Outpatient Surgery Magazine is examining the lessons learned from real-life incidents that put patients in jeopardy. If your facility has experienced a near-miss or close call that resulted in revisions and improvements to your safety protocols, we'd like to tell your tale in our upcoming Manager's Guide to Patient Safety.

E-mail managing editor Daniel Cook at dcook@outpatientsurgery.net if you've handled any of the following patient safety situations:

Screening and treating patients for Staphylococcus aureus before elective orthopedic surgery can reduce the risk of surgical site infection by nearly 60%, according to a recently published study.

More than 7,000 patients undergoing elective, inpatient orthopedic procedures at New England Baptist Hospital in Boston between July 2006 and September 2007 were screened for methicillin-sensitive and methicillin-resistant Staphlylococcus aureus with a polymerase chain reaction-based diagnostic test. Less than a quarter (22.6%) of patients were found to be staph carriers, with 4.4% testing positive for MRSA.

Patients who tested positive for either type of staph were instructed via pre-op phone calls to apply 2% mupiricin ointment to the interior of each naris twice daily and shower with 2% chlorhexidine gluconate once daily for 5 days. Researchers tracked patients' compliance with these treatment measures via follow-up phone calls, and patients were re-tested for staph carrier status when admitted for surgery. Patients in whom staph had been eliminated received pre-operative antibiotic prophylaxis with vancomycin; patients who still carried MRSA were treated to standard MRSA isolation precautions in addition to pre-op antibiotics.

In their study, published in the August issue of the Journal of Bone and Joint Surgery, researchers compared the SSI rate among the study group to that among patients undergoing orthopedic surgery during a control period - October 2005 to July 2006 - and found the infection rate fell 59% with the screening program in place, from 0.45% to 0.19%. They suggest that the pre-screening program may have helped reduce SSIs because patients were treated with intranasal mupiricin and CHG showers, and because identifying MRSA carriers allowed clinicians to switch pre-operative antibiotic prophylaxis to vancomycin.

Implementing a pre-screening program to identify and eradicate staph in elective orthopedic surgery patients "is feasible and can lead to significant reductions in postoperative rates of surgical site infection," conclude the authors.

Irene Tsikitas

In the wake of criticism that its approval process for medical devices lacks sufficient rigor, the U.S. Food & Drug Administration has proposed regulatory changes that raise the bar for reviewing products and strengthen the agency's ability to later revoke its approval.

Manufacturers seeking FDA approval to market medical devices under the 510(k) process would, under the proposal, be required to submit a greater amount of safety information than they have been. In addition, the proposal discusses guidelines for revoking previously granted approval if a device is found to be unsafe or ineffective.

The FDA's 510(k) pre-market approval process was designed in the 1970s to fast-track the review of medical devices similar in nature to those which had already earned approval, says a published report. Approximately 4,000 products receive such approval each year, as opposed to the 50 wholly new products which undergo a much more stringent review.

In recent years, however, after risky flaws were identified in items which had passed through the 510(k) process, after medical device division researchers reported pressure to approve items and after the division's head resigned, lawmakers and healthcare industry observers called for stricter oversight.

The proposed changes, which were drafted by internal FDA panels, are not binding and are subject to public comment for 90 days.

David Bernard

For which types of cases are your surgeons more likely to use surgical glue than sutures: Arthroscopy, ENT, general, GYN or plastics? Let us know in our weekly online poll and check back next week for the results.

Last week's InstaPoll asked how often you verify the potency of the chemical germicides used for scope reprocessing. Of the 96 responses we received, 59% said they test their germicides before every reprocessing cycle. Another 37% reported testing once daily and the remaining 4% said they test twice daily, once in the morning and once in the afternoon.

"We run 50 to 60 GI patients through daily, so to do a 3-minute test on the [germicide] every wash would probably require an additional tech to wash scopes," says one ASC administrator. "If we check it at 7 a.m. and 11 a.m., we believe we are providing proper disinfection. To check before each cycle would not only be time-consuming and decrease efficiency, but also would be expensive."

Dan O'Connor