Medical e-News Round-Up - Issue 58

This issue covers:

EU publishes lists of new harmonised standards

In the Official Journal of the European Union, the European Commission has recently published a new list of the harmonised standards that manufacturers of medical devices, implantable devices and in vitro diagnostic devices can use to demonstrate their products comply with EU law.

The standards were published as part of the implementation of the European Council’s Directive 93/42/EEC from 1993, which deals with medical devices and their regulation.

For active implantable medical devices, the Journal included five standards which had a date of presumptive conformity of the superseded standard by 30 June.

In addition, among the list of standards for medical devices was a reference to EN 60601-1-2:2015 Medical electrical equipment and the requirements in relation to electromagnetic disturbances.

First published 2015 and with a presumptive conformity date of 31 December 2018, this standard specifies immunity test levels for the safety of medical electrical equipment and systems, covering equipment for use in healthcare facilities or the home.

Full details of the latest EU announcement are available here

FDA guidance on 3D printed medical devices

The US Food and Drug Administration (FDA) has released draft guidance for three-dimensional printed medical devices.

The draft guidance has been issued for comment and industry response and outlines considerations for both design and manufacturing, including quality system requirements, and also for device testing issues.

The latter section describes the type of information that should be provided in premarket notification submissions, premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, de novo requests, and investigational device exemption (IDE) applications.

Included in the new guidance is advice on device design, software workflow, material controls, post-processing, quality data and process validation and acceptance activities.

The device testing section offers insight on device descriptions, mechanical testing, dimensional measurements, material characterizations, cleaning, biocompatibility and labelling considerations.

Medical device contract manufacturing growth forecast

An industry report anticipates that the medical device contract manufacturing market will witness significant growth during 2016-2021, driven by the rise in number of diseases worldwide.

The Labrinth Analytics report says that global medical device contract manufacturing market was valued at $43,596.0m in 2015, and is expected to reach $77,715.2m, at a CAGR of 10.3% during 2016-2021.

The USA was the largest market for medical device contract manufacturing, and accounted for 44.2% of the global market. However, Asian countries, particularly China and India, are proving to be attractive low cost destinations for OEMs, witnessing a stronger growth rate compared to other developed countries.

Electronic manufacturing was the largest segment in terms of revenue in the global medical device contract manufacturing market and accounted for 53.6% share in 2015. Rising demand for electronic contract manufacturing devices, low cost, speedy delivery of medical devices and growing healthcare infrastructure in the developing nations would boost market growth in the future.

Overview of global medical devices market

The world market for medical devices reached $381 billion in 2015, according to a new report. The Global Market for Medical Devices says that, despite challenging times in the market, there are is still plenty of opportunity for success for companies that remain optimistic and seek innovation.

Although the medical device market is described as ‘scattered’ market in which hundreds of companies worldwide participate, fifteen companies earn 40% percent of the total global revenue in medical devices.

In terms of market leadership, Medtronic has moved to the top of the device market due to its merger with Covidien. Johnson & Johnson, now second in the market, with GE Healthcare, Philips, Boston Scientific, and St. Jude Medical also among the top companies.

One of the most significant drivers of all healthcare services - and medical device markets - is the proportion of older people in the population. The population is ageing in the largest healthcare market of the United States, which alone is significant. However, other significant world healthcare markets are dealing with the challenge of aging populations, including those of Europe, Japan, and China.

As a result, the report says that the coming years will test the strategies of device companies to innovate and develop emerging markets as some of the traditional sources of revenues will be challenged.

Lower number of US device recalls

Reports in the USA have highlighted that medical device recalls during the first quarter of the year dropped to the lowest level since 2013.

According to the Q1 2016 U.S. Recall Index from Stericycle ExpertSolutions both the number of recalls and the number of recalled units fell approximately 30% from the two-year quarterly average.

Almost all of the recalls in the first quarter were categorised as less serious Class II recalls, with 9.6 million recalled, a significant drop from the 47.1 million Class II units recalled in the fourth quarter of 2015 or the 69.6 million units recalled in the third quarter of 2015.

The large majority of recalls in the quarter, 62.6%, were due to machine failure. This was also the cause of the two largest recalls in the quarter, which accounted for more than half of the total recalled units, the Index authors noted. Other reasons for recalls were quality (10.2%), sterility (9.9%), and calibration errors (7.1%).

The report said that, while cybersecurity and worries about the vulnerabilities of connected medical devices have made headlines recently, the statistics don't yet match the level of concern, with only 3.9% of the recalls in the quarter due to software.

EU deal for safer medical devices

Plans for stricter monitoring and certification procedures to ensure that medical devices including patient implants comply fully with safety and traceability requirements have been agreed by European MEPs.

Tighter information and ethical requirements for diagnostic medical devices were also included.

Confirming the progress made, Giovanni La Via, Public Health Committee Chair, said: “I'm delighted that we finally have an agreement on this key legislation, which will allow us to put in place high standards for the manufacture, authorisation and placing on the market of medical devices."

The agreement includes a number of measures to ensure devices used to treat patients are safe and effective. These include random inspections on producers after devices have been brought out on the market and stricter checks on notified bodies, which will have to employ medically skilled people.

Also proposed are additional safety checks for high-risk devices, such as implants or HIV-tests, involving not only a notified body, but also a special committee of experts to confirm that all requirements are being met.

Medical device manufacturers will be required to provide clinical evidence of the safety of their products, especially in the case of higher risk classes. Full details here

China reports medical device deaths

A total of 184 deaths suspected to have been caused by medical devices were reported in 2015, according to an annual report from the China Food and Drug Administration.

The deaths were among 47,249 cases of “adverse effects" suspected to have been caused by medical devices reported in the same period, an increase of 15.2 percent from 2014.

Medical devices that caused the most cases of adverse effects include polymer for medical use, syringes and puncturing instruments, medical dressings, physical therapy instruments, implants and artificial organs.

Manufacturers were urged to withdraw, replace of repair their medical products if they are found to have caused adverse effects – classified as any scenario in which they cause injury or the risk of injury – when operated under normal conditions.

Versatile new SafeTest 60 from Rigel

Rigel has introduced a new handheld safety analyser for the routine electrical testing of basic medical and laboratory equipment.

The new Rigel SafeTest 60 is a compact, robust and reliable safety analyser that is particularly well suited to high volume testing demands, with a simple colour coded user interface, push button operation and the fast step-through of test routines.

The general purpose tester includes a comprehensive range of safety tests for hospital and medical equipment such as medical beds and chairs, operating tables, hoists, infusion pumps, CPAP’s, centrifuges and other similar equipment that does not require patient lead testing.

As such, the SafeTest 60 is suitable for electrical testing to ensure compliance with a range of international safety standards including leakage testing to IEC 60601, IEC 62353, IEC 61010 and NFPA-99.

In addition, to meet the needs of some specific types of equipment, the unit also has the capability to carry out insulation testing in line with IEC 62353 and accurate high current, low energy earth bond testing to both IEC 62353 and IEC 61010.

In all cases, full manual control means only those specific tests that are required can be carried out, with minimised power breaks and full control of power cycles helping to ensure that testing is carried out quickly and efficiently – without any compromise in accuracy or integrity of testing.

The new Rigel SafeTest 60 is available in a wide range of power supply configurations to meet standard local operating conditions around the world. Details at www.rigelmedical.com/safetest60

UDI registration deadline reminder

With the deadline approaching for Class II medical devices to comply with unique device identifier (UDI) regulations in the USA, the Food and Drug Administration (FDA) is working to ensure that its infrastructure can support the sharp uptick in volume of devices being reported to the Global Unique Device Identification Database.

Manufacturers began submitting UDIs for the highest-risk devices, Class III, in September 2014, followed by implantable devices a year later. The deadline for reporting UDIs for Class II products is September this year, with Class I devices (tongue depressors, medical gloves, etc.) coming into compliance in 2018.

The initial deadlines are for UDIs on packaging and labelling. Manufacturers have another two years to put UDIs on the devices themselves, and the FDA is still working on guidance on just how that should be done. Full article is here

Diabetes Society security standard for connected smart devices

The Diabetes Technology Society has issued a cybersecurity standard for networked-connected smart medical devices.

The public platform, called DTSec, contains a set of performance requirements to improve cybersecurity through independent expert security evaluation. While the tool is targeted toward life-critical smart devices like insulin pump controllers and continuous glucose monitors, according to the standard's authors, DTSec could be applied to any medical product or component in the future.

The tool is intended to provide a blueprint for efficient, measurable security for networked electronic products and systems in any industry. The aim is to help device manufacturers, regulators and ultimately consumers by securing devices on the Internet of Medical Things to improve care and quality of life.

DTSec-approved labs will evaluate the smart medical devices to ensure the product meets security requirements, with the Diabetes Technology Society publishing the names of products that successfully pass the evaluation process. Info at www.diabetestechnology.org