By John Koon, Publisher, MEDS (Medical Electronic Device Solutions) www.medsmag.com

Publisher:

What is UL’s vision?

Dr. Terenzio Facchinetti: 

Dr. Terenzio Facchinetti, Manager of Business Development for UL Life and Health Sciences Europe and Latin America

When we speak of UL’s vision we need to take two different approaches: one for UL as a global company, the other for the UL Life and Health, which is one of the five UL Business Units (BU).

To respond to the first point, UL is a global team of about 10,000 people from mostly outside of the United States, working to promote “Safe Living and Working Environments for People.”

The vision is tightly linked to the mission UL gave itself  back when UL founder William Henry Merrill opened a one-room testing laboratory in 1894. Ever since then it has focused on advancing public safety by dedicating creativity and expertise to this subject.

The promotion of safe living and working environments is achieved at UL by applying safety science and hazard-based safety engineering. Through our testing, certification and educational work, we support the production and use of products that are physically and environmentally safe and sustain the prevention or reduction of loss of life and property.

Most important and at the heart of our vision and mission is to work with integrity and focus on quality to enhance the trust conveyed by our certification marks. To do that, we spend money to invest in our people and encourage our people to invest in themselves.

The vision of UL’s Health Sciences industry, which is part of the Life and Health Business Unit, is focused on the healthcare sector. The overall mission and vision for UL applies to the Health Sciences industry team as well.

In particular I would like to say that UL’s Health Sciences industry has recognized that, despite local regulations, healthcare is a global sector and the healthcare industry faces the same challenges everywhere: technology, safety and effectiveness. Therefore the mission of UL’s Health Sciences team is to be the world leader for innovative, customer-focused, market access solutions delivered locally. We provide testing and certifications to the relevant international regulatory requirements such as the mechanical and electrical safety of medical devices and laboratory equipment according to the IEC 60601 and IEC 61010 respectively. UL is a Notified Body for CE marking for medical devices and In Vitro diagnostics in Europe, a FDA third-party authorized person for 510(k) for the U.S. market, a CMDCAS recognized registrar for Canada, a PAL recognized certification body for Japan, a TCP for Taiwan, a certification body under the IECEE CB Scheme and more to support the industry global market access.

UL’s Health Sciences industry team recognizes the upcoming changes and developments in healthcare associated with what is known as eHealth, when medical devices, electronic health records, mobile phones and many more applications will be linked in the short future in a comprehensive interoperable environment.

UL and stakeholders in this sector are convinced that next to the technical feasibility and development, safe interoperability must be addressed, and UL took the lead on that.
 

Publisher:

What are the biggest challenges the healthcare industry is facing today?

 Dr. Terenzio Facchinetti:

It is documented that healthcare costs should be significantly reduced when healthcare interoperability (eHealth) is in place and fully deployed; the quality of the healthcare service will also improve. Interoperability, as the word says, means the capability to inter-operate among devices and systems. Today the approach to eHealth is primarily based on a single device or on a proprietary type of connectivity approach. The costs and regulatory requirements to expand it in a hospital or other system under the current conditions are too high. Therefore new ways need to be found, from the industry in terms that ease the implementation and maintenance of interoperability, avoiding systems that demand single-source solutions when systems expand or are changed, as well as by the regulators in supporting a fast clearance approach that also takes into consideration time, safety and effectiveness. So to answer the question, the biggest challenge that the healthcare industry is facing today is meeting the interoperability healthcare needs.

This is why UL, based on its long term experience in safety science and accreditations, is contributing to this undertaking through its standards development and safety competencies in this sector.

Publisher:

What is UL doing to help developers to overcome these challenges and capture new opportunities?

Dr. Terenzio Facchinetti: 

UL is driving the discussion for safe eHealth. In this context UL is linked to a variety of stakeholders and networks where industry and developers are part of it.

UL has announced through the American National Standards Institute’s (ANSI) Project Initiation Notification System (PINS), the development of a new standard for the safety of medical device interfaces in an interoperable environment.

Just recently UL became certified by Continua Health Alliance for testing medical devices and components for manufacturers interested in being certified through the Continua Alliance Certification program. The Continua Alliance Certification program’s mission is to establish a system of interoperable personal telehealth solutions that fosters independence and empowers people and organizations to better manage health and wellness.

Both activities are significant contributions, and along with its knowledge, UL continues to sustain new developments for the realization of a safe eHealth environment for the healthcare of tomorrow.

UL is open to work with manufacturers and developers on their new designs, developments and case studies to support, identify and address the safety issues, of course, under the integrity and confidentiality that is the constant of our daily work.

Publisher:

How does UL cooperate with other medical electronic device organizations in North America and internationally?

 Dr. Terenzio Facchinetti: 

Because eHealth is a rather “recent” topic that has become more and more important in recent years, and due to its breadth and complexity, there are a substantial number of stakeholders, associations and alliances that are involved and discussing the matter.

UL participates in a number of working groups and has close contacts with the most important ones, specifically in the sector of safety and regulatory, as these are the primary objectives of our work and competences.

 Publisher:

Who will drive eHealth and its interoperability?

 Dr. Terenzio Facchinetti: 

This is a key question. eHealth, and its interoperability, has a large number of stakeholders and players: medical device manufacturers, IT (software, hardware, infrastructure), M2M, operators, services, users, care givers, patients, associations (medical, patients, specialties, etc.), regulators and governments, and certifiers like us (UL).

All have different objectives and interests. In my view there is a unifying objective, which is a win for all parties: this is the development of a better quality, safe and cost-effective healthcare environment.

This can be driven only via new technologies, which will drive new product development and expansion of the healthcare industry.

Some of the other mentioned stakeholders have a very important role and position: just think about regulators with their role of taking care of the public health. They, like other stakeholders, might condition the way things will be deployed, however, I believe that the push and trigger will come from some others on the list.

The positive message is that I have observed noticeable movements toward solutions and that integrated approaches are continuously growing.