Patient Safety Monitor Journal answers your most important patient safety questions and offers field-tested compliance strategies to ensure your patient safety efforts measure up to The Joint Commission.
FDA ban on powdered medical gloves now in effect
The Food and Drug Administration’s (FDA) ban on powdered medical gloves went into effect on January 18. It’s now forbidden to use, advertise, and market powdered surgeon's gloves, patient examination gloves, and absorbable powder for surgeon's gloves at medical clinics and hospitals.
The Joint Commission also announced that all accredited programs are expected to comply with the FDA’s ban. Joint Commission surveyors will now issue citations on the ban under LD 04.01.01 element of performance (EP) 2.
Powders have been used to lubricate gloves for easy removal for more than 100 years. But since the 1930s alone, the type of powder used on medical gloves has been changed three times due to various medical risks. The powder currently used in medical gloves came under fire in 1997 when an FDA report found that it could cause severe airway and wound inflammation, granulomas, and post-surgical adhesions in the tissue between internal organs. Furthermore, aerosolized glove powder on natural rubber latex (NRL) gloves can carry allergens that can spark a respiratory allergic reaction in a patient or wearer.
“This ban is about protecting patients and healthcare professionals from a danger they might not even be aware of,” said Jeffrey Shuren, MD, director of FDA’s Center for Devices and Radiological Health, in a press release. “We take bans very seriously and only take this action when we feel it’s necessary to protect the public health.”
The current ban was published in March 2016 and was the result of three citizen petitions sent to the FDA between 2008 and 2011. That said, the FDA was certain of the harmful effects of powdered gloves back in 1997, but it chose not to ban them due to a lack of alternatives. The most common lubrication alternative at the time was chlorination, which was known to damage gloves’ material. The agency believed a ban at that time would cause a medical glove shortage or promote the use of unsafe alternatives.
How Palomar Health reduced nuisance IV alarms
People can grow used to anything, even alarms. Such is the danger of alarm fatigue; when excessive and nuisance alerts cause healthcare staff to become desensitized. When this happens, healthcare staff are more likely to have trouble prioritizing, managing, and responding to alerts, resulting in delayed treatment and patient harm.
Excessive alarms and alarm fatigue isn’t a new issue in healthcare. The Joint Commission’s Sentinel Event Alert (SEA) 50 on alarm safety reported that between 85% and 99% of alarms don’t require clinical intervention. Healthcare staff have been known to inappropriately tamper with alarm sensitivities, turn down alarm volumes, or silence them completely, according to the alert. The Joint Commission reported that between 2009 and 2012 there were 98 reported alarm-related events resulting in 80 deaths, 13 permanent loss of function cases, and five patients with minor injuries.
The accreditor also implemented phase II of its alarm safety National Patient Safety Goal (NPSG) in 2016, which requires hospitals to:
• Establish policies and procedures for identified high-risk alarms
• Address issues such as appropriate alarm settings, when settings should be changed, and who has the authority to change alarm parameters
• Educate staff on how to properly operate alarms to reduce alarm fatigue
Palomar Health, the largest healthcare district in California, successfully piloted an IV nuisance alarm reduction program at its flagship facility: Palomar Medical Center Poway and Pomerado Outpatient Pavilion. The Association for the Advancement of Medical Instrumentation (AAMI) held a webinar discussing the district’s results with LaQuoia Johnson, PharmD, BCPS, pharmacy supervisor at Forsyth Medical Center (formerly of Palomar Health), Carol Suarez, MS, Palomar Health clinical nurse specialist of pulmonary progressive care and medical-surgical telemetry acute care, and Diana Schultz, RPh, MHSA, Palomar’s medication safety manager.
“Medical device alarms are designed to save lives, but excessive and misleading alerts remain a leading technological hazard in hospitals,” said Schultz. “Clinical devices sound hundreds of alarms per patient per day, creating an environment that can overwhelm, distract, desensitize healthcare workers.”
ISMP's targeted medication safety best practices for 2017
Editor’s note: The Institute for Safe Medication Practices (ISMP) released its 2016–2017 Targeted Medication Safety Best Practices for Hospitals guide in December 2015. The first edition of the best practices came out in December 2013 and addressed specific medication safety issues identified by ISMP as causing fatal and harmful errors. This year there were five new best practices and two revised out of 11 total. Each of the best practices have been reviewed by an external expert advisory panel and approved by the ISMP Board of Trustees. Darryl Rich, PharmD, MBA, FASHP, is an ISMP medication safety specialist who spoke with PSMJ about the best practices.
PSMJ: Is there a difference between “targeted medication safety” and “medication safety,” or are the two synonymous?
Rich: No, they are not. First of all, medication safety has a lot of issues and a lot of strategies that can be used to prevent errors. And these [issues that the best practices are designed to prevent] are ones that are specifically and continuously reported as harmful or fatal to patients over 10 years or more by ISMP. We wanted people to focus on these specific best practices as a priority, [along with] all the other things we recommend.
PSMJ: Do you get numbers on how many facilities use your guidelines?
Rich: We have no idea. We put them out there and distribute them, but we have no way of knowing how many hospitals are using them. Hopefully, a lot.
PSMJ: Have incidents of medication errors increased, decreased, or remained level over the last five years or so? What factors do you think caused this?
Rich: For a lot of these—because we were looking specifically at harmful or fatal events—there weren’t big numbers to begin with. Originally, there may have been four or five deaths caused by incidents that the best practice should help prevent. But those are four or five deaths that could have been prevented.
Looking at actual numbers of medication errors that have been reported in the past few years, we’ve had no deaths reported for any of these issues for the targeted best practices since they were released. Some of them were released in December 2013 and the other group was released in December 2015.
We have seen some “near misses” that have occurred related to neuromuscular blockers, vincristine, and sterile compounding. These occurred in hospitals that did not implement the best practices. Of interest, we had four cases of errors reported related to oral methotrexate, but these occurred in retail pharmacies, not hospitals.
We routinely conduct surveys of how many [organizations] have implemented the best practices. For specific best practices, we’re seeing an implementation rate as low as 33% to a high of 96%.
Certainly ones that require a technology change such as a hard stop verification of daily doses of oral methotrexate in their computer system, using metric weights, or using automation for sterile compounding tend to have the lowest rates of compliance.
Study: Postoperative complications are a major concern for hospitals
A recent study sheds new light on the prevalence of postoperative complications.
In November 2016, a study published in the British Journal of Anesthesia (BJA) found that each year there are 50 million postop complications worldwide. Those complications in turn result in 1.5 million deaths. That’s a worldwide average of 16.8% of surgeries resulting in a postop complication and 2.8% of those complications resulting in death before a patient left the hospital. Researchers used data on 44,814 patients who underwent surgery within the same seven-day period, comparing different types of surgery with the frequency and severity of adverse outcomes. The patients came from 474 different hospitals in 27 different countries, ranging between high income (U.S., U.K., Germany) and low income (Uganda, Brazil, Romania).
The study found that the postop complication mortality rate for patients in high-income nations was 2.6%. Meanwhile in low-/middle-income countries the mortality rate is 3.3%. Which means that when a patient in the U.S. experiences a complication due to surgery, their odds of survival are only 0.7% better than if they were treated in another country.
Plus, patients in high-income countries were more likely to experience complications at all at 19% compared to 11% in low- and middle-income countries. Researchers theorized the difference may be because high-income nations offer surgery to higher-risk patients who are older, frailer, or have long-term diseases like diabetes or heart failure.
"These findings should serve as a wake-up call,” wrote BJA Editor-in-Chief Ravi Majahan. “We need to do more to prevent postsurgery complications—and particularly complications such as infection which are in many cases preventable, but as this research suggests are claiming the lives of three quarters of a million people worldwide, every year."
What can you really do about readmission rates?
Editor’s note: Janet Spiegel, MS, is a management consultant who has worked with several payer and provider organizations. She is currently a Lean senior strategic performance advisor at Martin’s Point Health Care in Portland, Maine.
When a healthcare leader charges a person or a team to solve some of the biggest national problems in care delivery—such as reducing hospital readmission rates—two things often occur: a surge of passion to make meaningful change, followed quickly by a sense of paralysis regarding where to start. But challenges, even massive ones like these, can be successfully addressed through a targeted problem-solving framework.
Define the problem
Reach out to your informatics/IT/data analytics team and let them know that you will need a partner for this effort. To start, ask for a report on your facility’s top 10 reasons for readmission. Using the Pareto Principle, you’ll likely see that 80% of the effects are caused by 20% of the causes. Let’s say your top two reasons for readmission are heart failure and COPD. Those are really big issues, so keep digging.
Go back to your data partners and ask for an analysis of readmissions due to heart failure and COPD in the last 12 months by patient age. What do you see first in the heart failure report? Are 80% of the readmitted patients over 60, for example? If so, ask your analyst what the patients were admitted for to begin with, or perhaps what counties those patients live in. Ask your analyst for his or her expert opinion on other data points worth analyzing. Keep asking questions about your results. This is called cause mapping: We want to keep asking what the causes are for the results so we can solve specific problems.
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