Experts answer your toughest questions about this practice
With increased pressures on same-day surgery programs to reduce costs, there is a dramatic increase in the number of providers who are participating in the controversial practice of reprocessing single-use items. One hospital reports saving almost $20,000 in the first year by reprocessing single-use items.
Many same-day surgery programs don’t have any clearly defined, comprehensive policies and procedures on this subject. And here’s the clincher: You may be liable if the reprocessed items don’t measure up to the original equipment manufacturer’s specifications even if you contract out the services, says Jan Schultz, RN, MSN, president of Jan Schultz and Associates, a consulting service in Allison Park, PA, that focuses on the reprocessing continuum in health care.
The concern over liability has been heightened by the stand taken by at least one manufacturer: United States Surgical Corp. in Norwalk, CT. U.S. Surgical inserted new language in its "Terms and Conditions" that attempts to restrict providers who want to reuse disposable instruments. Specifically, p. 8 of the 1997 Retail Price List for Auto Suture Co., a division of U.S. Surgical Corp., contains the following language:
By purchasing any product designed by Auto Suture Co. for "single use," "multiple use in a single procedure," "do not sterilize," or the like, the customer agrees to limit that product’s use in accordance with those express designations.
Many same-day surgery programs are not aware of the new language because they don’t review such standard terms from suppliers on a regular basis.
Vendors aren’t the only ones getting involved. The National Health and Medical Research Council in Sydney, Australia, has warned its state governments to control the reuse of single-use medical devices in hospitals. Health ministers were instructed to implement a ban on reused devices and compensate hospitals for the increased costs of purchasing new devices or introduce more stringent regulations to control reuse.
FDA to study public health impact
In the United States, the Food and Drug Administration (FDA) has taken an interest in the controversy. A working group including representatives from federal agencies and the private sector will meet this summer to examine the issue, says Larry Kessler, ScD, director of the Office of Surveillance and Biometrics, Center for Devices and Radiological Health, in Rockville, MD. It may take the FDA up to two years to study the public health impact, Kessler says.
In the meantime, same-day surgery programs continue to reprocess single-use items, including leg compression sleeves for use with sequential compression devices, pulse oximetry probes, endoscopy biopsy forceps, and some laparoscopy scissors, among others. While some same-day surgery experts say outright that single-use devices should not be reprocessed, others take a less conservative approach.
"We don’t say you should or should not," says Dorothy M. Fogg, RN, MA, perioperative nursing specialist at the Center for Nursing Practice, Health Policy, and Research at the Association of Operating Room Nurses (AORN) in Denver. AORN has published a checklist from the American Hospital Association regarding protocols for testing instruments to determine their safety and function after reprocessing (see p. 71).
"We say if you choose to do this, have these pieces in place and recognize you are assuming some liability for the reprocessed product," Fogg says. "If you have the capability to put protocols in place, that’s your choice."
Solutions for top 5 concerns
At this year’s national AORN meeting, AORN of Greater Kansas City’s research committee presented a poster on reprocessing disposable products. In a survey the committee conducted, nurses identified the following as some of their biggest concerns about reprocessing single-use items. To assist readers, Same-Day Surgery has interviewed experts in the field and addressed those concerns:
• How do we develop written reprocessing procedures?
When developing policies, use a multidisciplinary approach, advises Chris Lavanchy, engineering director of the Health Devices Group at ECRI in Plymouth Meeting, PA. (See "Decision Tree for Evaluating Single-Use Devices for Reuse," inserted in this issue.) Include persons responsible for infection control, risk management, engineering, central supply, ethics, and administration in the process, same-day surgery experts advise.
"They understand the various perspectives a hospital should have about this controversial area, and they should be ones setting the policy for reuse in a hospital," Lavanchy says.
Consultation with risk management is particularly important, says Sherron C. Kurtz, RN, MSA, CNOR, CNAA, director of perioperative services at Henry Medical Center in Stockbridge, GA. Reprocessing single-use items saved her facility almost $20,000 in the first year, Kurtz says. The risk management department raised questions about the reprocessing company, including how long the firm had been reprocessing and what kind of insurance it carried, Kurtz says.
And while company representatives said certain single-use items could be reprocessed up to five times, the risk management department recommended a more conservative approach of reprocessing those items four times.
Support from the operating room committee also was crucial, Kurtz emphasizes. Without such support, "they can kill you," she says. Be certain to tell surgeons when you start using reprocessed single-use items and ask them whether the items are operating as they’re supposed to, Kurtz advises. (To further assist readers who want to develop policies on reprocessing single-use devices, Same-Day Surgery has enclosed sample policies in this issue from Promina Gwinnett Hospital System and Nancy English, RN, CNOR, a consultant and clinical educator in Leawood, KS.)
• Is there any way to verify product safety and function?
Closely inspect the device to determine whether it can be cleaned adequately, Lavanchy suggests. Do research and perform tests to make sure you can reprocess single-use items safely and effectively, he advises.
"You might want to do repeated testing to see how much you can reuse before you have problems," he says.
The testing should examine areas such as freedom from chemical residue, function before sterilization, function after sterilization, and random sampling for quality control, says Jody Hueschen, RN, MN, CNOR, CNAA, chairman of AORN of Greater Kansas City’s research committee. Written procedures should specify which items can be reprocessed and should provide for sterility testing, Hueschen says.
Performance testing should be conducted on a device-by-device basis and sometimes on a model-by-model basis, Lavanchy says. "Just because you can reprocess one brand doesn’t mean you can do another," he points out. "Look at the effects of reuse on each model."
Fogg agrees that performance testing is critical. "If you choose to reprocess, you have to be able to guarantee product integrity, which means the form and function criteria of the original product," she says. "Some facilities have that capability; most don’t."
While many facilities choose to send single-use items to reprocessing companies, keep in mind that such companies guarantee the sterility but not the product integrity, Fogg emphasizes. Obtain copies of the tests they have conducted and determine how many samples they have done.
• Who is liable?
"That’s the million-dollar question," says Ronni Solomon, vice president of legal affairs at ECRI. Liability could fall on the facility reusing the devices, the surgeons or physician who approved their use, any reprocessing firms that are outsourced, or the manufacturers, she says.
"[The facility’s] practices, policies and procedures, informed consent, and decision-making process will be looked at carefully to make sure they’re reasonable," she says.
• Does reprocessing really save money?
Reprocessing single-use items is labor-intensive, Fogg points out. "If the protocol is set up as it should be, if there is enough sampling to have adequate size sample and the ability to test product integrity, I think it would be very costly."
Schultz agrees. "It’s not just the labor and materials most people think simplistically."
Consider all the costs, including:
staff time to develop a protocol;
special equipment or materials for reusing a device, such as equipment to handle performance testing of devices;
new chemicals to clean the products;
staff time to track reuse, surgeons’ satisfaction, and patient outcomes;
staff time to learn how to reprocess.
"Some say, We pay them full-time anyway. We’re not going to hire additional people,’" Lavanchy says. "But nonetheless, there is a cost associated with time doing this work. That has to be accounted for."
Even the research and testing has a cost associated with it, he emphasizes. "People think it’s a free ride because you’ve bought the device already, and it’s free next time," Lavanchy says. "Well, it’s not that simple. There is a true cost associated with each reuse. Keep that in mind when going through this, so you’ll benefit as much as you think you will."
Once you’ve examined all your costs, you might be surprised: It might be more cost-effective to stick with items labeled as reusable, he says. One consideration is volume, Lavanchy says. "If you have a small volume, and only use a couple a year, it’s difficult to justify reuse, even if the item is expensive," he says.
Schultz agrees. Reprocessing single-use items only makes sense for the high cost, high volume devices, she says, but those items are usually high-tech or new-tech devices and may become outdated quickly.
"The technology may move on, and you may have to redo the process before your recoup what you’ve already put in," she warns.
• Is the standard of care the same for each patient?
Some experts say if appropriate protocols are in place to guarantee form and function of the reprocessed item and guarantee sterility, there is no double standard of care.
"If you have an appropriate protocol, that means you are guaranteeing the product to be the same as if it were new," Fogg says. "I don’t think a patient is being compromised, because the patient is not getting any less care than the person who had it the first time."
Others aren’t quite so certain. "It’s an ethical issue open to debate at this point in time," Schultz says. "If you can demonstrate by your testing, etc., that what you’re reprocessing is as good as a new device, the answer is yes. But if you’re reprocessing without that level of assurity because of testing and quality control, in my view, the answer is maybe, which in ethical terms is a no. It’s not an absolute at all."
Management Advisory: Resource Management
Introduction
Patient safety is a primary concern in providing high-quality health care. The reuse of disposable (single use) devices intended by the manufacturer to be used only once is controversial. Each institution must address this issue in view of the needs of its patient population, its resources, and its legal liability for any failures of reprocessed items.
Decisions about the reuse of disposable (single use) medical devices should not be made piecemeal. Consistency of practice in all areas of the institution is of utmost concern. All reprocessing should conform to established reuse policies. Unless an institution can demonstrate and document that patient safety and device effectiveness are not compromised by reprocessing a disposable medical device, reprocessing is not recommended.
The American Hospital Association offers the following guidance to assist individual institutions in determining their reuse capabilities and formulating appropriate policies.
Reuse Testing Protocols
The objective of a reuse testing protocol is to identify the steps to be followed in assessing whether a device labeled single use only or disposable can be safely reprocessed and reused. This protocol should apply to devices that have been used and to devices that have been stored past their expiration dates or removed from their packaging material but not used. The protocol should include these steps.
• Review package labeling and manufacturer’s guidelines for use and possible reprocessing.
• If the manufacturer has not specified reprocessing guidelines, obtain information about the material properties of the device (stainless steel, PVC, rubber, latex, etc.). Ask the manufacturer whether the product can be safely reprocessed. If so, ask for recommendations for cleaning, sterilization, and repackaging the product.
If reprocessing guidelines cannot be obtained from the manufacturer:
• Establish the form and function criteria the reprocessed device will be expected to meet, such as physical appearance (color, shape, size, etc.) and function (moving parts, tensile strength, flexibility, etc.).
• Determine whether the institution has the capability to demonstrate that the device can be adequately cleaned and sterilized, if indicated. Review the material properties of the item and the cleaning and sterilizing methods available.
• Determine whether reprocessing is cost justified. Consider the device’s cost and the expected volume of use vs. the reprocessing cost and the risk/consequences of device failure.
• For each device, establish a testing protocol that takes into consideration:
A. patient safety;
B. number of items that must be tested to get a study sample;
C. number of times a device can be reprocessed and still meet form and function criteria;
D. employee safety;
E. procedures, chemicals, and equipment to be used in cleaning and sterilizing;
F. process controls, quality assurance monitoring, and documentation of test results;
G. testing of the reprocessed item in simulated use situations;
H. need for destructive testing to identify unacceptable changes to the material properties or the presence of residual toxicity;
I. documentation of test results;
J. method for labeling the reprocessed device and marking for successive reprocessing.
• Review testing protocols and results with appropriate institutional review groups, such as administration, infection control committee, legal counsel, materials evaluation committee, and device manufacturer.
• Determine the need for policies on pricing, informed patient consent, and documenting the use of reprocessed devices.
• Periodically review the use of reprocessed devices to ensure continued patient safety, employee safety, and cost effectiveness.
This management advisory was revised and approved by the Institutional Practices Committee in 1990. The original version of this document was first approved by the American Hospital Association in 1985.
Source: Reprinted with permission from the American Hospital Association. ©1990.
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