What’s New in the Patient Safety World

May 2010

·        Joint Commission: Medication Reconciliation

·        New Mechanical VTE Prophylaxis for Hip Surgery?

·        FDA’s Infusion Pump Safety Initiative

·        TMIT Patient Safety Documentaries



Joint Commission: Medication Reconciliation


The Joint Commission has announced its field review for its new medication reconciliation goal (NPSG.03.07.01) and is accepting comments up to May 11, 2010. The new goal is less proscriptive and appears to give hospitals considerable flexibility in their approaches. It does, however, link the medication reconciliation process to multiple other elements that are contained in several other standards related to medications and provides a graphic showing the links to many of those other standards (eg. that a pharmacists reviews all medication orders, etc.).


It requires hospitals collect information about a patient’s medications on admission or when the patient is seen in the outpatient setting. However, it allows the hospital to define the types of medication information to be collected in different settings. For example, while for admitted patients you would presumably collect information about medication name, dose, frequency, route, and time of last dose taken, for patients seen in the ER but not admitted you might require time of last dose taken only for high alert medications. It also allows the hospital to define the qualified medical professional who does the comparison.


The hospital still needs to compare that medication information with any medications ordered during the hospital admission/encounter and reconcile any discrepancies. This should also be done any time there are new or revised medication orders. And at discharge written information on the medications should be provided to the patient (and family, if appropriate).


The revised goal also stresses the importance of educating the patient about the importance of keeping updated information about their medications readily available.


Lastly, it requires that your performance improvement process evaluates the effectiveness of your medication reconciliation program.


We think that this revised goal is reasonable at this time. Until best practices become clearly defined for medication reconciliation we believer that hospitals need some latitude in their processes for ensuring safe and effective medication reconciliation. Hopefully as hospitals progress in their efforts to meet “meaningful use” of healthcare information technology, their will be enough interoperability to allow for adequate exchange of information about a patient’s medications across multiple healthcare venues.


See also our previous columns on medication reconciliation:





The Joint Commission.

National Patient Safety Goal: NPSG.03.07.01 (Medication Reconciliation)

March 30, 2010.






New Mechanical VTE Prophylaxis for Hip Surgery?


For years we have been looking for alternatives to anticoagulants to prevent venous thrombembolism in patients undergoing total joint replacements. As many as 50% of patients undergoing total hip arthroplasty may develop deep venous thrombosis (DVT) if no prophylaxis is given. While we often use mechanical prophylaxis (pneumatic compression devices) to supplement anticoagulants, the standard of care still recommends use of anticoagulant prophylaxis in those patients with no contraindications. Yet risk of bleeding complications remains a major fear in such cases.


A new paper (Colwell 2010) reports on a randomized prospective trial of a new mobile compression device in approximately 400 patients undergoing total hip arthroplasty. Patients were randomized to either low-molecular weight heparin (beginning the day after surgery) or the mobile compression device (beginning intraoperatively). Aspirin 81 mg. daily was allowed in the latter group. Major bleeding events occurred in none of the patients in the mobile compression device group and in 6% of the low-molecular weight heparin group. No statistically significant differences were seen for DVT or pulmonary embolism between the two groups.


Note, however, that this study was industry-funded and was not blinded to patients, physicians or investigators. More importantly, this study was not powered to compare the efficacy of this mobile compression device vs. anticoagulant prophylaxis. The authors estmate that a study comparing efficacy of this device vs. anticoagulant prophylaxis would require about 1500 patients per group.


So consider this a pilot study and look for a larger study to be done before you rush out and try to order these new devices. Having a means of reliably preventing DVT without the risk of bleeding complications is clearly in the best interests of patient care. But we need to be sure that the net benefit outweighs that we currently see with pharmacological prophylaxis.





Colwell CW, Froimson MI, Mont MA, et al. Thrombosis Prevention After Total Hip Arthroplasty. A Prospective, Randomized Trial Comparing a Mobile Compression Device with Low-Molecular Weight Heparin. J Bone Joint Surg Am 2010; 92: 527-535







FDA’s Infusion Pump Safety Initiative



The FDA has announced a new initiative taking a hard look at safety of infusion pumps. They have recently announced a new initiative collaborating with industry to make infusion pumps safer. The FDA has received 56,000 reports of adverse events related to infusion pumps between 2005 and 2009 and there have been 87 infusion pump recalls, many of which have been for serious safety problems. The main part of this new initiative will be working with manufacturers to improve design and engineering issues that have been identified as problematic. But many problems also occur at the user end. Their website has several excellent resources including examples of infusion pump problems (including software problems, alarm errors, user interface design issues, battery problems, fire risk, etc.) and risk reduction strategies for staff at several levels of your healthcare organizations, including home care nurses and even patients themselves. There’s even a brochure for patients on getting the most out of their pump. This is an excellent resource that every healthcare organization should become familiar with.


Since we had been planning to do another article on infusion pump safety, we used this timely opportunity to do our April 27, 2010 Patient Safety Tip of the Week “Infusion Pump Safety”. See that Tip for our recommendations combined with the FDA recommendations on what you should be doing about infusion pump safety in your organizations.





New FDA initiative on infusion pump safety




FDA infusion pump risk reduction strategies







TMIT Patient Safety Documentaries


Texas Medical Institute of Technology, which has merged with the Quaid Foundation, has just released a powerful video documentary on patient safety “Chasing Zero: Winning the War on Healthcare Harm” that will be airing on the Discovery Channel. You can watch the video online as well. The video features interviews with both physician leaders in the patient safety movement and powerful stories told by laypersons, such as Sue Sheridan, who have become outstanding voices for patient safety after medical errors affecting their loved ones. You’ve heard us say many times that stories, not statistics, are what promote patient safety. This video is one that your Boards of Directors need to view as well as your staffs and communities.





Texas Medical Institute of Technology/Quaid Foundation

TMIT patient safety documentaries

Chasing Zero: Winning the War on Healthcare Harm







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