MRI Vs. Rest of Medical Devices or MRI with Rest of Medical Devices
Carrying out MRI scans with other implanted medical devices has always been of concerns to healthcare agencies. While in past this worry revolved around electronic implants , it has now encroached into non electronic devices such as stents and others. Below are trail of news which indicates the seriousness of situation and precautionary measures taken by FDA around the same:
1.FDA issuing new guidance on MRI safety and compliance for different device types.
2.Issues of cochlear implant compatibility with MRIs
3.Companies’ gearing up to launch more number of implants which are MRI compatible. Sector which has made a head start in this space is pacemakers segment which involves companies such BSC, Biotronik and Others.
4.Companies raising funds to improve their devices with priority set on increasing their products MRI compatibility ( Flowonix raising USD 40 million for its next-gen infusion pump with increased MRI compatibility)
Compatibility of medical devices with MRIs has been worry point for medical devices which contain embedded electronics in them. Lately this has taken a toll on passive implants such as stents and others, which if subjected to magnetic field can result in equal futile results as former ones . While pacemakers have been preparing for this situation way back and have sufficient expertise and progress made around the same, Cochlear implants are still trailing the path or trying to finding an ideal solution for the problem in hand.One of the other device segment which was seen making significant progress in developing MRI compatible devices is Infusion device category.
As the issues concerns us all, FDA recently lays down foundation addressing the need of the hour through ASTM defined standards. These standards mandate every medical device manufacturer to label their devices with one of the below mentioned tag:
1. MR safe
2. MR Unsafe
3. MR conditional
4. MRI not evaluated
We believe adherence to this norms are likely to address majority of the issues in regards to MRI compatibility, needless to say medical device companies can offer their support by integrating this requirement during design study of their respective device types.