Opportunities for Poka Yoke to Reduce Medical Device Errors in Hospitals
Poka yoke has been used in health care to prevent life-threatening mistakes. There are many examples in health care where mistake proofing through poka yoke has been implemented on medical devices. Human errors and faulty medical devices can threaten the safety of patients; poka yoke techniques, used together with employee training, can reduce the chances of these errors occurring.
Common Errors in the Use of Medical Devices
When patients go for treatment in a medical institution, the last thing they expect is to be maimed or injured. Yet many people die or are injured every year by the medical devices that are supposed to help them get well.
Medical devices to be used in the diagnosis and treatment of patients are designed and manufactured to the highest of standards. Any failure of these devices can lead to misdiagnosis, serious injury or even death and their reliability must be constantly guaranteed.
Using the lean manufacturing mistake-proofing technique of poka yoke, manufacturers of medical devices have designed safety features that reduce the possibility of a serious error occurring. Though they have not been 100% effective, these poka yoke techniques have gone a long way in preventing serious injury, misdiagnosis, and death of patients. The Food and Drug Administration (FDA) has strict standards on medical device safety and will order a recall of any equipment that does not meet these standards.
Insulin Infusion Pump
These devices deliver insulin to patients suffering from diabetes and have proven to be one of the most effective ways of managing the disease. However, a number of safety incidents of concern have occurred regarding the devices. These include leakages and infiltration of the pumps with foreign bodies. There have also been reports of accidental needle-sticks which can lead to wrong medication levels.
Just recently, a number of vascular stents were recalled due to failure to deploy. When this happens, the patient is in further danger from restricted blood flow within the vessels. New vascular stent technology allows the stent to degrade uniformly thereby negating the need for a follow-up procedure to remove them.
When balloons refused to deflate during procedure, peri-catheter aspiration was the only recourse to deflate the balloon. When the balloon is deflated in this way, it is possible for catheter debris to enter the system and cause even more damage.
These machines, which provide a continuous supply of anaesthetic gases and oxygen, have automatic ventilation devices that make the process of administering anaesthesia more accurate and efficient. When the automatic ventilation devices in anaesthesia machines fail to operate properly, there can be serious implications for the safety and health of the patient. Recently there was an FDA recall of anaesthesia machines that did not meet the requirement that electrical components must have a specific clearance from the housing of the machine. This can lead to the machine failing due to the by-pass current that flows within the interior of the machine.
The food and drug administration (FDA) has recently reported that software failures account for over 20% of all recalls of medical equipment. Faulty software within medical devices can lead to serious consequences for the patient such as misdiagnosis or overdose of medicines. There is also risk of loss of confidential and personal medical data through malware and viruses due to the increased interconnectivity of devices. To mitigate the risk of software failures in medical devices, the FDA now regularly inspects this software using industry best practices.
Air embolism and contamination of dialysis machines can be very serious to the patient. Air embolism occurs when an air bubble passes undetected through the machine into the patient’s system. It can lead to seizures, cyanosis, and eventual death of the patient. The detectors must be operational at all times and there should a way of capturing the problem before it gets to the patient.
Hip and Knee Implants
Improperly fitted hip and knee implants can lead to fractures which are very painful and seriously affect the mobility of patients. The cases of poorly fitted hip and knee implants have increased over the years, with many people filing lawsuits to get compensation for the pain and suffering they have had to endure because of faulty devices.
A centrifuge can pour out its contents if the safe speed is exceeded or the equipment lid is opened before the rotors have stopped. This is dangerous, especially if one is centrifuging infectious materials or human samples. Safety devices in centrifuges that prevent opening of the lids before the machine stops, together with properly laid-down procedures, helps prevent such risks from occurring.
Electrosurgical Grounding Pad
Electrosurgical equipment that uses electricity for cutting and ablation of tissue must be well grounded so that the risk of burns to the tissue is minimized. The electrosurgical grounding pads have been known to cause burns if not properly grounded. The grounding pad is supposed to safely return the current to the generator through a cord. There are instances where extended use of the electrosurgical equipment has led to severe burns to the patient.
The insertion of a spinal or epidural catheter is a necessary and usually safe procedure that has a high success rate. However, in very rare cases, the catheter has been known to break during removal. Due to the sensitivity of the spinal area, many doctors opt not to remove a catheter fragment that is left in the patient’s body. This fragment can turn out to be a source of discomfort to the patient and future complications can occur.