This piece was originally published in the May 2017 issue of electroindustry.
Peter Weems, Director, Policy and Strategy, MITA
If all service providers applied appropriate service and maintenance programs, potential gaps in the quality of medical imaging equipment performance would be greatly reduced or eliminated at provider facilities.
Currently, the U.S. Food and Drug Administration (FDA) only regulates service activities performed by original equipment manufacturers (OEMs). Third-party and in-house servicing operations are not held to the same minimum quality, safety, and regulatory requirements as OEMs. Although many third-party service organizations regularly perform quality work, the lack of oversight, regulation, or consensus standards present serious concerns for patient safety and device performance.
Since at least the mid-1990s, MITA has been working with the FDA and other stakeholders to address these concerns regarding medical imaging devices. Beginning in 2015, MITA renewed its push to get the FDA to finally take action to better protect patient safety.
Last year brought a flurry of activity as the FDA opened a public docket and held a workshop on this issue. Both the docket and the workshop were excellent opportunities for the multitude of stakeholders to present their views and discuss the challenges and opportunities facing the medical device servicing industry.
Although the discussions were often emotional and there are still wide gaps in agreement, the FDA collected a large amount of constructive information, and stakeholders gained a better understanding of each other’s concerns. Despite all of this activity, it is still unclear whether or when the FDA will implement a solution to this problem.
Given the uncertainty on the regulatory front and the lingering lack of consensus, MITA believes there is now an opportunity to develop a standard on servicing medical imaging devices. Through NEMA, its parent organization, MITA is an American National Standards Institute (ANSI)–accredited standards development organization.
In order to establish a common understanding and improve servicing quality, MITA has launched an initiative to develop a standard for medical imaging device service providers. This standard will establish minimum requirements for an appropriate quality system and provide guidance to stakeholders, including, but not limited to, accreditors, manufacturers, servicers, and provider facilities.
Recognizing the importance of a balance of interest groups in this standards development process, MITA has formed a canvass group of OEMs and stakeholders representing third-party servicing organizations, in-house clinical engineers, hospital systems, the FDA, the Joint Commission on Hospital Accreditation, and others. In addition to input from the canvass group, there will also be an opportunity for public comment on the standard. Feedback from this varied group will represent the consensus view of the medical imaging device servicing industry in the final standard.
It is our hope that this standards development process will produce a document that will form the foundation of best practices in the industry.