Medical Device Daily Washington Editor
FDA continues its crackdown on the medical device industry, the latest being a recommendation to healthcare providers that they jettison any System 1 sterilizers made by Steris (Mentor, Ohio). The Dec. 3 letter takes the unusual step of urging providers to replace their SS1s "as soon as possible to ensure continued patient safety."
FDA's action comes on the heels of an Aug. 15 warning letter to Steris citing the firm for changes to the SS1 that the agency deemed significant, but for which the company did not obtain clearance. According to the warning letter, those changes include a replacement for a circulation pump undertaken in 1999 to improve flow of sterilant through the device lumen.
Other changes include those to a high-pressure pump, to the system's connectors, and to the sterilant used in the SS1. The warning letter states that each of these individually would have necessitated the filing of a 510(k), although the letter does not state whether this is intended to mean a traditional 510(k) or one of the alternates, such as an abbreviated or special 510(k).
According to the letter to healthcare facilities, the agency is in possession of "some reports of malfunctions of the SS1 that had the potential to cause or contribute to serious injuries to patients, such as infections." FDA states that infections associated with a device reprocessed in the SS1 "may be difficult to attribute to the SS1 and may go unreported." FDA states further that it has received reports of injuries, "mostly burns from exposure to the sterilant solution."
Sterilization generally speaking seems to be of concern at the agency as demonstrated by a Nov. 19 communication to healthcare facilities regarding sterilization of endoscopes during reprocessing. On the other hand, the Aug. 15 warning to Steris was the second warning to the firm in less than a year. FDA wrote the company a Sept. 25, 2008, warning letter to the firm regarding operations at its plant in Coventry, Rhode Island (Medical Device Daily, Oct. 22, 2008).
FDA's letter to healthcare professionals advised that if facilities "have an acceptable alternative to the SS1 to meet your sterilization and disinfection needs," the facility "should transition to that alternative as soon as possible to ensure continued patient safety." If no alternative is immediately available, the agency states, the facility should "take steps to obtain legally-marketed substitutes for the SS1."
Steris had not responded to a call for comment by press time Friday.
HealthSouth associate fined $3 million
The Department of Justice announced recently that a sports medicine orthopedic clinic operating in Los Angeles, the Kerlan Jobe Orthopaedic Clinic, has agreed to shell out $3 million to settle charges that the clinic accepted kickbacks from HealthSouth (Birmingham, Alabama).
According to the Dec. 1 DoJ statement, HealthSouth gave Jobe a number of inducements including stock option grants, forgiveness on equipment loans, and "a disproportionately high ownership interest in a jointly owned ambulatory surgery center" for referrals to HealthSouth facilities. HealthSouth is said to have also made donations to the Kerlan Jobe Foundation in exchange for referrals.
DoJ states that Jobe was required to enter into a corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services "as a condition of continued participation in government healthcare programs." The action, according to DoJ, is associated with a settlement between HealthSouth and DoJ that cost the company almost $15 million "for improper financial relationships with Kerlan Jobe and an [unnamed] Alabama sports medicine clinic," which DoJ acknowledges was reported by the new management team that took over at HealthSouth in 2007.
HealthSouth's founder and then-CEO Richard Scrushy was indicted and eventually convicted in 2006 for a range of charges, including money laundering, and was ordered to pay damages of roughly $2.8 billion. Neither the HealthSouth nor the Kerlan Jobe web sites list any press statements on the matter.
IRB cited for lack of quorum
Conflict of interest still occupies a large place on the regulatory radar screen, including where institutional review boards (IRBs) are concerned. This was made clear in the Nov. 20 warning letter to Centra Health (Lynchburg, Virginia), which cited the IRB for counting a board member who had a conflict of interest as a qualifying voting member in reviews of ongoing studies.
The first citation states that Centra had used a retroactive re-approval of an ongoing study, the name of which was redacted, rather than review the study on schedule. The IRB's proposed correction, FDA states, was inadequate because Centra did not include documentation of the proposed fix, which is said to include "a spreadsheet and an e-mail calendar ... to remind the IRB when a study is due for renewal."
The stickiest part of the warning letter, however, was that Centra voted in January 2007 to approve a study despite not achieving a quorum. According to FDA, the board counted toward the quorum a member of the IRB who was conflicted, and FDA asserted in the warning letter that this member "should have been excluded in the total count of voting members." The warning letter states further that a similar situation arose in May 2007 involving two board members who were conflicted but who were nonetheless counted toward the quorum.
Centra's response to this finding on the 483 apparently indicated that the IRB was of the view that "an abstention does not break a quorum." FDA states that according to the pertinent regulations, ""a majority is defined as more than 50% of the total voting members of an IRB (excluding alternates)." Hence, the agency argues, Centra "did not maintain the required majority to review" studies. FDA also asked for proof of corrective action.
Centra was also cited for failure to document "the actual numbers of members who voted for, against and abstained" from votes" in reference to two IRB meetings held in May 2007. The warning letter states that the IRB's minutes noted only "unanimous approvals." The IRB's response was said to assure FDA that future notes would be more exhaustive, but the agency requested "evidence of the corrective actions."
Mark McCarty, 703-268-5690