls
A recall is a method of removing or correcting marketed products that are in violation of laws administered by the Food and Drug Administration (FDA). Recall does not include a market withdrawal or a stock recovery (removal of un-marketed devices under the manufacturers' control). Medical device recalls are usually conducted by the manufacturer voluntarily using 21 CFR 7, to protect public health. However, if a manufacturer fails to report a malfunctioning device or initiate its recall, the FDA can issue a recall order under 21 CFR 810 and start legal action against the manufacturer.
Medical device recalls may result from manufacturing defects, labeling deficiencies, failure to meet premarketing requirements [PMA, 510(k)], packaging defects or other nonconformance problems. Recalls are of different classes depending on the relative degree of health hazard they pose to the user, class I posing the most hazard.
Class I - reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Class II - remote probability that the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
Class III - a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
A manufacturing firm may decide of its own volition and under any circumstances to remove or correct a distributed product. A firm that does so because it believes the product to be violative is requested to notify immediately the appropriate FDA District Office. Such removal or correction will be considered a recall only if the FDA regards the product as involving a violation that is subject to legal action, e.g., seizure.
When a device is found to be in violation of the FDA regulations, it is first subject to a health hazard evaluation by the FDA. Data evaluation is done to detect if the device has caused any diseases or injuries during use, or can contribute to other clinical conditions. Various assessments are conducted to evaluate
* hazards in all segments of population;
* degree of seriousness of the hazard in the exposed population;
* likelihood of hazard occurrence; and
* consequences of the potential hazard.
Based on these results and other evaluations, the FDA assigns a Recall Class to the device being evaluated.
Once the device is assigned for recall, the recall firm develops a recall strategy based on the heath hazard evaluation. The recall firm in most cases is the manufacturer of the device. The recall strategy determines the
* Depth of Recall - level of distribution chain up to which recall is to extend. Can be user level, retail level or wholesale level.
* Public Warning - to alert the public of the violative device being recalled.
* Effectiveness Checks - to verify that all consignees have received notification about the recall and have taken appropriate action.
The recalling firm is to submit periodic recall status reports to the appropriate FDA district office. The FDA assesses the progress of the recall through these reports an their frequency is determined by the relative urgency of the recall and will be specified by the FDA for each recall case. A recalling firm may request termination of its recall based on its progress. A recall will be terminated when FDA determines that all reasonable efforts have been made to remove or correct the product in accordance with the recall strategy, and when it is reasonable to assume that the product subject to the recall has been removed and proper disposition or correction has been made commensurate with the degree of hazard of the recalled product.
Medical device recalls may result from manufacturing defects, labeling deficiencies, failure to meet premarketing requirements [PMA, 510(k)], packaging defects or other nonconformance problems. Recalls are of different classes depending on the relative degree of health hazard they pose to the user, class I posing the most hazard.
Class I - reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Class II - remote probability that the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
Class III - a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
A manufacturing firm may decide of its own volition and under any circumstances to remove or correct a distributed product. A firm that does so because it believes the product to be violative is requested to notify immediately the appropriate FDA District Office. Such removal or correction will be considered a recall only if the FDA regards the product as involving a violation that is subject to legal action, e.g., seizure.
When a device is found to be in violation of the FDA regulations, it is first subject to a health hazard evaluation by the FDA. Data evaluation is done to detect if the device has caused any diseases or injuries during use, or can contribute to other clinical conditions. Various assessments are conducted to evaluate
* hazards in all segments of population;
* degree of seriousness of the hazard in the exposed population;
* likelihood of hazard occurrence; and
* consequences of the potential hazard.
Based on these results and other evaluations, the FDA assigns a Recall Class to the device being evaluated.
Once the device is assigned for recall, the recall firm develops a recall strategy based on the heath hazard evaluation. The recall firm in most cases is the manufacturer of the device. The recall strategy determines the
* Depth of Recall - level of distribution chain up to which recall is to extend. Can be user level, retail level or wholesale level.
* Public Warning - to alert the public of the violative device being recalled.
* Effectiveness Checks - to verify that all consignees have received notification about the recall and have taken appropriate action.
The recalling firm is to submit periodic recall status reports to the appropriate FDA district office. The FDA assesses the progress of the recall through these reports an their frequency is determined by the relative urgency of the recall and will be specified by the FDA for each recall case. A recalling firm may request termination of its recall based on its progress. A recall will be terminated when FDA determines that all reasonable efforts have been made to remove or correct the product in accordance with the recall strategy, and when it is reasonable to assume that the product subject to the recall has been removed and proper disposition or correction has been made commensurate with the degree of hazard of the recalled product.
Friday, August 24, 2012
Complaint Handling
Any communication that points to some deficiencies in the product identity, quality, durability, consistency, security, efficiency, or performance of a product or device after it is released for distribution, is considered as a complaint. As seen under MDR, complaints concerning device-related deaths, serious injuries, or malfunctions must be reported to the FDA.
Manufacturers are to maintain a detailed record of all complaints and solve them in a timely and efficient manner. The complaint handling system of a company can define the efficiency of its Quality System. Each manufacturer must establish and maintain procedures for receiving, reviewing, and assessing complaints by an officially designated unit. A good complaint handling system can
* Provide a suitable solution to the problem;
* Improve customer relations and customer satisfaction;
* Evaluate weaknesses in the product and help resolve it;
* Increase company's accountability and transparency;
* Reduce medical device reporting;
* Reduce costs and improve production schedules;
* Reduce employee confusion.
The GMP regulations state certain requirements that are to be included in any complaint handling system. All manufacturers should:
1. document, review, evaluate, and file all complaints;
2. formally designate a unit or individual to perform these activities;
3. determine if an investigation is necessary;
4. record the reason if no investigation is made;
5. assign responsibility for deciding when not to investigate; and,
6. determine if the complaint requires an MDR report.
A sample complaint handling system is depicted in the image below:
(Source: http://www.assurx.com/software-solutions/complaint-handling-management.htm)
All complaint records should have some basic details like
* sequential number of the complaint;
* origin of the complaint;
* customer information;
* product information;
* any corrective actions already taken;
* details of the complaint;
* and dates, signatures, assignments, etc.
These records should be maintained by the company for review during FDA audits.
Manufacturers are to maintain a detailed record of all complaints and solve them in a timely and efficient manner. The complaint handling system of a company can define the efficiency of its Quality System. Each manufacturer must establish and maintain procedures for receiving, reviewing, and assessing complaints by an officially designated unit. A good complaint handling system can
* Provide a suitable solution to the problem;
* Improve customer relations and customer satisfaction;
* Evaluate weaknesses in the product and help resolve it;
* Increase company's accountability and transparency;
* Reduce medical device reporting;
* Reduce costs and improve production schedules;
* Reduce employee confusion.
The GMP regulations state certain requirements that are to be included in any complaint handling system. All manufacturers should:
1. document, review, evaluate, and file all complaints;
2. formally designate a unit or individual to perform these activities;
3. determine if an investigation is necessary;
4. record the reason if no investigation is made;
5. assign responsibility for deciding when not to investigate; and,
6. determine if the complaint requires an MDR report.
A sample complaint handling system is depicted in the image below:
(Source: http://www.assurx.com/software-solutions/complaint-handling-management.htm)
All complaint records should have some basic details like
* sequential number of the complaint;
* origin of the complaint;
* customer information;
* product information;
* any corrective actions already taken;
* details of the complaint;
* and dates, signatures, assignments, etc.
These records should be maintained by the company for review during FDA audits.
Thursday, August 16, 2012
Steps for manufacturing successful product
According to the FD&C Act, it is required that domestic or foreign manufacturers have a quality system for the design and production of medical devices intended for commercial distribution in the United States. The regulation requires that various specifications and controls be established for devices; that devices be designed under a quality system to meet these specifications; that devices be manufactured under a quality system; that finished devices meet these specifications; that devices be correctly installed, checked and serviced; that quality data be analyzed to identify and correct quality problems; and that complaints be processed. Thus, the QS regulation helps assure that medical devices are safe and effective for their intended use. More details can be obtained from
◦ The Quality System Regulations – 21CFR 820(QSR’s)and
◦ ISO Standard 13485:2003.
The QS consists of four major actions: Design -> Manufacture -> Distribute -> Monitor performance. The FDA's QSR manual shows how any new entrepreneur can start a successful medical device company by sequentially following the steps below.
1. Obtaining information on GMP requirements;
2. Determining the appropriate quality system needed to control the design, production and distribution of the proposed device;
3. Designing products and processes;
4. Training employees;
5. Acquiring adequate facilities;
6. Purchasing and installing processing equipment;
7. Drafting the device master record;
8. Noting how to change the device master records;
9. Procuring components and materials;
10. Producing devices;
11. Labeling devices;
12. Evaluating finished devices;
13. Packaging devices;
14. Distributing devices;
15. Processing complaints and analyzing service and repair data;
16. Servicing devices;
17. Auditing and correcting deficiencies in the quality system; and,
18. Preparing for an FDA inspection.
It is to be noted how each of the steps is a comprehensive process in itself. These steps if followed according to the FDA protocols will ensure production of a successful medical device.
◦ The Quality System Regulations – 21CFR 820(QSR’s)and
◦ ISO Standard 13485:2003.
The QS consists of four major actions: Design -> Manufacture -> Distribute -> Monitor performance. The FDA's QSR manual shows how any new entrepreneur can start a successful medical device company by sequentially following the steps below.
1. Obtaining information on GMP requirements;
2. Determining the appropriate quality system needed to control the design, production and distribution of the proposed device;
3. Designing products and processes;
4. Training employees;
5. Acquiring adequate facilities;
6. Purchasing and installing processing equipment;
7. Drafting the device master record;
8. Noting how to change the device master records;
9. Procuring components and materials;
10. Producing devices;
11. Labeling devices;
12. Evaluating finished devices;
13. Packaging devices;
14. Distributing devices;
15. Processing complaints and analyzing service and repair data;
16. Servicing devices;
17. Auditing and correcting deficiencies in the quality system; and,
18. Preparing for an FDA inspection.
It is to be noted how each of the steps is a comprehensive process in itself. These steps if followed according to the FDA protocols will ensure production of a successful medical device.
Informed Consent for clinical trials
About 3% of the US population participate in Clinical Trials. Also, new treatments or interventions under study are not always better than, or even as good as, standard care. Even if a new treatment has benefits, it may not work for every patient. In addition, health insurance and managed care providers do not always cover clinical trials. It is therefore essential for patients to understand all the risks involved in a clinical trial before being a part of it. The FDA requires that all subjects of a clinical study sign an informed consent before starting the clinical trial.
Informed Consent (21 CFR Part 50) is a written notification to human subjects involved in clinical investigations that provides them with sufficient opportunity to consider whether or not to participate in the study. The basic elements of an informed consent are:
1. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
2. A description of any reasonably foreseeable risks or discomforts to the subject.
3. A description of any benefits to the subject.
4. Disclosure of appropriate alternative procedures or courses of treatment.
5. A statement describing the extent to which confidentiality of records identifying the subject will be maintained.
6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available.
7. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights.
8. A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
The FDA follows strict regulations for clinical trials. No clinical investigator may involve a human being as a subject in research unless the investigator has obtained the legally effective informed consent from the subject.
Informed Consent (21 CFR Part 50) is a written notification to human subjects involved in clinical investigations that provides them with sufficient opportunity to consider whether or not to participate in the study. The basic elements of an informed consent are:
1. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
2. A description of any reasonably foreseeable risks or discomforts to the subject.
3. A description of any benefits to the subject.
4. Disclosure of appropriate alternative procedures or courses of treatment.
5. A statement describing the extent to which confidentiality of records identifying the subject will be maintained.
6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available.
7. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights.
8. A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
The FDA follows strict regulations for clinical trials. No clinical investigator may involve a human being as a subject in research unless the investigator has obtained the legally effective informed consent from the subject.
Wednesday, August 15, 2012
Clinical Trials
Clinical trials are defined by the FDA as, "trials to evaluate the effectiveness, safety and toxicity of medications or medical devices by monitoring their effects on large groups of people". Clinical trials have to be approved by the IRB and they are an essential part of PMAs. Good Clinical Practices (GCPs) are employed to maintain a regulated approach to clinical trials.
Clinical trials can be categorized into different types based on what they are done for.
1. Treatment trials - These seek to find new treatment approaches or compare to identify the most effective treatment available.
2. Prevention trials - They are done to identify approaches to prevent a specific type of disease from developing in people not exposed to it previously.
3. Early detection/screening trials - They are done to find new ways to identify a specific disease/problem in people even before they develop symptoms.
4. Diagnostic trials - These are done to figure out how new tests or procedures can be used to identify a specific disease in suspected population.
5. Quality of life/ supportive care trials - These trials try to identify ways of improving the comfort and quality of life for people with a disease/problem.
The results of a clinical trial is of much significance. Irrespective of the number of subjects or data involved in a clinical trial, the outcome is usually one of the following four types (in case of treatment trial):
Positive trial ‐ Superior (new treatment is better than standard treatment)
Non‐inferior trial ‐ Equivalence (new treatment is equivalent to standard treatment)
Inconclusive trial ‐ Neither superior nor inferior (new treatment is not clearly better nor clearly worse than the standard treatment)
Negative trial ‐ Inferior (new treatment is worse than the standard treatment)
A clinical trial usually starts with a clear investigational plan and an IRB approval for the study. Some components to be considered in the investigational plan are:
– Clinical study protocol - Study, hypothesis and design; Primary and secondary endpoints; Inclusion/exclusion criteria; Sample size and statistical analysis. It is essential to have a clearly defined and firm study protocol that cannot be changed during the course of the study.
– Risk analysis
– Informed consent form
– Case report forms
– Investigator agreement
– Clinical sites (number of sites / investigators / IRBs)
– Bibliography
– Instructions for Use
– Clinical study duration
Clinical trials can be categorized into different types based on what they are done for.
1. Treatment trials - These seek to find new treatment approaches or compare to identify the most effective treatment available.
2. Prevention trials - They are done to identify approaches to prevent a specific type of disease from developing in people not exposed to it previously.
3. Early detection/screening trials - They are done to find new ways to identify a specific disease/problem in people even before they develop symptoms.
4. Diagnostic trials - These are done to figure out how new tests or procedures can be used to identify a specific disease in suspected population.
5. Quality of life/ supportive care trials - These trials try to identify ways of improving the comfort and quality of life for people with a disease/problem.
The results of a clinical trial is of much significance. Irrespective of the number of subjects or data involved in a clinical trial, the outcome is usually one of the following four types (in case of treatment trial):
Positive trial ‐ Superior (new treatment is better than standard treatment)
Non‐inferior trial ‐ Equivalence (new treatment is equivalent to standard treatment)
Inconclusive trial ‐ Neither superior nor inferior (new treatment is not clearly better nor clearly worse than the standard treatment)
Negative trial ‐ Inferior (new treatment is worse than the standard treatment)
A clinical trial usually starts with a clear investigational plan and an IRB approval for the study. Some components to be considered in the investigational plan are:
– Clinical study protocol - Study, hypothesis and design; Primary and secondary endpoints; Inclusion/exclusion criteria; Sample size and statistical analysis. It is essential to have a clearly defined and firm study protocol that cannot be changed during the course of the study.
– Risk analysis
– Informed consent form
– Case report forms
– Investigator agreement
– Clinical sites (number of sites / investigators / IRBs)
– Bibliography
– Instructions for Use
– Clinical study duration
Failure Modes and Effects Analysis (FMEA)
Failure modes and effects analysis (FMEA) is a tool used for identifying all possible failures in a
* design,
* manufacturing or assembly process,
* product or
* service.
It follows a step-by-step approach to detect possible failure modes and based on its priority, corrective actions are applied.
“Failure modes” denotes the ways in which something might fail. Any potential or actual errors or defects that can affect the customer are termed failures. The consequences of those failures are studied and described under “Effects analysis”.
Once the failures are identified they are prioritized according to the seriousness of their consequences are, their frequency and the ease of their detection. The FMEA aims to take actions to eliminate or reduce failures, based on their priority.
The steps involved in the FMEA process are:
1. The scope of the FMEA is identified. The scope can be a design, process or service.
2. Identify key functions of the scope.
3. List potential failure modes of each of the function. (How can this function go wrong)
4. Identify the effects for each failure mode. (How will this failure affect the manufacturer, customer..)
5. Rate the severity(S) of each effect on a scale of 1 to 10, 10 being most severe.
6. Identify the causes of all the failure modes. (Why does the function go wrong)
7. Rate the causes for each failure mode in terms of occurrence (O), 10 denoting the most frequent cause.
8. Identify the controls in the scope to detect the cause.
9. Rate the controls on the basis of detectability (D), 10 denoting extremely weak or no control.
10 Calculate Risk Priority Number (RPN). This is done by multiplying the ranks of severity, occurrence and detection (S*O*D). If, we had a severity of 10 (very severe), occurrence of 10 (happens all the time), and detection of 10 (cannot detect it) our RPN is 1000. This is a serious issue with great priority.
11. Identify the most critical issues by sorting the RPNs.
12. Assign corrective actions and deadlines.
13. Perform corrective actions and re-score the S, O and D numbers as applicable and calculate new RPNs.
A sample FMEA template can be seen in the figure above. It is a template specific for process FMEA as seen in http://lssacademy.com/2007/06/28/10-steps-to-creating-a-fmea
* design,
* manufacturing or assembly process,
* product or
* service.
It follows a step-by-step approach to detect possible failure modes and based on its priority, corrective actions are applied.
“Failure modes” denotes the ways in which something might fail. Any potential or actual errors or defects that can affect the customer are termed failures. The consequences of those failures are studied and described under “Effects analysis”.
Once the failures are identified they are prioritized according to the seriousness of their consequences are, their frequency and the ease of their detection. The FMEA aims to take actions to eliminate or reduce failures, based on their priority.
The steps involved in the FMEA process are:
1. The scope of the FMEA is identified. The scope can be a design, process or service.
2. Identify key functions of the scope.
3. List potential failure modes of each of the function. (How can this function go wrong)
4. Identify the effects for each failure mode. (How will this failure affect the manufacturer, customer..)
5. Rate the severity(S) of each effect on a scale of 1 to 10, 10 being most severe.
6. Identify the causes of all the failure modes. (Why does the function go wrong)
7. Rate the causes for each failure mode in terms of occurrence (O), 10 denoting the most frequent cause.
8. Identify the controls in the scope to detect the cause.
9. Rate the controls on the basis of detectability (D), 10 denoting extremely weak or no control.
10 Calculate Risk Priority Number (RPN). This is done by multiplying the ranks of severity, occurrence and detection (S*O*D). If, we had a severity of 10 (very severe), occurrence of 10 (happens all the time), and detection of 10 (cannot detect it) our RPN is 1000. This is a serious issue with great priority.
11. Identify the most critical issues by sorting the RPNs.
12. Assign corrective actions and deadlines.
13. Perform corrective actions and re-score the S, O and D numbers as applicable and calculate new RPNs.
A sample FMEA template can be seen in the figure above. It is a template specific for process FMEA as seen in http://lssacademy.com/2007/06/28/10-steps-to-creating-a-fmea
Monday, August 13, 2012
Usability Testing
Usability testing culminates the full testing of a product to ensure that the product is ergonomically designed according to user needs. This process involves iterative prototyping of the product such that all components of the design can be tested, refined and retested throughout development. Usability testing requires;
1. A prototype - A working model of the device is essential to simulate the device-user system and the user interface as defined by the device hardware and software. Mock-ups, storyboards, screen prints or other interactive computer models can be used to evaluate the efficiency of the user with the interface design.
2. Scenarios - Some usability testing requires written scenarios to allow participants simulate a working environment (like a operating room) where the device is used. This would allow for checking the realism and accuracy of the device. Physicians or other healthcare professionals can help with this step.
3. Requirements and Measures - Requirements are based on user interviews, observations, manufacturer’s experience, market analyses, and literature reviews. These should be quantitative and linked to safe device use. Measures used for testing enable the detection of errors or other events of non-conformance with the requirements. This might be as simple as a verbal response or a subjective impression of usability.
4. Facility - It is important to simulate the environment of device use. Test facilities can be a regular usability lab or a medical facility depending on the resources and the nature of the test.
5. Test Participants - Small testings can be done using two or three employees as participants. However, full usability tests would require larger samples drawn from the user population. For a device intended for a fairly homogenous population, most problems can be eliminated from data obtained with about 10 individuals representative of that population.
Also, it is crucial to obtain performance data from actual device users. If the device cannot be safely and effectively used by test participants under test conditions, healthcare professionals will definitely have problems with the device under actual conditions of use. Thus, thorough development of requirements and usability testing of the design would ensure safe and effective use of the device in its use environment.
1. A prototype - A working model of the device is essential to simulate the device-user system and the user interface as defined by the device hardware and software. Mock-ups, storyboards, screen prints or other interactive computer models can be used to evaluate the efficiency of the user with the interface design.
2. Scenarios - Some usability testing requires written scenarios to allow participants simulate a working environment (like a operating room) where the device is used. This would allow for checking the realism and accuracy of the device. Physicians or other healthcare professionals can help with this step.
3. Requirements and Measures - Requirements are based on user interviews, observations, manufacturer’s experience, market analyses, and literature reviews. These should be quantitative and linked to safe device use. Measures used for testing enable the detection of errors or other events of non-conformance with the requirements. This might be as simple as a verbal response or a subjective impression of usability.
4. Facility - It is important to simulate the environment of device use. Test facilities can be a regular usability lab or a medical facility depending on the resources and the nature of the test.
5. Test Participants - Small testings can be done using two or three employees as participants. However, full usability tests would require larger samples drawn from the user population. For a device intended for a fairly homogenous population, most problems can be eliminated from data obtained with about 10 individuals representative of that population.
Also, it is crucial to obtain performance data from actual device users. If the device cannot be safely and effectively used by test participants under test conditions, healthcare professionals will definitely have problems with the device under actual conditions of use. Thus, thorough development of requirements and usability testing of the design would ensure safe and effective use of the device in its use environment.
HFE and Risk Management
Studies show that the frequencies and consequences of use-related hazards of medical devices might far exceed those resulting from device failures. This necessitates the incorporation of Human Factors Engineering (HFE) principles in the device design process. HFE identifies and addresses potential use-related hazards that arise due to interactions between the user and the device.
Most designers only consider the most apparent (e.g., fire) or well-known use problems and thus limit to only relatively few user actions that cause device failure. According to the FDA, use-related hazards occur for one or more of the following reasons:
• Use of devices in ways that were not anticipated,
• Devices are used in an anticipated way, but inadequately controlled,
• The user's physical, perceptual, or cognitive abilities are not sufficient for the device use,
• The user’s expectations or intuition about device operation are inconsistent with actual device use,
• The effects of the use environment on device operation is not understood by the user, or
• The user’s physical, perceptual, or cognitive capacities are exceeded when using the
device in a particular environment.
The device-user system, thus consists of three major components:
1. Use environments,
2. User characteristics and
3. Device user interface characteristics.
The interactions of these components can thus result in a safe, effective, or unsafe and ineffective use of the device. This can be depicted in the following image.
HFE approaches can be incorporated into the design of medical devices within the risk management process to account for the changes in the device-user system. FDA defines risk management as the systematic application of management policies, procedures, and practices to the tasks of identifying, analyzing, controlling, and monitoring risk.
HFE incorporation into risk management can be achieved by four steps:
• Identify use- related hazards that are anticipated (derived analytically) and unanticipated (derived empirically),
• Describe the hazardous use scenarios that can occur,
• Develop and apply strategies that can control these use-related hazards, and
• Demonstrate safe and effective use of the device (validation).
The risk management process by which use-related hazards can be addressed is shown below,
A more detailed description of the process can be found in the FDA document, "Medical Device-Use Safety: Incorporating Human Factors Engineering into Risk Management."
Most designers only consider the most apparent (e.g., fire) or well-known use problems and thus limit to only relatively few user actions that cause device failure. According to the FDA, use-related hazards occur for one or more of the following reasons:
• Use of devices in ways that were not anticipated,
• Devices are used in an anticipated way, but inadequately controlled,
• The user's physical, perceptual, or cognitive abilities are not sufficient for the device use,
• The user’s expectations or intuition about device operation are inconsistent with actual device use,
• The effects of the use environment on device operation is not understood by the user, or
• The user’s physical, perceptual, or cognitive capacities are exceeded when using the
device in a particular environment.
The device-user system, thus consists of three major components:
1. Use environments,
2. User characteristics and
3. Device user interface characteristics.
The interactions of these components can thus result in a safe, effective, or unsafe and ineffective use of the device. This can be depicted in the following image.
HFE approaches can be incorporated into the design of medical devices within the risk management process to account for the changes in the device-user system. FDA defines risk management as the systematic application of management policies, procedures, and practices to the tasks of identifying, analyzing, controlling, and monitoring risk.
HFE incorporation into risk management can be achieved by four steps:
• Identify use- related hazards that are anticipated (derived analytically) and unanticipated (derived empirically),
• Describe the hazardous use scenarios that can occur,
• Develop and apply strategies that can control these use-related hazards, and
• Demonstrate safe and effective use of the device (validation).
The risk management process by which use-related hazards can be addressed is shown below,
A more detailed description of the process can be found in the FDA document, "Medical Device-Use Safety: Incorporating Human Factors Engineering into Risk Management."
Human Factors
Human factors is a discipline that seeks to improve human performance in the use of a device/equipment by developing a hardware and software design compatible with the user's abilities. It is often referred as human engineering or ergonomics. A medical device can be used safely and effectively only if the interaction between the operating environment, user capabilities, stress levels, and device design is considered when the manufacturer designs the device.
Device design should take into account the basic physical and sensory capabilities, perceptional and cognitive abilities, device expectations, user's mental model of the device capabilities and design, use environments, and all possible categories of users, including the patients themselves.
User interface designing is an important aspect of an ergonomic design. Some basic considerations include,
* Control/Display Layout and Design
* Simple device logic, microprocessing and software design
* Design and code systems to avoid device mis-installation
* Alarms and alert systems
* Device maintenance
* Packaging
The following figure gives a brief outline of the steps involved in usability engineering or human engineering.
Human Factors Standards and Resources
AAMI HE75 – Design Reference
AAMI HE74 – Human Factors Process
IEC 62366 – (Process) Application of usability engineering to medical devices
FDA.gov; FAA.gov
Device design should take into account the basic physical and sensory capabilities, perceptional and cognitive abilities, device expectations, user's mental model of the device capabilities and design, use environments, and all possible categories of users, including the patients themselves.
User interface designing is an important aspect of an ergonomic design. Some basic considerations include,
* Control/Display Layout and Design
* Simple device logic, microprocessing and software design
* Design and code systems to avoid device mis-installation
* Alarms and alert systems
* Device maintenance
* Packaging
The following figure gives a brief outline of the steps involved in usability engineering or human engineering.
Human Factors Standards and Resources
AAMI HE75 – Design Reference
AAMI HE74 – Human Factors Process
IEC 62366 – (Process) Application of usability engineering to medical devices
FDA.gov; FAA.gov
Sunday, August 12, 2012
Design Controls
Design controls are a system of checks and balances for systematic assessment of the design during all phases of development. It consists of an interrelated set of practices and procedures that are incorporated into the process of design and development. As a result, discrepancies between user requirements, design and the product can be avoided to create a design that will translate into a successful device. The application of design controls to a design process can be depicted in the figure below.
* Design Input - It consists of physical and performance requirements that are the basis of device design. The design input requirements are unambiguous, self-consistent and expressed with quantitative limits of tolerance. The device use environment is also properly characterized and all requirements are thoroughly reviewed.
* Design Output - It consists of the results of each design phase and the total design effort. The finished design output is usually the device master record. Design output includes production specifications as well as a description of the materials which define and characterize the design. The total finished design output is the device with its packaging, labeling and the device master record.
* Design Review - It consists of a documented, comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems. Formal design reviews can be designed to detect problems early in the development process. As the design nears completion, the flexibility of implementing optimal solution decreases and the cost to correct design errors increases.
* Design Verification - It is the confirmation by examination and provision of objective evidence to show that the device meets the manufacturer's requirements. It follows a three-pronged approach employing tests, inspections and analyses and is to be documented systematically.
* Design Validation - It is the process of establishing that the device specifications conforms with user needs and intended use. It usually follows design verification and it provides assurance that the design will conform with user needs and intended uses.
All changes made during the design process are documented as the design history file, which is a compilation of records describing the design history of the finished device. Design validation is followed by design transfer where the device design is translated into production specifications. Manufacturing processes are employed to produce a device based on the production specifications. The device is then sterilized, packaged, labelled and marketed, with the FDA approval.
* Design Input - It consists of physical and performance requirements that are the basis of device design. The design input requirements are unambiguous, self-consistent and expressed with quantitative limits of tolerance. The device use environment is also properly characterized and all requirements are thoroughly reviewed.
* Design Output - It consists of the results of each design phase and the total design effort. The finished design output is usually the device master record. Design output includes production specifications as well as a description of the materials which define and characterize the design. The total finished design output is the device with its packaging, labeling and the device master record.
* Design Review - It consists of a documented, comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems. Formal design reviews can be designed to detect problems early in the development process. As the design nears completion, the flexibility of implementing optimal solution decreases and the cost to correct design errors increases.
* Design Verification - It is the confirmation by examination and provision of objective evidence to show that the device meets the manufacturer's requirements. It follows a three-pronged approach employing tests, inspections and analyses and is to be documented systematically.
* Design Validation - It is the process of establishing that the device specifications conforms with user needs and intended use. It usually follows design verification and it provides assurance that the design will conform with user needs and intended uses.
All changes made during the design process are documented as the design history file, which is a compilation of records describing the design history of the finished device. Design validation is followed by design transfer where the device design is translated into production specifications. Manufacturing processes are employed to produce a device based on the production specifications. The device is then sterilized, packaged, labelled and marketed, with the FDA approval.
Friday, August 10, 2012
Good Laboratory Practices (GLP)
GLP's are regulatory guidelines designed to prevent malpractices in research and development. The GLPs are designed to promote the quality and validity of the test data. GLP was imposed on the industry by regulatory authorities, in the same way as good manufacturing practice (GMP) had been before, and followed by good clinical practice (GCP) afterwards. FDA issued mandatory requirements for GLP on June 20, 1979 and they apply for all non-clinical studies used to evaluate safety. It is also instituted by all OECD(Organization for Economic Co-operation and Development) countries.
The fundamental requirements of the GLPs focusses on standardization of 5 categories:
1. Resources: organization, personnel, facilities and equipment.
2. Rules: protocols and written procedures.
3. Characterization: test items and test systems.
4. Documentation: raw data, final report and archives.
5. Quality assurance unit.
The main goal of the GLPs is to make results reliable, repeatable, auditable and recognized by scientists worldwide.
It aims at making False Negatives and False Positives markedly obvious to validate results better and to promote mutual recognition and comparison of study data universally.
The fundamental requirements of the GLPs focusses on standardization of 5 categories:
1. Resources: organization, personnel, facilities and equipment.
2. Rules: protocols and written procedures.
3. Characterization: test items and test systems.
4. Documentation: raw data, final report and archives.
5. Quality assurance unit.
The main goal of the GLPs is to make results reliable, repeatable, auditable and recognized by scientists worldwide.
It aims at making False Negatives and False Positives markedly obvious to validate results better and to promote mutual recognition and comparison of study data universally.
Tuesday, August 7, 2012
Biocompatibility Testing
Biocompatibility of a device is based on device component materials, part of body exposed to device and the duration of exposure.
Device classification based on contact:
* Surface Devices - Devices in contact with skin (electrodes, external prosthesis, fixation tapes), mucous membrane (contact lens, colonoscopes) and breached or compromised surfaces (dressings, occlusive patches).
* External Communicating Devices - Devices in contact with blood path indirectly (blood administration sets, transfer sets), tissue/bone/dentin communicating (laparoscopes, dental fillings, skin staples) or circulating blood (intravascular catheters, immunoadsorbents).
* Implant Devices - Devices principally in contact with tissue (pacemakers, drug supply devices) or bone (orthopedic pins, plates) or blood (heart valves, stents).
Device Classification based on exposure:
* Limited Exposure: < 24 hours * Prolonged Exposure: > 24 hours but < 30 days (single, multiple or long-term use) * Permanent: > 30 days (single, multiple or long-term use)
The biocompatibility tests required for a device is decided based on the biocompatibility matrix.
Device classification based on contact:
* Surface Devices - Devices in contact with skin (electrodes, external prosthesis, fixation tapes), mucous membrane (contact lens, colonoscopes) and breached or compromised surfaces (dressings, occlusive patches).
* External Communicating Devices - Devices in contact with blood path indirectly (blood administration sets, transfer sets), tissue/bone/dentin communicating (laparoscopes, dental fillings, skin staples) or circulating blood (intravascular catheters, immunoadsorbents).
* Implant Devices - Devices principally in contact with tissue (pacemakers, drug supply devices) or bone (orthopedic pins, plates) or blood (heart valves, stents).
Device Classification based on exposure:
* Limited Exposure: < 24 hours * Prolonged Exposure: > 24 hours but < 30 days (single, multiple or long-term use) * Permanent: > 30 days (single, multiple or long-term use)
The biocompatibility tests required for a device is decided based on the biocompatibility matrix.
Monday, August 6, 2012
FDA General Controls
General Controls:
Minimum requirements for all device classes. Includes
• Registration of all domestic device manufacturers and importers.
• Listing of all marketed devices by domestic and foreign manufacturers.
• Adhering to Good Manufacturing Practices (GMP’s).
• Filing of Premarket Notification (510k): To notify FDA of the intent to market a medical device.
• Proper device labeling.
• Maintenance of all device records and reports.
General Controls include the provisions of the Act pertaining to:
Adulteration;
Misbranding;
Device registration and listing;
Premarket notification;
Banned devices;
Notification and repair, replacement, and refund;
Records and reports;
Restricted devices; and
Good Manufacturing Practices.
Minimum requirements for all device classes. Includes
• Registration of all domestic device manufacturers and importers.
• Listing of all marketed devices by domestic and foreign manufacturers.
• Adhering to Good Manufacturing Practices (GMP’s).
• Filing of Premarket Notification (510k): To notify FDA of the intent to market a medical device.
• Proper device labeling.
• Maintenance of all device records and reports.
General Controls include the provisions of the Act pertaining to:
Adulteration;
Misbranding;
Device registration and listing;
Premarket notification;
Banned devices;
Notification and repair, replacement, and refund;
Records and reports;
Restricted devices; and
Good Manufacturing Practices.
Medical Device Design Process
The process of designing a medical device consists of the following steps:
1. Identifying user needs - This may involve identifying problems with existing diagnostic tools, prosthetic or surgical devices, or recognizing a whole new unexplored market (novel device based solutions for diseases). The primary user of medical devices are physicians who either prescribe or incorporate these devices on/in patients.
2. Reviewing marketed solutions - The next step is to understand the technology and the shortcomings of existing solutions(if any) to the problem.
3. Developing possible solutions - This is the major brainstorming step where solutions are conceived for the problem based on the user needs. Many possible solutions can be obtained to solve the problem.
4. Identifying the best possible solution - In this stage, the results of the previous step are compared and the solution which best satisfies the user needs is selected.
5. Device Design Criteria - The solution selected is translated into design inputs for the design process.
6. Device Design Process - This is a comprehensive step where the design inputs are manipulated to develop a product design.
7. Developing a Prototype - The design is now engineered to produce a working model or prototype of the device.
8. Verification and Validation - This prototype is tested to check its compliance with the design needs and user needs. Based on the outcome of this step, the steps 6-8 might undergo several iterations.
9. Packaging and Marketing - Once the device is ready, it is sterilized and packed according to FDA standards and is ready for marketing.
The FDA regulatory process must also go hand in hand with the device design process. This would enable timely release of device into the market.
1. Identifying user needs - This may involve identifying problems with existing diagnostic tools, prosthetic or surgical devices, or recognizing a whole new unexplored market (novel device based solutions for diseases). The primary user of medical devices are physicians who either prescribe or incorporate these devices on/in patients.
2. Reviewing marketed solutions - The next step is to understand the technology and the shortcomings of existing solutions(if any) to the problem.
3. Developing possible solutions - This is the major brainstorming step where solutions are conceived for the problem based on the user needs. Many possible solutions can be obtained to solve the problem.
4. Identifying the best possible solution - In this stage, the results of the previous step are compared and the solution which best satisfies the user needs is selected.
5. Device Design Criteria - The solution selected is translated into design inputs for the design process.
6. Device Design Process - This is a comprehensive step where the design inputs are manipulated to develop a product design.
7. Developing a Prototype - The design is now engineered to produce a working model or prototype of the device.
8. Verification and Validation - This prototype is tested to check its compliance with the design needs and user needs. Based on the outcome of this step, the steps 6-8 might undergo several iterations.
9. Packaging and Marketing - Once the device is ready, it is sterilized and packed according to FDA standards and is ready for marketing.
The FDA regulatory process must also go hand in hand with the device design process. This would enable timely release of device into the market.
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