Medical equipment maintenance managers and technicians carry a hefty responsibility. Their jobs are to maximize equipment uptime so patients – people like you and me – can receive the diagnostic care and treatment needed to stay healthy. Our lives can depend on the success of their work.
That’s no small task given the ever-changing operational requirements and complex nature of equipment like ultra-sound machines, MRIs, x-ray machines, ventilators, and CT scanners. According to the World Health Organization, there are more than 1.5 million types of medical device products on the market (WHO factsheet No. 346). Countless parts, exacting calibration requirements, and the latest technology incorporated into over a million device types make ongoing maintenance a monumental challenge.
Luckily for medical equipment maintenance managers, all new medical equipment starts its life with a high degree of quality. The US Food and Drug Administration (FDA) has strict standards when it comes to the manufacture of medical devices. Their most current publication, the Medical Device Quality Systems Manual – A Small Entity Compliance Guide, First Edition specifies quality assurance methodology for every aspect of production, ensuring a high degree of operational excellence and top notch equipment.
Once medical equipment is operational, however, the ongoing maintenance and repair is demanding. Aftermarket maintenance and repair regulations are also stringent. According to the FDA’s postmarket requirements for medical devices:
“Medical device manufacturers as well as other firms involved in the distribution of devices must follow certain requirements and regulations once devices are on the market. These include such things as tracking systems, reporting of device malfunctions, serious injuries or deaths, and registering the establishments where devices are produced or distributed. Postmarket requirements also include postmarket surveillance studies required under section 522 of the act as well as post-approval studies required at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application.”
Additionally, the FDA is proposing new regulation requiring a unique device identification (UDI) system to manage medical devices. The new regulation is intended to improve equipment safety and effectiveness, postmarket surveillance, quality of care and patient safety. The UDI project is being coordinated internationally through the Global Harmonization Care Task Force (GHTF) – now the International Medical Device Regulators Forum. Although generally supported by the medical device community, the resulting regulation may mean some scrambling on the part of maintenance and repair managers and service providers as they seek to accommodate the new bar coding system. New draft guidelines could be released as early as February 2013.
Medical Device and Diagnostic Industry’s (MD & DIs) Heather Thompson adds some insight on the topic in her post, “Unique Device IDs ‘A Single Source of Truth’ Says FDA Jay Crowley.” According to Thompson, the “FDA wants industry to start planning now for unique device identification—and the Agency is eager to help.”
Enigma is watching carefully as the new regulation takes shape. We see some striking similarities between the highly regulated, individually tracked aviation industry where we have created solutions for many years, and the evolving medical equipment industry also headed toward individual identification. For years, Enigma’s InService MRO software has helped aviation maintenance and repair organizations (MROs) individually track, manage and service aircraft in a highly regulated industry.
Our InService EPC software has also brought our expertise to the medical equipment industry, tracking and supporting the maintenance and repair of medical equipment. Customers like Toshiba America Medical Systems (TAMS) have already incorporated InService EPC to manage service and parts information on their magnetic resonance imaging machines (MRI) MRIs and CT scanners.
Although the challenges of medical equipment maintenance and repair may appear daunting, guidance from the FDA, the medical device community and software developers like Enigma will help to smooth the regulatory transition, enabling medical equipment managers and technicians to maintain and service the machines that deliver the diagnostic care and treatment we all need.