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April 03, 2006 Volume 15 No. 7
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It was 6 p.m. on a Friday when Duke University Health System (DUHS) received a notice from RASMAS (the Risk and Safety Management Alert System) about a voluntary recall of human tissue. That same evening a Duke community surgeon contacted DUHS about a similar voluntary recall of human tissue. A vendor had contacted the surgeon and informed him that tissue purchased in the past at an outside hospital was part of a voluntary recall due to lack of appropriate documentation as to the original source of the tissue. Despite the impending weekend, a rapid response DUHS team began researching the problem and identifying and blocking the recalled tissue from use in surgeries already scheduled for Saturday morning and Monday morning. By Monday evening, the team had contacted all surgeons who routinely use tissue during surgery to inform them about the recall, and had identified all patients who might have been affected by the use of the suspect tissue before the recall was put in place. They had also arranged for free testing for patients to ensure no diseases had been passed on through the tissue. By that Tuesday, Duke was communicating with patients, and working with the state of North Carolina to ensure physicians across the state knew about the recall. On Wednesday afternoon, the federal Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) sent out a national advisory. “Because we were using the new RASMAS [Risk and Safety Management Alert System], and because Duke has set up a senior recall team, we were out in front in responding to this issue,” says Mike Cuffe, M.D., vice president for medical affairs at DUHS. “Thankfully, in this, as in other cases, our actions quickly minimized the number of affected patients across our health system, and testing later bore out that no patient was adversely impacted.”
No Longer Chasing Cats
“There is no industry-wide standard for safety recalls for health related products,” explains Jane Pleasants, assistant vice president for procurement and supply chain management for DUHS. “The recalls and advisories can come from vendors, from the FDA, from physicians who have heard from vendors, from trade journals, or even originate here at Duke with our staff or the Voluntary Reporting System (VRS). After receiving the alerts, we used to email alerts to over 300 people at Duke, but we had no easy way of documenting that anyone had responded to the alerts. With RASMAS and our new Senior Recall Team, everything is much more orderly.” RASMAS is a web-based subscription service that provides comprehensive notification, distribution and management of product alerts in healthcare organizations. It was developed at Johns Hopkins in concert with Mitretek, a non-profit company in Virginia. Started in 2004, RASMAS now has over 100 hospitals subscribing to its service. In December 2005 it received the “Best New Patient Safety and Disclosures Award” from the Health Care Research and Innovations Congress. RASMAS collects the alerts nationally from many places, and then sends them over the Internet to subscribers in a standard format. It also allows user hospitals the ability to better manage internal alerts. “RASMAS makes the recall process manageable by organizing it,” explains Pleasants. “Instead of feeling like we are trying to drink from a fire hydrant, with RASMAS we get the information we need in a more controlled manner.”
Think Globally, Act Locally
“Sometimes, a recall notice that might be urgent for a drugstore " such as a child-safety cap malfunction on a particular batch of aspirin " is not as urgent in a hospital setting,” says Davis. If DUHS has purchased the item in question, Davis or Berson uses the RASMAS system to forward the alert to designated responders in each entity of the health system, including its three hospitals, outpatient clinics run by the Private Diagnostic Clinic (PDC) and Duke University Affiliated Physicians (DUAP), and Duke Health Community Care (DHCC). These responders are the ones who physically search the shelves for the product and remove it from circulation, then close the loop by sending a report back through RASMAS. “What is great about RASMAS is that we can set the level of urgency and RASMAS tracks whether we receive the response within a set amount of time,” says Davis. “That way if someone is on vacation or can’t access their email, we know about it promptly and can pass the alert on to someone else for action.”
Taking Responsibility for Recalls to the Top
“The Senior Recall Team is on call 24/7,” says Cuffe. “We have a commitment to patient safety that starts at the top.” “If we feel a recall could affect the ongoing health of patients, we identify affected patients, employees or providers and develop a clinical response to the potential medical problem. We also create a communication plan to assure we provide consistent information to patients, providers and others. And we track and document the costs and outcomes involved with product revision and recall,” says Cuffe. “I don’t know of any other health system that has this level of senior level commitment to patient safety through the recall process.”
Bringing Responsibility Back to the Front Line
“We’ve run RASMAS in parallel with our old systems for many months, and we are certain RASMAS is catching all the recalls we used to catch,” says Pleasants. “But we still need front-line staff to be on the alert for alerts. We know that some employees -- from pharmacists to secretaries to clinical engineers -- may still be receiving recall or safety alerts. Technology is wonderful -- but the reality is that our employees are still the ones with the greatest responsibility for patient safety.” |
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