- NICE doubts new medical device regulatory legislation
- FDA ups surveillance of high-risk medical devices
- New guide to electrosurgery testing
- Medical device partnership: The way ahead?
- Make a date with Rigel
Medical device industry experts are expressing concerns that the new legislation to regulate medical devices currently being debated by the European Union (EU) does not go far enough in ensuring safety and effective patient care.
Bruce Campbell, along with Andrew Stainthorpe and Carole Longson from the UK´s National Institute for Health and Care Excellence (NICE), argued in the latest edition of the BMJ (British Medical Journal) that data gathering is still not happening the way it should.
They believe that the present regulatory process in the region is inconsistent, opaque and operates in the interests of manufacturers. Manufacturers of all medical devices, ranging from bandages to life support machines, are presently required to obtain a CE mark for a new device to be introduced into the European market.
The NICE team, however, cautioned that the amount of clinical evidence needed for CE marking is typically small, and cannot guarantee desired patient care, citing recent events such as the PIP breast implant scandal.
The experts also suggested the implementation of device tracking to help trace patients and recall devices; improved coding for new procedures; use of registers and data linkage and better post-marketing surveillance.
Campbell and his team concluded: "None of the currently proposed changes in legislation, in Europe or elsewhere, includes all of our suggestions to improve acquisition of data".
More at www.bmj.com/
The US Food and Drug Administration (FDA) is creating a largely automated surveillance system to monitor safety of high-risk medical devices and has authorised a smartphone app for doctors to simplify reporting deaths and injuries to the agency, reports The Wall Street Journal.
It says the agency´s efforts are designed to spot early on possibly dangerous flaws in high-risk medical devices like defibrillators, pacemakers, heart valves and joint implants.
In recent years, when some of these medical devices have malfunctioned, it has taken months or even years before authorities were certain whether the flaws were a major public-health hazard or simply or isolated events.
The FDA has until now relied on a relatively scattershot system that includes mandatory reporting of certain events by companies and hospitals but voluntary reporting by doctors. As a result, in previous cases where defibrillator leads or wires which sometimes fractured and led to deaths, it took months before the manufacturer and the FDA were certain that the device was unfit for use.
FDA senior officials have previously discussed plans for such a surveillance system, and they recently disclosed new details of it in interviews with The Wall Street Journal. The early-warning system will rely on electronic medical information including patients´ medical records and bills, insurance databases and companies´ registries of experience with individual devices.
"We´re transforming this network into a modern system that uses electronic health information," said William Maisel, the deputy director for science in the FDA´s medical-device center. The agency expects to issue a final rule this year creating a number called a unique device identifier. Each medical device will have such a number.
The concept of using heat as a form of therapy and treatment to stop bleeding has been used for centuries but today electrosurgery treatment is highly advanced and involves the controlled production of electrically induced heat through the passage of high frequency AC currents through biological tissue, allowing the current to cut or coagulate the tissue at the same time, minimising blood loss, shortening operating times and aiding faster patient recovery.
Electrosurgery generator units (ESUs) have become a crucial piece of equipment in the majority of operative settings and are among the most useful and common instruments used by surgeons today.
However, like other electrically operated medical devices they need to be tested regularly to ensure that they are safe for use and to help, Rigel Medical has produced a comprehensive guide ‘An Introduction to Electrosurgery’.
A free copy plus more about the Uni-Therm is available at www.rigelmedical.com/uni-therm
Most electronics manufacturers changed their supply chain processes to comply with the Restriction of Hazardous Substances (RoHS) directive in July 2006 - and many lessons and best practices learned from these can be offered to the medical device world, writes Simin Bagheri in MD+DI.
Medical device companies looking to sell their products in Europe must comply with the law by July 2014, and similar legislation is anticipated in China, Japan, and North America; so Simin Bagheri believes that medical device makers can gain by partnering with institutions that have demonstrated experience and expertise in RoHS implementation at a global level.
By doing so, they can take advantage of the work that was already done by consumer electronics OEMs and tackle the new challenges unique to the healthcare technology industry.
The sooner medical device manufacturers start redesigning their products and planning their go-to-market strategy, the more time they will have to perform all of their required testing and evaluations before the fast approaching deadline, she reports.
She says that it is important to begin the conversion process early to prevent stockpiles of non-compliant inventory, which would be deemed unusable after July 2014. Using a partner with global presence and expertise in RoHS compliance practices can help get the process started and ensure medical device manufacturers can perform the required testing and evaluations well before the RoHS deadline.
Read her article in full at www.mddionline.com/
Just a reminder that you can see us at events and shows throughout this year and next including AAMI (June 1-3, 2013, Long Beach, CA, USA); MEDICA (November 20 – 23, 2013, Dusseldorf, Germany) and Arab Health (27 - 30 January 2014 Dubai International Convention & Exhibition Centre).
We look forward to meeting you and telling you about our products - so make sure you have all the details and keep abreast of the latest news by visiting our website www.rigelmedical.com/events.
Do you use Rigel Medical equipment? - If you think you may have a story for future e-news bulletins, please let us know by contacting us here.