ROANOKE TIMES
Copyright (c) 1997, Roanoke Times
DATE: Sunday, March 9, 1997 TAG: 9703070003
SECTION: BUSINESS PAGE: 1 EDITION: METRO
SOURCE: SANDRA BROWN KELLY/THE ROANOKE TIMES
ROANOKE GENERAL surgeon Thomas Henretta sews up incisions the old-fashioned way: with a hand-threaded needle. He shuns disposable sutures with pre-attached needles both as a matter of pride in his skill and as a way to save on costs.
His needles get sterilized and reused.
"It's something like 40 to 50 times more expensive if you use the pre-threaded ones," Henretta said.
He also avoids the disposable staplers that are used to close incisions in intestines.
"I always hand sew. It's more accurate," he said.
The medical profession must return to using less disposable equipment, said the surgeon with 28 years experience.
His practice, Jefferson Surgical Clinic, keeps both disposable plastic and reusable glass syringes on hand, and you know which one Henretta prefers. But not every surgeon works where he has options, he said.
Sometimes, operating room staff have grown up with disposables and aren't trained to even thread the needles. Generally, though, the trend is to look for ways to cut costs much like the waitress who leaves unopened butter and jelly packs for the next guest. Once upon a time, she would have scooped everything into the trash.
Something similar happens regularly in hospital operating rooms.
For example, the operating room staff knows which supplies Henretta and other surgeons routinely use during a surgery and only those items are brought into the operating room. If a prepackaged surgical tray includes materials a surgeon likely won't need, those items are left behind to be repackaged in sterile covering and made available for another surgery.
The return to a less wasteful business is one of the "good parts" of managed care, Henretta said.
"If you're going to practice in today's modern society, waste has to be eliminated. It's too expensive," he said.
The scissors used to clip away a gallbladder when the surgery is performed through a small scope inserted into the patient's abdomen are a good example of the money involved. Reusable scissors for the surgery cost about $18; the throwaway scissors cost close to $90.
"The nonreusable is sharper, but I don't think it makes $60 more difference," Henretta said.
But not every disposable instrument or device has a reusable counterpart, and therein hangs the real controversy in the health care industry. Increasingly, hospitals are reusing items labeled for one-time use.
Instruments used in surgeries performed with the laproscope, or lighted scope, are at the center of the controversy surrounding the reuse issue.
"When you look at some of these products that are disposable, they have these little grooves [that make them harder to clean] ," Bishop said. "Everybody's concerned about cost, but you have to be concerned about safety."
The practices of rescuing unused materials and reusing medical instruments labeled for single use have become so common that a dozen new national businesses have sprung up to repackage sterile materials and rework the used instruments. At the same time, trade associations and federal agencies are working on guidelines to assure patient safety in the midst of the growing frugality.
The Food and Drug Administration first issued reuse directives in 1977. Recently, though, the agency met with the Centers for Disease Control and the Health Care Financing Administration to revisit the issue.
"We wanted to try to find out what kind of reports of problems we're getting and to decide how best to measure if reuse is a problem," said Sharon Snider, FDA spokeswoman.
The agency doesn't regulate hospital practices, but it knows that the reuse practice has become more extensive, she said.
"We've had some concerns. We're not sure the safety has been established," Snider said.
Currently, the only data available are reports manufacturers and hospitals must submit if serious injuries or patient deaths are related to the malfunction of devices.
In the past five years, the department has gotten fewer than 100 reports of infections, injuries from sterilizing chemicals or mechanical failure where a single-use device was involved. Even these don't indicate whether reuse of the device was the cause, she said.
Another 600 reports are about reuse of hemodialyzers with kidney patients. They do not indicate much of a problem because during the period covered by the 600 reports, about 40 million dialysis treatments took place. Plus most of the reports preceded a change in the sterilization practices of dialysis clinics, said the FDA.
From the recent meeting, however, the FDA decided to do pilot studies to assess the size of the problem of single use. The Centers for Disease Control and the Veterans Affairs Medical Centers will be involved in the studies, which should begin by summer, Snider said.
Definitive data would be welcome, said the Emergency Care Research Institute, a health research agency in Plymouth Meeting, Pa.
ECRI recently issued a report on reuse of devices that basically said there is no literature to support it as a good or bad practice, said Chris Lavanchy, engineering director for the institute's health devices group.
ECRI also looked at regulatory and legal aspects of the issue and found that there are no regulations and that reuse decisions are left up to hospitals or surgical clinics.
Perhaps the greatest concern to emerge from the research for the report was one of ethics.
"It's a question that you have a process with one main objective - to save a hospital money. It has no therapeutic value for the patient," Lavanchy said. "Is this the right thing to do in health care environment?"
Money's the inspiration in reuse, no question about it, says a California nephrologist who is a spokesman for the National Kidney Foundation. The cost of new dialyzers can amount to 30 percent of total reimbursement for the procedure, said Dr. Jimmy Roberts of New West Dialysis Clinic in Chico.
Probably 90 percent of patients with end stage renal disease are dialyzing with reused hemodialyzers, the filtering devices that take waste out of the blood, he said.
If the devices are resterilized and reprocessed according to standards of the American Association for Medical Instrumentation, they shouldn't create problems, he said.
Even so, the Dialysis Outcomes Quality Initiative, a program of the national foundation, plans to issue even stricter guidelines on the reuse issue in April, he said.
Any facility trying to decide which devices to reuse must base the decision on safety issues first and then cost effectiveness, experts agree.
Everyone agrees that the most important issue in reuse is whether the device can be cleaned.
"A basic tenet in sterilization is that if you can't clean it, you can't sterilize it," said Lavanchy.
"You always have to make sure it's safe," said Kereen Mullenbach, vice president of patient care services at Columbia Lewis-Gale Medical Center in Salem.
That's one reason Lewis-Gale is following the trend and not reusing as many items as some hospitals do, she said.
Some hospitals are reusing a little item called an "eater," which acts like a PacMan in arthroscopic knee surgery to chew bad cartilage into bits so it can be suctioned out. The "eater" has too many nooks and crannies to be cleaned, so Lewis-Gale doesn't reuse it, said Nancy Obenshain, director of surgery.
"We also don't reuse any catheter," she said.
Catheters are flexible tubes inserted into narrow openings, such as arteries, to remove or introduce liquids. Many hospitals reuse the balloon catheters used to reopen clogged arteries in a procedure called angioplasty. It's one of the practices being questioned. Some experts believe the balloons lose too much strength with one use to be effective in reuse.
The concerns of reuse in general are sufficient to have rallied more than the FDA.
ECRI, which has been tracking reuse for about 10 years, put together a checklist a hospital can use to evaluate the companies that offer resterilization services.
"We haven't come forth and devised a protocol for each device, but we put together a list of things people are asking about," Lavanchy said.
The Association for the Advancement of Medical Instrumentation in Arlington has started to sell a book on the topic. It originally was published by the Canadian Healthcare Association and explores the issues and is a guidebook to help organizations establish a reuse policy and plan.
The manufacturers also have spoken.
The Health Industry Manufacturers Association just issued a position paper opposing reuse of single-use devices. It also supported the right of manufacturers to design and label devices for single use, opposed government intervention with the manufacturing processes and called for the FDA to regulate companies who reprocess the disposable items.
Still, some health care workers wonder whether manufacturers are being fair in deciding what is a single-use item and what can have a second go-around.
Roberts, the California kidney specialist, believes some devices are labeled for single use by manufacturers "as a protective mechanism."
"It's not in their interest to have the devices reused," he said.
Roanoke surgeon Henretta said he's seeing some changes from manufacturers, however.
Each year he attends the annual meeting of the American College of Surgeons, which always features extensive manufacturers' exhibits.
"What we're starting now to see are signs saying: 'Buy our product; it's cheaper.' For the first time, we're starting to see emphasis on that," Henretta said.
LENGTH: Long : 179 lines ILLUSTRATION: PHOTO: Roger Hart. 1. Jackie Claytor (right), central supplyby CNBtechnician, carries a bin of used surgical instruments for Bea
Brown, another technician, who will put them in the
washer\decontaminator at Columbia Lewis-Gale Medical Center in
Salem. 2. Single-use arthroscopic blades routinely reused elsewhere
but not by Roanoke Valley hospitals. 3. Nurse Nancy Obenshain,
director of surgery at Columbia Lewis-Gale Medical Center in Salem,
oversees instrument sterilization for the hospital. 4. Jackie
Claytor, central supply technician at Lewis-Gale, rolls out a cart
of packaged surgical medical supplies to the Steam Autoclave for the
final sterilization process for reusable instruments. color.