Medical e-News Round-Up - Issue 54

This issue covers:

New FDA draft guidance on interoperability of medical devices

The US Food and Drug Administration has issued new draft guidance for medical device manufacturers on the use of interoperable devices.

The new draft recognises the growing importance of medical products that can securely exchange data and other information, but warns that appropriate safety conditions need to be properly considered.

The advance of interconnected devices could be a boon for patient care, particularly in cases where device-specific information, such as unique device identifiers (UDIs), and patient-specific data, such as electrocardiogram (ECG) waveforms, contained within a medical device can be relayed to other devices or used to fill electronic health records to improve health care decisions.

In making the document available for comment and industry response, the FDA notes that the increased use of interoperable medical devices has the potential to foster rapid innovation at lower cost, but that failures in the device design can result in unforeseen safety and effectiveness issues for the device or for the system.

For example, the FDA notes that “errors stemming from inadequate interoperability can occur, such as the transmission of weight in kilograms when the receiving medical device assumes the measurement is in pounds, and that can lead to patient harm and even death.”

The draft guidance is intended to highlight what device manufacturers should consider to ensure the safety and effectiveness of their interoperable devices, particularly for designing systems with interoperability as an objective; conducting performance testing and risk management activities; and specifying the functional, performance and interface characteristics via labelling. Full details here

New Rigel ventilator tester

We've extended our range of test instrumentation for biomedical equipment with the introduction of a specialist ventilator tester.

The Rigel VenTest 800 gas flow analyser is ideal for both bench top and field service testing of all commonly available ventilators to verify that the ongoing accuracy and reliability of the equipment remains within the required performance standards.

Precise sensor technology enables the VenTest 800 to accurately measure flow, pressure, temperature, and O2 concentrations bi-directionally and is compatible with 13 gas standards and 7 gas types.

The three model range includes a standard VenTest 800 analyser for use with all standard ventilators, including adult, neonatal, paediatric and high frequency equipment, as well as anaesthesia machines and spirometers. In addition, specially adapted models for the testing of vacuum measurements (VenTest 810) and low flow pressures (VenTest 820) are also available.

The VenTest 800 incorporates a simple, intuitive user interface and graphics display for ease of operation during testing and calibration settings. Details at www.rigelmedical.com/VenTest800

NCCoE infusion pump security program

The US National Cybersecurity Center of Excellence (NCCoE), a part of the National Institute of Standards and Technology (NIST), is giving device manufacturers the opportunity to participate in a project to improve the security of infusion pumps.

The NCCoE is running a programme to look at the security and safety risks associated with the ability of infusion pumps to connect to networks and other devices.

By investigating these issues, NCCoE, plans to create a solution guide for improved wireless security and is looking for equipment vendors to participate in creating a guide and provide their technologies to help develop standards for their uses.

More specifically the goal is to help organisations and providers implement improved security controls by identifying the people and systems that interact with infusion pumps, defining the interactions between those people and systems, performing a risk assessment, and identifying mitigating security technologies. Details here

Discussion on the medical device market in Europe

An interesting debate on the future of the medical device market in Europe appears on the online news portal Dotmed.

The medical device industry in Europe employs 575,000 people in the EU and its total sales amount to €100 billion ($109 billion), according to the European Commission. The industry includes about 25,000 companies and 95 percent of them are small and medium-sized.

The article notes that against this background, the industry is continually growing and changing with the managed equipment services model becoming more popular and customers searching for more dedicated and unbiased partners that can assist them with both acquiring and servicing equipment.

In the future, industry commentators anticipate that there will be a steady migration away from the OEM service model to a combination of in-house service, independent service and OEM service models all in the same account. It is suggested that the OEM will continue to maintain the newer equipment while in-house and independent service will handle the more mature pieces of radiology equipment.

This migration will be driven by the development of supply channels that will include repair parts, available engineer talent and technical support that is reliable. The full article is available here

Healthy picture for Australian medtech sector

Australia now outpaces the United States in terms of medical technology sales per capita. This is one of the headline facts from a review of the Australian medtech scene carried on mddionline.com.

The article reports that per capita sales of medical technology products was $10.2 billion from 2012 to 2013 for its 23 million people, while U.S. revenue was approximately $110 billion in 2015 for a population of 319 million.

Experts and executives attribute the success of this relatively young industry to a mixture of its educated population, strong academic institutions, favourable regulatory and R&D environment, and government support.

It is also surprising that, according to the Medical Technology Association of Australia (MTAA), nearly 40% of the country’s medtech companies did not exist prior to 2000.

In recent years, other changes have eased the regulatory burden. In November 2014, the Therapeutic Goods Administration (TGA) started allowing Australian device makers to use CE certification to sell in Australia (except for Class III devices with a medicine or biologic). TGA has also tried to shorten its review times and use more postmarket regulation.

The full article is available here