Periprosthetic Fracture Plate Functioning - Assignment Example

Medical device development and exploitation Periprosthetic Fracture Plate Name of Student Name of University Date Table of Contents Section 1: Medical Device Directive 2 Classification of the fracture plate 2 Simple flow diagram of the CE marking process 2 Summary of the activities 4 Section 2: Risk Management Report 4 risk analysis (RA) of the fracture plate(COUNCIL DIRECTIVE 93/42/EEC) 6 Failure Mode and Effects Analysis (FMEA) 8 Design/ user characteristics 11 Conclusion 15 Section 1: Medical Device Directive This medical device is manufactured from titanium and is designed so that the prongs generate a positive clamping on the bone, but with sufficient flexibility to allow the prongs to be positioned around the femur. This solves the problems associated with other plates available in the market. A new fracture plate has requires additional proximal and distal fixation providing enhanced support for the fracture together with compression of the fracture site, encouraging union and early mobilization (Langkamer and Ackroyd, 2006). Classification of the fracture plate In order to classify the fracture plate various factor have to be considered as listed in in IUMDD 93-42-EEC. Therefore the classification for the fracture plate is class IIb as per medical device directive IUMDD 93-42-EEC. This is because the new fracture plate developed is used with additional proximal and distal fixation providing enhanced support for a fracture. The main purpose of the fracture plate is to assist in compression of the fracture side. It generates supportive clamping of the bone but it gives flexibility for position of femur. Therefore the classification comprise with rule 8 where by it states “all implantable devices and long-term surgically invasive devices are in class IIb unless they are intended to be placed in the teeth, have direct contact with the heart or central nervous system or have biological impact in the body. Simple flow diagram of the CE marking process The simple flow diagram is useful in explaining concepts during CE marking process. A simple flow diagram shows how marking flows but does not really show the program logic or processing steps. The following is a simple diagram showing Simple flow diagram of the CE marking process; Summary of the activities The summary of the activities and requirements that are needed to carry out in order to be in conformity with the MDD are as following Activity 1: we begin by classifying the fracture plate according to Annex IX of MDD Activity 2: making a decision conformity assessment route that is Annexes to be applied. This will use the following table Activity 3: register the fracture plate for medical use Activity 4: the conformity procedures details in the Directive are followed Activity 5: labeling is done and CE Marking is affixed on fracture plate Section 2: Risk Management Report Medication hazards are among the leading threats to the safety of patients. Studies show that more than 7,000 patients confined in hospitals die from medical hazards each year in the United States (Flynn, Liang, Dickson, Xie & Suh, 2012). This means that at average, a hospital patient in the United States is at the receiving end of at least one medication each day – and this makes medication hazards “the most common cause of preventable adverse patient events” (Flynn, et al., 2012, p. 180). However, because there are varying rates of medical hazards between hospitals, this is an indication that organizational factors could possibly contribute to this “lapse in patient safety” (Flynn, et al., p. 180). Medication hazards are defined as “any errors in the prescribing, dispensing, or administering of a drug, whether an adverse consequence occurred or not” (Franklin, 2012, p. 30). risk analysis (RA) of the fracture plate(COUNCIL DIRECTIVE 93/42/EEC) EN ISO 14971:2007 Annex C. ref. Applicable (YES / NO) Characteristic Potential hazards. C.2.1 What is the intended use and how is the medical device to be used? Yes fracture plate uses prongs to secure the bone but with additional proximal and distal fixation providing encouraging union and early mobilization clamping on the bone, but with sufficient flexibility to allow the prongs to be positioned around the femur failure of the fracture plate requiring a replacement Use of wrong size of plate Degradation of the fracture plate due to long term use and effects Wear and tear of the plate due wrong usage Loosening of the clamps C.2.2 Is the medical device intended to be implanted? Yes The fracture plate is implanted to allow reunion of bones Toxicity of materials Infection Corrosion of magnets Degradation/failure of implants due to long term use and effects C.2.3 Is the medical device intended to be in contact with the patient or other persons? Yes patients tolerate it well “without any residual sequalea both anterior and posterior parts of the bone might be accessed not much tension is placed across the joint and surrounding tissues Accidental damage of the plate during implant Loosening of the clamps holding bone Revision surgery Fracture of plate due to flaw in manufacture C.2.4 What materials or components are utilised in the medical device or are used with, or are in contact with, the medical device? Yes Medical device uses titanium materials and likely contact with patient Infection Fracture of plate due to flaw in manufacture Wear and tear of plate usage As mentioned above Potential hazard are among the most prevalent cause of adverse patient events. It is a fact that medical device are the ones in the forefront of causing this hazards. In short, failure of the medical device plays very crucial roles in ensuring patients recovery. Despite the high rate of medical device hazards in the country, medical hazards may be prevented. Potential risks arise from multiple causes, including insufficient staffing, nurse fatigue, skill mix, heavy workloads, multiple medication orders, “lack of familiarity with medical device, complex and critically ill patients requiring high technology and a lack of knowledge relating to medication policies” (Franklin, 2012, p. 31). Technologies have also been found to play significant roles in potential hazard, such as medication-related support services like computerized physician order entry. This technology is in its early stages, hence, the mistakes committed because of this. Familiarization, training and constant use will likely eliminate this source of potential risks. The best way to deal with Potential hazards is through preventive measures. The manufacture has made a set of recommendations that would help prevent the occurrence of Potential hazards, such as putting in place systems that would ensure safety, better labeling, and education of both nurses and patients so that they know how medical device would be used the patients' systems. Moreover, Potential hazards may be prevented through adequate and updated training as well as cultivating a collaborative culture within the health care organization, among other things Failure Mode and Effects Analysis (FMEA) For healthcare FMEA, it should be in an area of high-risk with “high severity, high probability, or both” (Abujudeh & Kaewlai, 2009, p. 546). There are three Steps of the FMEA in conducting the hazard analysis or the FMEA proper. The goal here is to spot failure modes and their causes and effects. Failure modes are defined as different means in which the processes or sub-processes can fail to reach its goal (Abujudeh & Kaewlai, 2009, p. 547). This step answers the basic questions, such as: What might fail in the process? Why might it fail? What is the effect if the process indeed fails? With these questions, the team can recognize all possible failure modes for each process and subprocesses. The relative risk of a failure and its effects consist of three factors: severity, probability occurrence, and detection capability. Severity-Severity is the outcome of the failure should it happen. The severity of each failure mode is assigned a score ranging from 1 to 10, with 1 having no danger and failure does not cause any injury nor has no effect on the system. The score of 10 means it is extremely dangerous or catastrophic and failure could result to death and or system breakdown. The failure of the process in the provision of care to patient will be catastrophic (Smith, Wijdicks, Jansson, Boykin, Martetschlaeger, de MeijeR, Millett, & Hackett, 2013). Probability of occurrence- This is the likelihood or chance that the failure mode will happen. It is also assigned a score of 1 to 10, with 1 having the remotest possibility of occurrence or failure mode almost never happens and nobody can remember since last failure happened. A score of 10 means the probability of it occurring is certain and that failure happens at least once a day or failure almost always happens(Smith, Wijdicks, Jansson, Boykin, Martetschlaeger, de MeijeR, Millett, & Hackett, 2013). Detectability- This is the ability of catching the error or hazard in care before it causes any harm. Likewise, it is assigned a score of 1 to 10, with 1 being almost certain of its detectability and that there are checks in place to prevent failure. A score of 10 means a zero chance of detection, without any means for failure detection (Smith, Wijdicks, Jansson, Boykin, Martetschlaeger, de MeijeR, Millett, & Hackett, 2013). Design/ user characteristics Ref. Hazard Failure cause Effects on patient/product/user Initial risk estimation Control measures Residual risk estimation Sev. Prob. Risk Sev. Prob. Risk 1 Toxicity of materials Use of titanium in the medical device There is tissue reaction after implantation 4 3 12 Use of samarium cobalt or Zirconia or silicone elastomer in coating of the medical device as it is acceptable in clinical use Use of clinically acceptable materials in packaging 5 3 15 Wear of prongs of the medical device There will be no clamping on the bone 4 3 12 Testing of prongs for wear and tear Analysis after every failure to understand the cause of failure 5 2 10 Patient sensitivity with titanium material Patient tissue may have negative reaction after implanting 3 2 6 A warning should be in the package on the tissue reaction, consequence of titanium materials and effects of implants 4 3 12 2 Mechanical failure Use of wrong materials in manufacturing Failure of bone healing leading to re-surgery 3 3 9 Test rigidity and strength Carry out clinical study 3 2 6 Wrong design of the medical device Failure of bone healing leading to re-surgery 4 3 12 Use experienced manufacturers feedback to have proper design Laboratory tests to improve design 4 1 4 3 failure of implants due to long term use and effects Insufficient information on patient and device Recovery takes a long time 5 3 15 Indicate about the allergies of a given patient laboratory results ad prior diagnoses; The digitization of all medical activities Warning of detrimental of device to the patient. 5 1 5 4 Infection Patient’s implants is not monitored which is a requirement even after implant Failed health of patient 3 2 6 Train staff on how to implant the device effectively 3 1 3 Revision surgery Lack of adequate experience in assessing life-threatening vital signs cardiovascular function failure 4 2 8 Training of usage and how life-threatening mis-implants can be. 4 1 4 sufficient knowledge on the effects and hazards of fracture plate May cause permanent damage of bone 5 2 10 Enforcement of hospital guidelines for procedural implant The patient must then be under the careful watch of qualified personnel 3 2 6 Accidental damage of the plate during implant Lapse in competencies of the physician Wrong implant 4 3 12 Physician should have the core skills needed in the provision of procedural medical device implants Staff was distracted of an incoming clinical responsibility 4 1 4 Fracture of plate due to flaw in manufacture Manufacturer wrongly manufacture plates with flaws Patient is further injured 3 3 9 Manufacturer follows laid down standards 4 1 4 Procedural sedation should be used to achieve a state that allows patient to tolerate painful procedures during re-surgery (Godwin et al., 2005, p. 178). However, in addition to the procedure of hip reduction, sedation presents an independent hazard or risk factor for morbidity and mortality. Deep sedation affects both sympathetic and parasympathetic functions. It does not just deaden painful stimuli; it has significant effects on other body functions such as respiration. The patient must then be under the careful watch of qualified personnel (Bates, 2007). In moderate sedation, there is depression of consciousness, but the patient purposefully responds to verbal commands. The cardiovascular function is usually not affected and the airway is patent with spontaneous adequate ventilation (Millett, Hurst., Horan and Hawkins., 2011) Careful monitoring of the patient before, during, and after the procedure is essential which includes observing patient’s appearance, monitoring airway patency, and patient’s response to stimuli. The role affords a position of knowing every angle of the rules, standard operating procedures, and other policies with regards to the different processes of care provision and allied services. It is the physician’s responsibility to know what these guidelines are and that it is dutifully followed by everyone concerned from the doctors down to institutional workers, especially those involved with the clinical aspect. The physician can initiate a move to review all guidelines and to ascertain if they are up-to-date and appropriate for its own operations (Bates, 2007). Zeroing in on the problems on a superficial review, the severity of the consequence, the death of a person, merits decisive action, but it should be kept in mind that RCA applies to any problem – be they be severe, mild, or moderate in implication. Instigating a root cause analysis allows the identification of the origin of a given problem; finding the primary cause will lead to what really happened, to why it happened, and to figure out what to do so that it does not happen again (MindTools, 2011, para. 6). This approach guides decision makers and other actors to see things in the proper perspective, especially in healthcare where critical moments and windows of opportunity really count(MindTools, 2011, para. 8). Another appropriate method that should get incorporated in the system is the Failure Modes and Effects Analysis. FMEA undertakes a proactive, systematic approach in evaluating a process to delineate what might fail and to assess its impact; it consists of three steps namely: Failure modes that identifies what can go wrong, failure causes to see why a failure can happen, and failure effects to appraise the consequences of a failure (Institute for Healthcare Imrovement (IHI), 2004, p. 1). FMEA is an evaluation process to ascertain possible failures in a set of operating procedures, to be able to act proactively on a possible problem, and to avoid to position of having to react on adverse events when failures happen. The physician, in the capacity of having a pivotal function, must push the agenda in the multidisciplinary team handling FMEA to conduct such probes in every angle of the care process. To assist in the process, the physician may suggest availing of the interactive FMEA Toll on Quality HealthCare.org (IHI, 2004, p. 3). Conclusion The RCA does away with superficial evaluation and searched for what really caused the circumstances surrounding the failure of the plate. It takes into account the origin of actions and resultant actions. It pinpointed the errors committed so that corrective measures can be formulated. The FMEA further shows that this and other sentinel events can be avoided by properly instituting measures where established and proven guidelines will be followed. Every scenario and every procedure can be seen through the lens of FMEA to ascertain areas that can go wrong. These areas of possible aberrations can be evaluated leading to appropriate recommendations, which after careful scrutiny of a multidisciplinary team, will then be institutionalized by the hospital( Renfree, Conrad and Wright 2010). References Abujudeh, H.H., & Kaewlai, R. 2009. Radiology failure mode and effect analysis: What is it? Radiology, 252(2), 544-550. Bates, D. 2007. Preventing medication errors: Summary. American Journal of Health-System Pharmacy, 64S3-9. doi:10.2146/ajhp070190 COUNCIL DIRECTIVE 93/42/EEC - concerning medical devices Franklin, N. 2012. Identifying medication documentation errors using had handwritten versus pre-printed ICU flowcharts. Australian Journal of Advanced Nursing, 29(3), 30-39. Flynn, L., Liang, Y., Dickson, G. L., Xie, M., & Suh, D. (2012). Nurses' practice environments, error interception practices, and inpatient medication errors. Journal of Nursing Scholarship, 44(2), 180-186. doi:10.1111/j.1547-5069.2012.01443.x Godwin, S.A., Caro, D.A., Wolf, S.J., Jagoda, A.S., Charles, R., Marett, B.E., & Moore, J. 2005. Clinical policy: Procedural sedation and analgesia in the emergency department. Ann Emerg Med, 45, 177-196. Institute for Healthcare Improvement (IHI). (2004). Failure modes and effects analysis. Retrieved from (Accessed On 9th February, 2016) International Standard organisation, 2007. Medical devices — Application of risk management to medical devices. ISO 14971 Langkamer, V & Ackroyd C., 2006. Removal of Forearms plates: a review of the complications. Journal of Bone and joint surgery Millett P., Hurst J., Horan M. & Hawkins R., 2011. Complications of clavicle fractures treated with intramedullary fixation.J Shoulder Elbow Surg 20(1):86–91 MindTools., 2011. Root cause analysis: Tracing a problem to its origins. Retrieved from (Acessesed On 9th February, 2016) Renfree T, Conrad B & Wright T., 2010. Biomechanical comparison of contemporary clavicle fixation devices. J Hand Surg Am 35(4):639–644 Smith, S., Wijdicks, C., Jansson, K., Boykin, R., Martetschlaeger, F.,de MeijeR, P. Millett, P. & Hackett, T., 2013.Stability of mid-shaft clavicle fractures after plate fixation versus intramedullary repair and after hardware removal. Knee Surg Sports Traumatol Arthrosc Read More