Is my Printer or Monitor FDA approved?

     We are frequently asked this question and it seems like a simple question.  Questions include "What is the minimum resolution for a mammography printer?" and "What about thermal imaging technology?  Is it the same as laser imaging?"  The answer however is not that simple.  Rather than referring to an FDA list of approved mammography printers,  you must be certain that your printer is approved by your digital unit vendor.

Look especially at questions 2 & 3 referenced from the Policy Guidance Help System. The safest bet is to contact your digital unit manufacturer to review what printers were approved in the PMA (premarket approval) process for your unit. The regulations don't address printers, but the FDA does RECOMMEND (not require) that you use printers approved by your unit vendor. So, rather than an issue of minimum resolution, printer technology or FDA approval, it's an issue of what the image receptor manufacturer approves.

Referenced from the Policy Guidance Help System:

Other Modalities Quality Control Tests

Citation:

900.12(e)(6): Quality Control tests — other modalities. For systems with image receptor modalities other than screen-film, the quality assurance program shall be substantially the same as the quality assurance program recommended by the image receptor manufacturer, except that the maximum allowable dose shall not exceed the maximum allowable dose for screen-film systems in paragraph (e)(5)(vi) of this section.  

Discussion:

Question 1: What are the required quality control tests for new mammographic modalities?

Mammography systems with image receptor modalities other than screen-film must undergo periodic quality control tests following procedures that are recommended by the manufacturer of the mammographic modality. As is the case for screen-film QC, the facility must keep records of these tests and all applicable corrective actions for the longer of: last 12 months or since the last annual inspection which verifies compliance, or until the test has been done two additional times at the required frequency. 21 C.F.R. 900.12(d)(2). Regardless of the mammographic modality, the mean glandular dose delivered during a single cranio-caudal view of an FDA-accepted phantom must not exceed 3.0 milligray (mGy) (0.3 rad) per exposure. 21 C.F.R. 900.12(e)(5)(vi). If the test results exceed the action level, corrective action must be taken within the required time frames. 21 C.F.R. 900.12(e)(8). 

Question 2: Can a facility use printers and monitors that were not specifically approved as part of its FFDM unit?

FDA recommends that only printers and monitors specifically approved or cleared for FFDM use by FDA’s Office of Device Evaluation be used. However, a facility may use other printers and monitors. Facilities need to ensure that all printers and monitors used by the facility with its FFDM unit comply with a quality assurance program that is substantially the same as that recommended by the FFDM manufacturer and pass the facility’s accreditation body’s phantom and clinical image review process. At the current time, no accreditation body reviews soft copy images so we recommend that the soft copy images be of such quality that if they were submitted they would pass the facility’s accreditation body’s phantom and clinical image review process.

Note: Each softcopy and hardcopy mammographic image used for final interpretation must indicate identifying information (view and laterality, technologist identification, patient name, etc.) (21 CFR 900.12(c)(5)). 

Question 3: Can a manufacturer hook up a printer or monitor to its FFDM unit if the printer or monitor were not part of its original Pre-Market Approval (PMA)?

Manufacturers will need to check the exact wording of their PMA to see if this is allowed. However, the facility is not restricted by the PMA and may hook up and use printers and monitors other than those approved by FDA for use with the manufacturer's FFDM unit as long as they meet the requirements specified in question #2. 

Question 4: Must a facility perform all the required QC testing on a laser printer even if the facility is using only soft copy for final interpretation and is using the printer only to provide final interpretation quality hard copy images to patients, their representatives, and health-care providers or for retention purposes? If not, is the facility subject to citation during an MQSA inspection?

Yes to both questions. Even if a facility is using the printer only for these purposes and never actually provides a final interpretation report based on the hard copy images, it still must perform all the required printer QC tests at their appropriate frequencies or, prior to printing clinical images for patients and health-care providers or for retention, whichever is less.

Because of a misunderstanding in the professional community regarding QC testing in these situations, we have not universally enforced this requirement. However, this guidance serves to clarify this matter and those facilities that fail to perform the required QC testing after July 1, 2007 will be subject to citation.

Question 10:  Is there a list that shows the laser printers that have been cleared for mammography by the FDA? If not, how can I determine if FDA has cleared a given laser printer for mammography use?

No.  Although FDA has cleared many printers for FFDM use through the 510(k) process, FDA does not keep a list of cleared printers, other than what is available in FDA’s 510(k) database at http://www.fda.gov/cdrh/510khome.html#database. You can search this database by product code, device name, applicant name, decision date, and other elements, including a simple word search. Another way to find out whether a particular printer has been cleared for FFDM use is to check the device’s labeling or to have the printer manufacturer provide you with written documentation showing that the printer has been cleared by FDA for FFDM.