Welcome to the new Outpatient Surgery website! Check out our login FAQs.
This Just In
Coming Soon to an OR Near You
Bill Meltzer
Publish Date: October 10, 2007   |  Tags:   News

Coming Soon to an OR Near You
Meet Penelope, the $100,000 Robotic Scrub Nurse
Pending FDA approval, Penelope, a portable robot that can stand in for a live scrub nurse in some surgeries, may make its market debut this year. The robot can hand instruments to the surgeon during basic general surgeries such as simple excisions, hernias and some breast cases, eliminating the need for a human and freeing a nurse for patient care, says developer Michael Treat, MD, the director of laparoendoscopic surgery at Columbia Univer-sity's surgery department.

Penelope is a cart on wheels that holds a platform (a back tray, front Mayo stand and side instrument tray), a software-controlled robotic arm and the electronics - including the main CPU, microcontroller, digital camera, microphone and speakers. In the OR, the arm's electromagnetic gripper unpacks a sterile general instrument case from the back tray, arranges the 12 most-likely-to-be-used instruments on the cart's Mayo stand, puts the rest on the side tray and delivers them at the surgeon's request. Surgeons put used instruments in a sterile-transfer zone, and Penelope returns them to the Mayo stand.

Penelope is likely to pose some challenges because it is not an extension of the surgeon, like other OR robots, and displaces a nurse, says Dr. Treat. Still, he says, his experience and research show nurses become very excited about Penelope once accustomed to it.

Dr. Treat's team is working to better enable Penelope to track the surgeon's hand. The robot also needs custom sterile drapes. And since it cannot handle needles, the surgeon must draw the medications. Dr. Treat hopes to develop robot-ready needle packs and pre-loaded syringes and to upgrade Penelope to handle vascular and orthopedic instruments.

Dr. Treat says Penelope costs out to about $7 per hour over its life, based on an estimated $100,000 price.

- Dianne Taylor

Inside The Numbers
Inside The Numbers

  • 2,405: Number of sentinel events reviewed by JCAHO since January 1995
  • 1,616: Number of sentinel events facilities have self-reported to JCAHO since January 1995
  • 12.3%: Percent of sentinel events reviewed by JCAHO that pertain to a wrong-site surgery
  • 292: Combined number of hospital (274) and freestanding ambulatory (18) wrong-site surgeries reviewed by JCAHO
  • 11.5%: Percent of sentinel events reviewed by JCAHO that pertain to a medication error
  • 233: Combined number of hospital (229) and freestanding ambulatory (four) medication errors reviewed by JCAHO
  • 34: Number of anesthesia-related sentinel events in all care settings reviewed by JCAHO
  • 1: Number of office-surgery sentinel events reviewed by JCAHO since 1995

SOURCE: JCAHO Sentinel Event Statistics as of December 17, 2003

Orthopedic Surgery
Survey: Ortho Costs Jump Dramatically
The cost of doing orthopedic surgery jumped 12.3 percent nationwide, and liability insurance skyrocketed 26 percent in 2002, according to a new MGMA survey of 138 orthopedics groups. Additionally, staffing costs rose 8 percent.

In general, however, medium to large orthopedics practices generate higher revenues after deducting practice costs than facilities with fewer utilizing physicians. Practices utilized by seven-to-12 full-time-equivalent physicians earned median revenue of $505,927 after costs. Those with 13 or more ortho docs performed about the same, with a median revenue of $504,250. Those with three-to-six docs made $435,497.

Economic Credentialing Pits Hospitals vs. Physicians
Physician-Investors in Ohio Surgical Hospital Lose Hospital Privileges, May Head to Court
Seventeen physician-owners investing in New Albany (Ohio) Surgical Hospital (NASH) lost their hospital privileges at OhioHealth, Columbus, on Jan. 31 when a change in OhioHealth policy took effect. In a published report, orthopedic surgeon and physician-investor Carl Berasi, DO, calls the action "economic credentialing," saying that if it is allowed, "it will end all private practice of medicine in the United States."

Economic credentialing is the quickly growing practice of hospitals' issuing credentials based more on business interests and less on clinical competence. In this instance, when the physician-owners announced in spring 2002 that they planned to open 42-bed NASH, OhioHealth's board of directors appointed a task force to review the impact on the hospital and the options available, says David Morehead, MD, the chief medical officer at OhioHealth.

Despite the fact the task force estimated that $50 million would be shifted away from Columbus's three major integrated health systems - Ohio Health, Ohio State University and Mount Carmel - the board of directors decided to change hospital policy so that physicians who invest in hospitals with inpatient capabilities would be considered to be voluntarily relinquishing their privileges, says Dr. Morehead.

"The board struggled with this decision," says Dr. Morehead. "But it thinks it's the right thing to do. About $216 million is spent annually by the three health systems for charity care. And the board believed the conflict-of-interest situation, recognized nationally by anti-kickback and Stark laws and the recent Medicare bill, has a significant social concern.

"As one of the board members said, after several hours of discussion one night, 'It's impossible to be a partner and a competitor at the same time.'"

According to a NASH spokesman, the physicians are investigating the possibility of legal action.

In a similar case in Ohio, a trial court ruled a hospital was justified in changing its credentialing policy to "protect its business interests" after a group of physicians investing in an ASC sued, says Lorin Patterson, Esq., a partner with Shook, Hardy and Bacon, LLP. However, he says, "the American Medical Association has been extremely vocal in its opposition to economic credentialing," and the Office of Inspector General has solicited feedback on the practice to try to determine whether it's a violation of the anti-kickback statute. OIG may release some form of guidance document by fall. In addition, the Ohio State Medical Association pledged in a release on its Web site to "aggressively oppose any effort to implement economic-credentialing policies against physicians."

- Stephanie Wasek

Risk Management
Gauging Risk For Outpatient Surgery
The overall health of patients older than 65 and a surgery's invasiveness influence the chance of a hospital stay or death, according to a study in the January Archives of Surgery.

The study looks at 16 types of outpatient surgery, including cataract removal, hernia repair and knee arthroscopy; 360,780 were done at HOPDs, 175,288 in ASCs and 28,199 in a doctor's office. Some key results:

  • No patients died on the day of surgery at an office; four at an ASC (2.3 deaths per 100,000 procedures) and nine at an HOPD (2.5 per 100,000).
  • Death rate one week post-op: 35 per 100,000 for offices, 25 per 100,000 for ASCs, and 50 per 100,000 for HOPDs.
  • Hospitalization within a week was most likely for HOPD patients (21 per 1,000), second for office patients (9.08 per 1,000) and third for ASC (8.41 per 1,000).

- SW

FDA Issues Warning Letter to Staar Surgical
The FDA says it found several flaws in STAAR Surgical's manufacturing and medical device reporting practices during a routine inspection, alleging in a recent warning letter that Staar mishandled reports of "serious injuries attributed to the IOL/ICL, cartridges and injectors" and didn't assure the FDA that its test laboratories used validated methods to test raw materials and finished devices. Staar and the FDA met Jan. 14 to review the company's corrective-action plan as well as the company's overall quality-control system. The compliance issues shouldn't delay Staar's projected spring approval and release of the Implantable Contact Lens (ICL), Staar President and CEO David Bailey said in a teleconference.

Surgical Relief for Fecal Incontinence
Patients receiving the Secca procedure can obtain substantial relief from chronic fecal incontinence even if non-surgical methods failed, according to a multi-center study of 50 patients published in the December Diseases of the Colon and Rectum. In the procedure, proprietary to Curon Medical, the surgeon delivers radiofrequency energy to the muscle of the anal sphincter to improve its barrier function. The study was a prospective, non-randomized trial conducted at five centers and funded in full by Curon, says a company spokeswoman. According to population-based studies, fecal incontinence affects up to 16 million, or one in 13 U.S. adults.

Mobile Customer Support
Karl Storz Endoscopy-America, Inc., is the first original equipment manufacturer in the industry to offer mobile repair services. The FST program provides on-site maintenance and repair of Karl Storz products by company-trained field-service technicians. Services include endoscope exchanges, minor repairs on most instruments, educational in-services and regularly scheduled tray evaluations and preventative maintenance checks. FST services don't cost extra for Protection 1 customers.

Revised Hospital Outpatient Drug Reimbursements
The recent Medicare Reform Act extends by two years the revisions CMS made last year to hospital drug reimbursements under the HOPPS. CMS recently published its interim final regulation defining specific classes of separately reimbursable outpatient drugs. The 2004 and 2005 payments are subject to payment minimums and maximums based on the type of drug (sole-source patent drug, innovator multiple-source or generic multiple-source). The rule also changes 2004 payment rates for pass-through outpatient drugs and biologicals.