Medical e-News Round-Up - Issue 53

This issue covers:

Revisions to medical devices quality management standard

The world’s most popular standard for medical device quality management, is now under review.

There have been two public consultations on ISO 13485, which generated around 1,500 comments from trade associations, manufacturers, academia and individual experts.

A final draft of the standard has now been released incorporating changes made following the feedback and a revised standard is expected to be published in spring 2016.

The new ISO 13485 is applicable across the whole supply chain and seeks to address the entire lifecycle of a medical device. The standard specifies requirements for a quality management system (QMS), where an organization needs to demonstrate its medical devices meet applicable regulatory criteria.

Some of the key changes include harmonisation of regulatory requirements, inclusion of risk management throughout the QMS, additional clarity on validation, verification and design activities and strengthening supplier control processes. Also included are some recommendations on software for QMS, manufacturing and the medical device.

Existing certification customers will have three years from the date the new edition publishes, to transition from ISO 13485:2003 and the associated European Standard EN ISO 13485:2012

In accordance with the consensus-based approach, BSI, the UK National Standards Body, participated by providing technical input and commentary and has made further background information available here

New Rigel 288 safety analyser is a big Plus for faster medical device testing

The new Rigel 288 Plus brings faster and safer testing of medical devices and installed equipment in hospitals and healthcare facilities.

In this new battery powered tester, Rigel’s renowned 288 automated safety analyser incorporates new features to provide enhanced performance and faster testing of electrical safety to IEC 62353 and leakage tests in accordance with IEC 61010, IEC 60601, NFPA, AAMI and AS/NZ3551.

The Rigel 288 Plus now offers insulation testing between 50 VDC - 500 VDC to meet the test requirements of low voltage DC power supplies, and because it is the smallest analyser of its type, it is easier to transport from site-to-site by field engineers.

Up to 10 individual patient leakage circuits can be checked in a single test routine, while a further benefit is the ability to automatically warn users of incorrect test set-ups, helping to avoid incorrect readings – it is the only tester providing automated verification of secondary earth paths and incoming mains configuration.

The Rigel 288 Plus also features Rigel’s unique earth bond technology, which combines high and low test current to ensure the accuracy of the protective earth path, helping to accurately identify any potential wear and tear. This can help to avoid the need for any unnecessary cable replacement, providing further cost savings.

John Backes, Strategic Product Manager at Rigel Medical, said "We have moved to meet the market need to improve the test functionality of the popular 288, delivering faster and safer testing of medical devices and installed equipment.

“Our customers wanted even more flexibility by testing medical installations and fixed installed equipment for earth continuity and leakage current using batteries alone. Now they can with the new Rigel 288 Plus.”

New CFDA manufacturing guidelines

The China Food and Drug Administration (CFDA), China’s medical device market regulatory agency, has published four new guidelines concerning good manufacturing practices for manufacturing facilities in the country.

The new CFDA guidelines cover Good Manufacturing Practice onsite inspections, onsite inspections for sterile devices, onsite inspections for implantable devices and onsite inspections for in vitro diagnostic (IVD) reagents.

The publication of the guidelines follows a CFDA order issued earlier in 2015 on surprise inspections of medical device manufacturing facilities in China, also expected to target primarily domestic companies. Further details on the new guidelines are available here.

FDA guidance on cybersecurity for medical devices…

The US Food and Drug Administration (FDA) has issued a draft guidance outlining important steps medical device manufacturers should take to continually address cybersecurity risks to keep patients safe and better protect the public health.

The draft guidance details the agency’s recommendations for monitoring, identifying and addressing cybersecurity vulnerabilities in medical devices once they have entered the market. The draft guidance is part of the FDA’s ongoing efforts to ensure the safety and effectiveness of medical devices, at all stages in their lifecycle, in the face of potential cyber threats.

Cybersecurity threats to medical devices are a growing concern. The exploitation of cybersecurity vulnerabilities presents a potential risk to the safety and effectiveness of medical devices.

While manufacturers can incorporate controls in the design of a product to help prevent these risks, it is essential that manufacturers also consider improvements during maintenance of devices, as the evolving nature of cyber threats means risks may arise throughout a device’s entire lifecycle.

Suzanne Schwartz, Associate Director for science and strategic partnerships in the FDA’s Center for Devices and Radiological Health, said: “All medical devices that use software and are connected to hospital and health care organizations’ networks have vulnerabilities—some we can proactively protect against, while others require vigilant monitoring and timely remediation.

“The draft guidance will build on the FDA’s existing efforts to safeguard patients from cyber threats by recommending medical device manufacturers continue to monitor and address cybersecurity issues while their product is on the market.” Full details are here.

…as safety targets are also extended

The US FDA has announced plans for more use of ‘real-world evidence’ to track the safety of medical devices.

The plan, outlined in FDA’s Center for Devices and Radiological Health’s (CDRH) Strategic Priorities report for 2016-2017, will see the agency building a national medical device evaluation system as part of efforts to more quickly identify safety signals, particularly through electronic health records (EHRs), registries and medical billing claims in which unique device identifiers (UDIs) are being used.

“Access to the large amounts of electronic clinical data being generated and collected today can be used to identify safety signals and support risk-benefit analyses when data quality is ensured and advanced analytics are applied,” the FDA said.

The FDA says by the end of 2016, it expects to increase by 40% (compared to a 2015 baseline) the number of premarket and postmarket regulatory decisions using real-world evidence. And by the end of 2017, the agency expects to double (compared to 2015) that same number. The report is available here.

India seeks greater medical device independence

The Indian Department of Biotechnology (DBT) has announced a new collaboration with the All Indian Institute of Medical Sciences (AIIMS) and leading research institutes to develop the medical devices technology in the country under the ‘Make in India’ initiative.

“Our aim is to make India self-reliant in the medical devices sector. As our healthcare sector is vast and requires high quality medical devices for advanced medical care, we are calling on the medical technology innovators to collaborate and develop affordable and need based technologies for the common man,” opined Dr Harsh Vardhan, Minister for Science, Technology and Earth Sciences.

Giving paramount importance to healthcare, government of India has given the consent to scientists at DBT and leading research institutes like AIIMS and IITs to come up with innovative medical technologies under the Make in India initiative to transform the country and propel the nation to greater heights through social and economic growth.

Medical technology industry in India is 4th largest in Asia and was valued at $6.3 billion in the year 2013. At present the industry is witnessing 10-12 per cent growth per year. With medical devices industry growing at this pace, industry experts are expecting that the government will do a humongous spending of $250-350 every year for innovation, research and new development in the country.

“Realising the growing importance of healthcare, the Department of Biotechnology is promoting the medical devices sector through various programmes for affordable products relevant to societal and public health,” said Vijay Raghavan, Secretary of DBT. Further details here.