Sunday, February 28, 2010

Secondhand woes

The Baltimore Sun had an article this week on reprocessing of single-use devices. This was quite a controversial topic for hospital epidemiologists about 10 years ago, but I hadn't heard much about it recently. Now there's a new argument for it--it's good for the environment. I also think the green argument could be used to encourage alternatives to contact precautions giving the vast amount of consumables it requires. Anyway, in 2001, I wrote a piece about reprocessing of single-used devices that has survived multiple hard-drive to hard-drive transfers but I never did anything with it. So I dug it out and pasted it below.

Secondhand Woes
Healthcare is not the profitable venture it once was and hospitals in the United States have fallen on hard times. In an attempt to stay afloat, hospitals have looked long and hard at ways to reduce cost. To that end, healthcare consulting firms have advised hospitals on numerous ways to cut corners, going so far as to recommend that bed linens not be changed on a daily basis.
One area of cost savings that hospitals have found quite tempting to explore is the re-use of medical devices that are labeled by the manufacturer for single use only. Obviously manufacturers of medical devices have an incentive to label products as single use so that more devices will need to be purchased. However, some devices should be used one time only based on the type of materials used in manufacturing or by a design so intricate that cleaning of the device is not feasible. Nonetheless, many single-use devices can be appropriately sterilized without damaging the integrity of the product, and reused without difficulty. Consider the case of the $600 catheters that are used by cardiologists to test the heart for abnormal rhythms. These catheters are typically inserted into a major blood vessel and threaded into the heart. Many hospitals have found that the reuse of these catheters after sterilization can result in significant cost savings. This is only one example of the hundreds of products labeled as “single use” that can be reused after appropriate reprocessing.
In response to the increasing frequency with which single-use devices are being reused in hospitals, the FDA has issued guidelines to standardize the cleaning and sterilization process so that the reused devices are safe for patients. This will heighten the accountability of hospitals and businesses that provide reprocessing services.
As a physician trained in infectious diseases, microbiology and public health, I must admit that I am bothered more by the ethical issues surrounding reuse of devices labeled as single use only, than I am about the potential for the transmission of infectious diseases via these devices.
Clearly, there does exist a small risk of transmission of infectious diseases via reused devices. However, it seems likely that this risk is no higher than for the thousands of devices designed for reuse, and which are, in fact, routinely reused after sterilization. Most surgical instruments, for example, are reused on a daily basis in hospitals without any problem. Of course, any process that involves humans is inherently prone to error and therefore entails some risk.
The ethical questions surrounding reuse of single use devices are, I believe, more challenging. First, do patients have the right to know if their procedure will involve the reuse of a product designed and labeled for single use? If they have this right, do they have the right to request that a new device be used for their procedure? And what do we do when patients refuse to accept a used device?
The ethical quagmires don’t end there. Much of the cost savings that can be generated by reusing devices occurs by charging all patients the cost of a new device, even though some patients will not get a new device. How many of us would be willing to pay the factory sticker price for a used automobile? Moreover, how incensed would we be if we paid the sticker price for a car we thought was new, but was not? We have laws that prevent this type of fraudulent activity.
Lastly, which patients will receive the new devices and which ones will get the reused? Could it be that indigent patients will end up with the hand-me-downs, while insurance-card-carrying patients will get the shiny, new ones?
The ethical questions are really not that difficult to resolve. First, hospitals should inform patients on admission about their policy for reuse of single-use devices and supplement this with a brochure that gives patients who want more detail the information they need. Physicians performing procedures involving these devices should ensure that patients understand the issues. Secondly, it is imperative that hospitals that decide to reuse devices develop a system that insures that the selection of a device for a patient is done in a completely random manner. In this way, the corporate executive stands the same chance of receiving the used device as does the man who lives under the bridge. Lastly, the charges for devices must be adjusted to reflect the number of times a product can be used. If a product can be reused five times, then the charge for the product should be the new charge divided by five, plus the cost of reprocessing. If hospitals prorate the charges, the financial impetus to reuse devices may melt away.
The patient must come first. And putting patients first requires honest dialogue. Healthcare administrators must not allow the bottom line and deceptive practices to be guideposts for the way that we provide care because the doctor-patient relationship is too precious to be subjected to harm by dishonesty. What’s best for the patient is, in the end, what’s best for all of us.

1 comment:

  1. I wonder how this can be acceptable to the FDA when the product has not been funtionally tested after exposure to the sterilization method. For example, I know that balloon's become embrittled after exposure to gamma radiation. Who will perform the ASTM testing after a series of exposures to be sure the device will not harm a patient? It sounds like the hospital is manufacturing a medical device without having the authority or data to do so?

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