Today Is November 6th, 2014 Time: 17:31 Hrs. PDT HEADLINE: Latest Ebola Fear: Safety Of Lab Equipment Transcript: When physicians at the Nebraska Medical Center got their first Ebola case in September, 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 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 gotten Ebola, see many of the restrictions as irrational. They cite guidance from the Centers for Disease Control and Prevention, 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 two 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, so we had to find an alternative. |As fear of Ebola has spread across the general population, raising debates over traveler screenings, quarantine policies, even school closures, the medical community has encountered its own set of fears and abundance-of-caution policies. Some, such as the reluctance of some clinicians to treat infected patients, were expected. But health officials have been surprised by the restrictive policies manufacturers put on blood-testing equipment, which is critical for constant monitoring of Ebola patients electrolyte levels and organ functions. Concerns about the restrictive equipment policies were raised Thursday 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. LAB CONCERNS WIDESPREAD Despite the CDCs reassurances, concerns about handling Ebola samples in lab environments are widespread. The nations four big commercial diagnostic 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. Still, the policies are getting attention in the medical community. Thats partly because all four of the commercial lab services – Quest Diagnostics, LabCorp, ARUP Laboratories and Mayo Medical Laboratories – are well-versed in handling specimens containing dangerous pathogens, yet they nevertheless have adopted unprecedented restrictions on Ebola samples, citing concerns about worker safety and the risks of shipping samples to their labs. Theres a generalized panic, and people in health care are not immune, says Amesh Adalja, a Pittsburgh 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. AN UNWELCOME SURPRISE At Emory University Hospital in Atlanta, doctors had three days notice before getting the first U.S. Ebola cases – a 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 $14,000 device: The policy calls for the Piccolo to be incinerated after its use of 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. Other equipment manufacturers also announced restrictions. For example, Sysmex, which makes a hematology analyzer used at Emory and many other labs, advised that it would not have its technicians service equipment from isolation wards used for Ebola patients. In a statement to USA TODAY, Sysmex said its policy addresses concerns about contamination risks for technicians, who could be sidelined by even the suspicion they might be infected. Having employees isolated or placed in quarantine could potentially have an adverse impact on our resources available to serve many of our customers, the company said. The immediate impact at Emory has been manageable, Ritchie says, because the hospital is keeping its Ebola isolation unit intact and equipment used on those patients will remain there for the foreseeable future. Sysmex has offered to train hospital technicians to service its devices in that unit, he says. Other equipment, such as the Piccolo, also will remain in use. 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. THE DUMBEST POLICY Clinton Severson, CEO of Abaxis, says he was unaware of the incineration policy issued for Piccolos until after it 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. Hospital officials say the uncertainty surrounding manufacturers policies on diagnostic equipment adds to an already complex equation as their institutions scramble to prepare for Ebola patients. Its a pretty big hurdle for clinical labs to be prepared to provide lab testing to patients known or suspected to have Ebola, says Daniel Diekema, president of the Society for Healthcare Epidemiology of America and head of the infectious disease division at the University of Iowa College of Medicine. One of the concerns, because of these messages from (equipment makers), is: Are we going to have to buy all new equipment and make a large capital investment. Some of the machines involved cost tens of thousands of dollars. Diekema expects more companies will adjust their policies as the initial fear and misinformation about Ebola subsides. Abaxis is not the only one that says its policies are evolving. At Quest, the biggest of the commercial diagnostic labs, officials say their policy of refusing all Ebola samples could change as more information on the virus becomes available. To protect the health and safety of our employees and patients, we thought it was prudent to limit our handling of specimens to patients who have been certified as Ebola-free, Quest spokeswoman Wendy Bost says. We continue to evaluate the situation and would consider amending our current policy if there were a compelling public health need. As the uncertainty around Ebola policies lingers, some hospitals have decided simply to focus on whats immediately necessary to care for any patients – and worry about the equipment issues later. Yes, Im annoyed that instrument manufacturers are acting the way theyre acting, but thats not my primary concern – my primary concern is to be ready for these patients and to care for them, says Ron Lepoff, clinical lab director at the University of Colorado Hospital. This virus only lasts 21 days on a dry surface, so we can always just let (the equipment) sit behind a locked door for four weeks and then look at how to clean it, Lepoff says. If worst comes to worst and we have to throw it out, I wouldnt be happy about it. But if it means the life of one patient, Ill throw the thing in the incinerator myself. Source: usatoday/story/news/nation/2014/11/06/hospital-laboratories-ebola-equipment/18546709/
Posted on: Fri, 07 Nov 2014 01:31:42 +0000
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