Medical e-News Round-Up - Issue 13
- FDA move boosts safety
- Rigel 288 on test at Siemens
- Uni-Therm: The measurement of success
- Anticipating future design
- India moves to fill skills gap
- IEC 62353…the debate goes on
The U.S. Food and Drug Administration is proposing that most medical devices distributed in the United States carry a unique device identifier (UDI) in a move that will see an improvement in the quality of information in medical device adverse events reports.
This will assist the FDA in identifying product problems more quickly, better target recalls and improve patient safety.
The FDA has worked closely with industry, the clinical community and patient and consumer groups and conducted four pilot studies in the development of this proposed rule and is seeking comment on the proposal for 120 days.
"The safety of medical devices is a top priority for the FDA, Congress, industry and patients," said FDA commissioner Margaret Hamburg. "The unique identification system will enhance the flow of information about medical devices, especially adverse events and, as a result, will advance our ability to improve patient safety."
With certain exceptions, under the proposed rule, a UDI would include a device identifier, which is a unique numeric or alphanumeric code specific to a device model; and a production identifier, which includes the current production information for a device.
The FDA is proposing a risk-based, phased-in approach to implementation, focusing on the highest-risk medical devices first and exempting low-risk devices from some or all of the requirements. Full details at www.fda.gov.
Engineers at healthcare equipment manufacturer Siemens Healthcare are using Rigel 288 electrical safety analysers to undertake rapid electrical safety checks on Siemens MR, CT, nuclear, PET, ultrasound and radiotherapy equipment at hospitals and other medical facilities in the UK.
The portability and versatility of the Rigel 288 enables the engineers to move more swiftly, completing electrical safety testing in a more expedient and cost effective way, meeting the recurrent and post repair test requirements of IEC 62353 for medical devices.
Siemens Healthcare is one of the world’s largest suppliers to the healthcare industry, offering core competence and innovative strength in diagnostic and therapeutic technologies as well as in knowledge engineering, including information technology and system integration.
Siemens’s Michael Bernard said: “We are very happy with the 288. It can perform any test required on portable medical equipment to any standard currently in operation throughout the world.
“It is the smallest and lightest unit on the market, is easy to use and has many features that would allow for future expansion."
The 288 features Bluetooth technology for the wireless connection of bar code scanners, label printers and other accessories. As well as storing the results of electrical tests, the instrument also has the ability to record user defined inspections and measurements from specialist electro medical equipment such as SpO2, NIBP, ECG and other patient devices.
The new Uni-Therm measures the performance of electrosurgical generators including high frequency leakage, high current, power distribution and patient return plate alarm testing. A high power load bank enables performance testing up to 6A RMS with a duty cycle of up to 100% making the analyser an extremely versatile test instrument for calibrating and performance testing of conventional and high power electrosurgical generators.
The large array of internal resistors, ranging from 0-5100Ω in 5Ω steps provide not only the most accurate and detailed power curves but safe working practise by providing all necessary resistors within a single enclosure. Uni-Therm is compliant with IEC 60601-2-2* and capable of verifying and calibrating all major electrosurgical generators whilst guiding the user through all test procedures automatically and most of all safe.
* IEC 60601-2-2 specifies the requirements for the safety of high frequency surgical equipment and HF surgical accessories used in medical practice.
Full product details at www.rigelmedical.com.
The EU directive on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS) is a fine example of why device manufacturers making instrument and equipment purchasing decisions today must anticipate the medical device designs of the future, writes blogger Dave Selin.
He says RoHS restricts the use of lead and other potentially hazardous substances such as cadmium and mercury that historically have been at the heart of electronic products of all kinds. The medical device industry has been exempted from compliance for now by the EU because of product failures that might occur if substitute materials prove unreliable over the long term in real-world conditions.
Many agency reviewers are now at work to determine if implanted devices should be permanently excluded from RoHS restrictions. Meanwhile, research continues on the likes of lead-free alloys for use in device electronics. In other words, nobody really knows what the future holds and how product designs will need to change in the coming years or decades.
This is one of many examples showing why purchasing decisions must take into account much more than the grid of products being made today. Test instruments and assembly equipment must be evaluated in terms of how flexible they are in adapting to product specs of the future.
Read in full at http://medtechinsider.com.
The Federation of Indian Chambers of Commerce and Industry (FICCI) has joined forces with the All India Council for Technical Education (AICTE) - the advisory body for all matters relating to technical education - to develop vocational courses in the healthcare sector to improve medical device skills.
According to FICCI, rapid technological advances in medical, diagnostic and management systems are creating a need for adequately trained personnel but there are limited formal training and education programmes in India - corporate and private hospitals run their own training programmes, but they are not standardised and are not accredited nationally.
FICCI has set up a task force to improve existing skill sets by identifying gaps and suggesting academic and training programmes, related curriculum and appropriate training requirements and has submitted 12 healthcare and paramedic course curricula to AICTE.
These include a bachelor’s degree for paramedical technicians in laboratory, blood transfusion, radiography, operation theatre and critical care. The FICCI website (www.ficci.com) has more.
Should medical equipment manufacturers consider their end of production line testing based on IEC 62353 routine procedures instead of IEC 60601 type tests? That’s the question Rigel Medical associate director John Backes poses in his latest Linked In debate. To read what industry infomers are saying and to join in, click here.