By K. Richard Douglas
Duties of the biomed department include the responsibility that medical devices are functioning to certain specifications. The efforts of well-trained biomeds supports the efforts and procedures of clinicians around the globe on a daily basis. It is well known that mechanical and electronic devices can malfunction, stop working or be influenced by the environment they operate in. The increasing role of technology in most medical devices means that software, firmware, networking or complexity can further impact their operations.
Technology has introduced additional risks, which means that the potential for technology-related incidents has increased. Recently, the failure of insulin pump software, that connects the insulin pump to an iPhone, resulted in the pump’s battery draining sooner than normal.
The technical issue is alleged to have led to 224 injuries. While this type of incident is beyond the purview of the biomed shop, it points to the susceptibilities that technology adds to the complexity of modern health care. It is a two-edged sword.
In this case, the FDA is investigating. Preliminary findings have already been made public.
What caused the incident and how can a recurrence be prevented? The approach to this investigation is usually more comprehensive, and possibly exhaustive, than a cursory assessment would indicate. There are best practices that the “investigators” should adhere to.
Incident management in the health care setting requires an observance of best practices by all involved. What should biomed’s first reaction be when made aware of an incident, such as a device malfunction?
“Similar to whenever we call a vendor for tech support, our first question to end users should be: ‘Was a patient harmed or nearly harmed?’ This is still a learning process for many team members to make second nature. There’s also the issue that the person placing the call is not always the person who was using the device so information and the severity of the issue can be lost,” says Renato Castro, CHTM, CBET, assistant manager of biomedical engineering at Stanford Health Care Tri-Valley in Pleasanton, California.
He says that if a device is involved in an incident, the biomed team member should gather as much information as possible.
“Sequester the device into biomed custody (if possible, any disposable or consumables involved should also be sequestered by the clinical team). Ask staff if an incident report has already been placed; if not, then request that one be made. Pulse in biomed leadership to the situation. From there, biomed leadership should be reaching out to either the risk management team, compliance officer, or patient safety officer – each organization tends to have a different point person or team for these incidents so make sure you know who the appropriate party is to make sure the incident report was filed,” Castro says.
He says that he generally has his teams dedicate a place in the shop for the sequestered device.
“I would then also have them put a large visible sign saying something along the lines of ‘not for clinical use’ or ‘inspection in progress’ and send a notice to the rest of team about the device and to not touch it until further instructions,” Castro adds.
Nick Inderdahl, manager of biomedical engineering at ProHealth Care Inc. agrees.
“The equipment should be kept somewhere that it won’t likely be put back into service. Attaching some sort of service record usually helps, and if it has good notes, anyone can read and identify why it is there and what is being done with it,” he says.
Inderdahl also says it’s a good idea to reach out to the safety and/or the risk management group to give them a heads up and start conversations.
“Make sure aid is rendered to the patient if needed, verify the safety of the staff, isolate the device for investigation and record any settings used,” says Mike Powers, MBA, AAMIF, CHTM, CDP, director of healthcare technology management at Intermountain Health.
He says investigate the performance of the unit, and see if the issue is reproduceable. Record data needed for completing FDA MedWatch form 3500A. Repair the unit, verify operation with manufacturer. Return it to service or send it to the manufacturer for invasive testing. Complete and send in form 3500A. Report it to ECRI and their event database.
Powers points out that the meaning of “incident” can have vastly different meanings between biomed and IT.
Studied Guidelines
Health care providers are not alone in their efforts to address an incident, reporting it or responding to it. ECRI, an organization focused on health care technology and safety, has created a best-practices approach to managing these often-serious events.
“Hospital errors are the third-leading cause of death in the United States. After an incident occurs, it becomes imperative that a comprehensive investigation is completed to prevent recurrence and limit risk to the organization. However, missteps and gaps in the process, or a lack of investigation experience and resources, can leave organizations open to recurrence and costly claims,” says Barbara Malanga, director, preventative solutions and device safety operations-device safety at ECRI.
She says that ECRI has developed a 7-point approach to manage and investigate health care incidents that considers the process from beginning to end. They call it the IMI Plan. It includes (1) awareness, (2) response, (3) fact gathering, (4) analysis, (5) conclusions (6) recommendations, and (7) legal considerations.
Malanga says that when biomed is made aware of a device malfunction, its first course of action should be to remove that equipment from service.
She says that it is important that health care facilities have a pre-established response plan and that all potentially involved personnel (including clinicians, biomedical engineering staff and risk managers) are trained in how to execute the plan.
“Assuming that there is no persistent unsafe condition present, which would require you to first secure the area, the first step after an incident is to attend to the injured. This may include a patient, clinicians, other hospital staff or visitors,” Malanga says.
The second step would be to preserve the equipment and the environment, if applicable. It is important to preserve anything that may have caused or contributed to the incident.
“Step three is to report the incident. Incidents should be reported in a timely manner to the appropriate person within your facility who will follow-up and coordinate the investigation. A health care system can only act on and analyze events that are reported,” Malanga says.
She says that the next steps would be to sequester equipment. Devices or equipment that are suspected to have caused or contributed to an incident should be set aside in a secure area with limited staff access. Then, gather evidence. This may include photos that document what happened, information that was stored by the devices used (e.g., logs), information from the health record, a detailed summary of what happened, exemplar equipment, device documents, relevant policies and procedures, device purchase information and service history.
“Although incident response is typically coordinated by risk management personnel, biomedical engineering often plays a role and can be the source of critical equipment-related information,” Malanga says.
A Resourceful Approach to Notification and Tagging
At the Houston Methodist Hospital, which serves the Greater Houston area, the HTM department devised an acronym to outline a process that is known as the “STARR process.” Clinical engineers Zachary Smith, Cristian Delgado, Hani Khalil and Bailyn Piecewicz all provided insights into how the process works at their medical center.
“TAPS (Transparency and Accountability in Patient Safety) is a reporting system for Houston Methodist employees – any employee can submit a TAPS event – for all patient-involved incidents. Within the TAPS system, the reporter will select the appropriate ‘safety event level of harm.’ Clinical engineers in biomed are automatically notified if a report is submitted that involves medical devices. Clinical engineers have access to the TAPS database where notes and findings must be inputted,” Smith says.
The process involves a tag that is completed by the reporter of the incident.
“For the last R (Report as TAPS event via Biomedical Engineering Dispatch) – this dispatch call would come directly to biomed from the end user, and a service report would be created for that specific device. It would be under the category of ‘incident’ (as compared to ‘routine’ or ‘non-urgent’),” Smith explains.
He says that the clinical engineers will then act as the investigator for the TAPS event for the biomedical engineering department. They will do the following as needed: Speak with the involved staff about what occurred, who was involved, settings used. Examine device – pull event logs, check for defects, contact OEM with questions, etcetera.
These steps are usually done with help from experienced biomed technicians.
Once [the] issue is identified, typically biomed will make any necessary repairs to device, set up corrective action plan with the unit and the patient safety department; re-education, OEM discussion for setting changes, etcetera.
“Biomedical engineering tracks work order codes to determine patterns in equipment, problems, education needs and user errors,” Smith says.
They then report the findings to the hospital safety committee.
What to Preserve after an Incident
Because it is so important to preserve a malfunctioning medical device and anything relevant to that device, Malanga provides an acronym that allows biomeds an easier approach to memorizing what steps to take.
“Staff should be educated and periodically reminded about the importance of evidence preservation. The acrostic S.A.V.E.D can be used to help staff remember what should be saved,” she says.
S – Settings: Document what the equipment settings were and whether there were any displayed error codes.
A – Accessories: When possible, leave accessories and components assembled as they were at the time of the incident.
V – Valuable Data: Save paper printouts that may have been generated during the procedure. Print or download data that is stored by the equipment as soon as possible. Be aware that stored patient data may be lost when the equipment is powered down. Although alarm and error logs are usually retained, they can sometimes be displaced if the equipment remains in use.
E – Equipment: Equipment should be preserved in the state it was at the time of the incident until it can be examined and tested by qualified personnel with proper documentation.
D – Disposables: Save disposables, including packaging, if possible. Sometimes it is important to know what the serial number or lot number is on the disposables used. This may require retrieving it from the trash.
“The two most common mistakes analyzed by ECRI during our incident investigations include: 1) personnel throwing away disposables, and 2) losing data stored in the device’s memory,” Malanga says.
She adds that it also may be important to preserve the environment in which the incident occurred if environmental factors are believed to have played a role.
“The investigation team may want to consider certain aspects such as: temperature, lighting, electrical power, medical gas supply or unusual odors,” Malanga suggests.
She says that failure to sequester equipment can result in a claim of spoliation of evidence if devices involved in an incident are discarded, altered or their stored data is lost.
When to Engage Outside Help
Malanga says that while many hospitals have the resources to perform internal investigations into these incidents, there are times when additional resources should be brought in.
“Many hospitals perform their own investigations of health care incidents. Often with the assistance of the biomedical engineering department and/or the original equipment manufacturer (OEM). Although hospitals should ensure that an internal accident investigation be performed and have a mandate to do so, there are some circumstances in which it may be unwise to rely solely on an internal investigation,” she says.
For example, incident investigations carried out by hospital personnel, and in some cases, by personnel actually involved in the incident, can be susceptible to bias.
“With internal investigations, the same person responsible for the maintenance of the devices or equipment may become tasked with testing the incident devices or equipment as part of the investigation. In a sense, they are investigating themselves,” Malanga says.
She says that events involving serious injury or death are likely to result in legal claims by the injured party or the estate of the deceased. The defense of such claims may involve court testimony.
“Biomedical engineers’ and associated technicians’ main responsibilities are to maintain devices and equipment so that they continue to work properly and safely, and meet the manufacturer’s performance specification. They are often not well-equipped to perform incident reconstruction, devise simulations, or explore possible mechanisms of injury, and may not be the best choice to render expert opinions. A third-party investigation by a trained investigator can relieve the facility’s staff from the pressure and stress resulting from being assigned ‘expert’ responsibilities in the event of a claim,” Malanga adds.
Responding to an incident that could have had dire consequences, or one that actually did, requires a methodical approach that considers many variables that allow for an effective investigation. Knowing these steps, and having a system in place to respond to these incidents, is just one more role that the HTM team provides in its capacity as prepared professionals.
ECRI’s Healthcare Incident Management and Investigation (HIMI) Course trains risk managers, biomedical engineers and providers how to broadly manage and investigate any type of health care incident from its inception to potential litigation. Developed by ECRI’s experienced team of investigators, the course consists of six 20-minute online, interactive modules. Each module describes a case study based on a real-life investigation and teaches users how to apply ECRI’s seven-point incident management and investigation (IMI) plan.
