In the biomedical and hospital field, much is said about medical devices, maintenance, new medical technology, management, and parts; engineers, technicians, and other staff are also related to the term "nomenclature" specifically to identify medical devices, each medical device in the world regardless of the brand or model has its own identifier code (UDIs), but, who is in charge to establish that codes? Well, the FDA is in charge of that, which is based on the GMDN (The Global Medical Device Nomenclature) that works as an international standard (ISO 15225) and is a non-profit association, whose function is to create a system of agreed descriptors to identify medical devices, which will subsequently receive a UDI.

The GMDN is managed by the GMDN Agency, which is made up of a group of regulators, manufacturers, and providers of medical devices, which are in charge of standardizing the naming and grouping of devices, all in order to improve communication in the hospital environment and help regulators to understand better the use of medical equipment while supporting patient safety.

A UDI is an identifier code created in a readable way for humans and machines that serves to modernize the surveillance of technology and its management, also to facilitate the whole part of marketing and innovation of devices, in order to generate a UDI it is required a GMDN, that is to say, that it is within a very specific category, a UDI, as its name suggests, is unique, however, hundreds of UDIs can share the same GMDN term or code. A GMDN term represents a group of generic medical devices in a database and allows these to be harmonized. A UDI cannot have more than one GMDN term or code, so they try to generate them as detailed as possible.

GMDN term lists and databases are updated daily, new terms are added based on requests from users developing new technology, and some existing terms may be modified to broaden the scope of the term or to indicate that the term became obsolete in case it no longer accurate to describe a product. if you are registered with the GMDN and have a list with the terms that you requested or simply match your interest or products, if they are modified or become obsolete, you will be notified via email. The lists of each licensee or client are private, encrypted with a password, and cannot be seen or accessed by another licensee, likewise, as a user, you do not have access to see the complete list of terms within the GMDN database, rather, it shows you the most relevant codes or that can be useful to you according to your range of products, if you require the more than 24,000 terms within the database, you must request special access, in which you will be granted a 5-digit code to access the full list of terms.

In order to label a medical device with its UDI, the FDA requires that the GMDN term to which the UDI is linked be current, that is, not obsolete. If the equipment was already labeled with its UDI previously and some time has passed and the GMDN term of the UDI becomes obsolete, it is not necessary to relabel the device, it is only necessary to notify the FDA about the new GMDN term in which said medical device is found, In this way, the FDA will update its GUDID (Global Unique Device Identification Database) and the expenses relabeling costs will be avoided.

In the summer of 2021, the FDA released a draft of what would be the final guide for UDIs, after eight years of launching the UDI Rule, aimed at manufacturers (labelers) and issuing agencies accredited by the FDA, the final guide describes the requirements and recommendations so that they meet the objectives of the device identification rule, in the document you will be able to observe the two forms in which a UDI is presented, which are the easy-to-read form and the automatic data capture form through of technology. However, this new guide rejects requests from manufacturers which include changing the way data is displayed and removing data delimiters since the UDI should be the most important data in the label and precede other data. In the new guide, you can also find recommendations for independent software labeling requirements. This restructuring of the guide for IDUs was carried out as a result of hundreds of medical errors that occurred as a result of the incorrect identification of medical devices, which caused confusion about how to use them.

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In this post, CMS proposed "public reporting of clinical quality measure data", specifying limited criteria for each type of organization.

According to NPR Health News, April 18, 2017, "The move follows steps CMS took several years ago to post government inspection reports online for nursing homes and some hospitals."  Nursing Home Inspect at http://projects.propublica.org/nursing-homes/ allow the public to review deficiencies.

In response, The Joint Commission responded, "The Joint Commission is opposed to the CMS proposal to make all accreditation survey reports (including statements of deficiencies) and acceptable plans of correction publicly available on the websites hosted by accreditation organizations."

We observed on the ProPublica page that the data is not shown relative to patient count, actual incidents, benchmarks or other factors.  This does support TJC arguments that it would inhibit participation and cause hospitals to seek deeming organizations that present the friendliest findings.

If the information presented is not uniform and educational, it is possible a member of the public could choose to travel 30 minutes further for a critical heart procedure because an exit door was inappropriately left open or locked according to a report.  An assortment of comments on Yelp can be very helpful when selecting a care-giver for dentistry or dermatologist.  For critical and long term care, it is good there is a healthy debate taking place about the nature of information to be reported.  Maybe the deeming agencies need to be proactive about working with AAMI and similar organizations to standardize public reporting before they are ordered to do so.

Many arguments have been made in support of "transparency."
Whatever reporting is required, the expected benefit should be supported by evidence.
According to the CMS post, these accreditation organizations are affected:

Under CLIA (Clinical Laboratory Improvement Amendments), additional organizations are recognized:

For now, the change is on hold indefinitely.  CMS.gov posted on 8-2-1017 in a fact sheet (CMS-1677-F):
"After consideration of the public comments received, CMS decided that it would be best if the proposal was not finalized and instead, the proposal was withdrawn. CMS is committed to ensuring that patients have the ability to review the findings used to determine that a facility meets the health and safety standards required for Medicare participation. However, we believe further review, consideration, and refinement of this proposal is necessary to ensure that CMS establishes requirements, consistent with our statutory authority, that will inform patients and continue to support high quality care."

This single matrix is now used to evaluate risk instead of various criteria that varied by EP.  It is a simple 3 level risk evaluation relative to a 3 level scope.  The new evaluation has no effect on events that are an immediate threat to life and therefore this is shown above the matrix.

JCnewSAFTERmodel

Placement on the matrix is based on surveyor experience, definitions, context and team discussion.  "Anchors" are specific examples which have been compared to a pain scale indicating the examples have various levels of severity.  We read one report that a "library of anchors" will be produced by TJC over time.  (Compass Clinical Consulting, Feb 20, 2017)

If there is an ITL (Immediate Threat to Life), the organization has 72 hours to eliminate the ITL.  If it can not be eliminated in that time, an emergency plan that can take up to 23 days (including the 72 hours) to complete.

In all other cases, there are 60 days to show evidence of compliance, including Who, What, When and How.

For  non-compliance in the red or dark orange regions, the evidence much also include leadership involvement and preventive analysis.  Also these will be consider for special consideration in future surveys through the next full survey.

Leadership involvements looks first at the sustainability of changes and support from the top levels of leadership. Examples give of support are providing resources, speaking out on behalf of the change and establishing plans for period measurement of and reporting on the changes.

Preventive analysis assures that the corrective action is global and not only a solution for the specific case.  The analysis reviews underlying reasons.  The focus is in preventing future incidents.

The SAFER matrix applies to the entire organization and results will be included in the report as the EC (Environment of Care) rules cited displayed on the matrix. If examples or one EP fit into more than one risk group, it will appear in the most severe group.

Initial evaluation (June 2016) roughly estimated about a fifth of findings were in the widespread and about 2/5ths were limited.  The JC Extranet site further defines Likely as harm that can happen at any time without any contributing factors.  Moderate likelihood may require other contributing factors or conditions.

(Key Sources: Presentations by George Mills and Caroline Heskett of The Joint Commission 2016-2017)

Relevant information presented by TJC (The Joint Commission) before 2017:

For the past several years, facilities management and hospital safety have been under a microscope during Joint Commission surveys, particularly since the addition of dedicated Life Safety Code surveyors whose sole responsibility is to review the physical environment for compliance with safety standards. Joint Commission surveys are no longer on a set schedule--while they are approximately triennial, surveyors can arrive unannounced and without warning at any time, requiring organizations to be in a state of continual readiness. Leadership needs to acknowledge that Joint Commission surveyors can arrive when they themselves are not present, and must make sure that their staff members, from the ground floor up to unit directors, are prepared for survey.

This is particularly challenging in the area of medical equipment and what the responsibilities are for staff from top to bottom. George Mills, MBA, FASHE, CEM, CHFM, director of the Department of Engineering at the Joint Commission, spoke recently at the Association for the Advancement of Medical Instrumentation (AAMI) conference on what the Joint Commission survey process is with inspection of medical instrumentation and what surveyors will be looking at.
To begin with, surveyors will examine the inventory, looking to see if the work has been done according to schedule and what the organization has determined for frequency of inspections.

By role

Department leaders should be not only qualified, but must know how the inventory of devices was created. If organizations are using Alternate Equipment Management (AEM) processes, department leaders should understand and evaluate the monitoring process as well as its effectiveness. What is the organization’s criteria? What is the completion rate for the AEM processes?

Equipment maintainers must have a working understanding of the process and strategy of equipment maintenance, both according to manufacturer guidelines and AEM processes if used. They must be prepared to address the completion of scheduled work and how to address repeated work orders if asked by surveyors.
Equipment users must also be prepared to demonstrate a high level of knowledge. They should be able to address the reliability of the equipment, know what the response time is when the equipment fails, and have an understanding of the organization’s culture of safety.
Equipment users should be trained on equipment use, and be prepared to address customer satisfaction within the department.

Policies and procedures

Surveyors are going to look at policies and procedures, Mills said. Specifically, they will ask how equipment is evaluated to ensure there is no degradation of performance and how to identify and address if there are any mis-calibrations.
Policies and procedures should address how equipment is tested for calibration.

Surveyors will also look at errors and near misses. How are incidents investigated, according to your policies and procedures? Was an equipment failure preventable? Did the use of AEM processes contribute to the equipment failure? And how do your policies and procedures dictate how potentially unsafe equipment will be sequestered to avoid further potential harm?

Surveyors will want to know how an organization evaluates potential modifications to its medical device and equipment maintenance strategy.
They will also examine the accuracy of an organization’s inventory, with focus on evaluation of High Risk and Life Support equipment. How the organization indicates the use of AEM for specific equipment is a necessary requirement. Staff should be prepared to answer the question: is grouping of like equipment acceptable?
Lastly, when evaluating the organization’s inventory, the question should be addressed: are the  imaging/radiological devices and medical laser devices exempt from AEM?

Surveyor focus

Surveyors will have a focus on High Risk equipment, and will expect that appropriate manuals are available. Documentation of inspections, tests, activities, and frequencies of use should be accurate and readily available--documentation issues have been one of the most-cited standards for 2013 and even earlier, a challenge which many organizations still struggle mightily with.

Staff should be prepared to discuss organizational strategies for equipment maintenance and explain how current policies are appropriate and effective in order ensure that medical equipment on site is reliable.
Lastly, Mills mentioned some of the most challenging standards for 2013, all of which organizations are still struggling with even as 2014 comes to a close. These include many physical environment issues, including corridor clutter, ventilation, fire barrier penetration, documentation of inspections and testing, smoke barrier penetration, maintenance of an 18” clearance from the ceiling, and unsafe environment standards.

Leadership would do well to maintain a firm understanding and keen eye on medical equipment policies, procedures, and processes as well as staff awareness and training in preparation for upcoming Joint Commission surveys.

" ... Including about 100,000 annually at a cost of $30B in North America alone. ... Inadequate hand hygiene remains a frequent and modifiable contributing factor, as established from hospital outbreaks of methicillin-resistant Staphylococcus aureus, vancomycin-resistant Enterococcus, and other hospital-acquired infections. ... ... A classical study, for example, found that physicians had about half the rate of compliance when compared with nurses (30% vs 52%, p<0.001). ... Here, we explore a different account for why the problem might not be solved by changing the personalities or motivations of physicians. Specifically, we suggest that the circumstances surrounding physicians in hospitals are rife with behavioral factors conducive to failures of hand hygiene."
Why even good physicians do not wash their hands.

Federal Consensus Standards for Medical Devices

The Center for Devices and Radiological Health (CDRH), which is a part of the Food and Drug Administration (FDA), is responsible, in conjunction with the Standards Management Staff (SMS), for the development and implementation of both national and international medical device consensus standards. This involves working closely with the Standards Developing Organizations (SDOs) and advertising standards liaison representative positions to maintain an appropriate standards database. SMS publishes updated medical device standards no less than twice annually.

See organizational and contact information for the SMS below or visit: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/default.htm:
organization
Recognized Consensus Standards The FDA’s database of recognized consensus standards can be accessed at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm
search-database

 Procedures for the Use of Consensus Standards
The CDHR and SMS believe that conformance to their domestic and international consensus standards ensures the safety and/or effectiveness of a health device. Designers and manufacturers of new health devices can benefit from conformance to these standards since such conformance often eliminates the need to review the test data that applies to the standards when seeking regulatory approval. It should be noted, however, that conformance to the consensus standards will not always be a satisfactory basis for waiving regulatory decisions about a new device.
The CDHR and SMS believe that compliance with their consensus standards represents “the least burdensome approach in all areas of medical device regulation,” but also encourages those who believe an alternative approach would be less burdensome to contact the CDHR Ombudsman at this email address: CDRHOmbudsman@fda.hhs.gov. More information about the office of the Ombudsman can be found at www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHOmbudsman/default.htm.

General Use of Consensus Standards in the Premarket Applications Review Process
Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. Conformity to the recognized standard should, in these cases, minimize the amount of data and documentation needed in the 510(k) submission to demonstrate substantial equivalence and, thus, streamline the premarket review process.
Applicants referencing a national or international standard should include a completed Standards Data Form for 510(k)s (FDA Form #3654, Form Approved OMB #0910-0120) as part of their 510(k).

Declaration of Conformity
If a manufacturer decides to conform to one or more recognized consensus standards in its premarket review process for a new device, the manufacturer must submit a “declaration of conformity” to the standards. A manufacturer can use in-house testing or third-party analysis to determine a device’s conformance to consensus standards. The manufacturer is also expected to maintain all records relating to its compliance with the standards.
The FDA recommends that submissions showing a device’s compliance with a consensus standard indicate “yes,” “no,” or “not applicable” for all sections of that standard. Any deviation from the standard should also be clearly indicated.
The FDA states that a declaration of conformity to a recognized consensus standard should do the following:

Review of Documentation
When a manufacturer’s declaration of conformity is deemed to conform adequately to FDA-recognized consensus standards, the aspects of the device addressed by the consensus standard are acceptable. There are, however, occasions in which a reviewer may have specific concerns and request additional information from the manufacturer.

Recognition of New and Revised Consensus Standards
To recognize a new standard or a new version of an existing standard, the FDA will post updated information in one of the Supplemental Information Sheets on CDRH's internet page and publish a notice in the Federal Register. The FDA will accept a declaration of conformity to a standard after it is recognized.

Additional Information
Scott Colburn, Director, Standards Management Staff, Office of the Center Director (OCD), is available to answer questions on consensus standards and issues related to declarations of conformity. He can be reached at (301) 796-6287.

Jon Stewart interviewed Atul Gawande on this book "Being Mortal".  Gawande reports that a group of cancer patients choosing palliative care at end of life lived 25% longer than those choosing more severe medical care.  The study was of stage 4 lung cancer patients.  The discussion of end-of-life tradeoffs started with the statement that 17% of people die at home and most die in other institutions.  There was some mention of his previous book, "Checklist Manifesto" which sounds like a book we need to pick up.  The importance of planning medical checklists can be and will be followed is important.

Joint Commission 101

Patient Safety - Joint Commission, National Patient Safety Goals (NPSGs)

The Joint Commission

The Joint Commission is an independent (not government), not-for-profit organization which accredits and certifies more than 20,500 health care organizations and programs, including hospitals, doctors’ offices, nursing homes, behavioral health facilities, office-based surgery centers and home-care services.

The purposes of The Joint Commission include helping health care operations improve the quality and safety of the care they provide, as well as reduce the risk of adverse outcomes.

In 2002, in keeping with its mission to continuously improve health care for the public, The Joint Commission launched a National Patient Safety Goals (NPSGs) program to address specific safety concerns.

The Patient Safety Advisory Group

A Patient Safety Advisory Group was formed – a panel of prominent safety experts composed of nurses, physicians, pharmacists, risk managers, clinical engineers and other professionals with hands-on experience addressing patient safety concerns in a variety of clinical settings. The panel’s purpose is to advise the Joint Commission on the development and updating of the NPSGs, the first of which became effective January 1, 2003.

The Patient Safety Advisory Group works with the Joint Commission to identify emerging safety concerns. They seek input from practitioners, care-providing institutions, consumer groups and other entities invested in patient safety. The Patient Safety Advisory Group uses the information to advise the Joint Commission in the effective use of NPSGs, standards, surveys, performance measures, educational materials, Sentinel Event Alerts and The Joint Commission Center for Transforming Healthcare (to be discussed.)

2014 National Patient Safety Goals (NPSGs)

There are different sets of NPSGs for particular settings, including:

Some of the goals are applicable to all settings. The full text containing the NPSGs can be purchased from Joint Commission Resources, http://www.jcrinc.com

Sentinel Event Alerts

An additional safety operation of The Joint Commission is the management of what the commission calls sentinel events; reports of the events are called Sentinel Event Alerts.

A sentinel event is an unintentional, unexpected, occurrence which results in death, serious physical and/or psychological injury, or confers the risk of serious adverse outcome if the event were to recur. These events are not related to the natural course of the patient’s disease or condition. Inherent to the definition of adverse outcomes is loss of life, limb or function.

Such events demand immediate attention and responses. They differ from medical errors, although some errors may trigger sentinel events, and sentinel events can increase the risk that medical errors will occur.

The Joint Commission, during the accreditation process, critiques the organization’s response to sentinel events. Already accredited organizations will have periodic, scheduled reviews, as well as random, unannounced reviews and for-cause investigations.
Accredited organizations are expected to respond appropriately with timely, credible analysis, to find the root cause of the adverse event. The analysis focuses on procedures and systems, not on individuals. The organization then must develop a plan for action, to reduce the risk of recurrences.

Some of the sentinel events that are reviewable under The Joint Commission’s Sentinel Events Policy include (not all inclusive):

Examples of sentinel events which are not reviewable, under the same Joint Commission policy include (not all inclusive):

Procedures for Implementing the Sentinel Event Policy

The Joint Commission staff will determine whether an event is reviewable based on available information they received about the event. Urgent threats to health or safety are referred to Joint Commission Executive Leadership for authorization to conduct an immediate, unannounced for-cause survey. The organization of interest must submit the complete root analysis and the action plan within 45 days from the date the event was reported.

The Joint Commission staff assess the acceptability of the organization’s response to the reviewable sentinel event. If the root cause analysis information and action plan are deemed to be thorough and credible, the organization is assigned one or more Sentinel Event Measures of Success (SE MOS). An MOS is a numerical or quantifiable measure that determines if a planned action was effective and sustained.

If the response is unacceptable, Joint Commission staff will provide consultation to the organization on the unmet criteria and extend an additional 15 calendar days beyond the original submission date for the organization to demonstrate acceptable analysis and an appropriate plan for action.

If the amended report does not meet established criteria, or The Joint Commission determines that the organization has not made serious improvement efforts, accreditation may be affected.
If the report is acceptable, The Joint Commission determines appropriate follow-up – usually reassessment in four months.

Universal Protocol for Preventing Wrong-site, Wrong-procedure, Wrong-person Events

The Joint Commission’s Universal Protocol applies to all invasive procedures. Those which place the patient at the most risk involve general anesthesia or deep sedation. The protocol is based on the following principles:

The Universal Protocol is most effective in environments which promote teamwork, and all members are empowered to pursue patient safety.
Timing and location of preprocedure verification of patient identity and site marking must be determined by an individual organization. The frequency and scope of preprocedure verification is determined by the type and complexity of the procedure. Preprocedure verification, site marking, and time-out procedures must be as consistent as possible throughout the organization. Site marking is not required when the person performing the procedure is with the patient from the time the decision to do the procedure is made, through to completion of the procedure.

Joint Commission Center for Transforming Healthcare

The Joint Commission, in 2008, created a Center for Transforming Healthcare, to tackle the most critical healthcare quality and patient safety problems. With the NPSGs, core measures, and high standards for accreditation, hospitals and other organizations that deliver healthcare can determine where to focus their resources, to have the greatest impact on quality and safety. However, some major shortcomings in quality and patient safety persist, despite considerable efforts to find solutions, including hand hygiene, wrong-site surgery and hand-off communication. The demand is great for more specific, effective and durable solutions.

The Center participants – some of the nation’s leading hospitals and health systems - are using a systematic approach to analyze the underlying causes of dangerous breakdowns in care, and to develop proven solutions to the more complex problems.

The Joint Commission makes available the proven solutions to the more than 20,500 healthcare organizations it accredits and certifies. With the proven solutions, significant advances in safety for all have been made in health systems and processes of care.

In September 2010, the Targeted Solutions Tool (TST) was introduced. The Joint Commission Center for Transforming Healthcare developed the application. It guides healthcare organizations through a step-by-step process to accurately measure their organizations’ performance, identify the barriers to excellent performance, and direct them to proven solutions that are customized to address the particular barriers of each organization.
The TST currently provides targeted solutions for hand hygiene, wrong-site surgery, and hand-off communications. Targeted solutions for surgical site infections, heart failure hospitalizations, patient falls, sepsis and others will be incorporated into the TST as the center completes their development.

National Patient Safety Foundation

The National Patient Safety Foundation (NPSF) is a not-for-profit organization dedicated to identifying problems in safety and creating solutions for both patients and healthcare workers. The NPSF, although it has a similar mission to that of The Joint Commission, it is entirely independent, with no affiliation to the commission.
The NPSF partners with patients, families, communities, healthcare workers and institutions to address safety issues, solve problems, and provide education in regard to patient and healthcare worker safety.
Among its educational resources is the NPSF On-line Patient Safety Curriculum. The 10 – module course is approved for continuing education credit by the Joint Commission and the American Board of Medical Specialties. The NPSF can be reached at (617) 391-9900 and www.npsf.org.

References

Institute of Medicine: www.iom.edu

The Joint Commission: www.jointcommission.org

The Joint Commission Sentinel Events: www.jointcommission.org/sentinel_event_policy_procedure

The Joint Commission: Patient Safety: www.jointcommission.org/topics/patient_safety.aspx

The Joint Commission Resources: www.jcrinc.com

The National Patient Safety Foundation: www.npsf.org

The Center for Transforming Healthcare – Joint Commission: www.centerfortransforminghealthcare.org

Risk Management Plan

1. Introduction

Risk management is mostly defined as the systematic applications of management. Risk management is to be integrated with different activities like device design control activities and other compliance activities. The main importance of applying risk management to medical devices is to provide the patient with safety. In risk management, the risk evaluation process is a key step.

1.1 Risk Management Procedures

Risk management involves a three-step procedure:

1) Hazards Identifications:

The hazard identification process should account not only for hazards directly related to the medical devices, such as designs and manufactures, but this is also used in the clinical worlds.

2) Risks Assessments:

In risk management, it includes some difficulties of risk assessments are difficult of measurement of the quantities, potential loss and probability of occurrence. There is more chance of errors to measure these contents . Risks with more potential loss and a less probability are often treated differently from other less potential loss. In practically, it is more difficult to manage, but in theory. it is nearly equal priority. The risk assessments face many problems like rareness of resources, specifically time.

Expressed mathematically:

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3) Risks Mitigation:

Risks mitigation is the process of an organization defining the measures to minimize or the process by which an organization introduces specific measures to minimize or remove unnecessary risks and operations. Risk mitigation is also the process of developing some options and actions to increase opportunities and reduce damage to project objectives. Risk mitigation handling options include:

Assume/Accept:

Acknowledge the existence of risks, make decisions about medical devices and accept them without engaging in special efforts, which is controlled.

Avoid:

Adjust program requirements or constraints to eliminate or reduce the plan risks. This is used to avoid the financial or technical problems.

Transfer:

Reassign organizational accounts and responsibilities and provide the authorities to different people who have the ability to accept the risks

Watch/Monitor:

Monitor the environment for changes that affect the nature and/or the impact of the risk.

Control:

Implement actions to minimize the impact or likelihood of the risk.

1.2. Principles of Risk Management

The organization identifies the following principles of risk management:

1.3. Risk Management Process

 

2. Medical Device Risk Analysis

Medical devices are providing risk analysis services. Risk analysis is a structured tool for the evaluation of potential problems. Risk analysis could be encountered in connection with the use of anything, like driving a car or using medical devices. Risk analysis of medical devices includes:

2.1 Why should we perform risk analysis?

2.2 Ways of Risk Analysis

1) Hazard Identification: Toltec has experience with many types of medical devices and can assist you in understanding what hazards exist. The main examples of risk analysis of medical devices are as follows:

3. What is Hazard?

3.1 Hazard Detectability

Hazard detection accounts for the likelihood of discovering and correcting a hazard or failure mode prior to an incident. Detection of hazards provides an inverse relationship between the level of detectability and the degree of risk seriousness. Detectability should then be scaled such that increasing scores denote a decreasing likelihood of hazard detection.

3.2 Hazard Correctability

The hazard correctability factor rates the relative ease of mitigating a certain risk. It accounts for the associated feasibility and effort required in reducing a particular risk to the lowest practicable level. In other words, in assessing the level of hazard correctability, both the availability of technical solutions and their economic feasibility and budget constraints should be considered. Practicability has main two procedures, and these are as follows:

1) Technical practicability: Ability to mitigate the risk regardless of cost

2) Economic practicability: The ability to reduce a risk without making the medical device into an unsound economic proposition

3.3 Types of Hazards

1) Biological hazards: These include bio-contamination, bio-incompatibility, incorrect formulation, toxicity, allergen-city, mutagen-city, ontogeny, carcinogenicity, re-and/or cross-infection, progeny-city, inability to maintain hygienic safety and degradation.

2) Physical and Mechanical hazards: These include erroneous data transfer, lack of, functional checks, inadequate maintenance, lack of adequate, loss of electrical/ mechanical integrity, inadequate packaging, re-use and/ or improper re-use.

3) Others: These include electricity, radiation, volume, pressure, supply of medical gases and supply of anesthetic agents.

4) Medical hazards: Hazards related to the use of the medical device, etc. This medical hazard includes trained and untrained people, width, etc.

5) Energy hazards: These include heat, electrical vibrations, etc.

6) Communication hazards: These include mistakes and experts errors, complexes or confused systems or unknown devices and their states, etc.

4. Methods of a Risk Analysis

The risk analysis includes the three factors of risk assessment, risk communications and risk managements. This risk analysis is to assure that medical devices processed in healthcare institutions are sterile. A risk analysis is performed to identify the risks to reduce the likelihood of a sterilization failure occurring.

Step 1) Risk Assessment: The risk analysis begins with a risk assessment. The possible risks are reviewed and then rated to assess which risk or risks pose the highest vulnerability. The CSSD Risk Assessment form can be completed using the following steps:

Step 2) Risk Management: Next are the risk managements, which perform some actions that are known for the risks rated as the highest in huge . This plan is used to reduce the failure of risk which is occurring when it is used . This is the part of the risk analysis which is used to eliminate the risks and to develop the plans.

Step 3) Risk Communication: A risk analysis should be conducted annually or whenever major changes occur. This step is used to provide communication between the different people for managing the risk plans.

5. General Requirements for Risk Management

1) National Regulatory Requirements: XXX shall establish, document and maintain a quality management system to ensure that all known potential risks within the field of application of risk management to medical devices are identified and that all relevant risks are controlled in such a manner that the products of our company do not harm the user/consumer.

2) Risk Management Process: The XXX shall establish and maintain a process for identifying hazards associated with devices, estimating and evaluating the risk and alternatives of the risks, controlling the risk and monitoring the risk. The XXX shall document the risk management processes, which include:

3) Management Responsibilities: There are many management responsibilities of general requirements. These are:
Policy: The top management of our company is committed with regard to evaluates, IDs, and risk controls, which is related to a safety plan. The risk management plan is used to communicate with the organizations so that they can easily understand the problems.

Suitability: The company’s management shall review the continuing suitability and effectiveness of the quality management system at defined intervals to fulfill the requirement of customers and authorities, satisfy the company’s stated risk management policy and meet the company’s risk management objective.

6. Qualification of Personnel

6.1 Task, Responsibilities and Authorities
The Managing Director is the leader responsible for overall system qualities, policies of risk management and objectives. The responsibilities and policies of risk management plan are as follows:

6.2 Risk Management Team
XXX has set up the risk management teams, which are used for developing, maintaining, establishing and reviewing the system of quality managements. The managers or director of management has selected the technical manager as the quality management representative, who shall have the defined authority for:

6.3 Risk Management Plan
The risk management file is the subset of the risk management plan. These include following:

6.4 Risk Management File
The company will have to save and maintain the record of all the risk management activities in the risk management file for the particular medical device or accessory being considered.

7. Medical Device Users

A medical device can be easy for one person to use safely and effectively, but creates present problems for different people. On the other hand, the medical devices that are easy for a certain group of users to use safely and effectively could be difficult for different groups. The users have to needs the medical devices so that they users can use it safely and effectively.
7.1 Characteristics of Medical Devices Users
The main characteristics of medical devices users are as follows:

7.2 Medical Device User Interfaces
A well-designed user interface will facilitate correct actions and will prevent or discourage actions that could result in hazards. The user interfaces are as follows:

8. Document Risk Management Activities for Device Use

In risk management, it can help demonstrate that a manufacturer has addressed the needs of the intended users and documented the incorporation of human factors engineering (HFE). Submitting this documentation can streamline and facilitate, which is the part of the pre-market review process that is concerned with safe and effective device use. The information that should be included with the device use documentation is described below.

8.1 Device Overall

8.2 Device User Interface

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8.3 Device Use

8.4 Device User Population

8.5 Device Use Environments

8.6 Use-Related Hazards

9. Verification and Validation

The validation and verification process of medical devices are as follows: Testing and evaluation processes and results associated with determining.

10. Scope of the Medical Devices

The scope of the medical devices is as follows:

11. Performance Measurements of Medical Devices

Performance measurement is the measurement of the accuracy of the medical device or the medical system. It is using by the standard measurement system whose accuracy is known and is the determination and the record of the deviations. It is established whether the medical devices are appropriate to the international standards or not. The problems are also determined if the device is not adequate to the international standards.
11.1 Objectives of Performance Measurements
In the objective of the performance measurement, the following procedures are observed.

References

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