CHAPTER 7

Patient Implants and Medical Devices

Version 1
8-20-07

Chief of CAMRIS Technical Staff
Norman Butler 215-349-5298
mr5research@uphs.upenn.edu

Scope & application
Overview
Definitions
Clearance Procedure
MR Technologist Responsbilities
Investigators Responsibilities
Documentation and Forms
Important Phone Number

Scope &Application
1.1 This SOP is intended to provide the standard for evaluation of the safety and compatibility of implanted devices in MR Research subjects.

2.0 Overview
2.1 The use of metallic implants and active electronic devices in management of medical conditions is very now very common. It is the purpose of this SOP to outline standard methods used to confirm the safety and compatibility of implanted devices or foreign bodies that may be inside or attached to research subjects. It is expected that these processes mentioned are in follow-up to the screening method outlined in CAMRIS SOP Safety 001 Ver1 (Patient Screening and Preparation).

3.0 Definitions
3.1 MR Session - scheduled time for subject to be in the MRI Suite

3.2 MR Suite - Area inside the magnet room cipher lock.

3.3 Contraindication- An implant or medical device that renders the carrying out of a MRI procedure inadvisable.

3.4 Implant - A passive or active device that has been placed inside a patient's body to correct or alleviate an existing medical condition.

3.5 Medical History - a list of a person's previous illnesses, present conditions, symptoms, medications and health risk factors.

3.6 ASTM - American Standard for Testing Materials - one of the largest voluntary standards development organizations in the world-a trusted source for technical standards for materials, products, systems, and services.

3.7 SUBJECT - this is the individual that has been recruited for participation in the research study and will be signing the informed consent as a participant.

3.8 CAMRIS Implant/Device approval form - This form is available on the CAMRIS website - www.mmrrcc.upenn.edu/CAMRIS - The form is filled out and submitted to CAMRIS for review when normal avenues for evaluating MR compatibility information are not available or special consideration is needed.

3.9 MRI SAFE - defined by the ASTM International document is applied to an item that poses no known hazards in all MR environments. MR SAFE items would include non-conducting, nonmagnetic items such as a plastic Petri dish. The document further states that an item may be determined to be MR SAFE by providing a scientifically based rationale rather than test data. Unlike the previous FDA's definition of MR Safe, the new MR SAFE may only be applied if the item is 100% safe, without exception, regardless of MR system field strength or any environmental or extenuating circumstances. The universal icon to be used for all MR SAFE products is a green square with white capital letters "MR", or, a white square with green border and green capital letters "MR". Items marked with the green MR SAFE icon may be taken into, used, or placed anywhere within any MR environment without risk or potential harm

3.10 MRI Conditional - defined by the ASTM International as an item that has been demonstrated to pose no known hazards in a specified MR environment with specified conditions of use. Conditions that may be used to define the specified MR environment include field strength, spatial gradient, RF fields, specific absorption rate (SAR) as well as the potential for additional conditions such as operational conditions for a device. The MR CONDITIONIAL label is used to alert the user that there are certain limitations to the usability of the item, or the testing that was performed. As an example, an item may have been tested for a 1.5-Tesla system, but not a 3-Tesla. Items bearing the MR CONDITIONAL icon should include additional information on the label, as to what the conditionality of use is, such as a gauss-line restriction or SAR level limitation. The icon designated for MR CONDITIONAL marking is a yellow equilateral triangle with a black border and black capital letters "MR" inside.

3.11 MRI Unsafe - defined by the ASTM International is any item that is a known threat or poses a hazard in all MR environments. An example of an MR UNSAFE item would be a pair of ferromagnetic scissors, or any item constructed of ferrous metals. The MR UNSAFE icon consists of a white circle with red border and diagonal strike through and the capital black letters "MR" inside.

4.0 Clearance Procedure for Implants
4.1 Clearance of Implanted devices is to be done prior to the MRI Session. Any time spent on this screening process during the MRI Session time will be counted against the time slot.
4.2 All implants whether MRI safe or not must be documented on the MRI screening form
4.3 Surgical implants must be defined by one of the following processes
4.3.1 Manufacturer model number and/or serial number. This is usually available through Material Identification Cards that are given to the subject by the Surgeon or manufacturer of the implant.
4.3.2 Surgical or procedural reports which specifically identifies the model and/or manufacturer of the implant. Enough information must be given in order to check the implant compatibility.
4.3.3 Review and verification of implant information by the Primary Investigator and his/her acknowledgement of MR safety status by signature on the CAMRIS Implant/Device approval form.
4.4 Implant clearance is to be done in advance of the scheduled MRI session
4.5 All study subjects should be accompanied by an Investigator or Research Assistant for the MRI session. Issues regarding MR Safety will not be easily addressed if the Investigator is not represented during the subjects MRI session.

5.0 MR Technologist Responsibilities
The Technologist will verify the completion of the MR Screening form. The form must be reviewed and acknowledged through signature by the MR Technologist before the patient enters the room. Any possible contraindications must be thoroughly investigated and issues resolved prior to patient entering the MRI.

5.1 The MRI Technologist will assist in investigating the compatibility of implants using the following methods:
5.1.1 Evaluate the implants safety based on the "Clinical Practice Standard" of the Hospital of the University of Pennsylvania Radiology Department.
5.1.2 MRI Implants and Devices Safety Manual "by Shellock"
5.1.3 MR Safety information on www.mrisafety.com
5.1.4 Patient records available through MEDVIEW

5.2 Scenarios:
5.2.1 If the implant is commonly scanned in the clinical arena then the subject may be scanned.
5.2.2 Documentation is reviewed and has a rating of "MR Safe" the subject may be scanned.
5.2.3 Implant Documentation is reviewed and the implant has a rating of "MR Conditional" Then the Primary Investigator must sign the MRI screening form. 5.2.4 No documentation can be gathered and verification of the implant is not possible then the Subject cannot be scanned until documentation is secured and verified.
5.2.5 In the event of "MR Unsafe Implants" the MR session will be cancelled.
5.2.6 The rating for the implant in question is "MR Safe" for a field strength greater than the MR Unit proposed for use during the MR Session then the MRI scan may be done
5.2.7 The rating for the implant in question is "MR Safe" for a field strength less than the MR Unit proposed for use during the MR Session then the Primary Investigator must sign off for the MRI to be done.

6.0 Investigator Responsibilities
6.1 Supply pertinent documentation of implant MR safety and/or compatibility. 6.2 Submit a completed MR screening form and/or a completed *CAMRIS Implant/Device approval form for the subject.
6.3 Be available during the subject session for questions that arise concerning implant compatibility or safety.

7.0 Documentation and Forms
7.1 MRI Screening Form is available through CAMRIS Website or copies may be picked up at the MRI scanners. These must be completed and reviewed before the subject is allowed to enter the MRI Suite.
7.2 CAMRIS Implant/Device approval form is available on the CAMRIS Website and should be used in instances where MRI compatibility is not clearly defined or available to the Investigator.
7.3 Medical Record Number must be established for each subject and the subject must be scheduled in the "V10" Radiology Scheduling system as described in the CAMRIS SOP Procedural 001 Version1 "Patient Scheduling".. Establishing and maintaining current subject information in the V10 system allows for documentation of procedures and patient history. In the event of a complication during the subject research session this information is readily available for subjects treatment.

8.0 Important Phone Numbers
8.1 Norman Butler - Clinical Research Technical Supervisor - 215-349-5291 OR 610-209-8438
8.2 Alex Kilger R.N. - CAMRIS Administrator - 215-349-5470
8.3 Dr. Larry Dougherty - CAMRIS Physicist - 215-349-5274
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