The ever present and passionate debate surrounding who should and how imaging equipment should be serviced has received yet another argument thrown into the mix.
The Medical Imaging and Technology Alliance (MITA) released a quality standards whitepaper in February 2019 entitled “Requirements for Servicing of Medical Imaging Equipment”. MITA predominately works to represent the OEMs and influence policy in Washington D.C.
It’s no surprise that MITA’s whitepaper release would cause some concerns and rumblings from service entities and third-party independent service operators (ISOs).
What are the benefits?
We’ve identified two clear points within the paper that only serve to better ‘intended use’ and patient outcomes.
A clear definition and clarification between remanufacture and service
Consistent definitions of minimum requirements for maintaining medical imaging equipment
Recommendations on the qualifications of service personnel – without directive that training must be provided by the OEM
What concerns are still present from ISOs & In-House teams?
There is still no intention of MITA or the OEMs working with these outside vendors to provide service documentation
An omnipresent push from MITA for the FDA to enact ISO:13485 requirements for service providers
Fortunately, this paper represents a voluntary standard, rather than policy directive, towards service of imaging equipment. Thus, creating the opportunity for OEMs and third-party service providers to find agreement in basic quality standards and definitions.
So far, the FDA has not enacted any regulations towards ISO requirements such as the ISO:13485, however, ISOs will consistently have to monitor the growing debate and push for policy change from MITA.
For now, third-party operators will continue to operate and provide service under such guidelines as:
“Each service provider shall have sufficient personnel with the necessary documented qualifications to assure that all activities required by this Standard are correctly performed. The qualifications may include a background in medical imaging technology, clinical application, and use, associated components, systems, and appropriate regulatory compliance knowledge.”