In Brief

• The necessity of the risk management plan (RMP) has been studied before the launch of the medical device and medicinal product.
• Risk management documents/plan for medical device is done and verified through FDA QS regulations and ISO 14971.
• For medicinal products the risk management documents/plan is achieved by
• If more than one medicinal product is studied, article 14(2) of Regulation (EC) No 1394/2007 provides a layout for RMP for such advanced therapy medicinal products (ATMP)

Introduction

Risk is considered as an incident that might occur at any point of time, which might eject either it’s positive or negative affect on project.  Risk can occur due to many factors taken into consideration and one has to understand that not a single factor is responsible for any damage. For example, a case may need permission from environmental department to carry out the work, but if the man power assigned might not be sufficient to continue the work as the risk involved is the available personnel may not complete the work in stipulated time or might take longer time to issue a permission or those documentations may not be adequate for the activity. Such risks show tremendous impact on the economy of the projects which are pre planned and scheduled to perform. However, most of the projects possess some risks and through risk management documents/plan (RMP), some technical techniques help in monitoring those activities. Hence, risk management is necessary to implement on all those documents whose probability of having risk is found to be high.It includes processes for risk management planning, identification, analysis, monitoring and control. Many of these processes are updated throughout the project lifecycle as new risks can be identified at any time. It’s the objective of risk management to decrease the probability and impact of events adverse to the project.

The need for risk management documents/plans (RMP)

Usually most of the medical devices that are designed and medicinal products which are prepared to reach the doctors first and later to patients, considering that their usage is believed to be safe on patients, but sometimes unknowingly both doctor and patient experience the risk either due to device or medicine. Hence, it is essential to understand why the risk management is needed for both medical device and medicinal product, one has to follow FDA QS regulations and ISO 14971 for medical deviceto check the quality of the device and to know its post-product development which would explain the risk management process of medical device. On the other hand, as perV^th module of GVP, it is necessary to document all the risk management system which must be identified and considered to lower the risks of medicinal products. In addition to this, it is checked whether pharmacovigilance activities are sufficient enough or any other new necessary activities have to be included. Risk minimising activities are mentioned or not or may have to introduce new rules to minimize the risks. Hence, the intention is to identify the risk involved in usage of medical device and medicinal products to analyse and evaluate its safety in medicine field.

RMP: What it involves

At present ISO 14971-2019 was accepted by American National Standard and was progressed further by AAMI application of Risk Management to Medical Devices Working Group. This involves discussion on the quality management and common aspects of the usage of medical devices including in vitro diagnostic devicesand any harm to the humankind and its severity in presence of ethical committee members. They revise and review the efficiency of the medical device every five years to upgrade the advancement of the any technology that might have occurred. Although, risks are discussed, parallely the benefits are also assessed and attention is given on the medical device which would be considered safe. It also estimates the risks related to data and security systems. Moreover, the necessity for production and post-production activitiesmust be cleared and revised and if necessary it should be restructured depending on the reviews on the safety of the medical device.

On the other hand, RMP of medicinal products involves identification and characterization of thesafe usage of the medicinal product and it also rectifies and quantifies the potential adverse risks prior to the pharmacovigilance plans. It should involve all the safety measures appropriately or else it must revise for extra safety of the medicinal product. Further, Article 14(2) of Regulation (EC) No 1394/2007 provides a layout for RMP for advanced therapy medicinal products (ATMP). It includes information if the RMP considers more than one medicinal product, in that situation separate information on each medicinal product must be mentioned along with the total population size for each medicinal product. Hence, analysing the risk management plan for both medical device and medicinal product is important before its launch².

 RMP: What it offers

Under the jurisdiction, risk management documents/plan is necessary to prior analyse the risks before the medical device is marketed. It offers protective measures towards products (medical device and medicinal product)against its damage. It ensures safety of the product when used to treat patient, and clearly provides an idea on its adverse reactions.  It also rectifies if any device is unsafe and reaches the market, it is immediately corrected with efficiency.

RMP outputs

The output of risk management plan can either be qualitative which grade the range of the risk as high, medium or low and sometimes risk score can define its risk rank. In quantitative output, it measures or estimates the probability of the risk consequence.Thus, quantitative risk estimation can resolve or focus on a specific consequence at one particular time.Risk management plan when implemented on medical devices and medicinal products, it can avoid the minute errors in manufacturing process before it reaches to the stakeholders. It even benefits various organizations to check back or revise the yearly plans to be implemented. Most of the risks are eliminated through RMP by applying techniques that monitor the events that have crucial impact and affect the outcome of the project¹.

References

1. Risk Management Plan. https://www.fda.gov/media/71543/download
2. ISO 14971:2019 [UNKNOWN]. Medical devices — Application of risk management to medical devices. ICS:040.01. Medical equipment in general
3. Guidance on the format of the risk management plan (RMP) in the EU – in integrated format. EMA/164014/2018 Rev.2.0.1 accompanying GVP Module V Rev.2 Human Medicines Evaluation. 31 October 2018.
4. Medical devices—Application of risk management to medical devices. Association for the Advancement of Medical Instrumentation. Approved 10 May 2019 by American National Standards Institute.
5. Medical devices—Application of risk management to medical devices. ISO 14971:2019(en)

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• Humans differ in their biological reactions to medical products or drugs but not all adverse reactions associated with the use of medical products can be detected during clinical development.
• Even the most comprehensive clinical trials could not detect some adverse effects. Healthcare Analytics Services captures as many of these adverse reactions are rare, from worldwide sources, is important for continued patient and drug safety.
• Pepgra lists the reporting of side effects and its necessities in their blog

Introduction

Drugs approved by the Food and Drug Administration for sale must be safe, meaning that the drug’s significance appears to be higher than the predictable risks and should be useful. Both the prescription and over-the-counter medicines possess side effects. Side effects, also known as adverse effects, are unwanted or unexpected events or reactions caused due to the drug intake for therapeutics clinical research. Side effects can differ from small problems like a running nose to life-threatening conditions, like the risk of a heart attack may get increased. Several things can affect who does and does not have a side effect when taking a drug – age, gender, allergies, how the body absorbs the medication, vitamins and dietary supplements that may be consuming for a while. General side effects include stomach upset, dry mouth, and dizziness says the Clinical Biostatistics services. A side effect will become severe if the result is death or any life-threatening condition, hospitalization for many days, disability, permanent damage, or exposure during pregnancy, causing disability. It is essential to contact your doctor or pharmacy specialist if you think you might have experienced a side effect after using a medicine. They will let you know if you need any medical care. They will also consider if you need any change of treatment in all the Clinical research organization.

Reporting suspected side effects

Many people will not experience any problems when using medicines. However, Healthcare data analytics services conclude that all medications have some risks associated with their internal use, and very few people may experience effects (also known as an adverse reaction).

What is the side effect?

An adverse reaction is a ‘gradual or immediate response to a medical product that is deleterious and accidental’. Healthcare data analysis includes any harm associated with using medications, including overdose, misuse or medical errors.

Actions to perform when you experience side effects

If you think that you have experienced an adverse reaction to a drug, you need to contact your healthcare professional who will advise any treatment required to treat the illness. They will also report the issue to the corresponding site on your behalf when a drug is without Clinical trial Monitoring Services.

If anybody wants to directly report an adverse reaction, they can search the healthcare analytics on the internet. Anybody can report issues relating to the safety of medications to the online reporting service. It includes patients, caretakers, and common public and healthcare professionals in the hospitals by pharmaceutical regulatory consulting services.

Reporting a side effect

You can report a side effect in several ways:

• Go directly to your doctor, pharmacist or nurse who can then notify the HPRA.
• Use the online reporting service.
• Download a copy of online adverse reaction report form and email completed forms to med safety services through online
• Printing our adverse reaction report form and posting a completed copy by Freepost.

Filling an adverse effect report form

Specific mandatory fields are required to submit an adverse reaction report via the online systems successfully. These include reporting person details and a contact mail address. The latter facilitates the return of a unique report identifier number to confirm the submitted report successfully. The confirmation mail from the online reporting service will also contain a PDF version of the information reported. Besides, the following minimum criteria include a ‘good’ side effect report with healthcare data analytics services:

• An identifiable patient with their initials/age/sex/record number)
• An identifiable medical product with its name or active substance if the brand is unavailable)
• An identifiable reporter
• An identifiable reaction

The above information is the minimum criteria needed for a ‘good’ side effect report, additional information regarding details relating to the reaction like medical history, other medication consumed, the clinical study design of a drug and action taken with the medicine useful for pharmacovigilance literature search services.

All the additional relevant information is beneficial in the evaluation of the healthcare data analytics suspected adverse reaction.

Once the HPRA reviews the report, the reporter contacts for further follow-up information that is useful to evaluating the identified adverse reaction, permission may be requested to contact a healthcare professional from the hospital or clinic directly for any other required information.

Importance of reporting suspected side effects

• Patients are able to identify the impact of medicines they have consumed, particularly on their quality of life and health.
• Systems for consumers or patients reporting are an essential tool to encourage ‘spontaneous reporting’, which contributes to gain the overall knowledge of the safety of medicine/drugs and the patient experience.
• The patients’ role in reporting adverse drug effects is a critical element of building an improved system of pharmacovigilance services.
• The involvement of patients is now at the edge of the new medications for safety monitoring.

Conclusion:

Any drug can cause unwanted or unexpected side effects. Immediate detection and recording of side effects of drug reactions are essential so that unrecognized hazards can be identified promptly. The regulators will take appropriate actions to ensure that medicines are used with safety. It is explained in this Healthcare Analytics Solutions with the biomedical research services.

References:

1. Dubrall, D., Schmid, M., Alešik, E., Paeschke, N., Stingl, J., & Sachs, B. (2018). Frequent Adverse Drug Reactions, and Medication Groups under Suspicion: A Descriptive Analysis Based on Spontaneous Reports to the German Federal Institute for Drugs and Medical Devices from 1978 to 2016. Deutsches Ärzteblatt International, 115(23), 393.
2. Freifeld, C. C., Brownstein, J. S., Menone, C. M., Bao, W., Filice, R., Kass-Hout, T., & Dasgupta, N. (2014). Digital drug safety surveillance: monitoring pharmaceutical products on Twitter. Drug safety, 37(5), 343-350.

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• E-labelling is not new evidence; nor is its use partial to the life sciences business.
• Creating the latest product data available online adds value across various industries, particularly in healthcare analytics solutions.
• Pepgra gives you the challenges and uses of e-labelling (electronic labelling) in the healthcare data analytics companies.

Introduction:

E-labelling (electronic labelling) plays a severe role in the medical devices industry, as it confirms to improve operational efficacy, maintain brand consistency, obtain obedience and support business growth. Hence, the healthcare data analytics solutions move towards adopting end-to-end e-labelling life cycle procedures, starting from label content creation to review and approvals. How are they beneficial and what kind of challenges one would face while adopting them? Let us know in detail.

E-labelling for Clinical Devices – Beneficial factors

As a piece of the EU’s new Clinical Device guidelines, any device producer with a site should distribute client data to it in electronic structure. Other worldwide wards have comparative prerequisites, which put a new accentuation on e-naming as a control: the electronic distributing of naming substance, including Instructions/directions for Use (IFU/DFU).

Better Utility and Data

• Simple admittance to data, upgraded comprehensibility and more justifiable for clients so they can get all the item data
• Customization for country-explicit labels and plans
• Expanded proficiency and utility through online evaluation by a controller and other related Healthcare Data Analysis.

Environment Friendly and Time Saving 

• Diminished utilization of materials for labels and decreased natural effect
• The general season of the assembling interaction is abbreviated
• The big data analytics in healthcare on e-labels can be refreshed distantly for a product

Practicality and Upgraded Understanding Safety

• The e-labels save cost, paper and space and dispense with the danger of IFU (Instructions for Use) getting lost or isolated from their related devices for healthcare data analytics
• They are tough and are not liable to blurring or pollution
• They upgrade device security and improve data trade by making successive updates to the electronic IFUs

Utilizing QR Codes:

• The QR codes are generally speedy and straightforward and help to associate the controllers and purchasers to the site facilitating consistency and with different prerequisites
• Given the expansion of cell phone access using free applications, the QR codes are utilized in a broad scope of settings and permit the client to examine the QR codes and access the critical data

E-labelling for Clinical Devices – Difficulties

Multilingual Labelling

• The labels should be securely and precisely tweaked in proper area dialects to get to a few topographies and hold fast to the country-explicit naming necessities, plans and Administrative prerequisites
• Any labelling mistakes can make the danger of brand picture harm, particularly during item reviews. Nonetheless, mark Lifecycle Management Solutions (LMS) have become a powerful weapon in the language the board stockpile and a demonstrated, approved naming programming framework will eliminate the apparent complexities of locality language detailing same time meeting country-explicit prerequisites.

Overseeing Complexities of Extension

• With steady consolidations, acquisitions and developments, the labelling tasks of clinical devices are altogether influenced.
• A labelling programming framework will improve the name trustworthiness and consistency and help deal with the naming information. All the more successfully, aiding each part of the by and large naming interaction, including adherence to country-explicit necessities and decreasing the requirement for physically observing the naming cycle.

Controlling Mark Deformities

• Expanding labelling mistakes lead to visit item reviews, other than affecting operational proficiency and benefit.
• Robotized vision frameworks are acquainted with guarantee more powerful, proficient, and secure methods of zero-imperfection naming.

Absence of Gear and Specialized Capacities

• Network issues are experienced while checking e-labels with handheld devices for healthcare analytics
• To guarantee network, versatile, or Wi-Fi internet providers can be utilized. Additionally, scanners, that can peruse, and store labels disconnected can be used, and the labels can be checked later when the device interfaces with an organization

Conclusion:

More or less, e-labelling will decrease the manual intercession and give collected quality data, improve quiet security, consistency, and brand respectability, diminish the natural effect, and in particular, it will be financially savvy. The solitary inquiry device makers should ask themselves now: “would we say we are e-labelling prepared”? Do a complete examination with an Administrative labelling master for clinical devices. Stay educated. Stay consistent. Pepgra gives you the challenges and uses of e-labelling (electronic labelling) in the healthcare analytics companies.

References:

1. Ângelo, A., Barata, J., da Cunha, P. R., & Almeida, V. (2017, September). Digital transformation in the pharmaceutical compounds supply chain: Design of a service ecosystem with e-labelling. In European, Mediterranean, and Middle Eastern conference on information systems(pp. 307-323). Springer, Cham.
2. Bolislis, W. R. R., Mortazavi, C., Riccioni, R., Schaeffer, P. E., & Kühler, T. C. (2019). From Print to Screen: Regulatory Considerations to Adopting Innovative Approaches for Patient Information and Safety. Therapeutic innovation & regulatory science, 1-8.
3. Gassner, U. M. (2007). E-labelling & the Comitology Procedure–Outcomes of the MDD Review Process.

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Manufacturers perform post-market surveillance to gather and assess experience obtained from medical devices that have been placed on the market and determine the need for any action. Post-market surveillance is an important tool for ensuring that medical devices remain safe and effective and taking action if the hazard of continuing to use the device outweighs the benefit. The examination of post-market monitoring experiences can also reveal areas where the medical device could be improved.

Introduction

Like many other worldwide regulatory frameworks, the WHO Global Model Regulatory Framework for Medical Devices, which includes in vitro diagnostic medical devices, necessitates the deployment of post-market surveillance systems. Receiving and assessing comments are the bare minimums for post-market monitoring, but this may be broadened to include other tasks. The operations of national regulatory authorities (NRAs) acting in response to reports of adverse events received, known as vigilance, are also included in the WHO Global Model Regulatory Framework for Medical Devices. The terms “adverse event” and “incident” may be used interchangeably in various jurisdictions. The word “incident” will be used in this advice to refer to a variety of experiences that may be obtained when using a medical device.

The WHO Global Model Regulatory Framework for Medical Devices defines post-market surveillance as the activity of NRAs. Market monitoring is the term used in this paper to describe the operations carried out by NRAs. The phrase “post-market monitoring” is only used in this text to refer to processes carried out by manufacturers. As a result, post-market surveillance, vigilance, and market surveillance are all interchangeable concepts. Users’ insights about the use of medical devices are shared with manufacturers. Manufacturers notify NRAs of specific instances and inform them of the steps taken. The NRA will look into the manufacturers’ inquiries and any further steps. This has to do with NRAs’ market surveillance obligations. The term “market surveillance” refers to the entire set of operations carried out.

Basic principles of post-market surveillance

Manufacturers of medical devices undertake pre-market evaluations of product quality, safety, and performance before releasing them into the market. Risk management concepts are used to decide risk reduction and residual risk tolerance. However, problems may develop once the medical equipment is on the market.

Manufacturers’ responsibilities

Even though medical devices are conceived, developed, manufactured, and distributed worldwide following extensive pre-market testing, residual concerns regarding safety and performance will persist throughout the product’s lifetime. This is attributable to various reasons, including intrinsic product variability, factors impacting the medical device’s use, environment, human interaction, and medical device failure or overuse. Before a medical device is released on the market, design and development processes guarantee that the remaining risks are acceptable compared to the anticipated benefits.

Actions of users about manufacturers’ post-market surveillance

Post-market surveillance mechanisms

The information that can/will be gathered during post-market surveillance is dependent on the information that can/will be collected. The manufacturer must first determine the post-market surveillance objectives for any given medical device or collection of medical devices, and the maker must next decide which sources are required to achieve these goals. Data will be grouped and analysed based on this.

Electronic post-market surveillance system for medical devices

The gathering of information concerning adverse occurrences using medical devices and communicating such information among Health Care Institutions and Manufacturers Competent Authorities is a fundamental problem in the health care industry. An Electronic Post Market Surveillance System that solves the problem above effectively and securely while adhering to international standards. The PMS Server Application is deployed on the premises of the manufacturers/suppliers, while the PMS Client Application is installed at the Health Care Institutions. The PMS programmes are used to manage PMS Reports and Responses, and they include significant characteristics, including user-friendly interfaces, interoperability, and various implementations based on performance and cost requirements. The system was assessed methodically.

Conclusion

The goals and methods for post-market monitoring for medical devices undertaken by manufacturers with the help of their economic operators, market surveillance conducted by regulators, and the participation of other stakeholders in these processes are discussed in this paper. It explains the steps required after a medical device is placed on the market to ensure that it continues to meet the standards for safety, quality, and performance.

About Pepgra

Pepgra has a lot of post-market surveillance (PMS) report writing knowledge. The European Medicines Agency (EMA), the Food and Drug Administration (FDA), and other local nation criteria are followed by our PMS specialists. Pepgra CRO contributes to the advancement of public health by detecting and assessing safety indications from available data sources using evidence-based techniques and then recommending appropriate regulatory actions such as labelling changes, Risk Evaluation and Mitigation Strategies (REMS) communication of relevant safety information. Pepgra CRO, with its extensive understanding of the pharmaceutical business and remarkable in-house skills, provides high-quality and cost-effective post-marketing monitoring services to its clients.

References

1. Chaudhry, Junaid, et al. “Enabling Technologies for Post Market Surveillance of Medical Devices.” (2018).
2. Vlachos, I., Dimitris Kalivas, and Ourania Panou-Diamandi. “An electronic post-market surveillance system for medical devices.” Computer methods and programs in biomedicine2 (2003): 129-140.

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All biomaterials and medical devices must comply with various Pharmaceutical Regulatory standards and rules to receive clearance. It covers a range of processes and regulations, including commercialization, clinical development, good manufacturing practice, and post-market surveillance. Global rules and regulatory challenges relating to biomaterials and medical devices are discussed. Particularly effective for smaller businesses that may not have the funds to hire a full-time vigilance specialist. Risk management, intellectual property protection, marketing authorization, university patent licences, and general good manufacturing practice are covered in the methods and regulations.

Introduction

Medical Device Regulatory Affairs has many advantages for patients, but they also have a lot of risks, especially those meant to be implanted. The purpose of national medical device regulatory authorities is to safeguard patients and the general public from dangerous goods while also allowing for the rapid introduction of novel technologies that can benefit patients and promote public health.

Based on risk assessment, the regulatory framework and standardized test techniques for medical devices, including biomaterials, are now harmonized worldwide. In this broad context, new implanted biomaterials should pass a set of regulatory tests before receiving marketing authorization. Physical and chemical categorizations, biological in vitro and in vivo studies, and clinical investigations require examinations. For traditional biomaterials and implanted devices, this approach is well-established. However, emerging revolutionary goods, such as Nano biomaterials, tissue engineering materials, and 3D-bioprinting tissues and organs, confront regulatory difficulties that act as hurdles to their timely delivery to patients.

The most recent research on the contradictory concerns emerges when evaluating newly created biomaterials and medical devices. First, a background on regulatory procedures in the United States and the European Union is presented, and a discussion of the definition of medical innovation in the medical device regulatory consulting services. The links between medical device legislation and innovation are examined on this basis. Finally, examples of cutting-edge medical technology are examined.

Methods

This open search corrected other original scientific publications and reports relevant to the articles studied in the systematic search from various regulatory bodies, consulting and expert groups, and governmental departments. These publications are especially significant because numerous stakeholders are concerned about the ethical, scientific, and legal aspects of medical device innovation, so these topics are covered in several places. However, not all of the publications evaluated in our study are cited owing to length limitations.

Medical device regulations

The Device Amendments of the United States Food and Drug Administration (FDA) produced the first regulation for devices intended for human use, and the FDA had a unique position among national regulatory bodies all over the globe until recently. The Center for Devices experts in regulatory affairs and Radiological Health (CDRH) is now in charge of premarket approval of medical devices in the United States and post-market surveillance of these devices.

Most Class I medical devices must be registered with the FDA but are not required to undergo a 510(k) premarket review. However, they must adhere to general controls such as manufacturer registration and announcement to the FDA before marketing, good manufacturing performs (GMP), appropriate branding and labelling, and available post-market reporting procedures. To meet regulatory criteria and post-market supervision, Class II medical devices must have particular labelling requirements.

Clinical studies, done in line with Good Clinical Practices (GCP), are required by the FDA for “high-risk” devices to establish safety and effectiveness. These trials can be costly and take years to complete. After receiving FDA investigational device exemption (IDE) approval, the devices are clinically approved. Unless its “substantially equivalence” to a lawfully sold Class I or Class II item can be proven, a device that has not been on the market is deemed a Class III.

Regulations’ Impact on Medical Device Innovation

Regulatory concerns influence the whole innovation cycle, and they must be considered throughout the design and development of medical devices and during pre-clinical and clinical testing, product regulatory testing, manufacturing, and post-marketing surveillance. As a result, the collaboration between medical device developers and national regulatory bodies is crucial for innovation and competitiveness.

To show compliance with the “Essential Principles of Safety and Performance of Medical Devices,” quality and risk management systems must be incorporated throughout the life cycle of medical goods. The identification and description of dangers connected with medical devices and their accessories; risk analysis, evaluation, and control; and monitoring the efficacy of that control are all part of risk management.

Conclusion

Strong medical device laws exist to safeguard patients and the rest of society from dangerous items and improve public health by bringing new products to market that can benefit patients. However, the risk of releasing devices that haven’t been thoroughly tested exists, and an effective review procedure is still a source of worry for academics, business, government, and the general public. The categorization of medical goods into pharmaceutical regulatory affairs, biologics, and medical devices is the cornerstone of the world’s most advanced regulatory systems; nevertheless, novel combination products prove problematic to the present product classification scheme. Furthermore, the use of emerging technologies in medical device design, such as nanotechnology, tissue engineering, and 3D printing, emphasizes classifying medical devices into risk classes. Even at the earliest phases of the invention process, the duty for ensuring the safety and efficacy of devices relies not only on national regulatory authorities but largely on researchers, manufacturers, and clinicians.

About Pepgra

Pepgra CRO provides high-quality Clinical and Regulatory Expert Services to its clients. Our regulatory services experience draws heavily on the most recent research to assist you in designing and implementing clinical and regulatory frameworks that meet your needs. Our pharmaceutical and biotechnology industries clients have been very pleased with our regulatory services. Our regulatory affairs professionals from the world’s leading pharmaceutical companies focus on assisting in developing new medical products, the integration of regulatory principles, and authoring and submitting appropriate reports to health authorities.

References

1. Guerra-Bretaña, Rosa Mayelin, and Andrea Lucía Flórez-Rendón. “Impact of regulations on innovation in the field of medical devices.” Research on biomedical engineering34 (2018): 356-367.
2. Gurman, Pablo, O. Rabinovitz, and Tim B. Hunter. “Regulatory challenges on biomaterials: focus on medical devices.” Biomater Sci Integr Clin Eng Approach223 (2012): 48.

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