Health Policy Formulation and Analysis

Health Policy Formulation and Analysis

HLT 314V

Grand Canyon University: Healthcare Systems

Radiography Compliance for Electronic Devices

When in a role providing care in a radiography department, it is pertinent to set a high standard of quality and meet patients’ satisfaction. It an unexpected circumstance when a facility has an unfortunate safety issue due to the lack of information provided by the ordering physicians, patients unable to give extended health histories, unable to provide medical device cards for the device in use, and no charting within the system. Compliance is essential to follow appropriate measures to allow for safe patient care.

Problem Finding Information on Patient Medical Devices

Radiography has many safety initiatives implemented already due to ionizing radiation. Overview of exploring the effects of x-ray irradiation from imaging on removable medical devices, such as glucose monitors or insulin pumps (FDA, 2018). The FDA has received a small quantity of reports of adverse incidents during CT imaging of insulin pumps (FDA, 2018). Safety is always the number one factor when treating patients. Risk management is always segment of the incident reporting and collaborating within organizations when implementing safety measures. It is always best to be proactive when dealing with health risk (Cannavale, Santoni, Passariello, & Arbarello, 2013).

Evidence of Problems with Exposure to Certain Devices. The adverse experience noted in FDA reports the following adverse safety and health risks: (FDA, 2018).

Insulin pumps are another area of concern regarding compliance standards. Insulin pumps are a life-sustaining medical device used to treat diabetes. The pump delivers insulin twenty-four hours a day through an infusion set inserted into the patient. The table below is an example of just one list of recommendations from one company regarding exposure to radiation (The Animas insulin pump is a life-sustaining medical device used to treat diabetes. The pump delivers insulin 24 hours & a day via an infusion set inserted into the user’s body., 2014)

  • Low blood sugar (hypoglycemia) and high blood sugar (hyperglycemia)
  • loss of consciousness
  • ketoacidosis, related to diabetes
  • petite or grand mal seizures
  • light-headedness
  • syncope
  • falls and related injuries
  • heart failure
  • hypertension (high blood pressure)
  • one death (FDA, 2018).
ProcedureCC Recommendation
CARDIAC CATHETERIZATIONDo Not bring pump or Transmitter/Sensor into the same room where the procedure is being performed.Teflon/plastic infusion set can remain in. Other types of infusion sets must be removed.
COLONOSCOPYPump, infusion set, and Transmitter/Sensor can remain on/in.
CT SCANSDo Not bring pump or Transmitter/Sensor into the same room where the procedure is being performed.Teflon/plastic infusion set can remain in. Other types of infusion sets must be removed.
EKGPump, infusion set, and Transmitter/Sensor can remain on/in.
ELECTRO-CAUTERYDo Not bring pump or Transmitter/Sensor into the same room where the procedure is being performed.Teflon/plastic infusion set can remain in. Other types of infusion sets must be removed.
LASER SURGERY Pump, infusion set, and Transmitter/Sensor can remain on/in.
MRIDo Not bring pump or Transmitter/Sensor into the same room where the procedure is being performed.Teflon/plastic infusion set can remain in. Other types of infusion sets must be removed.
NUCLEAR STRESS TEST (myocardial perfusion imaging)Do Not bring pump or Transmitter/Sensor into the same room where the procedure is being performed.Teflon/plastic infusion set can remain in. Other types of infusion sets must be removed.
PACEMAKER/AICD ReprogrammingDo Not bring pump or Transmitter/Sensor into the same room where the procedure is being performed.Teflon/plastic infusion set can remain in. Other types of infusion sets must be removed.
THERAPEUTIC RADIATION/ ONCOLOGY(cancer treatment radiation)Do Not bring pump or Transmitter/Sensor into the same room where the procedure is being performed.Teflon/plastic infusion set can remain in. Other types of infusion sets must be removed
ULTRASOUNDPump, infusion set, and Transmitter/Sensor can remain on/in.
X-RAY, BODY FLUOROSCOPY(chest, neck, abdomen, torso, etc.)Do Not bring pump or Transmitter/Sensor into the same room where the procedure is being performed, unless a lead apron that completely covers pump is worn during the procedure. Teflon/plastic infusion set can remain in. Other types of infusion sets must be removed.
X-RAY, BONE DENSITOMETRYDo Not bring pump or Transmitter/Sensor into the same room where the procedure is being performed, unless a lead apron that completely covers pump and Transmitter is worn during the procedure. Teflon/plastic infusion set can remain in. Other types of infusion sets must be removed.
X-RAY, DENTALDo Not bring pump or Transmitter/Sensor into the same room where the procedure is being performed.Teflon/plastic infusion set can remain in. Other types of infusion sets must be removed.
X-RAY, MAMMOGRAMDo Not bring pump or Transmitter/Sensor into the same room where the procedure is being performed.Teflon/plastic infusion set can remain in. Other types of infusion sets must be removed.

(The Animas insulin pump is a life-sustaining medical device used to treat diabetes. The pump delivers insulin 24 hours & a day via an infusion set inserted into the user’s body., 2014)

The recommendation below is a warning listed on the FDA website for patients regarding insulin pumps.

Constructing a Solution. The simplest form of providing information for patient care is charting. Electronic health records (EHS) are available to many practices. The available information would be found within the patient chart for practices using the same EHR or system. Unfortunately, many sites and many vendors exist in the software world today. The transfer of reports and details and receiving a consent for this information can be a timely process, thus defeating the purpose of accessible, prompt informative policy measures.

  • Imaging exams involving scans directly over the electronic device for more than several seconds require additional care and should not be performed unless the device can be safely relocated or turned off. Examples of these scans are CT perfusion exams or interventional studies such as CT fluoroscopy. If the above recommendation is not possible and the scan is warranted , precise monitoring of the device during and after the study is required (FDA, 2018).
  • Be aware that interference is possible and be prepared to conclude the scan if the patient communicates any symptoms that are adverse. Although adverse symptoms are rare, they can include alarm sounds from the pump, lightheadedness, fainting, seizures and loss of consciousness (FDA, 2018).

The patient should be provided with an identification card concerning care and familiarity of the medical device for examinations, diagnostic testing, and compliance. This is also a very sensible option to abide by, Inadequacy of this policy is loss of the card, availability to carry it always for unknown appointments or last-minute urgent care needs. This also defeats the purpose of accessibility and delays treatment as well.

The third options would be a national reporting website to register a medical device with a patient. This website would then be available to all medical facilities with proper authorizations and accreditations to do so. This would allow for proper assessment of the device and contraindications of care for procedures, diagnostic studies, and even possible adverse results of noncompliance.

Result of Denial of Policy. Negligence can quickly turn into litigation, income loss. Risk management can run a practice into litigation when standards and compliance are not met (Cannavale, Santoni, Passariello, & Arbarello, 2013).

Compliance and standards can be difficult with the best intentions of providing optimal care and high practice of safety initiatives. Sometimes information is not available that could be present to support and taking an initiative in achieving utmost benefit for the patient and the facility. Proper tools for such instances could make such practices improved and save patients time and frustration for the patient and departmental staff (Cannavale, Santoni, Passariello, & Arbarello, 2013).

Impediment in care while a technologist researches the medical device on the internet, contacts the company for compliance, or searches within a chart for the name of a device, may result in the delay of a critical finding from a diagnostic study being delayed. Such delay may result in a poor outcome for the patient. Failure to diagnose and delay in diagnosis are the more standard negligence claims (Church, 2004).

Risk of fault of the medical device and the risks associated with malfunction of the device causing harm to the patient is also a concern which would lead to a negligence issue (FDA, 2018).

Recommendations. The fundamental issue of risk and error management is to develop processes and safeguards aimed at reducing or preventing the occurrence of errors and minimizing the degree of harm. Such behavior should reduce the risk of harm to the patients and, thereby, malpractice litigation. Creating standard protocols and rules should prevent and minimize incidents (Cannavale, Santoni, Passariello, & Arbarello, 2013)

Facilities are trying to align missions with the dimensions of care highlighted in the Institute of Medicine report Crossing the quality chasm which states that patient care should be safe, effective, efficient, patient-centered, and timely—categories that are applicable to the radiology field (Successful quality management system in a radiology department.2018).

With this information to guide decisions about policy protocols the best solution would be a policy to provide the patient with information regarding the care of the medical device with a card to reference to carry, and if unavailable a national website easily accessible to medical device look up and quick information guide of compliance. The optimal outcome would be an implementation of electronic charting as well but with different software systems availability to information would be a difficult matter to transmit and receive consent for release is timely, thus making the national medical device look up much easier for accessibility.

References

Cannavale, A., Santoni, M., Passariello, R., & Arbarello, P. (2013). Risk management in radiology. Radiology Management, 35(5), 14. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/24303642

Church, E. J. (2004). Legal trends in imaging. Albuquerque, New Mexico: American Society of Radiologic Technologists. Retrieved from https://lopes.idm.oclc.org/login?url=https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=106557699&site=eds-live&scope=site

FDA. (2018). Interference between CT and electronic medical devices. . Retrieved from https://www.fda.gov

Successful quality management system in a radiology department. (2018). Retrieved from https://healthmanagement.org/c/imaging/issuearticle/successful-quality-management-system-in-a-radiology-department

The Animas insulin pump is a life-sustaining medical device used to treat diabetes. The pump delivers insulin 24 hours, & a day via an infusion set inserted into the user’s body. (2014). Attn: Medical imaging personnel