MEDTEQ is a venture established in July of 2009, using the experience of the principle engineer, Peter Selvey. The object is to provide a combination of free and fee based support material for test laboratories, auditing agencies and manufacturers with respect to medical electrical equipment, with a greater focus on the functional side (performance, clinical safety) of the medical device.
Peter Selvey's experience started in February 1987, as trainee with Sydney County Council's Testing Laboratories (now TCA, or Testing & Certification Australia). The 4 year traineeship was based on 3-6 months stays in various laboratories, from delicate ppm measurements in calibration standard laboratories through to pumping explosive currents up to 220,000A into fuses and switch gear in a high power test station. Other interesting subjects included megavolt lightning simulation, testing the HV isolation ability of fire extinguishers, chemical and electrical tests on transformer oil insulation; thermometry; metrology; photometry; before finally landing in the appliance testing laboratory working with Australian and IEC safety standards. Although the time was short, the experience gained in these laboratories continues to help more than 20 years later, tackling issues such measurement principles and accuracy in patient monitoring; knowing the mechanism behind dielectric heating of insulation in HF surgical equipment; and understanding what the L and H means on a mains fuse.
In 1991, working together with Leo Barnes, he helped to open Australia's first "electromedical laboratory" , which soon became NATA and CB scheme recognised for many standards in the IEC 60601 series. After Leo Barnes left for TUV SUD Japan in 1997, Peter took over as laboratory manager for medical electrical equipment. In addition to testing for local medical manufacturers, TCA also established a scheme, driven by hospital purchasing plans, to review the quality of test reports on imported medical products. The scheme included a physical inspection of the product design, allowing exposure to a wide range of medical devices. Studying at night, he also completed a Electrical Engineering Degree with first class honours, majoring in instrumentation electronics, and selecting subjects such as microcontroller systems and biomedical engineering.
In May 1999, as a fresh graduate and fully intent to change careers towards design of medical equipment, he was instead sidelined by an offer from TUV SUD Japan, as an auditor (MDD, ISO) and test engineer based in Tokyo. Using the hands on experience from TCA, he quickly gained qualification for a wide range of medical devices, and began a 7 year period of extensive travel for audits and on-site testing not only in Japan, but through Asia-Pacific region, including considerable work in China. With a keen interest in design, software, microprocessors, he was also the first non-German and one of only a handful of engineers to be qualified for "functional safety" testing: hands on evaluation of protection systems in high risk devices such as dialysis systems, infusion pumps and surgical lasers. His role in the region included training and support for other test engineers and auditors for electrical safety, performance and functional safety. He also was the primary engineer in establishing TUV SUD Ohtama's medical test laboratory, TUV SUD's first laboratory in Japan, writing from scratch a complete ISO 17025 laboratory quality system. During the time with TUV SUD, the most challenging role was as project manager and principle engineer for MDD Annex III testing of several dialysis systems, a device of daunting complexity having around ten different ways to kill a patient. These evaluations would easily extend over 12 months, starting from preliminary design review through to actual testing, documentation and the final negotiation with the certification body.
In August 2006, in a bid to restrict travel, he moved to UL Japan, taking his young family to the "small" town of Ise, in Mie-ken (Japan), where he initially worked as a test engineer covering basic electrical safety according to UL 60601-1. Quickly bored, and with the support of management, he embarked on a new and unusual approach to getting a laboratory qualified in the CB scheme for medical standards: in-house testing. Until that time, most test laboratories relied extensively on witness testing for particular standards (IEC 60601-2-xx), due to the special and rare nature of testing. But the approach in UL Japan was to establish actual testing ability through the design of test set ups and equipment, covering patient monitoring, ECG, infusion and endoscopic equipment. The success was clear: zero no-conformities/observations in the CB audit, and a wide range of standards added to the list for UL Japan MED category. This approach was also used twice in UL Taiwan, each time with great success, with the final total of 16 medical standards. While the equipment provided in the first 2007 audit was somewhat crude, it evolved over 2 years to include microprocessor based systems for testing a range of ECG products, and includes a notoriously difficult task of adding large, fast pacemaker spikes with decaying overshoot profiles with slower, smaller ECG waveforms, while still maintaining laboratory accuracy. In the meantime, UL started to make greater use of his background in MDD, ISO auditing, which unfortunately lead to an increase in travel, conflicting with a the needs of a young family.
In July 2009, he left UL Japan to establish MEDTEQ, with the intent to design materials that can be used to support medical device evaluation. To date, MEDTEQ has further refined and expanded the range of ECG test equipment, designed new equipment for measurement of HF high voltage, HF current, precision pressure, precision temperature, automated systems for NIBP safety system analysis, precision IBP simulator, and an NIBP training system. He has finally succeeded in the 2 year quest to design a stable high frequency insulation tester, and has started work on software to manage and build safety test reports, from raw data to high level result.