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Medical e-News Round-Up - Issue 32

This issue covers:

Medical device recalls nearly double in a decade

Recalls of defective medical devices nearly doubled in the decade from 2003 through 2012, according to a Food and Drug Administration report.

The total number of recalls rose to 1,190 in 2012, up from 604 in 2003. There was a sharp increase in recalls where the defective product carried a reasonable probability of death. In 2012, there were 57 of these so-called Class I recalls - up from seven in 2003.

A recall means a product is removed from the market, or that it is corrected in response to a defect.

The analysis by the FDA's centre for medical devices was undertaken in part to respond to a 2011 report by the Government Accountability Office and noted that recalls by companies often came too late to do much about the defects in products.

Steve Silverman, director of the FDA medical device centre’s office of compliance, said the rate of recall lags industry growth - the numbers of medical devices increased by about 25% from 2008 through 2012.

Wanda Moebius, a senior Vice President at the industry trade group AdvaMed, said: "The increase in recalls...can be attributed primarily to companies taking a more cautious, pro-active, patient-centric approach to quality, safety and reporting of events to FDA."

Diana Zuckerman, President of the National Research Center for Women & Families and a critic of FDA device regulation, said: "You have to wonder whether a more rigorous regulatory effort before devices went on the market would have avoided these recalls." More at http://online.wsj.com/

Go with the (Multi) Flo for compliance with IEC 60601

Instant high and low flow verification, bolus volume and occlusion and back pressure measurement is provided by Rigel Medical’s Multi-Flo infusion pump analyser.

Meeting the needs of IEC 60601-2-24, covering particular requirements for the safety and performance of infusion pumps and control, the high performance analyser incorporates unique measurement technology allowing testing of the latest developments in infusion pump testing and features variants of one, two and four independent channels.

Each channel can be tested simultaneously across a range of 100 μL (microlitre) to 1,500 mL per hour with results stored in the instrument’s large internal memory. With a sampling rate of 1Hz, the Multi-Flo can accurately detail any changes in flow, volume and pressure rates, providing a real-time picture of the quality of infusion.

A rugged and compact all-in-one housing with integrated infusion programme memory makes the Multi-Flo a fully stand-alone instrument while an onboard memory stores test data and allows fast transfer to the PC for traceability.

Multi-Flo can also be used with Rigel’s Med-eBase PC software to provide enhanced and easy control and configuration as well as electronic recording and management of medical device safety testing programmes. Asset information can be quickly and accurately inputted directly via a compact Bluetooth barcode scanner or an optional keyboard. Full details at www.rigelmedical.com


Medical devices: better controls and traceability to ensure patients’ safety

Stricter monitoring and certification procedures to ensure full compliance and traceability of medical devices have been agreed by the European Parliament.

MEPs have also tightened up information and ethical requirements for diagnostic medical devices used for example in pregnancy or DNA testing.

The proposed legislation seeks to increase patient safety and to strengthen traceability from producer to patient, without creating additional burdens for innovative small manufacturers.

Rapporteur Dagmar Roth-Behrendt (S&D, DE), whose report was approved by 541 votes to 19, with 63 abstentions, said: "We talk about products that are supposed to help patients in their suffering, in their illness. We should assist doctors in making sure they are using the best and safest products to help their patients...We need a much better system."

Parliament's amendments would strengthen the procedure for placing new medical devices on the market so as to ensure that unsafe products or devices that have undergone insufficient controlled trials on patients can no longer be used on or in them.

MEPs say that in future, notified bodies should have a permanent team of in-house experts who meet up-to-date qualification requirements. A new group of bodies should assess devices considered ‘high risk’ – those, that for instance, can be implanted in the human body.

More at, http://www.europarl.europa.eu/.

Optical company sees the benefits of Uni-Therm

Field engineers at Olympus KeyMed Ltd have turned to Rigel Medical’s Uni-Therm analyser for improved in-service performance testing of its electrosurgical devices. These items of equipment use electricity to produce enough heat to enable surgeons to cut body tissue or seal bleeding vessels during operations.

More than 20 Uni-Therm units are used to allow automation of the performance testing of Olympus' electrosurgical equipment, resulting in greater efficiencies. Already, the new testers have enabled engineers working at sites across the UK to accurately measure the performance of each device and complete high frequency leakage, high current, power distribution and patient return plate alarm testing.

Compliant with IEC 60601, the high performance Uni-Therm is capable of verifying and calibrating the electrosurgical equipment while guiding the engineer through all test procedures automatically and most of all safe.

Olympus is a leading manufacturer of advanced optical and digital equipment for the healthcare and consumer electronics sectors, leading the way in designing endoscopy and microscopy products among others.

Martin Wallace, head of field service at the Southend-on-Sea based company, said: "Rigel supplies us with a range of high performance, high quality instruments, which provide the engineers with convenient, easy-to-use and accurate testing solutions."

"The Uni-Therm incorporates an excellent range of features for a tester of its size, while the added value benefits, like improved connectivity and ease-of-use, are particularly impressive."

"The ability to import and export data is also a particularly beneficial feature, enabling us to store test information which can then be easily retrieved and used for quality control purposes at a later date."

India consulting stakeholders on Bill on drugs, medical devices

India’s Government does not want to rush through legislation aimed at regulating trade, manufacture and sale of drugs and medical devices and is instead carrying out consultations with various stakeholders, according to a report in the Economic Times.

The report quoted Minister of State for Health, Abu Hasem Khan Choudhury: "For the bill to have maximum impact, it is important for us to consider the views of other ministries, the industry and the civil society. We do not wish to hastily push forward a draft Bill without listening to the views of all stakeholders."

The Drugs and Cosmetics (Amendment) Bill, 2013, proposes changes in the regulation of the import, export, manufacture, distribution and sale of drugs, cosmetics and medical devices and to ensure safety, efficacy and quality in conduct of clinical trials.

The Bill, which seeks to set up the Central Drugs Authority, was introduced in Parliament in August 2013 and later referred to the Standing Committee on Health and Family Welfare. The Committee came up with its recommendations last December.

The minister claimed that once finalised, the Bill would ensure the highest standards of safety and efficacy.

In the report, Choudhury refers to the concerns of the medical devices industry: "Medical devices and drugs are very different and we want to ensure that the distinction in their regulation is taken to the last mile.”

Read full article at http://articles.economictimes.indiatimes.com/


See Rigel at EBME

Don't forget you can catch Rigel Medical in May on stand C1 at the EBME Associates 2014 seminar in Milton Keynes. There, you will be able to find out more about the company's range of medical device testers and analysers.

EBME aims to share knowledge and improve awareness - raising the profile of the medical devices sector and its commitment to service, quality and excellence - and will feature a combination of presentations and audience debates led by expert speakers, including a reveal of the latest innovations in medical devices. The seminar is offered free of charge to delegates - details at http://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.


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