From here, links to national or regional standard organizations are indicated. In other cases it is a charitable organization which will receive the container and give the donated medical supplies to a local healthcare institution. It is important, therefore, that medical device marketing and advertising are regulated to prevent misrepresentation of a medical device and its performance. There are many complicating factors in the interpretation of this presentation. However, poor manufacturing management can produce inconsistency in the quality of products, such that non-conforming devices can filter through the production line to the market, even when the original prototype has been well-designed.
Take Action Repair of critical hospital equipment is vital to the managing costs, and it's vital to providing patients with the care they need. Another aspect of product representation, however, is verbal presentation by the vendor. An in-house engineer can repair broken equipment cheaply and quickly—so staff can get back to the business of saving lives. The user also has the responsibility to ensure proper maintenance of medical devices during active use and safe disposal of obsolete medical devices. Increasing numbers of young women reaching reproductive age increases the need for maternal, newborn and child health services.
Applicants who are not nationals of this country will not be considered. Useful web sites include: www. This study examined 112,040 pieces of equipment. However, in a subset of 1,242 pieces from 10 hospitals in Indonesia, only 52 pieces 4. Furthermore, it is easier to measure objectively and quantify performance than clinical effectiveness. Neither the World Health Organization nor the principal author warrant that the information contained in this publication is complete and correct and shall not be liable for any damages incurred as a result of its use. Technical committee members include representatives from national medical device regulatory authorities and the regulated industry.
This rather high unavailability of critical medical equipment in public hospitals in developing countries motivates this study, hence the necessitating the need to implement optimal maintenance strategies and operational protocols for maximizing equipment availability. Other organizations also produce documents on international standardization. This mandate may, or may not, have a legal basis. Non-technical language, graphics, tables and memory anchors are used to present an overview of medical device safety issues and regulatory philosophy. In this chapter, a general introduction to standards will be provided. The government has the responsibility of overseeing that medical devices sold in the country are safe and effective.
Performance means technical performance plus effectiveness see section 2. However, the principles of a good maintenance program will be the same if it is in an urban area in a high-income country or a rural setting in a low- to middle-income country. The above discussion highlights the inherent risk of a medical device. Manufacture Good, functional medical devices are produced when the manufacturing process is adequately managed. A common regulatory framework is proposed integrating the five regulatory systems with the most advanced medical device regulations, along with the applicable regulatory tools. This often results in frequent failure of the medical devices and as a result, low availability.
In turn, this leads to delayed treatment and consequently, access to affordable and quality healthcare by the disadvantaged in the society. Compounding the knowledge problem is the fact that most of the equipment comes from outside of the country. The Internet functions effectively because globally agreed-upon interconnection protocols exist. Their development has been overseen by a recognized body, thus ensuring that the process 4. Conception and development The scientific principles upon which a device is based are fundamental to its safety and performance. An effective medical equipment maintenance programme consists of adequate planning, management and implementation. Purchasers of home-use medical devices should be aware of associated risks and take the responsibility to become educated in the functions and correct operating procedures for those devices.
The health technology life cycle diagram back cover illustrates the policy process that needs to be in place. There are only a few published studies that have documented their inventory methods. Once the programme has been defi ned, fi nancial, personnel and operational aspects are continually examined and managed to ensure the programme continues uninterrupted and improves as necessary. May or may not lead to problems. Devices manufactured for a particular person, or those built within a health facility and not commercially supplied, are exempt from the requirement to be registered or listed. Finally we suggest future research which will be the starting point to develop tools and policies for better medical devices management in the future.
Hospitals and medical centers requesting medical equipment donations would be expected to make sure they can repair the devices and get spare parts, he adds. A problem may not lead to an adverse event but corrective or preventive actions are required. Medical devices are increasingly available for home use, making the Public the direct user. Vendor any person who sells medical devices. Shared understanding and responsibility are achieved through communication and mutual education, which can be effectively achieved by having all stakeholders participate in establishing the process that ensures safety and performance of medical devices.
Global communication would be very difficult without international standardization. In fact, on average, only about 40% of medical equipment in resource poor settings is out of service. All devices carry a certain degree of risk and could cause problems in specific circumstances. This situation calls for an effective approach to prioritize maintenance jobs based on certain importance criteria to make the best use of the available budget. Some have adopted responsible practices. Timely development and periodic revision by expert groups make medical device standards effective and efficient tools for supporting health care.
This is used to identify challenges and unmet opportunities for circular design in the medical sector. However, these area health centres and rural health clinics are in urgent need for upgrade, repair or renovation. Problem a broad term that covers possible faults of the device, difficulties in using the device or an undesirable outcome associated with the use of the device. In general, risk assessment is based on experience, evidence, computation, or even guesswork. For example, a blood collection syringe with a blunt needle would perform badly for collecting blood and could inflict injury.