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Joint Commission seeks comment on total hip and total knee replacement measures

The Joint Commission is still working on six measures for its new advanced certification for total hip and total knee replacement and is seeking public comment up through January 2016.

The Joint Commission began accepting applications for its new program in December and on-site reviews for the program will being in early 2016. The certification is available for hospitals, critical access hospitals, and ambulatory surgery centers already accredited by The Joint Commission.

Update: Program requirements for total hip and total knee replacement advanced certification will go into effect in March 2016

FDA to provide more frequent info on medical device injuries and deaths

In 2016, the Food and Drug Administration (FDA) will be taking a stronger stance on reporting medical device complications and deaths. The agency’s newly published draft guidance will allow it to report early warnings signs associated with medical devices before the reports have been fully analyzed.

The FDA currently releases safety warnings and recalls on its website. That said, prior to this guidance the agency was unable to release any information on possible complications and injuries related to said warnings until after the all reports had been fully analyzed. The issue was that the agency receives hundreds of thousands of device safety reports in need of vetting each year.

Device manufacturers and other interested parties have until February 29 to comment on the draft.

Where’s my sponge? AORN updates guidelines for preventing retained surgical objects

Despite being labeled a “never event,” surgical items are accidentally left inside a patient 4,500 to 6,000 times every year. In response, the Association of periOperative Registered Nurses (AORN) updated its Guidelines for Prevention of Retained Surgical Items. The guidelines recommend standardizing count and reconciliation procedures to prevent items being left inside a patient. Some of the recommendations include:

1. Doing the initial count before the patient arrives in the operating room.
2. Having both the RN circulator and scrub person conduct the counts. The same two individuals should perform all the following counts throughout the procedure.
3. Establishing a standardized protocol for recording the counts during surgery on a count sheet or count board.
4. Establishing a no-interruption zone in the operating room, where non-essential conversation and activities are restricted. This prevents the team from becoming distracted and losing track of items.
5. Checking instruments and devices immediately after removal from the surgical wound to see if any parts or fragments came off inside the patient.

You can read the rest of the AORN Guidelines here.

Video gives sanitation advice for ambulatory care centers

The Joint Commission recently posted a new video Cleaning, High-Level Disinfection and Sterilization in Ambulatory Care Settings. The video covers infection control specialist Lisa Waldowski’s presentation on the benefits of infection prevention and the Joint Commission’s tracer program during their 2015 Annual Ambulatory Conference. The video is a prelude to The Joint Commission’s 2016 webinar Cleaning, High-Level Disinfection, and Sterilization for Ambulatory Care Organizations.

Joint Commission accepting hip and knee replacement certification applications; posts 2016 review guides

Starting December 17, The Joint Commission will be accepting advanced certification applications for total hip and total knee replacement. The new certification is available for hospitals, critical access hospitals, and ambulatory surgery centers already accredited by The Joint Commission. On-site reviews for the program will begin in 2016.

In other news, the Joint Commission also posted its 2016 review process guides for
disease-specific care, advanced certification for palliative care, healthcare staffing certification, and the corporate addendum to the healthcare staffing certification. There have been no changes to any of the guides since they were last updated.

Joint Commission posts prepublication standards online

The Joint Commission just posted prepublication standards for disease-specific care critical access hospitals, nursing care centers, laboratories and point-of-care testing. The standards have not been officially published in print or added to the Joint Commission’s collection of e-manuals.

New opioid prescribing guidelines created to stem addiction

The Centers for Disease Control and Prevention (CDC) formally announced a draft of its new opioid prescribing guidelines on December 14. The guidelines aim to stem the rise of opioid addiction in the U.S. while still providing pain relief to patients who need it. Some of the key provisions of the CDC guidelines are:

• Consider the use of non-pharmacologic therapy and non-opioid therapy for chronic pain. Opioids should only be prescribed if the expected benefits for pain and function are greater than the risks.
• Establish treatment goals before starting long-term opioid therapy. Physicians should only continue prescribing opioids if there is “clinically meaningful improvement” that outweighs safety risks.
• When starting opioid therapy, doctors should prescribe short-acting opioids instead of extended-release, long-acting opioids.
• When opioids are started, doctors should prescribe the lowest possible effective dosage.
• When prescribing for acute pain, the lowest effective dose of short-acting opioids should be prescribed and only in quantities for the expected duration of the pain.
• Patients should be evaluated within one to four weeks of beginning long-term opioid therapy, and be reevaluated at once every three months afterwards to assess benefits and harms of continued treatment.

The guidelines are open for public comment until Jan. 13.

Update:
The opioid guidelines have been postponed to later in the year. Within days of being release, the guidelines were criticized as unfairly restrictive to patients needing pain care. The CDC will have the National Center for Injury Prevention and Control’s Board of Scientific Counselors review the guidelines and public comments on January 7. The comment section is still open at this time.

Deadline for December webcast fast approaching; Learning about survey hot spots for 2016

There’s still time to join the December webcast on CMS and Joint Commission hot spots for 2016.

Join Bud Pate, REHS, and Lisa Eddy, RN, CPHQ, on Wednesday, December 16 at 1 p.m. ET as they examine current survey focuses and point out where CMS and The Joint Commission will concentrate their efforts during your next survey.

In just 90 minutes, find out how to prepare for your next accreditation survey and comply with the most troublesome CMS and Joint Commission requirements. Pate and Eddy will provide strategies for preparing your staff for survey and give you valuable tips about what surveyors will expect when they arrive at your facility.

For more information and to register for the webcast, call HCPro customer service at 800-650-6787 or visit the HCPro Marketplace.

Joint Commission and AABB partner to establish a patient blood management certification program

Starting in 2016, healthcare facilities that conduct blood transfusions will be able to receive a new form of certification from the Joint Commission and the AABB. The Patient Blood Management Certification program is aimed at educating hospitals on the benefits of an evidence-based, multidisciplinary approach to the transfusion decision-making process.

The AABB is an international association focusing on cellular therapies, transfusion medicine and blood management and the certification is based on their Standards for a Patient Blood Management Program. 

Boston Scientific issues immediate recall of device guidewires

The Boston Scientific Corp. issued an urgent medical device recall of its RotaWire “Elite” core wires and wireClip Torquer guidewires on November 27. The company said the guidewires may crack and detach from the Rotablator Rotational Atherectomy System (RRAS). The RRAS is used to open narrow arteries and cut away at plaque, improving blood flow to the heart. When the guidewires crack, the pieces can be left inside the artery causing tamponade or heart attacks. Boston Medical has learned of three incidents of guidewires cracking so far, with one case resulting in a patient’s death.

The recall comes in the wake of a FDA safety communication on intravascular devices. Since 2014, the FDA has received 500 medical device reports on peeling hydrophilic and/or hydrophobic coatings on intravascular devices, with the majority of reports submitted for vascular guidewires.

The FDA encourages healthcare professionals and patients to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. Facilities still using these guidewires are told to stop using them immediately. All affected products should be returned to Boston Scientific and distributors should notify any customer who may have received the product.