Medical Device Daily Washington Editor

Physio-Control (Redmond, Washington), maker of external defibrillators, has been in the news quite a bit over the past year and a half, and is now drawing more ink because of a recent class I recall of 249 units of its LifePak CR Plus automated external defibrillators (AEDs).

The company initiated the recall because the units were loaded with software written for its semi-automated AEDs.

According to the Sept. 11 statement, the company already has completed the recall of the affected units, which when activated would display a prompt to "press the shock button to deliver therapy." Physio-Control indicated that the shock button is covered on the automated units and as a consequence, "it is possible that therapy could be delayed or not delivered at all, possibly resulting in death."

The company notes that one complaint has surfaced in connection with one of the affected units and that as of Sept. 2, it "has notified all affected customers and shipped replacement devices at no charge." In the meantime, the company recommends that customers either remove the unit or "remove and discard the shock button cover" per instructions it has provided.

The firm's owner, Medtronic (Minneapolis), had attempted to spin off Physio-Control last year, but production problems halted the plan (Medical Device Daily, Jan. 18, 2007). Medtronic signed a consent decree with FDA earlier this year over quality problems at Physio-Control's plant in Redmond (MDD, April 29, 2008), but FDA's warning letter database indicates no issuance of a warning letter.

The company reported last month that one of its AEDs would be the first in space (MDD, Aug. 14, 2008).

Ann Devine, public relations manager at Physio-Control, told Medical Device Daily that the problem with the incorrectly downloaded software was due to a "keying-in error." She also said that the hardware design of the LifePak CR fully automated unit is essentially the same as the semi-automated unit for which the software in question was written, hence the availability of the shock button on the automated version.

Regarding the company's persistent problems with regulations governing good manufacturing practices, Devine said, "We're working very closely with FDA and with a third-party auditor" to bring operations into compliance. She said the company and FDA have not yet set up a future inspection date to check on the company's corrections.

Warning for contract manufacturing

The Aug. 27 warning letter to Sgarlato Labs (San Jose, California), maker of infusion pumps for pain management for surgical patients, suggested a problem with adherence to the company's standard operating procedures, but the text of the letter also indicated that Sgarlato had contracted the manufacture of its pumps to a third party, continuing a trend of warnings citing firms that engage in the practice.

The warning letter led with a citation for lack of procedures for testing "incoming product." The letter, which was extensively redacted, noted that Sgarlato "was unable to provide any receiving inspection documentation for" at least one lot of an incoming product that was not identified due to redaction.

For another lot, the relevant company documentation indicated that someone at the company "did not test these pumps, had to fill order," and a set of lots of incoming pumps were, according to company documents, simply not tested with no explanation offered in the relevant documents.

FDA described this as "a serious deficiency in receiving and acceptance, and indicates your firm introduced untested pumps into interstate commerce."

In the case of procedures for testing existing inventory for expiration, the warning letter indicated that Sgarlato had no procedures at all. According to FDA, the company "shipped a Pain Free pump kit ... with the expiration date on the label blackened' out with a marker." The pump is said to have had a shelf life of two years, but the date of the sale and information about the discrepancy between date of expiry and date of sale was redacted.

Perhaps the most telling citation was that executive management failed "to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency." The warning letter stated that company documents indicated a management review took place last year, but FDA said the company "was unable to provide documentation of a management review" in that time frame.

Other citations included lack of procedures for quality audits, for corrective/preventive action, and for complaint handling. At press time, the company had not responded to calls for comment.

FDA seeks input on LASIK

The hearing held earlier this year by the ophthalmic devices advisory committee made clear that at least a few patients were given LASIK (laser-assisted in situ keratomileusis) treatment despite exhibiting pupils that fell outside the approved range of diameter, and while the raw numbers of adverse events were small, the severity of those events gave FDA reason to more closely track LASIK.

According to numbers presented at the April 25 meeting, FDA has received 140 reports on the procedure over the past decade, which amounts to less than one complaint for every 10,000 patients (MDD, April 29, 2008). However, the few problems have included visual haloes and dry eye.

The agency followed up with an announcement in the Sept. 12 edition of the Federal Register that opens a docket for comment on LASIK. Specifically, FDA is "seeking ways to better understand quality of life issues following LASIK procedures that may relate to safety and effectiveness."