US FDA research and development medical instrument tracking system
Release date: 2008-05-04 US FDA research and development medical instrument tracking system
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The US Food and Drug Administration's Instrument and Radiological Health Management Center expressed its desire to issue a draft instruction for a system to be used nationwide by the end of 2008. This system is used to identify personal medical equipment and supplies, and it is much more convenient to locate and recall the above items.
At the same time as the recommendation letter is prepared, the US Food and Drug Administration is currently considering the end-users of the RFID industry and the RFID system in the food health market. Introduce input devices. This is the CDRH's release manager, Ann Ferriter, who told the attendees at the RFID Journal LIVE! 2008 conference in Las Vegas last week.
About two years ago, the US Food and Drug Administration began investigating how a unique device identification system could facilitate the automation of information collection. Information collection includes: manufacturer, structure, model, special attributes, serial number, as well as production volume, manufacturing number and product expiration date (see US Food and Drug Administration for medical equipment and supply installation identity authentication system). In August 2006, the US Food and Drug Administration issued a notice to the medical device industry, health care companies, and equipment users to seek advice on the following four items: current use of UDI systems, installation of a complete set of standard UDI The necessity of the system, what role the US Food and Drug Administration should play and the expected expenditures and benefits in advancing the system.
At the end of the three-month collection of comments, the US Food and Drug Administration hopes to draft a specification in early 2007 and publish it for public comment and comment, but in the end it failed to achieve this goal. The US Congress put pressure on the Food and Drug Administration seven months ago to establish the system, but did not specify a deadline (see the US Food and Drug Administration to establish an authentication system for medical devices and supplies).
Last week, Ferriter told RFID Journal LIVE! attendees that CDRH is currently investigating whether radio frequency identification technology in hospitals and other health care devices will cause radio frequency interference or pose a threat to health. She said CDHR hopes to further examine the potential threat of using RFID technology on medical instruments.
The organization is currently studying whether radio frequency identification devices operating in 134.2 kHz, 13.56 MHz, 433.5-434.5 MHz, 902-918 MHz or 2.4 GHz will pose a threat to other electronic products in the healthcare environment. Ferriter uses a pacemaker as an example. It can't tell which pulse is the RF reader and which is the pulse heartbeat. She said: "We have not found any examples of radio frequency interference yet." Other RF-sensitive devices include: infusion pumps, hearing aids, defibrillators, and programmable heart valves.
The US Food and Drug Administration recognizes the benefits of RFID technology in tracking and visualizing the health care industry. Ferriter said that her institution would review more research results anyway, especially for the 13.56 MHz straps used in hospitals. She told the RFID industry: “I hope you do a lot of research experiments†and called on participants to share their findings with the Food and Medical Administration.
There is currently no specialized tracking system or medical instrument serial number identification system in the United States, said Jay Crowley, senior patient safety consultant at CDRH. When the prescription drug is affixed with an identification code indicating the product category. Medical instruments are not. Furthermore, the US Food and Drug Administration is currently investigating a biographer system for pharmaceutical products. This system records every detail of the drug in the supply chain. (See the US Food and Drug Administration's high-profile electronic resume)
Forgery is the most notable problem in prescription drugs, Crowley said. He said that the incident of falsifying high-priced medical equipment has also occurred, but such cases are not common. As Crowley said, the most important thing at the moment is the ability to quickly identify the location of a given device in the event of a recall. For drugs, the Food and Drug Administration is able to locate the drugs that need to be recalled because they carry the serial number themselves. "But for medical devices, this recognition process does not exist," he said.
The US Food and Drug Administration may eventually install a similar resume system for medical devices, but it is not currently being drafted. Instead, the organization wants to be able to locate the specified project in the case of a recall and determine the date of manufacture and expiration of the product. “At this point,†Crowley said. “We are working hard to put the infrastructure in place. This way we can guarantee the infrastructure we have installed when we can install the resume.â€
Crowley said that no country has a national medical device tracking system, although many countries are currently working with the US Food and Medical Administration to develop the system. The agency is currently working with Japan, China, the European Union and several other South American countries to develop this serial number coordination system, which is recognized worldwide.
Currently, Crowley said that the US Food and Drug Administration is still studying the medical device market. “We are currently trying to explain some issues, such as how the recognition system should be, how it works, and a better understanding of the meaning of the supply chain.†He said the identification system can cover anything, whether it's a box of rubber gloves or a light machine gun worth $30,000. The technical requirements for tracking requirements and tracking can vary from item to item.
Crowley explained that many types of devices can and should use RFID technology (target tracking technology). However, barcodes are also being considered. "We want to do our best to ensure technical neutrality," he said, although he also expects the Food and Drug Administration to recommend an easy-to-read label with an electronically encoded ID number.
——Shanghai Medical Device Industry Association
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