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Helpful MCN Healthcare Resources
CareFusion has initiated a recall of Avea Ventilators in response to a potential malfunction of an AVEA ventilator-specific 5 psi pressure transducer. The affected AVEA ventilators may develop a failure mode over a period of time, where, by design, the ventilator activates false Extended High Ppeak or Circuit Occlusion audio and visual alarms, opens the safety valve and stops ventilating. If this occurs, alternate ventilation support will be required to reduce the potential of hypoxemia or hypercapnia.
The global recall involves AVEA ventilators manufactured, serviced and distributed from July 1, 2011 to March 15, 2015. A list of affected model and serial numbers is available at the CareFusion website, link provided below.
The company has notified customers of the recall with an urgent recall letter.
The AVEA ventilator is only used in hospitals and other health care facilities and is intended for continuous breathing support for neonatal through adult patients.
- CareFusion does not require the return of affected AVEA ventilators.
- If an AVEA ventilator exhibits a sustained Extended High Ppeak or Circuit Occlusion alarm followed by the opening of the safety valve that cannot be cleared by powering the ventilator off and back on again, immediately remove the ventilator from service, provide alternate ventilation and contact CareFusion Technical Support at the contact information listed below to report the issue.
Read the MedWatch Safety Alert, including links to the Press Release and the CareFusion website and product photos, at the link below.
Joint Commission's (TJC) National Patient Safety Goal 09.02.01 requires accredited organizations to reduce the risk of falls. The statistics on falls are concerning. According to recent Centers for Disease Control and Prevention data, each year a typical nursing home with 100 beds reports 100 to 200 falls. Further, 10% to 20% of nursing home falls cause serious injuries; 2% to 6% cause fractures. In hospitals, falls are the most frequently reported incident on adult inpatient units. The Agency for Healthcare Research and Quality reports that the rate of falls ranges from 1.7 to 25 falls per 1,000 patient days depending on the unit, with geriatric psychiatry patients having the highest risk.
A Fall Reduction Program evaluates the risk of patient/resident falls and implements strategies to reduce the risk of falling while also minimizing injury that may result from falls that do occur.
Key Elements in a Fall Reduction Program include:
- A detailed fall-related assessment that includes a fall history, fall-risk.
- Flexible and adaptable strategies that reflect the fact that patient/resident falls occur in a multitude of situations and are attributable to numerous causes.
- Implementation of strategies to reduce patient/resident falls.
- A comprehensive staff education and training program that includes topics such as gait training, appropriate use of assistive devices, and the impact of medications on fall-risk.
- Education for patient/resident and families on fall prevention.
- Continuous evaluation of the fall prevention program
- According to TJC, every organization must decide how to define a patient/resident "fall" although organizations should check local and state laws which may define "fall".
- A fall reduction program should include all patients/residents that receive care, treatment and services. There should not be "blanket exceptions" for classes of patient populations, e.g., pediatric population.
Included with today's notice are example policies relevant to a fall reduction program.
The US Food and Drug Administration recently released a series of frequently asked questions about digital breast tomosynthesis (DBT) training requirements under the Mammography Quality Standards Act (MQSA). Under MQSA, personnel need to receive 8 hours of initial training prior to independently using any new mammographic modality, which is defined as a modality in which the person has not previously been trained.
As of April 2015, three DBT systems have been approved for marketing in the United States: Hologic Selenia Dimensions, GE SenoClaire, and Siemens Mammomat Inspiration. Due to the technological differences between these DBT systems, and differences in their FDA-approved Indications for Use (IFU), each manufacturer's DBT system is currently treated as a separate mammographic modality under the MQSA definition. However, the FDA's Division of Mammography Quality Standards (DMQS) recognizes that there are many features which are common to different DBT systems, while some features are unique to each specific system. Therefore, training must include both the common features of DBT and the unique features of the particular DBT system, but these two aspects of the training may be obtained either in a single training program or in separate settings. Once personnel have received training in the common features of DBT, they do not need to repeat this portion of the training when receiving training in the unique features of a particular system.
Key Takeaways from FDA's Frequently Asked Questions:
- Resident and Fellow training can be obtained during residency or fellowship. The documentation of initial DBT training provided by a residency or fellowship program must specify the particular DBT system(s) whose unique features were included in the training.
- Under MQSA, the new modality training, including the training on the unique features (the technological differences and the IFU) of a particular DBT system, does not need to be provided by the manufacturer. The individual providing the training must be a qualified instructor, defined as "an individual whose training and experience adequately prepare him or her to carry out specified training assignments."
Note: Each of the currently approved manufacturers, Hologic, GE, and Siemens, offers training on its own system; however, third-party training courses as well as informal training can also satisfy the requirement for new mammographic modality training under MQSA. For example, peer training by a qualified peer who has previously met the training requirement is permitted.
- Training should be designed for an intended audience-interpreting physicians, medical physicists, or radiologic technologists-since it should emphasize those unique features of the system that fall into the area of responsibility of the intended audience.
- DMQS will accept signed attestation, using DMQS's recommended form (link provided below) or a form with similar elements, to document that personnel received training in the unique features of a particular manufacturer's DBT system.
- Once personnel have received their 8 hours of training in the common features of DBT, they do not need to repeat this portion of the training when receiving training in the unique features of another particular system. Supplemental training on the unique features of a particular DBT system can typically be offered in less than 8 hours. Example scenarios include:
o Personnel who have already received 8 hours of general DBT training also need documentation of training in the unique features of the particular DBT system they will use.
o Personnel who have received 8 hours of training on one specific DBT system which they will use also need documentation that specifies the system whose unique features were included in the training.
o Personnel who have received 8 hours of training on any one DBT system also need documentation of training on the unique features of another DBT system prior to independently using that other system.
- DMQS has not specified the number of hours of training needed on the unique features of the particular DBT system although supplemental training can typically be offered in less than 8 hours.
- Training on the unique features of a specific DBT system will typically include:
o The technological features of image acquisition, processing, and/or display, the quality control tests recommended by the system's manufacturer,
o The system's unique FDA-approved Indications for Use (IFU), such as the particular combination of views approved for screening mammography using that DBT system.
o Training intended for an interpreting physician, a medical physicist, or a radiologic technologist should emphasize those unique features of the system that fall into the person's respective area of responsibility.
- Documentation of training in the unique features of a particular manufacturer's DBT system must be either a course certificate or letter that clearly indicates that the training included the unique features of a particular system, or a signed attestation, using DMQS's form or a form with similar elements, to document training in the unique features.
Included with today's notice is an example DBT Training policy.
Featured Policy Library Manuals
MCN's NEW Ambulatory Surgical Center/Outpatient Surgery Department Policy and Procedure Manual is cross referenced to TJC standards, AAAHC standards and CMS regulations. Policies and procedures meet AORN and CDC recommendations and guidelines. This comprehensive reference guide has over 290 policies and procedures that are ready to customize to your organization. See also the Administrative Manual for Ambulatory Care Facilities and the Ambulatory Services EOC Manual.Read more »
MCN Healthcare’s Home Health Policy and Procedure Manual provides over 400 policies and procedures addressing administration, emergency management, human resources, medical records, infection control, safety and security, equipment management, medication management, performance improvement, patient rights and responsibilities, waived testing as well as patient care. The Home Health Policy and Procedure Manual is cross referenced to CMS regulations, TJC, ACHC, and CHAP standards.Read more »
The Medical Office Policy and Procedure Manual is cross referenced to Joint Commission standards for Ambulatory Care and Primary Care Medical Homes and NCQA standards for Patient Centered Medical Homes. This manual includes policies that meet OSHA requirements for safety and infection control, Human Resources policies and Medical Office Compliance Plan and much more!Read more »