HUMAN FACTORS

(the study of the interaction between the user and the device) FDA is interested in knowing about device use problems in order to minimize error and patient injuries that result from user error (5)  Human factors problems are more likely to occur with technologically advanced devices, such as programmable devices (6) Device use problems can happen in spite of adequate training and a high level of caution.

Examples of design problems that tend to induce user error include: complicated or unconventional arrangements of controls, displays, and tubing; poor design that makes installation and maintenance unnecessarily complex; ambiguous or difficult to read displays; confusing or unnecessarily intrusive alarms; hard to remember or confusing device operating procedures; inadequate device feedback or status indication that causes user uncertainty; and poorly designed labeling (7)

On the other hand, well-designed devices are those that are consistent with the user's experience; are logical and not confusing; minimize the need for depending on memory and making mental calculations; do not overtax the user's strength, dexterity, visual ability, or auditory capacity; alert the user to device-related problems; prevent users from making fatal errors that could otherwise occur easily; and are supported by readable and understandable labeling (7)

Health care practitioners can play an active role in device design by reporting information that they believe will help a manufacturer make a better device.

There are clinical settings which are exempt from MDR reporting requirement. These facilities include offices of physicians, dentists, chiropractors, optometrists,nurse practitioners, school‐based clinics, employee health clinics, and freestanding care units. However, health professionals who work under the auspices of a user facility are subject to their facility’s mandatory reporting requirements.

How and what must user facilities report?

User facilities are required to complete a mandatory reporting form (FDA 3500A) whenever they receive or otherwise become aware of information that reasonably suggests that a device has or may have caused or contributed to the death, serious illness, or serious injury of a patient in the facility. Mandatory reporting requirements by user facilities could also include device malfunctions and/or user error which results in death or serious illness/injury. See TABLE 1 for further clarification of the meaning of “caused or contributed” and TABLE 2 for the FDA definition of “serious illness/serious injury” related to device reporting.

The user facility has the responsibility for determining if the device­ related event is reportable based on the facts and circumstances observed by its medical or nursing personnel

User facilities have an add i t i o n a l responsibility to report, on a semiannual basis, all reports they submitted to FDA and the manufacturer within the previous 6 months. FDA uses these reports to monitor the compliance of the manufacturer with their reporting requirements.

Note: There are no mandatory reporting requirements for user facilities to report adverse events or problems with other medical products, such as medications. However, healthcare professionals a re encouraged to report these occurrences via the voluntary MedWatch reporting mechanism.

Death: Must be reported by the user facility to the FDA and the manufacturer of the device within 10 working days of the facility becoming aware of the event.

CASE EXAMPLE: A 35 year old female suffered a severe head injury in a car accident. Upon discharge from the hospital, she remained disoriented and easily agitated, and was followed by a home care

agency for further care. Her physician's orders included IV medications to be infused via an infusion pump, physical therapy, and an electric hospital bed for long‐term use. The patient was unattended one day for about 45 minutes, after which time the caregiver entered the room and found the patient's body hanging between the side rail of the bed and the floor. It appeared that the patient had attempted to get out of bed by slipping through the side rails. Her head became entrapped between the side rails and, unable to extricate herself, she was strangled.

Q ­ Is this death a reportable event?

A ­ Yes. Since the electric hospital bed (a medical device) might have caused or contributed to the patient’s death, the event is reportable by the home care agency (the user facility) to FDA and the manufacturer within 10 working days of becoming aware of the event.

Table 1 CAUSED OR CONTRIBUTED

“Caused or contributed” means that an incident was or may be attributable to a medical device. The medical device may have been a factor in a death or serious injury, including events which occurred as a result of:

Device failure Manufacturer defect Malfunction Improper/inadequate design Improper/inadequate labeling User error

Table 2 DEVICE­RELATED SERIOUS ILLNESS/INJURY

FDA defines a device‐related serious injury as an injury or illness that:

•  Is life‐threatening;

•  Results in permanent impairment/ damage to body function or structure; or

Necessitates medical/surgical intervention to prevent permanent impairment/damage of body function/structure

Serious illness/injury: Must be reported by the user facility to the device manufacturer within 10 working days of the facility becoming aware of the event. (If the manufacturer is unknown, the report should be sent to the FDA.)

FDA encourages user facilities to submit reports of device malfunctions that do not result in death or serious injury directly to the manufacturer using the mandatory reporting form (FDA 3500A). Although these reports are not mandatory under the law, they provide important information that can result in product recalls and other types of corrective action.

CASE EXAMPLE: A 56 year old male entered an outpatient treatment facility to receive radiation therapy for throat cancer. He subsequently sustained burns central to and bordering the treatment area. Upon further investigation by the facility, it was discovered that the Radiation Treatment Planning System (RTP) had a software problem which included an algorithmic error resulting in irregular field settings. Due to this error, the patient received a 22% overdose of radiation to areas outside of the central beam axis during the course of his linear accelerator‐based therapy. His radiation therapy was suspended, and he received treatment for his burns.

Q ­ Is this injury a reportable event? A ­ Yes. A software problem with the RTP (medical device) resulted in a serious burn injury to the patient, which required medical intervention to prevent permanent damage to body structure. The outpatient treatment facility (the user facility) should report this event to the manufacturer within 10 working days of becoming aware of the event.

CASE EXAMPLE: During a routine angioplasty procedure in a hospital, the tip of apercutaneous transluminal angioplasty catheter detached. The patient experienced no electrocardio

‐graphic changes or chest pain and was transferred to the medical intensive care unit. He ultimately underwent surgery to remove the wire tip of the catheter.

Q ­ Is this a reportable event?

A ­ Yes. Medical  intervention was necessary (one of the definitions of "serious"), after the device (catheter) malfunctioned, to prevent permanent impairment to body function. The hospital (the user facility) should report this event to the manufacturer of the device (within the 10 working day limit).

CASE EXAMPLE: A 40 year old female undergoing a laminectomy was administered what the anesthesiologist thought to be 100% oxygen (to bring her out of anesthesia).When the patient became cyanotic, the anesthesiologist immediately removed her from the ventilator, believing it was malfunctioning. The patient was manually resuscitated. Three hours later, in the same operating room, a four month old premature infant was in surgery for a ventriculoperitoneal shunt. When the same ventilator was used, and oxygenation had been initiated, the infant became cyanotic and CPR had to be administered. Upon investigation by the hospital, it was found that the oxygen hose was inappropriately assembled into the nitrous oxide inlet and the nitrous oxide hose was inappropriately assembled into the oxygen inlet. The biomedical engineering department documented that the manufacturing firm had delivered and set up the device for use.

Subsequently, no one had checked the ventilator connections prior to use of the device. Q ­ Is this a reportable event? A ­ Yes. The incorrect assembly of the ventilator connections (medical device) resulted in a life­ threatening event (one of the definitions of "serious"). This event should be reported by the hospital (the user facility) to the manufacturer (within the 10 working day limit).

CASE EXAMPLE: A flash fire occurred during a blepharoplasty procedure being performed on a 40 year old male in an outpatient surgical facility. The patient was receiving oxygen via nasal cannula. The surgeon was cauterizing with an electrosurgical cutting and coagulation device when a " golf ball‐ sized" flash occurred.  The patient's eyelashes, face, and cornea were burned. The burns were treated by debridement and ointment, and the patient ultimately required treatment by an ophthalmologist. The electrosurgical device was evaluated by the manufacturing firm and found to be functioning properly. The instruction manual contained warnings regarding fire hazards specifically with the use of electrosurgery in an oxygen enriched environment. Q ­ Is this event reportable even though the labeling warns of potential fires? A ­ Yes. The patient required medical intervention to prevent permanent impairment after receiving an injury attributed to the use of the device. The outpatient surgical facility (the user facility) should report this event to the manufacturer within 10 working days of becoming aware of the event.

CASE EXAMPLE: A 34 year old female with a nonpalpable breast lesion discovered by mammography entered an outpatient diagnostic facility for a large core needle biopsy under stereotactic guidance. The patient experienced no discomfort after the procedure, but a subsequent mammogram revealed that metal shavings and fragments from the 14 gauge needle had remained in the breast tissue after the biopsy was performed. This was due to multiple firings of the biopsy gun into the tissue that resulted in the needle hitting the cannula, causing the burring. Q ­ Is this event reportable under the law by the user facility? A ­ No. This is a device malfunction which did not meet the definition of a serious illness / i n j u ry. However, F DA strongly encourages user facilities to report device malfunctions to the manufacturer and/or MedWatch so that they can take appropriate action if needed.

CASE EXAMPLE: A nurse in a hospital was preparing to draw up a medication into a 5 cc syringe. In the process, he noticed the markings on the syringe were at an angle that made it impossible to draw up the medication accurately. He then checked the drawer where the syringes were stored and noticed at least 10 other syringes that were mismarked. Upon opening a new box of syringes, he discovered all the syringes were correctly marked. Q ­ Is this event reportable under the law by the user facility?  A ­ No.

Although this device problem is not reportable under the law, FDA would encourage the user facility to report it to the manufacturer and/or MedWatch

Of special note:

•  Health professionals need to be aware that if a patient brings his/her own medical device (i.e.,a wheelchair) into a user facility for personal use and the device causes or contributes to the patient's injury or death, the event is reportable under MDR (even though the device is not owned or leased by the user facility) because it occurred in a user facility (14)

. • Healthcare professionals who work in user facilities and sustain a device‐related illness/injury (or death) are considered “patients” of that user facility and any serious adverse event reportable under the law would be reported as if it had happened to a patient in that facility.

The role of the healthcare professional in user facility reporting:

It is critical that health professionals working in user facilities monitor and report all device problems in accordance with the procedures established by their facility.

These procedures will probably include:

• Removing the defective device from the patient area;

• Labeling the device with a description of the problem and the date;

• Recording the name, model number, and manufacturer of the device;

• Notifying the appropriate personnel;

• Filling out an incident report, and submitting all the evidence with the written report.

CASE EXAMPLE: A 2 year old female was admitted to the hospital with a fever of unknown origin and diagnosed with sickle cell anemia. The child was receiving D5W with potassium IV at 20 cc/hr per a large volume infusion pump. The mother, who was in the room with the child, heard the pump alarm and turned on the nurse call light. The nurse heard the pump alarming upon entering the room. The child was coughing and having difficulty breathing. When the nurse attempted to better open the patient's airway, the child became limp and unresponsive. A code was called and CPR was initiated. The patient was removed from the pump and transferred to the ICU, where she died several hours later. Q ­ What would be some of the device­ related actions which should be taken? A ­ A health professional witnessing this event needs to identify that the infusion pump might have contributed to the death of the pat i e n t . Established procedures within that facility must be followed. These procedures may include that the pump be labeled, removed from the clinical area , a n d checked to evaluate why it was alarming (whether it was programmed correctly, whether there appeared to be over/under infusion, whether the tubing was properly i n s t a l l e d, e t c.).  The healthcare professional should also notify the appropriate personnel within his/her facility (such as the risk manage r ) , and complete the necessary written report.