Pennywise and Pound Foolish
The patient's oxygen saturation on the pulse oximeter showed a dangerously low value. Narcan was administered. Intubation equipment was readied. The patient was groggy, but did not appear to be in significant respiratory distress. Another oximeter was obtained that showed a much better oxygen saturation value. The Rapid Response was called off, and the manufacturer of the medical device got a telephone call from a biomedical technician who was not happy.
Understandably the hospital personnel believed they had a bad pulse oximeter. They demanded that the unit be replaced. The manufacturer sent out a technical representative instead. He asked to see the sensor that was on the patient. Within a few moments he isolated the problem: the sensor - originally manufactured by the oximeter maker - was defective.
The BMET read the technical representative the riot act, until the technical representative pointed out that the sensor was not as it had come from the factory. It was, instead, a remanufactured or reprocessed sensor that had been supplied by a vendor that buys used sensors, replaces the adhesives, and returns the sensors to the hospital. While the clinicians believed they were using a new sensor made by the original product manufacturer, the purchasing department had a dirty little secret: it was cutting costs by re-using old equipment. This is a very common method of reducing costs.
Equipment reprocessors take what they call semi-critical and non-critical medical devices and resterilize them. This includes DVT compression garments, pulse oximeter probes, blood pressure cufs, infuser bags, cervical collars and splints. One prominent provider claims it uses High Level Disinfection procedures and Pasteurizes the equipment. It then affixes new adhesives and wraps the now-disinfected equipment for transport back to the facility. The cost for the service is usually less than the cost of a new probe, split, infuser bag, or DVT compression garment.
No responsible nurse would put Mr. Smith's barely used band-aid on Mr. Jones. No responsible nurse would take crumpled tissues from the trash bin, iron them, and stuff them back in a box for use. Yet every day across the country people take single-use patient items and in spite of clear warnings to the contrary either re-use them or send them to a reprocessor. They do this because there is a cost savings, and certainly over the short term that savings is real and measurable. But who is to blame when a medical error arises? And who shares the liability for using what amounts to hand-me-down medical goods?
Surely if the patient is harmed by a defective medical device - one that alarms when it should not, or fails to alarm when it should, the manufacturer might well have liability. But if a component of that monitoring system is something other than the original equipment manufactured by the medical device maker, liability may default to the facility using the equipment, or to the reprocessor. This because the manufacturer will be able to show the disclaimers that indicate it is not responsible for the results when used with anything other than original equipment.
In the situation where the reprocessor is actually the original product manufacturer this does not present a significant issue. If the manufacturer sells reprocessed devices, it also warrants them. The problem arises when Company A reprocesses Company B's sensor, but doesn't disclose that the sensor is reprocessed. Because the reprocessed sensor bears the name of original manufacturer, the original manufacturer often gets the blame. But it's the facility that is in for a surprise if there is a medical meltdown.
This because many reprocessors are small operations and do not have sufficient product liability insurance to cover their liability in the event that a defective sensor causes injury to a child or other patient.
The far better approach, even though more expensive, is to use original equipment. If a facility uses original equipment it has only one source to turn to if the product fails. If a reprocessor is used, the facility should investigate the company and make sure that it has sufficient insurance. A smart facility would even require the vendor to include the facility as an additional insured, and would require the reprocessor to "indemnify and hold harmless" the facility in the event of product failure.
Its easy to think of saving money in the short term. But a facility can be pennywise and pound foolish if it uses reprocessed goods that do not meet the original equipment manufacturers specifications, and those goods cause patient injury.