Latest Ebola fear: Safety of lab equipment ------------------------------------------ When physicians at the Nebraska Medical Center got their 1st Ebola case in September [2014], they knew theyd rely heavily on sophisticated blood-test machines to monitor the mans condition. They didnt expect the virus might leave the machines incapacitated for longer than the patient. Several leading manufacturers of high-tech diagnostic devices have alerted hospital laboratories that they will restrict service, support and warranties for equipment used to test blood and organ functions for Ebola patients. Fearing infections, some decline to have their technicians perform the tuning and maintenance the expensive devices often require. Others advise labs to quarantine the equipment after use on Ebola patients or even destroy it -- a policy that one companys own CEO calls the dumbest approach imaginable. Hospital officials, including some involved in treating the few U.S. patients who have [caught] Ebola [virus disease], see many of the restrictions as irrational. They cite guidance from the Centers for Disease Control and Prevention [CDC], which advises that devices used to test biological samples from Ebola patients can be disinfected and reused safely. They note that the same equipment has been used for years to test blood from patients with other infectious diseases, such as HIV and hepatitis, and reused without problems. If this unfounded behavior continues, it could significantly impact the way hospitals care for these people, says Steven Hinrichs, chair of pathology and microbiology at the University of Nebraska and its affiliated hospital, which has treated 2 Ebola patients successfully. These are good machines, we wanted to use them, but some (manufacturers) are saying you have to incinerate them if you do. ... Concerns about the restrictive equipment policies were raised Thursday [6 Nov 2014] at a meeting of a CDC lab safety advisory committee, which includes officials from an array of hospitals. The agencys position is that U.S. clinical laboratories can safely handle specimens from (Ebola) patients, but it reminds labs that strict adherence to safety protocols is especially important with those samples. Despite the CDCs reassurances, concerns about handling Ebola samples in lab environments are widespread. The nations 4 big commercial diagnostic laboratories -- Quest Diagnostics, LabCorp, ARUP Laboratories and Mayo Medical Laboratories -- which do specialized tests on blood and tissue for thousands of hospitals and doctors across the country, announced that they will not accept blood or tissue samples from Ebola patients. Those policies arent likely to have any immediate impact because the commercial labs arent supposed to get Ebola samples at this point. The CDC and designated state public health labs handle all confirmatory tests for the virus. Any follow-up lab work on infected patients is done at the hospitals treating them.... Theres a generalized panic, and people in health care are not immune, says Amesh Adalja, a Pittsburgh [Pennsylvania] physician on the Public Health Committee of the Infectious Diseases Society of America. We deal with a lot of blood-borne pathogens in lab settings, and there are adequate safety procedures (for Ebola).... But people are more comfortable making a decision that allows them to not actually make decisions, so they just say, Were not going to deal with this. At Emory University Hospital in Atlanta [Georgia], doctors had 3 days notice before getting the 1st U.S. Ebola cases -- a [male] doctor and a woman, both Americans, infected doing relief work in Liberia. They decided to do blood testing in a small lab in the isolation unit where the patients were treated, reasoning that it would limit the need to move infectious material through the hospital for analysis in its main lab -- and cut the risk of having to close the main lab for cleanup from a spill. Several weeks later -- after both patients were cured and released -- an e-mail was circulated by Abaxis, the manufacturer of a portable blood-testing device, the Piccolo, that Emorys doctors used to monitor the patients blood in the isolation lab. The e-mail advised that Abaxis had finalized a new service and warranty policy for the USD 14 000 device: The policy calls for the Piccolo to be incinerated after its use for testing Ebola patients. The directive put us in a bit of a quandary, says James Ritchie, director of Emory Medical Laboratories. By the time it came out, the lab already had decided on a method for cleaning the Piccolos, and Ritchie and his staff were confident that their approach was effective. Besides, he adds, the Ebola virus doesnt live long outside the body, so if the device were just locked away for a few weeks, any live virus would be gone. Ritchie compares the Ebola concerns to the fears surrounding HIV when it emerged in the 1980s. As with HIV, weve had incidents where people have said things like, If those samples are coming into the lab, were not coming to work, he says. The fear factor is really great right now. I think you have to really just keep talking it down. Clinton Severson, CEO of Abaxis, says he was unaware of the incineration policy issued for Piccolos until after it already had been sent to hospitals. Technically, that is the policy, because somebody wanted a policy and if nobody has been given any guidelines, I guess the safest thing to say is to blow it up, he says. But when people recommended that to me, I said, Thats the dumbest thing Ive ever heard in my life. Severson says the company decided to leave the policy in place while it investigated alternatives, and it has validated a cleaning protocol that will ensure Piccolos used to analyze Ebola samples can be reused for the general hospital population. A policy that outlines those cleaning protocols will be issued in the coming weeks, he says. Brian Petuch RBP CBSP Corporate Biosafety Officer Global Safety & Environment MERCK PO Box 4, WP44-204 West Point, PA 19486-0004 WP Office 215-652-4039 Fax 215-616-4246 Cell 267-278-3711 Text 2672783711@vtext
Posted on: Sun, 09 Nov 2014 15:48:31 +0000
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