ML20198A975
| ML20198A975 | |
| Person / Time | |
|---|---|
| Site: | 07001500 |
| Issue date: | 01/05/1982 |
| From: | Kinneman J, Mcguinness J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | |
| Shared Package | |
| ML20197F076 | List: |
| References | |
| FOIA-86-104 70-1500-81-01, 70-1500-81-1, NUDOCS 8605210373 | |
| Download: ML20198A975 (4) | |
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U.S. NUCLEAR REGULATORY COP 94ISSION OFFICE OF INSPECTION AND ENFORCEMENT REGION I Report No. 70-1500/81-01 Docket No. 70-01500 License No. SNM-1446 Priority G Category IV Licensee: Washington Hospital Center 110 Irving Street, NW Washington DC 20010 Facility Name: Washington Hospital Center Inspection at: 110 Irving Stret, NW, Washington, DC 20010 Inspection conducted: September 1, 1981 Inspector: h. NcI//uw //r/fd
'date signed JpMcGinness,RadiationSpecialist A, ived by wAv-
. D. Kinneman, Chief, Materials
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/ dite signed ddiological Protection Section Inspection Summary:
Inspection on September 1, 1981 (Report No. 70-1500/81-01)
Areas Inspected: Special, announced inspection of circumstances surrounding the implantation of Coratomic Model C-10lP nuclear powered pacemakers including review of licensed activities, review of patient followup, and disposal of exp' anted sources. The inspection involved 3.5 inspector h w s on site by one NRC inspector. ,
Results: One violation was identified. Violation - unauthorized receipt and use of licensed materials paragraph 3.
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DETAILS t
- 1. Persons Contacted 4
- D. Musgrave, Associate Administrator N. Smythe, M.D.
D. Sager, R.N..
- K. Williams, Radiation Safety Officer
- Denotes those present at exit interview
'2. Description of Licensed Activities Washington Hospital Center is authorized by License No. SNM-1466 to- i receive and implant nuclear powered cardiac pacemakers. The licensee has e implanted about 70 nuclear powered pacemakers of the demand responsive type. During 1980 and 1981 a total of 5 C-10lP pacemakers were implanted in patients.
A licensee representative provided the following information concerning the date and serial numbers of the devices implanted.
7 Date Serial Number Model Number
- 1. February 22, 1980 1150 C101P
- 2. January 19, 1981 .1154 C101P 3.. March 2, 1981 1151 C10lP
- 4. June 2, 1981 1156- C10lP
- 5. July 20, 1981 1157 C10lP The licensee representative informed the inspector that the first Model C-101P nuclear pacemaker was implanted under the assumption that the Model C-101P was essentially the same device as the Model C-101 for which the hospital was licensed. The plutonium-238 battery is the same in both -
devices. In addition, they understood that all other com'ponents had previous FDA-approval as part of other nuclear and/or lithium battery operated pacemakers. The licensee believed that there was no need to amend their license to'. include the possession and use of the Model C-10lP.
The second and third Coratomic Model C-10lP pacemakers were implanted at Washington Hospital Center (WHC) after the NRC informed Coratomic and WHC that NRC authorization'for distribution and implantation of the C-101P pacemaker required FDA authorization of the marketing of the device. -WHC assumed that the distribution of the Model C-10lP pacemaker would be permitted as custom devices under FDA regulations until a complete FDA approval could be obtained. Custom devices are exempt from most FDA requirements.
On May 29, 1981, the NRC's-Materials Licensing Branch learned that Washington Hospital Center was requesting permission to implant two more Model C-10lP pacemakers in addition to the three which had already been implanted.
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3 Basad en this request, a series of telephone calls ensued during which the MC told both the Washington Hospital Center and Coratomic that this proposed distribution and implantation of Model C-101P pacemakers was not authorized under their respective licenses. However, the Materials Licensing Branch granted an amendment authorizing the three pacemakers previously implanted on May 29, 1981.
On June 1,1981, the FDA gave Coratomic approval for implantation of two pacemakers additional as custom devices. Since WHC and Coratomic had been told that FDA and NRC were working together on this matter, both assumed that the FDA approval implied that Coratomic had authorization to ship the two C-101P pacemakers to Washington Hospital Center. The two devices were then shipped to the hospital. Coratomic was informed by the NRC that Coratomic's license required amendment before the pacemakers could be transferred to Washington Hospital Center which would also be required to amend their license for receipt and possession of the addition of Model C-10lP pacemakers following shipment of the devices. One of the two Model C-10lP pacemakers was implanted on the morning of June 2, 1981, due to a pressing medical need. The second was placed in storage at WHC until the license was amended on June 8, 1981 to authorize the Model C-10lP pacemakers already implanted and one addition. The final #
device was implanted on July 20, 1981 and as of September 1,1981, the hospital did not have any nuclear powered pacemakers in storage.
Currently the hospital is waiting for Coratomic to receive an approved FDA Investigational Device Exemption (IDE) for these devices and plans to participate in the IDE protocol.
The finding that the licensee implanted four Model C-10lP pacemakers between February 22, 1980 and June 2,1981 prior to authorization in their specific license constitutes noncompliance with Condition 9.8 of License SNM-1466.
- 3. Patient Follow-up The inspector reviewed records of follow-up visits made by patients who had nuclear powered pacemakers implanted at WHC. All patients made semi-annual visits to an authorized physician's office or telephoned their cardiograms into the office for proper evaluation, in accordance with license conditions.
Nuclear powered pacemakers from expired patients or malfunctioning pacemakers were retrieved and returned to the manufacturer in accordance with license conditions.
No items of noncompliance were identified.
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- 4. Exit Interview The inspector met with the licensee representatives denoted in paragraph 1 at the conclusion of the inspection on September 1,1981 and summarized the scope and findings of the inspection. The inspector emphasized the requirement that prior to receipt of any device containing licensed
, material, the license must be amended to authorize that licensed material. The licensee stated that they now clearly understand the NRC requirements in this area.
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