Radiation-Emitting Products

Under what circumstances must our medical physicist actually visit our facility in order to successfully carry out his/her responsibility to oversee our equipment-related quality assurance practices?

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At a minimum, the medical physicist must be on-site to perform or to provide direct supervision for the performance of:

1. The annual survey;

2. Mammography equipment evaluations. A mammography equipment evaluation must be conducted whenever a new unit or processor is installed, a unit or processor is disassembled and reassembled at the same or a new location, or major components of a mammography unit or processor are changed or repaired.

Determining when a medical physicist must be on-site in connection with adjustments, changes, or repair of equipment requires further discussion. Adjustments, changes, or repairs of equipment can occur as corrective actions for problems that caused the equipment to fail a quality control test, as the result of an unexpected equipment failure, or as a measure intended to prevent possible future inadequate equipment performance. All adjustments, changes, or repairs must include some form of verification testing to demonstrate that the affected equipment meets the applicable standards.

As noted, in the case of major adjustments, changes, or repairs, the medical physicist is required to conduct a mammography equipment evaluation on-site to confirm that the applicable standards in 21 CFR 900.12(b) and (e) are met. FDA also recommends that the medical physicist have a role in some other changes or repairs through the provision of "medical physicist (MP) oversight." By "MP oversight," we mean that the medical physicist should be consulted as to whether an on-site visit is required or if other personnel can verify that the standards are met, with direction by telephone or printed material from the medical physicist if needed. Finally, FDA recognizes that there are adjustments, changes, or repairs for which verification (that the adjusted, changed, or repaired equipment meets standards) can be performed by other qualified personnel (e.g. radiologic technologist or service representative with appropriate training/experience) without involving the medical physicist. However, the facility can consult their medical physicist in these situations if they wish.

The first column of the table, "Medical Physicist Involvement in Equipment Repairs," lists the adjustments, changes, or repairs in which the regulations require a mammography equipment evaluation. It also includes a number of adjustments, changes, or repairs that do not require a mammography equipment evaluation. The second column indicates whether the item is considered by FDA to be a major adjustment, change, or repair. If so, it is stated in the third column that the "MP conducts evaluation in person." For other adjustments, changes, or repairs, the third column indicates that FDA recommends either "MP oversight" or "MP involvement optional." In cases where the recommendation is "MP oversight" or "MP involvement optional", the verification may be accomplished by a qualified individual (as described in the previous paragraph) other than the medical physicist.

It is important to remember that in all cases, even those where FDA is recommending "MP oversight" or verification by a non-medical physicist, that some form of verification testing must be included as part of the adjustment, change, or repair.

Table: Medical Physicist Involvement in Equipment Adjustments, Changes, or Repairs

For any adjustment, change, or repair not listed in the table below, or if the facility is unsure as to the full extent of the adjustment, change, or repair, the facility should consult their medical physicist to determine the proper extent of his or her involvement in evaluating the item.

Item Major Repair Medical Physicist Involvement

Automatic Exposure Control

   

AEC replacement

Y MP conducts evaluation in person

Thickness compensation internal* adjustment

N MP oversight

AEC sensor replacement

Y MP conducts evaluation in person

AEC circuit board replacement

Y MP conducts evaluation in person

Density control - internal* adjustment

N MP oversight

Bucky (New to Faclity) Replacement

   

AEC sensor also replaced

Y MP conducts evaluation in person

AEC sensor not replaced

N MP oversight

FFDM detector also replaced

Y MP conducts evaluation in person

FFDM detector not replaced

N MP oversight

Cassette Replacement

   

Same screen speed

N MP involvement optional

Faster screen speed

N MP Oversight

Slower screen speed where the dose increase may exceed 3.0 mGy for the standard breast

Y MP conducts evaluation in person

Collimator

   

Replacement

Y MP conducts evaluation in person

Reassembly with blade replacement

Y MP conducts evaluation in person

Adjustment

N MP oversight

Compression Device

   

Pressure adjustment

N MP involvement optional

Thickness scale accuracy adjustment but only if it affects AEC performance

N MP oversight

Repair of auto decompression

N MP involvement optional

Compression Paddle

   

Paddle (new to facility) replacement

N MP Oversight

Deflection adjustment

N MP oversight

Adjustment due to extension beyond allowable limit, or visibility on images

N MP oversight

Darkroom

   

Repair of light leaks

N MP involvement optional

Safe light change

N MP involvement optional

Film Type/Speed Change

N MP oversight

Processor

   

Chemistry type change

N MP involvement optional>/td>

Fixer/Developer replacement

N MP involvement optional/td>

Installation

Y MP conducts evaluation in person

Reassembly

Y MP conducts evaluation in person

Replenishment rate adjustment

N MP involvement optional

Roller replacement

N MP involvement optional

X-ray Unit

   

kVp, mA or time internal* adjustments

N MP oversight

High voltage generator replacement

Y MP conducts evaluation in person

X-ray tube replacement

Y MP conducts evaluation in person

Filter replacement

Y MP conducts evaluation in person

Installation

Y MP conducts evaluation in person

Reassembly

Y MP conducts evaluation in person

Manufacturer's software modifications (see approved alternative standard)

Y MP conducts evaluation in person

FFDM detector replacement or repair

Y MP conducts evaluation in person

FFDM Display (monitor)/Printer Replacement

Check FFDM manufacturer’s QC manual Follow FFDM manufacturer’s QC manual

* Internal adjustments refer to equipment adjustments that typically cannot be made by the operator. 

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Page Last Updated: 08/18/2014
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