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Home       > Electronic Reading       Room       > Document       Collections       > General       Communications       > Information       Notices       > 1999       > IN 99-24

UNITED STATESNUCLEAR REGULATORY COMMISSIONOFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDSWASHINGTON, D.C. 20555

July 12, 1999
NRC INFORMATION NOTICE 99-24:      BROAD-SCOPE LICENSEES' RESPONSIBILITIES FOR REVIEWING AND APPROVING       UNREGISTERED SEALED SOURCES AND DEVICES- Addressees: 
- Purpose: 
- Description   of Circumstances: 
- Discussion: 
Addressees:
All medical licensees of broad-scope and master materials licensees.
Purpose:
The U.S. Nuclear Regulatory Commission (NRC) is issuing this information notice to alert addressees to NRC's expectations about their uses of either sealed sources or devices which are not listed in the registry of radiation safety information on sealed sources and devices. It is expected that recipients will review this information for applicability to their facilities and consider actions, as appropriate, to address these issues. However, suggestions contained in this information notice are not new NRC requirements; therefore no specific action nor written response is required.
Description of Circumstances:
With the advent of new investigational studies using intravascular brachytherapy radiation treatments to prevent restenosis of coronary and peripheral arteries after balloon angioplasty, there has been a significant increase in the use of unregistered sealed sources and/or devices. There has also been a marked increase in reported patient misadministrations and other events relating to device failures. After two reported patient misadministrations in early 1998, discussed in detail in NRC Information Notice 98-10, there have been additional patient misadministrations, and events reported. NRC is concerned by the unexpectedly high rate of reported events for a relatively small number of unregistered sources and/or devices being used in these trials.

A primary contributing factor in these events, was the failure of the broad-scope licensees to perform appropriate radiation safety reviews of the sources and/or devices, the treatment protocols, and the procedures to be used in the clinical trials. These reviews directly contribute to the safe use of material, and must be performed to provide your radiation safety committee with the information necessary to properly evaluate your participation in the proposed human research trial.

NRC has granted broad scope licensees the authority to use sealed sources and/or devices that you have fabricated or obtained from vendors without prior NRC or Agreement State review and registration. However, you also have the responsibility for conducting these activities responsibly and safely. For example, 10 CFR 33.13(c)(3)(iii) requires the review and approval of these safety evaluations by the radiation safety committee, for Type A specific licensees of broad-scope.

If you fabricate and use source(s) and/or device(s) of your own design, then it is clearly your responsibility to review the source(s) and/or device(s) and determine if they can be safely used for their intended use(s). This includes developing and enforcing any procedures or restrictions deemed necessary for the safe use of the source/device. Equally important, but frequently overlooked, are your responsibilities for performing these same essential radiation safety reviews when using unregistered source(s)/device(s) obtained from external suppliers, such as the sponsors of clinical trials.
Discussion:
What are the responsibilities of my Radiation Safety Committee (RSC) when reviewing an application for approval of a specific medical use of sealed source(s) and/or device(s)?
The requirements for radiation safety evaluations, reviews and   approvals are set forth in 10 CFR 33.13(c)(3)(ii) and 10 CFR   33.13(c)(3)(iii) for Type A specific license of broad scope. Thus, your   radiation safety committee is required to insure that a proper radiation   safety evaluation commensurate with the intended use of the source(s) and/or   devices have been performed. 
How do I determine whether or not I need to perform a radiation safety evaluation of a source or device?
Check if the source and/or device is presently listed in NRC's   Registry of Sealed Sources and devices as approved for your intended use. The   registry can be accessed online through the NRC web page or at the following   URL address: http://nrc-stp.ornl.gov/ssdr.html.   If it is registered by NRC or an Agreement State and is approved     for the intended use, then no radiation safety evaluation by your     institution is required. If either the source and/or device has not been registered or,     the source and/or device has not been approved for your intended use, then,     to use this source/device, you must perform the appropriate radiation safety     evaluation and submit it for approval to your RSC. Caution: You   must insure that both source and device are registered, approved for use   together, and approved for your intended use. In at least one case a source is   approved for intravascular brachytherapy use. However, the corresponding   manual afterloading device for this source is not approved for intravascular   brachytherapy. In such instances, you must perform the necessary evaluation of   the device, including any impact on the radiation safety of using the source   in the device, and submit your evaluation to your RSC for approval. 
Is there guidance available on how to perform a review?
The requirements for performing these evaluations by the NRC and   Agreement States are set forth in 10   CFR 32.210. The guidance for performing these reviews is contained in NUREG-1556,   Vol. 3, "Consolidated Guidance About Materials Licenses - Applications for   Sealed Source and Device Evaluation and Registration." The applicable guidance   is summarized in the following questions and answers for both sources and   devices. The full content of the NUREG is on the NRC web site at the following   URL address: http://www.nrc.gov/NRC/nucmat.html. We expect a review that determines if a source/device can be   safely used for its intended use at your institution. This review should be   commensurate with the level of risk that could be reasonably anticipated from   the source/device for your intended use and likely accident conditions. Since   the guidance covers all types of reviews, you may not need to conform to the   same rigorous review process that is referenced. It is your responsibility to perform this review, obtain any   necessary design and test information from the vendor and, if needed, conduct   operational or other tests to discover and evaluate potential radiation safety   hazards. The results of this review, along with any necessary conditions or   limitations on use, should be submitted to your radiation safety committee or   radiological safety officer, for approval. We have found that it is useful to   develop appropriate written administrative procedures for the conduct of   reviews and the approval or disapproval of the intended use by your radiation   safety committee. 
How do I perform the radiation safety review for sealed sources?
Evaluate the likely environments to which the source will be   subjected in normal use and in likely accident conditions. Normal use and   likely accident conditions should include use, handling, storage, and   transportation. Particular attention should be given to the chemical and   physical environments to which the source is exposed, such as normal saline,   various body fluids, sterilization procedures (temperature extremes), and   mechanical stresses that may be placed on the source (particularly by any   devices used to contain and effect source exposures). Perform this radiation   safety evaluation of the source, commensurate with any perceived risks from   the failure of, or damage to, the source encapsulation. To properly conduct this source evaluation, you will almost   certainly require detailed design and construction information from the source   vendor. Vendor test data, if available, could significantly reduce the effort   required to perform the necessary radiation safety evaluation. However, if   essential design or test data are unavailable, you may have to chose between   more extensive testing or withholding approval of the proposed use. It is also   your responsibility to verify the accuracy of the data used to achieve the   prescribed treatment dose values through either: (1) direct measurement with   an appropriately calibrated measurement system; or, (2) a thorough review of   the vendor's calibration procedures. A thorough knowledge of the radiation   profiles from the source and any device within which it is used is essential.   Specific conditions of use should be developed to ensure personnel exposures   do not exceed 10   CFR Part 20 limits. 
How do I perform the radiation safety review for devices?
A safety evaluation must also be performed for a device used to   contain, shield, and control exposures of the source. The scope and depth of   this evaluation should be commensurate with the risks from failure of the   device. The evaluation must also consider any operational limitations inherent   in the device design that could lead to unintended exposures to radiation.   This would require, at a minimum, sufficiently detailed design and   construction data to allow a full understanding of the construction and   operation of the device and its components and safety features. Integrity of the source/device under normal conditions does not   necessarily mean the product will perform its intended function after being   subjected to an accident or unusual conditions. Under accident or unusual   conditions, the design should still ensure that the byproduct material is not   dispersed, the source remains within the protective source housing, and the   shielding integrity is not comprised. Items that need to be considered in this   evaluation include: - Use of dissimilar materials that are incompatible and could cause   corrosion (i.e., aluminum and stainless steel in a marine or saline   environment) is avoided;     
- The materials used in the construction are not degraded by exposure to   radiation or other conditions of use;     
- Fixed shielding cannot be easily moved or become dislodged;     
- All moving parts [including the source(s)] have adequate spacing to ensure   they will not bind during use. This would include use conditions, such as   bending of the source transport system, and any external forces that could be   applied to the device and/or transport system during use;     
- If applicable, the device can be locked in a closed (safe) condition, but   not in an open (unsafe) condition;     
- Indicators are present that clearly identify whether the source(s) is   exposed or in a safely shielded condition;     
- Safety interlocks, barriers, or guards are used sufficient to prevent   accidental exposures in excess of those specified in the regulations;     
- If pneumatic or hydraulic systems are used, there are appropriate   filtration, relief valves, and operating pressures;     
- The device is designed to be fail-safe (i.e., loss of power or a failure   in the system would return the source to, or leave it in, the fully shielded   position); and,     
- If applicable, the device is hermetically sealed from foreign materials or   moisture. 

I completed my safety evaluation and discovered design weaknesses or other risk factors that could pose radiation safety hazards during the anticipated conditions of use. What do I do?
One or more of the following options will usually be available to   you:- Withhold authorization for the requested use;     
- Correct any discovered design limitations or defects; or,     
- Adopt mandatory written procedures and/or limitations on the use of the   source to compensate for, or avoid, any radiation safety hazards discovered.   

I intend to participate in a clinical trial under an approved Food and Drug Administration (FDA) Investigative Device Exemption (IDE). Doesn't the FDA's IDE review and approval process eliminate the need for me to perform a corresponding sealed source device review?
No, the FDA IDE review does not substitute for sealed source   and/or device safety reviews. IDE or 510K device approvals do not satisfy the   requirements in 10   CFR Part 30 and, in turn, 10   CFR Part 32. The FDA review process focuses on the medical safety and efficacy   of the entire protocol, including any sources and/or devices used, with   respect to the patient. The NRC review and approval process takes a more broad   review of the radiation safety of the device. In particular the NRC review   focuses on the protection of workers and general public as well as the   protection of the patient from unintentional radiation exposures from such   devices. The FDA reviews devices under several different processes, such as   the IDE process for human research applications, the 510K, or pre-market   approval (PMA) processes for routine patient treatments, as appropriate, to   ensure its regulatory requirements are met. Similarly, NRC and/or Agreement   State reviews are performed to ensure that the Commission's regulatory   requirements are satisfied. Dual FDA and NRC reviews are regularly performed for sources and   devices for routine medical use. After a device is reviewed and approved under   the 510k, or similar process by the FDA, it must then be reviewed and   registered by NRC or an Agreement State, before medical licensees of limited   specific scope can be authorized for their use by NRC or a broad scope   licensee is relieved of performing its own radiation safety evaluations. 
What are my options if I either do not have or, do not wish to commit, the resources necessary to perform these full radiation safety evaluations?
If NRC broad-scope licensees do not wish to become involved in the   radiation safety evaluation of unregistered sources and/or devices in medical   applications, then they can elect to restrict their use of sealed sources of   byproduct materials and/or devices to those that have been reviewed by NRC or   an Agreement State and listed in the Registry as approved for the licensee's   intended use. The use of either a registered source or a device for a use that   is similar to, but not the same as, an approved use, may be a feasible   alternative. If your proposed use differs little from the approved use, then   the necessary radiation safety review could be fairly simple. 
Why this emphasis on performance of proper radiation safety reviews of sealed sources and devices by broad scope licensees at this time?
NRC has observed a considerable increase in patient   misadministrations and other events related to the use of unregistered sealed   sources and devices in the new intravascular brachytherapy clinical trials. In   nearly all of these events, a failure on the part of the licensee's RSC to   require an appropriate radiation safety evaluation of source/device used was   at least a contributing factor. We have observed that our broad scope   licensees seem to rely too heavily on the source/device vendor to provide   most, if not all, of the information necessary for the radiation safety   committee to properly perform a radiation safety review of the source/device. For example, in the patient misadministrations cited in NRC   Information Notice 98-10, if our broad-scope licensee had, before the event,   performed the device evaluation that was performed after the event, and   presented the reported corrective actions to its radiation safety committee as   recommended conditions for approval of the intended use, this would have   constituted the type of review and RSC approval process expected of such a   licensee and the event might well have been prevented. 
This Information Notice requires no specific action nor written response. If you have any questions about the information in this notice, please contact the technical contact listed below or the appropriate NRC regional office.
/s/'d by       
Donald A. Cool, DirectorDivision of Industrial and Medical Nuclear       SafetyOffice of Nuclear Material Safety and   Safeguards
Technical Contact:Robert L. Ayres, NMSS 301- 415-5746 E-mail:   rxa1@nrc.govAttachments:1. List of Recently Issued NMSS Information Notices 2. List of       Recently Issued NRC Information Notices(NUDOCS Accession Number 9907070034)