Medical Device Daily Washington Editor
Diagnostics maker Merlin Labs (Carlsbad, California) took in a March 9 letter posted to FDA's web site last week, citing the firm for validation lapses as well as a failure to obtain a PMA, a 510(k), or an investigational device exemption for one or more devices. The heavily redacted warning letter also cites corrective action lapses among other miscues, and while the firm's web site indicates the company focuses mostly on tests for malaria and dengue fever, the site also indicates that Merlin offers a diagnostic for an unspecified type A influenza test.
Under the section dealing with validation, FDA states that the company had "no pre-approved validation protocol" for an unspecified diagnostic, and lacked "pre-established acceptance criteria" for at least one process validation. Among the specific functions noted in this heavily redacted citation are equipment cleaning and pouch sealing. The firm's response to the 483 was seen as faulty for one of these manufacturing processes because it was not accompanied by "a process validation protocol with pre-determined specifications and associated test results." According to the warning letter, Merlin indicated that it "visually inspect[s]" the process in question.
The letter cites a failure to validate a change of design, but the brevity of the citation and the degree of redaction leaves little detail other than that the firm asserted that "the design validation and verification data are in the design history file," but the response included no copies of the data.
FDA indicates that the company failed to undertake procedurally required corrective and preventive action for false positives in connection with a diagnostic, the name of which was yet again redacted. The company's response was that the false positives had not been confirmed and that "the lot in question met specifications," stating that its handling of the situation did not constitute a CAPA, but rather were "improvements based on business decisions."
Merlin's troubles for this citation seemed to largely hinge on the fact that a subsequent complaint involved another false positive, which the company apparently had confirmed and which prompted the unspecified changes to the diagnostic. FDA argues that such changes "would appear to constitute a corrective and/or preventive action" rather than just a business-based improvement.
The warning letter also cites Merlin for problems with equipment calibration and device history records, the responses for which were both deemed adequate. However, FDA said it could not evaluate the firm's response for a citation for employee training, and informed the company that its response to a citation for equipment cleaning did not measure up because it lacked specifics on the frequency of cleaning.
At press time, the company had not responded to calls from Medical Device Daily for comment.
Respironics recalls apnea monitors
Respironics (Murrysville, Pennsylvania) has announced a voluntary recall of almost 5,000 of the SmartMonitor line of infant sleep apnea monitors. The move is prompted by the discovery that the unit may fail to sound an audible alarm, although no problem has been noted for the alert light on the unit.
The recall, announced April 26, was prompted by a single report of an alarm failure notification and affects units manufactured between Jan. 16 and Nov. 13, 2008. This is classified as a class III recall due to the risk of serious injury or death, and Respironics is pulling back all units in distribution and calling for all units in use to be returned.
FCC may add spectrum for device wi-fi
The Federal Communications Commission reported recently that it may add to the bandwidth it permits for the operation of wireless medical devices, which may expand use of a variety of devices in a hospital setting.
FCC has had its eye on the spectrum question for some time, announcing more than three years ago its intent to establish what sort of bandwidth medical devices will need in order to allow new technology to move into the healthcare setting (Medical Device Daily, Aug. 1, 2006). The current proposal would allow device makers and hospitals to use "wireless micro-power networks" occupying four discrete slots of seven megahertz (MHz) each between 413 and 547 MHz, a bandwidth that is at present partly used for land mobile radio and radar operations. Currently, wireless devices typically operate in the range of 401 to 406 MHz, and the intent of the current proposal is to foster space for the operation of neuromsuscular stimulation devices.
NIH swamped by grant applications
In a tough economy, good news often draws much more vigorous responses than is typical, and such seems to be the case for the monies allocated to the National Institutes of Health in the economic stimulus package passed by Congress earlier this year.
The stimulus program has added more than $8 billion to NIH's typical budget of $23 billion for research grants, and the agency's Office of Extramural Research (OER) is said to be overwhelmed. A recent story in USA Today quotes OER's Cheryl Fells as pleading "help!"
Fells' office handles phone calls from researchers looking for information on how to fill out grant paperwork online, a sure target for increased activity. While the agency expected as many as 15,000 applications, NIH has been hit with 20,000 applications and the deadline, May 29, has not yet passed.
NIH has roughly $200 million available for two-year grants in addition to about $1 billion in funds pegged for construction as an economic stimulus. Another $300 million will go toward equipment funding, a sum that is said to be likely to increase.