August 11, 1998
| SUBJECT: | Ocenco, Incorporated EBA 6.5 Non-conformance |
The purpose of this notice is to inform respirator users that the National Institute for Occupational Safety and Health (NIOSH) and the Mine Safety and Health Administration (MSHA) have determined that Ocenco, Incorporated, EBA 6.5 self-contained self-rescue (SCSR) devices approved under TC-13F-104 and produced or factory serviced from June 1, 1997 through March 31, 1998 have been found to be in non-conforming condition. Accordingly, NIOSH and MSHA no longer considered these devices to be approved breathing apparatus. Prompt arrangements should be made to have the affected devices refurbished or replaced with approved 1-hour SCSR apparatus.
The Ocenco EBA 6.5 SCSR devices manufactured and serviced during the above-identified period of time may be equipped with a non-approved exhalation valve. Tests have shown that the non-approved exhalation valve results in an increased exhalation breathing resistance, well above the approval requirement level set forth in Title 42, Code of Federal Regulations, Part 84, Section 84.91(e).
The elevated breathing resistance should not significantly impact most users. However, some miners, especially those with breathing problems, may have an elevated risk associated with escaping a toxic mine environment. Due to the wide variability of individual physiological conditions, and in-mine conditions, affecting egress in the event of a mine emergency, this non-conforming breathing resistance has the potential, to have a negative impact on the user's ability to use the device effectively.
Based on these concerns, MSHA is notifying mine operators to make prompt arrangements to have the affected devices refurbished or replaced as quickly as possible. MSHA will monitor the mine operators' efforts to ensure the affected devices are refurbished or replaced with an approved 1-hour SCSR device. Operators will be afforded the opportunity to make an informed decision and make the necessary arrangements to ensure the affected devices are refurbished or replaced as quickly as possible.
Devices produced during the period June 1, 1997 through March 31, 1998 may be identified by the serial number, the first four digits of which indicate the year and the month of manufacture. For example, a serial number that appears as "9706XXXX" would have been produced in June of 1997, whereas a serial number that appears as "9803XXXX" would have been produced in March of 1998. Devices that were subjected to factory service during this period of time may be identified by the factory service date printed on the label that is visible through the cover of the device.
During a routine product audit, two Ocenco EBA 6.5 SCSR devices were tested and exhibited elevated levels of breathing resistance. Ocenco was notified of the results of the audit, and asked to stop sale of the EBA 6.5 as a NIOSH/MSHA approved respirator, effective March 10, 1998.
Subsequent testing conducted at NIOSH identified that a non-approved exhalation valve diaphragm was the source of the increased exhalation breathing resistance. A total of 23 devices were tested by NIOSH and all 23 devices tested had a measured exhalation breathing resistance well above the maximum allowable limit. MSHA notified the mining industry of the potential problem and instructed mine operators to inform the miners of the potential of an increased breathing resistance, and that the device should continue to function and should be used in the event of an emergency. This notification also informed the industry that NIOSH and MSHA were working with the manufacturer to identify the cause of the problem and arrive at an effective solution.
Ocenco has taken corrective action to assure that the exhalation valve diaphragm installed in units produced or factory serviced on or after April 1, 1998 will conform to the approval requirements. The corrective actions taken by Ocenco have allowed NIOSH and MSHA to lift restrictions on the sale of new devices.
As a part of the same audit, NIOSH also found the tested units to be difficult to open quickly and easily following the technique described in the manufacturer's instruction manual. To address this issue Ocenco modified the instruction manual to show the proper technique to use in opening the device. These new procedures are detailed in Ocenco's latest approved instruction manual, EB-07 dated May 1998. All users are advised to confirm receipt of this approved manual for use in their self-rescuer training.
Additional information regarding this subject may be obtained by contacting NIOSH at 1-800-35-NIOSH, MSHA Technical Support at 412-892-6923, or Mr. Richard VanDerveer, Ocenco, Inc. at 414-947-9000.
Sincerely yours,
Richard W. Metzler, Chief
Certification and Quality Assurance Branch
Division of Respiratory Disease Studies, NIOSH