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- Sri Kanya Alluru
- Why are medical devices stratified into different classes?
A wide range of medical devices are used daily, and many are being marketed. It is difficult to study each of these devices separately. In order to determine these devices complexity, and its level of harm a classification system is developed. The classification is assigned based on its marketing requirements and the risks or benefits it imposes. A basic classification system is required to classify and assign medical devices to each of these systems to get a thorough understanding of all devices, their intended use, labeling patterns and marketing criteria.
Medical devices are classified into 3 groups based on the degree of difficulty in assuring safety and efficacy. These medical devices are used by mankind in one or the other way so it is necessary to classify them so that they can be aware of the risks posed by each class. The various classes include
Class I: General controls
Class II: General controls and special controls
Class III: General controls, Special controls and premarket approval
This stratification helps FDA, manufacturers and patients. Class I devices are low risk devices, and require less regulatory control compared to other classes. These include elastic bandages etc. Class III devices are high risk and life sustaining so strict regulations are to be enforced in a manner such that these devices adhere to them. Examples include implants, pacemakers etc. By understanding these risk factors patients can be careful at the time of device use to assure their safety.
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FDA has classified almost 1700 medical devices into different categories known as panels based on their medical importance and their intended use such as all cardiovascular devices are assigned as one panel, all dental devices are grouped as another panel etc., which in turn are again assigned either under Class I, II or III devices. These devices are classified based on the device description according to 21 CFR 862-892.
For manufacturers in case of low risk devices such as Class I devices they are exempted from pre-market approval and so take less time for marketing thus benefitting manufacturers. So based on classification they can identify which products need approval and which of them are to be exempted enabling their marketing time.
2. Why is traceability important for the medical device life cycle? Who does it benefit – the manufacturer, FDA, both? Explain your answer.
Traceability is defined as the ability to thoroughly study a medical device from it design to the end process. It requires complete analysis and understanding of their uses. (“Effective Traceability of Medical Devices,” 2010). Traceability is an essential factor in device life cycle as it
- Enables product recalls,
- To determine the batch that has undergone recalls without enhancing recall of all devices
- To maintain records so that an efficient review and preventive measures can be enabled
It is the responsibility of each manufacturer to establish requirements for each type or family of devices to ensure the device safety, quality, and establish methods and procedures to design, produce, distribute, etc.
As a part of the quality system regulation or GMP principle documenting the details is essential for traceability. The manufacturer must prepare a batch record for every device/batch that is product and must be identified with a unique lot/control numbering system defined by the manufacturer and it represents the lots complete history. Distribution records of each where it was shipped must be kept by the manufacturer for traceability in the event of a recall.
The device GMP require manufacturers to be able to trace any device or device component by a control number if it is indented for surgical implant into the body to support or sustain life, and its failure to perform can be reasonably expected to result in a significant injury to the user. The Quality system regulations require companies to establish purchasing controls and institute post-distribution device failure investigations and corrective/preventive actions for defects or recurring technical problems.
It is the responsibility of the manufacturer to establish traceability controls to effectively handle complaint/failures and determine root cause so as to correct & prevent the reoccurrence and at the same time it would help the manufacturer to effectively handle the recalls both internally and also with FDA when required.
3. Review the Johnson and Johnson Quality Catastrophe article under Week 9 Readings. What areThe major lessons learned from Johnson and Johnson’s Quality Catastrophe?
Based on the events and circumstances in the article Johnson and Johnson and its subsidiaries had certainly put its consumers trust in turmoil by providing unsafe products.
Johnson & Johnson (J&J) expanded its businesses by acquiring and merging with companies manufacturing health products. Due to these acquisitions it has become a decentralized organization. It is unusual to see deficiencies in product quality and safety, as all the procedures and rules for safety are defined at the enterprise level, not at the product level.
The incidents mentioned occurred due to ignorance and profit making strategies of the corporate companies leaving the facts and safety concerns behind reality. These would cause lot of pain and suffering to the people relying on the product with their lives.
Tylenol incident occurred in the past has gained applause and appreciation for its best crisis management, but later incidents brought condemnation to the company.
The reason for this quality catastrophe occurred at J&J is mainly due to the following reasons.
Due to J&J decentralized organizational structure, the responsibility rest at the enterprise level not at the subsidiary level, CEO Weldon (2002-2012) put in place. Under his Leader ship many recalls, incidents occurred due to his negligence, and profit making mentality. They failed to meet with the regulations He clouded the issues in the factories (McNeil Factory odor), recalls (Motrin, Benadryl), lawsuits (Hip replacement) from the individuals, hospitals using their products by showing steady growth and properties to the investors and board of directors.
Product safety should be one of the top priorities while manufacturing consumer products. Ignoring these facts will cause jeopardy to the consumers and have adverse effects due to their use. Marketing products without proper research and tests will cause problems to the consumers. J&J failed to comply with these standards in their products (Ortho Evra, DePuy hip product), and caused harm and discomfort to the consumers emotionally and physically.
Food and Drug Administration (FDA) should be stringent with companies in imposing rules and regulations of the FDA. By imposing these laws FDA can ensure that the companies will provide high quality products to the consumers. In this case FDA ignored the J&J company product recalls, factories manufacturing standards, and their sanity conditions. Due to its ignorance people had permanent immobility, discomfort, and even deaths. This can be prevent if FDA had a structured program in allowing health products being market after certifying them they are safe, and define laws that would report medical incidents, and lawsuits to the FDA for review.
4. What are the regulatory challenges specifically for products in the mobile health space?
FDA recently issued the Mobile Medical Guidance for Industry, which mainly outlines the regulations for mobile space devices. The mobile app is designed to have a direct communication to patient. (Kim, 2014) Incorporating mobile apps, as a tool for health-based issues is a boon, when major challenges and risks associated with it are overviewed and are put in a right way so that they are beneficial to the public.
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Recently a large number of health and fitness apps, medical device apps are introduced and their number is constantly increasing day by day. But the major challenge underneath this is which of them are beneficial and can be categorized as medical apps. They are to be clearly understood and regulated. Software’s intended solely for the purpose of storage are exempted as medical apps, and those for serious health issues and diagnostic purposes are regarded as mobile health apps. Post market surveillance also has a major role to play. As these mobile health apps are pioneer and outstanding major challenges lies in diagnosis, monitoring and treatment (Brousseau, 2012).
Medical apps can be categorized into three groups. Firstly only a few apps meet the requirements of a device and help in diagnosis. Secondly, a large number of apps are not scrutinized or influenced by FDA such as calorie counters etc. and finally some apps, which have no benefits in medical field. In spite of so many of these apps FDA has to have a keen and a clear survey on which of them actually comes under mobile health category and regulate them(Brousseau, 2012).
Most challenging effect is that there might be loss of confidentiality because these social medias always face the risk of hackers. There are also serious risks associated with the misuse of mobile apps. But there are questions regarding how risks arise with these apps. So there is challenge for the improvement of adverse reporting system. It’s possible for a medical device to escape regulatory process and enter the market but such type of procedures impose risks to consumers so FDA has to monitor them thoroughly.(Vesely, 2014)
5. What was the most interesting thing you learned in the devices portion Of RGA 6100?
There are many interesting things that surprised me during my course. I could learn the regulations governing these devices, various medical device companies, their FDA approvals and lot more things. Today there are so many advances in medical device technology such as medical robotic technology for various surgeries, mobile health apps that helps in communication between doctor and patient, inhaled insulin more advantageous to diabetes patients and if we go on it would be an never ending discussion.
I found Lap-band interesting because of today’s obesity problems people are facing. Although there are several weight loss programs, fitness centers, they provide only short-term results and also have considerable health problems.(Ruchi Mathur, 2014) This lap-band is so advantageous that it ensures healthy weight loss and has long term results. This is an adjustable process as we can loosen or tighten it according to our convenience. (“Lap-Band Surgery Information,”)
Brousseau, Zachary. (2012). Experts Examine Regulation of Health-Related Mobile Apps, Software and Social Media. Retrieved 03/24/2014, 2014, from https://http://www.raps.org/focus-online/under-raps/under-raps-article/article/2479/experts-examine-regulation-of-health-related-mobile-apps-software-and-social-me.aspx
Effective Traceability of Medical Devices. (2010). Retrieved 03/21/014, 2014, from http://www.imb.ie/EN/Safety–Quality/Advisory-Warning–Recall-Notices/Medical-Devices/page-title-Effective-Traceability-of-Medical-Devices.aspx
Kim, Sun. (2014). FDA Regulations on Mobile Medical Apps. Retrieved 03/24/2014, 2014, from http://qbdworks.com/fda-regulations-on-mobile-medical-apps/
Lap-Band Surgery Information.). Retrieved 03/21/2014, 2014, from http://www.mills-peninsula.org/obesity/lapband.html
Ruchi Mathur, MD, FRCP(C). (2014). Lap Band Surgery(Gastric Banding). Retrieved 03/21/2014, 2014, from http://www.medicinenet.com/lap_band_surgery_gastric_banding/article.htm
Vesely, Rebecca. (2014). mHealth Regulations: What’s in Store? Retrieved 03/25/2014, 2014, from http://www.ihealthbeat.org/insight/2014/mhealth-regulations-whats-in-store
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