ML20141J073
| ML20141J073 | |
| Person / Time | |
|---|---|
| Issue date: | 06/03/1995 |
| From: | Siegel B NRC |
| To: | Stewart Schneider NRC |
| Shared Package | |
| ML20007J296 | List:
|
| References | |
| FRN-62FR4120, RULE-PR-20, RULE-PR-35 AE41-2-015, AE41-2-15, NUDOCS 9708140364 | |
| Download: ML20141J073 (3) | |
Text
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[)j From: "Barry Siegel" ("SIEGELBOMIRLINK.WUSTL.EDU")
'x To:
sxs40nrc. gov
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Date: Saturday, June 3, 1995 4:28 pm
Subject:
Proposed 35.75 (SMTP Id#: 53488)
Stewart:
I have a few concerns with the proposal (and with some of the associated material in the RG) for your consideration.
1.
In the 20 April draft, #164#35.75(b) included the phrase "in a year from a single administration" as a modifier of TEDE. Why was that phrase eliminated in the 1 June draft?
2.
When I noticed the change above, it also became obvious to me that the "in a year" modifier is missing throughout #164#35./5; shouldn't it be included explicitly?
3.
In #164#35.75(c), the new language refers to "...authori7.ing the release if the administered activity is in excess..." Considor a hypothetical situation where the administered activity is too much to permit immediate release under any circumstances and the patient is confined overnight.
The next day the patient is released based on a measurement of total body activity, but still has more l
retained activity than would be allowed for release based on conservative assumptions.
In this case the release relates to calculations performed on the o
basis of RETAINED activity rather than on the basis of ADMINISTERED activity.
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Does the phrase in question need to be altered to:
... authorizing the release
(
if the administered activity (or the retained activity at the time of release) is in excess..."???
4.
The table distributed at the ACMUI Meeting includes confusing information regarding instructions for patients who are breast feeding and regarding the need to interrupt breast feeding.
I think the table should include the following columns for each entry:
a.
Radiopharmaceutical b.
Dose to infant per mci administered to mother if no interruption of breast feeding.
Maximum administered dose for infant dose of 100 mrem if no interruption c.
of breast feeding.
(Threshold for requiring instructions) d.
Maximum administered dose for infant dose of 500 mrem if no interruption of breast feeding.
(Threshold for requiring cessation or interruption)
Usual administered dose for a particular diagnostic or therapeutic e.
procedure.
f.
Instructions required (because dose >100 mrem)? (Yes or No)
(
g.
Period of interruption REQUIRED to maintain dose <500 mrem?
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h.
Period of interruption RECOMMENDED to maintain dose <100 mrem?
If this seems too confusing, could break into two separate table consisting of (a) through (d) and of (a) + (e) through (h), respectively.
5.
The final column in the current breast-feeding table is confusing because it is based on interrupting to keep the dose below 100 mrem. This certainly is Al. ARA, but not necessarily good medicine and not required by the intent of revised #164#35.75. Hence both columns (g) and (h) recommended above are needed in the table.
- 6. The total number of records related to breast feeding following diagnostic nuclear medicine studies is an imponderable number, but could be large.
Thus the record-keeping bursen could be substantial. Hence, I am curious to know what type of record you have in mind in #164#35.75(d). In the case of something that requires a written directive, it will be relatively easy to modify the written directive form to indicate that the issue of breast feeding has been addressed, that instructions have been given, and that cessation of breast feeding (or interruption for some specific period of time) has been recommended to the patient by the authorized user.
Ideally, similar information also will be recorded in the medical record by the prudent physician, in the case of a study for which no written directive is required, but which could require interruption to keep the dose <500 mrem, was it your notion that some new form would have to be created and stored for easy retrieval to allow for NRC 1
inspection? Alternatively, the physician could make the record as part of the diagnostic report, but it would be much harder for NRC to find these records j g)
(e.g., need to review 10,000 reports to find 4 or 5 such circumstances).
l g
G In the final analysis, I am quite uncertain exactly how NRC proposes to use these records as an inspection or enforcement tool.
Except for the I-131 catastrophes, which very likely would come to light on their own, NRC really has no way of ever knowing if a patient who was breast-feeding got a dose of a radiopharmaceutical for which instruction or interruption was required, but not done.
This might lead the overly cautious regulator to the " logical" conclusion that a signed statement must be obtained from every woman undergoing a nuclear medicine procedure (and maintained for NRC inspection) attesting to the fact that she is not breast feeding (and, next " logical" conclusion, that she is not pregnant--better yet, you could require a pregnancy test!!!).
Sarcasm aside, I remain most troubled about this component of the rule.
Since compliance depends so much on licensees' honest efforts to attempt to identify the at-risk subjects (but the effectiveness of these efforts is not likely to be measurable by NRC without a major escalation in the regulatory burden), why not drop the record requirement related to breast feeding (except possibly for those radiopharmaceuticals that require a written directive) and inspect to see that licensees have adequate procedures to protect breast fed infants?? For example, the inspector could look to see what kinds of signs are posted in the department, could ask the technologists whether they routinely ask female patients about breast feeding, and could review the written instructions given to those breast feeding patients identified.
(If you read between the lines, you'll realize that what I am in part saying is that the cart has gotten before
(
T the horse--we really needed the pregnancy and breast feeding rule already
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completed or being de/ eloped in tandem with the breast feeding component of
O
- 164#35.75.)
l 7.
I presume the table wC1 need to show for the NARM radiopharmaceuticals that the information is being provided for the benefit of licensees (as part of the spirit of ALARA), but there is no requirement to follow #164#35.75 for these radiopharmaceuticals??
j 8.
The existing patient-instruction pamphlets (which were designed with I-131 in mind and, thus, indicate that breast feeding must be terminated) do not adequately address the breast feeding instruction / interruption issue. Should NRC be developing a samphlet or sieggested instruction language (for placement in the RG) to fill tiis void?
I thought this was going to be a brief note, but it has turned into a treatise.
I hope you find my coments helpful.
Old you solicit input from any other ACMUI members? If so, I would like to see their coments.
If not, I suggest that it would be valuable to send the 1 June draft rule, along with my coments, to several members of the Comittee. At the least, I would send to Swanson and Wagner (who unfortunately is on vacation, which may conflict with your time requirements).
l Barry i
CC:
jeg@nrc. gov >, " Larry W. Camper" <1wc@nrc. gov O
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