Product News and Recalls

Bypass Surgery Equipment Linked to 4 Pennsylvania Deaths

bypass heater-cooler linked to lethal hospital-acquired infectionsHeart bypass surgery may be one of the most complicated undertakings in modern medicine. Successfully completing a bypass operation requires absolute perfection in every regard; from the skill of the surgeons, to the flawless functionality of the equipment used to keep the patient alive.

Unfortunately, while outward appearances can appear to show a successful operation, contaminated equipment can cause harm that takes time to develop. Days, weeks, and even months can go by after the operation has been concluded before evidence appears of a hospital acquired infection.

The problem of hospital-acquired infections is not new. It is a very hot topic in the medical community as hospitals and medical researchers struggle to understand why tens of thousands of patients are leaving hospitals in worse condition than when they entered; assuming they survive and can leave at all.

The headlines are shocking: 37,000 Infection-related Deaths over Five Years May Have Been Preventable. FDA Taking Legal Action after Hospital-Acquired Infections in Texas.

A new threat has been unveiled as four patients in central Pennsylvania died as a result of the contamination of a critical device used in bypass surgery: the heater-cooler unit. The heater-cooler is used to regulate the patient’s blood temperature during bypass surgery. That temperature is controlled by a water circulation system within the device and US and European researchers have found that this water can become contaminated.

The Pennsylvania deaths aren’t the only ones attributed to the heater-cooler. Four patients died in South Carolina after acquiring infections last year that were similar to those that caused the Pennsylvania deaths. The microbes that caused the illness were the same that can be found in tap water. Tap water, incidentally, is commonly used in heater-coolers.

The machines in question were manufactured by an Italian company called Sorin Group. Company representatives advised customers earlier this year that their machines should be cleaned with bleach and that the water used during surgeries should be filtered and have a certain amount of hydrogen peroxide added to it.

Representatives at WellSpan York Hospital, the site of the four Pennsylvania deaths, have noted that their cleaning procedures “did not align perfectly” with the manufacturer’s requirements. When asked for clarification, a hospital spokesman admitted that WellSpan’s heater-coolers were, at times, not cleaned with bleach.

Manufacturer’s cleaning protocols are put in place for a reason and the failure to properly follow those protocols can lead to illness, disability, and death. This has been the case with contaminated duodenoscopes and it is now the case with heart bypass heater-coolers.

Duodenoscopes are complicated devices and have been documented as being incredibly hard to clean to manufacturer specification. However, heart bypass patients are dying because hospitals can’t add some bleach to water.

If households across the country are able to keep their homes clean with this common chemical, shouldn’t we expect hospitals to be able to do the same for devices that keep patients alive through critical surgeries?