Over the last few months a number of hospital-based and third-party engineers have contacted DOTmed to ask our opinion about what is happening at the FDA regarding radiological equipment regulations.
The FDA is researching performance standards. The current performance standards were established in the 1970s and the FDA feels that it is time for a second look.
The Center for Devices and Radiological Health (
CDRH) component of the FDA is reviewing the standards and has set up a committee to make recommendations regarding the standards.
Hospital-based engineers who spoke to DOTmed expressed concern that the new standards may be modified in such a way that it would deny them access to diagnostic software and the diagnostic tools needed to calibrate and maintain equipment.
The consensus is that patient safety will suffer if this happens.
Remarketers of medical equipment are also concerned because if used equipment cannot be serviced, then no one will buy used equipment.
We studied the FDA's web site which we found to be very complicated. We contacted industry insiders to learn their views.
Tom Quinn, a well-known and outspoken critic of the FDA, said that he is concerned that the OEMs will attempt to influence the FDA to narrow the scope of what hospitals and third party service firms are required to do. If the scope of requirements are narrowed, the OEMs will not be required to supply engineers with needed service software and tools. This would change the industry as we know it Quinn said.
Industry insiders told DOTmed that an IAMERS delegation visited Washington, D.C. this week to discuss this very issue. Diana Upton, president of the 100 member trade association of medical brokers and dealers was not available for comment.
In the coming weeks DOTmed will be investigating this issue further and reporting on it. In the meantime, we welcome your comments and encourage you to e-mail us at
news@dotmed.com and we will share your comments with our users.
