Reducing medical device errors at Patton Fuller Community Hospital

Integrating Theory and Needs Assessment

A major challenge that a number of health care facilities are facing is accidents related to medical devices. This is from many providers becoming overwhelmed with larger amounts of patients. As a result, the odds have increased of overworked staff members making some kind of error. Evidence of this can be seen in a study that was conducted by the Food and Drug Administration (FDA) along with the Consumer Product Safety Commission (CPSC). They found that between 1999 and 2000 there was a total of 454,383 injuries. ("Estimated 454,383 People," 2004) To deal with these issues the FDA has implemented the MedSun project. This was launched in 2002 with the regulators working in conjunction with hospitals to reduce the number of errors from medical devices. Moreover, the program is built upon the principals of the Safe Medical Devices Act of 1990, the Medical Devices Amendments of 1992 and state regulations. ("Medical Devices," 2012)

In the case of Patton Fuller Community Hospital, there is a $25,000.00 grant that was awarded to the facility. The purpose is to research and implement safety procedures that are in compliance with the MedSun project. To fully understand how this can be accomplished requires: conducting a needs assessment and examining how these policies are supporting different regulations. This is the point that we can offer specific ideas that will help to achieve these objectives.

Needs Assessment

The basic approach that Patton Fuller Community Hospital is taking is to create a protocol that can provide departments with the access they need. At the same time, there is a series of procedures in place to prevent any kind of security breaches such as: strict enforcement surrounding the retrieval of information and encryption. This has provided the hospital with a basic strategy for offering and controlling access to sensitive information.

However, the problems associated with medical device equipment makers can be addressed by focusing on select critical needs. The most notable include: improving collaboration between departments, increasing the number of interconnections and allowing staff to carry select mobile devices with them. These basic elements are important, as the combination of them will help to reduce medical device errors and improve the quality of care that is being provided.

In the case of improving collaboration between departments, the current infrastructure is allowing communication at certain levels. This is problematic, because it can increase the number of mistakes by not having some kind of reporting procedure in place. If communication can be improved, the quality of care would increase and the total amount of mistakes will decline. This is from establishing a culture of looking at these issues and directly addressing them. Over the course of time, this will force staff members to focus on all potential errors associated with medical devices. This is when the administration can create guidelines that will improve safety and reduce the number of incidents. (Wolf, 2008)

The way that this can occur is to have effective communication between the different departments and teams. This will give staff members the most accurate information about the patient's condition. At which point, everyone is aware of special circumstances and will take them into account. This is when the quality of care will improve and the total amounts of mistakes will fall. (Wolf, 2008)

Increasing the number of connections is troubling, as it could limit how quickly staff members have access to information. For example, the hospital is a member of several different federal databases that provide information about medical safety procedures (i.e. Med Watch). If there were improved connections between the different departments everyone will have access to the most up-to-date facts. This is when the number of potential mistakes will decline by letting the staff know about issues with specific medical devices. (Byer, 2002)

Allowing staff members to carry mobile devices with them will help to reduce errors by giving everyone access to the most current information. For example, if a nurse or physician is working with a patient. The wireless device will give them access to the patient's charts and any kind of advisories about using certain machines. This will improve the quality of care by giving all employees the most accurate information possible. This is when they can decide what tools to utilize when treating the patient (which reduces the odds of a mistake happening). (Carayon, 2010, pp. 477 -- 478)

How the Proposals can Support current Regulations and Enhance different Policies / Procedures

The approach that is recommended for the hospital is to install a protocol that will allow all of the different departments to interact with one another on a regular basis. This will make it easier for everyone to be able to communicate and share information. To achieve this objective, there will need to be increased connections between the network bridges. This will ensure that everyone is able to access the information when it is needed the most. The use of portable devices will serve as way of providing everyone with any kind of data instantly. This will help them to quickly diagnose the condition (which will reduce the number of medical errors). The way that this relates to medical devices is by giving everyone access to the most reliable information. This will improve the quality of the diagnosis and the kinds of tools that are utilized.

How do the Policies and Procedures Relate to the Safe Medical Devices Act of 1990, Medical Devices Amendments of 1992, and State-Specific Requirements?

The new and existing policies are taking into account the provisions of various aspects of the law. The way that this is accomplished is through using the policies of the status quo and augmenting it with new principals. For example, the Safe Medical Devices Act of 1990 gives the FDA the power to regulate the safety of medical devices. When the facility is implementing ways to improve these areas, they are complying with this provision of the law. (Samuel, 1991, pp. 192 -- 195)

Moreover, this conforming to the Medical Devices Amendments of 1992, as the law is requiring health care providers to use the Med Watch protocol. This is important, because our proposed solution will upgrade to this standard by having greater access to information. This means that Med Watch can help to make everyone aware of issues with medical devices and if they should be used. Over the course of time, this will reduce errors and ensure that there is a focus on safety. ("Medical Devices," 2012)

On the state level, the regulations have been taken and a number of different professional organizations have offered specific guidelines. A good example of this can be seen in the State of Washington. If there is an error that falls under specific categories, the staff must report this issue to the FDA. The most notable include:

The death is from a suspected adverse event.

The patient was at substantial risk of dying at the time of the incident.

Admission or the hospital stay was extended because of the situation.

The use of the medical device resulted in new conditions or corrective surgery.

These different elements are important, because they are showing how state laws will often take federal regulations one step further. In this case, the increased communication will make it easier to create a working platform that is in compliance with these regulations. This will ensure that that everyone knows when these principals should be applied. This is the point that there will be a focus on utilizing safety standards that go above and beyond these basic guidelines. ("Preventing Medication and Medical Device Errors," 2011)

The Timeline for Project Completion

The total timeline for implementing this project will take about six months. This will be divided into different phases to include: stages one, two and three. Stage one is when consultants will discuss with department heads the new strategy and what specific solutions could be implemented into the protocol. This would occur through a committee that will work with independent contractors to address the current and future needs of the facility. Once this occurs, is when the equipment will be ordered and tested inside a specific department. This step will take about two months of coordination and planning.

During stage two is when we will test the procedures using the Human Resource Department. This is from their need to communicate with everyone and their access to different areas of the hospital. When all of the issues have been worked out is the point that the system will be rolled out to the entire facility. This will take approximately two months to fully implement.

Stage three is when the entire hospital will begin working with the new MedSun protocols. This will be accomplished by conducting a massive training program. At first there will be refresher course that is provided to the entire staff. Then each department will send team members to be trained on the system. This is when consultants would work inside each department for a period of two weeks. At which point, there is focus on ensuring that everyone is capable of using the new applications through different levels of repeated exposure. The time frame to complete this stage is approximately two months.