Manufacturer: York Hospital warned of infection risk


The manufacturer of a device linked to a rare bacterial infection in at least eight York Hospital patients claims it sent hospital owner WellSpan a letter warning of the risk a year before the health care system started to investigate and several months before the surgery of a man whose bacterial infection likely contributed to his death.

Last week, WellSpan officials sent letters to 1,300 York Hospital patients relaying that they had identified the increased risk related to a heater-cooler device used during open-heart surgeries.

That information came as a result of a WellSpan investigation that began in July 2015, but a spokeswoman for Sorin Group, which makes the device, said the company sent a letter to its customers regarding the potential risk a year earlier.

Sorin Group was made aware "in early 2014" of a possible link between non-tuberculosis mycobacteria (NTM) — linked to infections in eight York Hospital patients, four of whom died — and its 3T heater-cooler device, according to spokeswoman Fern Lazar.

In July 2014, Sorin sent an "Important Information" letter to all of its device users "inform- ing them about the newly identified risk and reminding them of the importance of performing the equipment disinfection procedures strictly according to the instructions for use," Lazar wrote in an email.

During an internal review, York Hospital identified that its cleaning procedures for the devices did not perfectly follow Sorin's guidelines, including not periodically running bleach water through the device after it was drained, according to Dr. Hal Baker, WellSpan's senior vice president for clinical improvement.

One of the four dead in connection with the bacteria had his surgery at York Hospital on Dec. 15, 2014, according to WellSpan spokesman Barry Sparks.

The letter: WellSpan did not confirm or deny receiving Sorin's letter, but spokesman Brett Marcy wrote in a statement that the manufacturer's June 2015 Field Safety Notice (sent a year after the initial letter) was one of the main factors prompting the company's joint investigation with the state Department of Health — which forced the hospital to replace its devices — and Centers for Disease Control and Prevention.

Field Safety Notices are the official means by which medical device manufacturers notify health care organizations that an action is required to correct a safety issue, Marcy wrote.

Lazar wrote that, though Sorin received no information supporting a causative link between its device and the infection, the company elected to send its initial letter because it had learned that some users had not been performing water maintenance and disinfection practices according to its instructions.

The letter suggests that its customers "ensure that cardiac surgical staff members are aware of the mycobacteria risk and to review hygiene and surgical practices in the cardiac surgery operating room."

"Although water in heater-cooler devices is not intended to have direct contact with patient, it is nonetheless important to strictly adhere to the cleaning, disinfection and maintenance procedures set forth in the device's operating manual," the letter reads.

In its June 2015 notice, Sorin added an extra step to its cleaning process, which occurred as a result of the "newly identified risk," according to Lazar.

No more cases: Sparks wrote that no additional infections have been identified since WellSpan sent letters to patients last Monday, but the company doesn't expect to be able to confirm any additional infections for at least several weeks because of the slow-growing nature of the bacteria and inability to test for it without symptoms present.

The hospital's Nurse Call Center, whose number was provided in the letter, had received more than 400 calls as of Friday, according to Sparks, with the majority of calls coming on Monday and Tuesday. WellSpan initially had to increase the center's staffing levels to accommodate the high demand.

"Our staff members make every effort to get back to patients as quickly as possible," Sparks wrote.

WellSpan is planning to transition from the call center to a full-time nurse navigator to work with these patients to ensure they're receiving the care and treatment they need, he added.

The company also has said that if patients are found to have acquired this bacterial infection as a result of exposure during their open-heart surgery, WellSpan will provide them with the care and treatment they need at no cost. Sparks wrote that the company is in the midst of finalizing the details of that process.

— Reach David Weissman at