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U.S. Department of Health and Human Services

Medical Devices

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Inspection of Domestic and Foreign Manufacturers of Diagnostic X-Ray Equipment - Part II: Program / Implementation

PART II - PROGRAM / IMPLEMENTATION

  1. Objectives

    This is a continuing, non-statistical compliance program intended:

    1. To ensure that the regulated products and manufacturer quality control programs conform to EPRC regulations;
    2. To identify diagnostic x-ray products which fail to comply with the applicable performance standard requirements;
    3. To obtain correction of noncompliant products identified in l and 2 above by initiating appropriate administrative and/or regulatory action when necessary; and
    4. To provide guidance to manufacturers regarding compliance with applicable EPRC laws and regulations administered by FDA
  2. Program Management Instructions

    1. Planning Instructions

      1. The role of the individual investigator and field radiological health specialists is a critical factor for the effective implementation of this program. Field specialists such as X-ray Auditors and Regional Radiological Health Representatives have been specifically trained in general EPRC requirements and may have specialized training in the diagnostic x-ray performance standards.

        Only individuals trained in EPRC requirements should perform these inspections. Contact CDRH/OCER Diagnostic Devices Branch and DFI should the need for expertise, not otherwise available in the District, become apparent. At the discretion of CDRH and the district, radiological health specialists may be used to accompany a medical device investigator to conduct joint EPRC/medical device inspections. If an individual has training in both EPRC and medical device inspections, a single individual may conduct both portions of the inspection.

      2. Field radiological health specialists, their particular area of expertise, physical location and primary geographical areas of responsibility are listed in Part VI of this program.

      3. A list of foreign and domestic manufacturers covered under this program may be developed using available data systems including the Center Tracking System (CTS) and the Registration and Listing database. CDRH will provide access to necessary systems, help build queries to identify firms and assist in selecting firms for selection as needed.

      4. Based on the resources in the current FY workplan, field radiological health specialists will develop assignments for their organization. The assignments will be reviewed by his or her supervisor and entered into FACTS. Workplans should include district inspections, field tests, and known CDRH assignments. The establishment inventory and guidance from CDRH should be used to determine inspection and field test locations.

    2. Pre-announcement of Inspections

      Because these inspections are intended to cover both EPRC and medical device Quality Systems Regulations, these inspections must be pre-announced according to medical device inspection compliance program. Refer to instructions provided in the Guide to Inspections of Quality Systems, August 1999, and IOM Section 5.2.1.1, Pre-Announcements.

      If the inspection will only evaluate compliance with EPRC regulations pre-announcement remains necessary to facilitate the inspection. Pre-announcement ensures the firm is producing electronic products for the US market on the day of inspection, gives the firm time to collect all necessary procedures and records, and ensures appropriate individuals are available during the inspection. Section 537 of the Act permits inspection of any manufacturer for good cause, grounds for which may include introduction of any noncompliant product into US commerce, failure to comply with EPRC reporting requirements, or for purposes of investigating suspected problems with a manufacturer's quality control testing program and assessing product conformance with performance standards.

    3. Inspection Priorities

      Inspections and field testing of electronic product manufacturers should be prioritized using the following criteria:

      1. Manufacturers and products posing a potential risk to public health or with great public health impact. High-risk products may be identified by direction provided from CDRH, level of radiation emissions accessible to the public or volume of products on the US market.
      2. Manufacturers or products with known or suspected compliance problems discovered through field testing, report review, complaints or other reason.
      3. New manufacturers that have not yet been inspected.
      4. Products incorporating technology new to the US market or a major change in existing product.
    4. Resource Instructions

      1. Field personnel may require personal radiation monitors, such as thermal luminescent dosimeter badges, when performing tests under this program. Dosimeters must be worn when performing inspections of diagnostic x-ray manufacturers or diagnostic x-ray field tests. These monitors are available from the Winchester Engineering and Analytical Center (WEAC) Radiation Safety Officer. Regional Radiological Health Representatives (RRHRs) may also be able to provide dosimiters upon request. Part VI of this program contains the current list of contacts for WEAC.

      2. Field personnel are responsible for contacting OCER and OSEL to arrange to have their radiation measurement equipment re-calibrated annually. Any personnel that do not have the appropriate radiation meters may request that equipment be loaned by another district or by CDRH, if available.

        CDRH will be phasing out calibration services currently provided for a number of instruments in the field, and alternate sources of equipment maintenance and calibration services will be identified. CDRH will assist in identifying sources for these services, and will maintain an inventory of equipment that may be available for use by field staff on loan.