5 Infection Control Controversies

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Questions answered and answers questioned by leading infection experts.


In the past few years, several long-standing operating room practices have fallen by the wayside after research challenged their validity. Among these are the use of shoe covers as an infection control intervention and the use of cover gowns when leaving the OR suite. When we asked our panel of experts to address several infection control controversies that still may be roiling at your facility, here's what they had to say.

1. Should you reprocess SUDs?
In an effort to reduce supply costs, more surgery centers are reprocessing single-use devices (SUDs), either hiring a third-party to do it, or reprocessing in-house. But whether you should override original manufacturers' recommendations to do this - and what the rules should be - is a gray area.

Supporters of SUD reprocessing argue that it's a good way for a surgical facility to save money and point to recent FDA regulations as indicators of reprocessing safety; opponents say the risks outweigh the benefits and that research has not proven it's a safe practice.

According to a recent Outpatient Surgery infection prevention survey (n=101)

  • 81.2 percent of respondents never reprocess SUDs in-house;
  • 4 percent reprocess SUDs that have been used on a patient;
  • 16.8 percent do it on opened-but-unused SUDs;
  • and 5 percent reprocess unopened SUDs brought to the surgical site. Additionally, 61.4 percent never send SUDs to third-party reprocessors. Of those who do use a third-party reprocessor, 20.8 percent send used SUDs, 31.7 percent send opened-but-unused devices and 7.9 percent send those that were brought to the surgical site but unopened.

It's fine to reprocess in-house opened-but-unused SUDs, but those are also the only ones you should send to a third-party reprocessor, says Marsha Miller, RN, MEd, CNOR, manager of professional education and training for Advanced Sterilization Products. The guidance gets fuzzy when it comes to used SUDs. Terrence Fullum, MD, FACS, the chairman of the department of surgery at Providence Hospital in Washington, D.C., offers these arguments against the practice:

  • Most healthcare providers aren't comfortable using used, reprocessed SUDs. A recent survey released by the Center for Patient Advocacy showed 74 percent of surgeons and 79 percent of nurses believe that the use of reprocessed SUDs should be discontinued.1
  • SUDs aren't designed to stand up to the rigors of cleaning and sterilization because they weren't made with sterilization in mind. SUDs that have been reprocessed may malfunction or simply perform differently than intended. Small changes may not be visible during inspection, but they can lead to costly mistakes and even adverse outcomes.
  • The FDA, concerned about the safety of SUDs, issued the Medical Device User Fee and Modernization Act in 2002.2,3 It requires reprocessors to establish with validation data that a device they want to reprocess is substantially equivalent after reprocessing. Many of these requirements haven't taken effect yet, such as the labeling of reprocessed SUDs as such, which has been delayed for nearly two years.
  • While a reprocessing program may lower costs for instruments, consider the hidden costs, such as inventory and storage of new and reprocessed instruments, the possibility increased procedure time if a device doesn't function properly, additional staff time for cleaning and sorting and extra paperwork for materials management. The potential liability if a reprocessed instrument fails might outweigh the savings.
  • Some facilities that reprocess SUDs don't inform providers or their patients that they engage in the practice. This may violate the healthcare ethic of informed consent.

Still, "there are probably very few dangers associated with cleaning, sterilizing and reusing simple devices," says Outpatient Surgery's Dan Mayworm, who suggests you go to writeOutLink("www.FDA.gov/CDRH.reuse",1) for a list of commonly reprocessed SUDs and the degree of risk the FDA believes each device poses when reprocessed (high, medium or low). Don't, he says, ever consider high- (Class III) or medium-risk (Class II) devices for in-house reprocessing. You can view the classifications at writeOutLink("www.accessdata.fda.gov/scripts/cdrh/cfdocs/classification.cfm",1).

2. Is it acceptable to do "clean" and "dirty" procedures back-to-back?
Some OR managers, surgeons or administrators may worry that "clean" and "dirty" procedures - for example, a carpal tunnel release and a bowel resection - can't be performed in the same room, let alone back to back. "I'm not aware of any regulations requiring separation," says Mr. Mayworm. "All cases should be considered dirty, it's just that some are more dirty than others."

While it may be ideal to have one room dedicated to clean procedures and one dedicated to dirty ones, this isn't always possible. Smart scheduling can help. "Common sense should tell you that scheduling a total hip replacement, followed by a bowel resection, followed by a CABG, would be poor scheduling," says Mr. Mayworm. "It would make sense, though, to schedule the so-called clean cases first in the day and dirty cases at the end of the day if they are all going to be done in the same room."

Russell Olmsted, MPH, CIC, an epidemiologist for St. Joseph Mercy Health System in Ann Arbor, Mich., agrees: "There is no evidence that having a reserved room is better. You should have the same level of environmental care for all cases - clean well for all cases and follow standard precautions."

3. DO WE NEED ultraviolet germicidal lights in the OR?
Ultraviolet lamps are intended to destroy microorganisms in the air or on exposed surfaces, but relying on them might give OR workers a false sense of security when it comes to other infection control protocols, says Mr. Mayworm. Here's why:

  • they have limited penetrating power;
  • they're only effective when the lamps are properly cleaned, maintained and checked to ensure the appropriate intensity is being emitted;
  • they attract dust and thus reduce their germicidal effect;
  • they need to be changed regularly, which makes it easy to let the lamps surpass their effective lifespan;
  • when the terminal ends are blackened even slightly, they lose their effectiveness (even if they still glow blue-violet) and
  • UV light can harm eyes and skin, and personnel should never be directly exposed to it.

In addition, says Mr. Olmsted, "for them to work, the air has to pass by the UV lamps - and you'd have to have some sort of air flow to achieve this." For these reasons, the CDC doesn't recommend installing UV lights to prevent surgical site infection, and suggests keeping OR traffic to a minimum.

"It is far safer - and better - to effectively filter the air," says Mr. Mayworm.

HEPA Not Just for the OR

High efficiency particulate air (HEPA) filtration has many uses outside filtering the bacteria out of your ORs.

They are also used in hospital isolation rooms, pharmaceutical and computer chip manufacturing and other applications requiring "absolute" filtration. In addition, HEPA filtration is a way to sterilize fluids such as IV solutions. And beer - that's what "cold-filtered" is.

Today HEPA air cleaners, vacuum cleaners and air filters are used in a wide variety of critical filtration in the nuclear, electronic, aerospace, pharmaceutical, medical and household applications. HEPA air cleaners, vacuum cleaners and air filters are required by federal law to be used in all equipment for asbestos abatement.

- Dan Mayworm

4. Should you install a laminar flow/HEPA filtration system in your OR?
By its nature, OR air might contain microbe-laden dust, lint, skin squames or respiratory droplets that become airborne through normal activities such as breathing, talking or moving. Gowns and facemasks can only do so much - filtering the air can remove airborne bacteria and other contaminants before they settle on you or your patients.

Orthopedic surgeons used to wear so-called space suits to avoid contaminating a surgical site that could be exposed for several hours. But they were uncomfortable and cumbersome and quickly lost proponents (although some still insist on using them). The advantage was that they were self-contained and protected the patient from the surgeon. The disadvantage was that they did not control ambient air, which a laminar flow system and high-efficiency particulate air (HEPA) filters do. But do you need to go to the length and cost of installing such a system?

First, here's how they work: Laminar flow and HEPA filters combine to remove bacteria in that laminar flow directs air through a HEPA filter; HEPA filters capture from 99.97 percent to 99.99 percent of particles that are 0.3 microns or larger. A laminar flow system moves air in a unidirectional (laminar) pattern; ultra-clean air enters the OR at one end, moves through the room at a steady-but-imperceptible rate of about 1 mph, carries microbes with it and exits at the opposite wall. There, it is cleaned by HEPA filters, then re-circulated.

The critical question is "do the types of procedures being done warrant the expense of outfitting the suite to produce laminar flow HEPA-filtered air to the surgical site," says Mr. Mayworm. "The answer may well also depend on who is doing the surgery and who is paying for the filtration system."

Consider it if your facility performs mainly or strictly orthopedics cases, because you don't want bacteria settling on implants before they are put in patients. But, says Mr. Olmsted, the "CDC environmental infection control guidelines make no specific recommendation for laminar flow for ORs where joint prosthesis is performed."

Strictly clean the ducts and their filter systems, which provide sufficient safety and a good cost/benefit ratio for most surgical situations, says Mr. Olmsted.

5. single-use or reusable endoscope accessories?
As with many medical devices, when it comes to endoscope accessories such as snares and forceps, you have a choice: single-use or reusable. Which, from an infection-control standpoint, is better?

In terms of materials and designs, more endoscopy instruments can be steam sterilized than ever before. "It's the gold standard of reprocessing instruments, so if they're able to withstand the rigors, accessories should be steam sterilized," says an Olympus infection control expert. "But attitudes have not been changing as quickly as they should."

But, cautions Candy LeBlanc, RN, MSN, the manager of product consulting at Advanced Sterilization Products, endoscope accessories have "tiny little teeth like needles that take the bites out of the tissue - and it's very, very difficult to clean those tiny teeth."

Mr. Mayworm advises you to write a tempered approach into your policy manual.

"You can do either, and steam sterilization can be less expensive," he says, "but it needs to be done properly, including scrupulous cleaning before sterilization. Disposables are always more expensive, but they do have the advantage of being more convenient and free from any debris before use."

Mr. Mayworm's advice: Use steam sterilization if you have a well-trained staff. Otherwise, go with disposables.

Time to change?
Infection control research and techniques are constantly being updated. Stay on top of the latest developments, and weigh them against the old methods, efficiency, cost-effectiveness and common sense to help determine whether you change your practices.

References
1. Center for Patient Advocacy. Press release, "Reused Medical Devices Pose Health and Safety Risks to Patients: Survey Shows Majority of Doctors and Nurses Oppose Practice, Most Consumers Unaware of Practice." [Online] 5 December 2002.

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