{"id":127,"date":"2017-01-12T05:26:56","date_gmt":"2017-01-12T05:26:56","guid":{"rendered":"http:\/\/tgfrconsulting.com\/blog\/?p=127"},"modified":"2024-01-20T22:31:59","modified_gmt":"2024-01-20T22:31:59","slug":"risk-analysis-identification-of-hazards-and-harms","status":"publish","type":"post","link":"https:\/\/www.tgfrconsulting.com\/blog\/archived\/risk-management\/risk-analysis-identification-of-hazards-and-harms\/","title":{"rendered":"Risk Analysis &#8211; Identification of Hazards and Harms"},"content":{"rendered":"<div class=\"entry\">\n<p>The therapy centric risk analysis begins with the identification of the hazards and the associated harms for the therapy or procedure.\u00a0 Hazards, a potential source of harm, should be specific to the therapy or procedure. Mapping to the therapy or procedure makes it easier to identify the possible harms associated with the hazard.\u00a0 For example, the hazards associated with a drug delivery therapy can be characterized as<\/p>\n<ul>\n<li>Over delivery of drug by X% or over<\/li>\n<li>Over delivery of drug by less than X%<\/li>\n<li>Under delivery of drug by Y% or over<\/li>\n<li>Under delivery of drug by less than Y%<\/li>\n<li>Delay of therapy by over some time<\/li>\n<li>Delay of therapy by less than some time<\/li>\n<li>Interruption of therapy by over some time<\/li>\n<li>Interruption of therapy by less than some time<\/li>\n<li>Exposure to particulate matter (non-biologic)<\/li>\n<li>Exposure to biologics<\/li>\n<li>Exposure to EMI\/EMC<\/li>\n<li>Exposure to electrical current<\/li>\n<li>Exposure to hot surface<\/li>\n<li>Physical impact (drop or otherwise)<\/li>\n<li>Unintended release of patient information<\/li>\n<\/ul>\n<p>Additional Hazard Identification guidance can be found in EIN 60601-1 3rd edition in the risk management tables.\u00a0\u00a0 This list should be modified or extended for the specific medical application, but many of these apply to all devices.<\/p>\n<p>As noted, linking the hazards to the therapy or procedure allows a simpler mapping of harms to each hazard.\u00a0 Harms represent the impact of a hazard, and with the understanding of the therapy, the understanding of the harm is simplified.\u00a0 Each harm has an impact on a patient or clinician, and this impact has a severity.\u00a0 Severity for harms is usually characterized as follows<\/p>\n<h2 id=\"tablepress-3-name\" class=\"tablepress-table-name tablepress-table-name-id-3\">Severity of Harm<\/h2>\n\n<table id=\"tablepress-3\" class=\"tablepress tablepress-id-3\" aria-labelledby=\"tablepress-3-name\">\n<thead>\n<tr class=\"row-1\">\n\t<th class=\"column-1\">Severity of Harm<\/th><th class=\"column-2\">Description<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-striping row-hover\">\n<tr class=\"row-2\">\n\t<td class=\"column-1\">Catastrophic<\/td><td class=\"column-2\">Results in patient death.<\/td>\n<\/tr>\n<tr class=\"row-3\">\n\t<td class=\"column-1\">Critical<\/td><td class=\"column-2\">Results in permanent impairment or life-threatening injury.<\/td>\n<\/tr>\n<tr class=\"row-4\">\n\t<td class=\"column-1\">Serious<\/td><td class=\"column-2\">Results in injury or impairment requiring professional medical intervention.<\/td>\n<\/tr>\n<tr class=\"row-5\">\n\t<td class=\"column-1\">Minor<\/td><td class=\"column-2\">Results in temporary injury or impairment not requiring professional medical intervention.<\/td>\n<\/tr>\n<tr class=\"row-6\">\n\t<td class=\"column-1\">Negligible<\/td><td class=\"column-2\">Little or no injury<br \/>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-3 from cache -->\n<p>Each specific patient or user harm may have a wide range of impacts, with each impact having a specific severity and probability.\u00a0 As an example, infections due to biologics as a result of a therapy may have little impact (negligible) or may lead to death (catastrophic) in some rare cases. \u00a0The distribution of impact is a probability distribution as shown in the following table.<\/p>\n<h2 id=\"tablepress-4-name\" class=\"tablepress-table-name tablepress-table-name-id-4\">Harm Severity<\/h2>\n\n<table id=\"tablepress-4\" class=\"tablepress tablepress-id-4\" aria-labelledby=\"tablepress-4-name\">\n<thead>\n<tr class=\"row-1\">\n\t<th class=\"column-1\">Harm<\/th><th colspan=\"5\" class=\"column-2\">Severity<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-striping row-hover\">\n<tr class=\"row-2\">\n\t<td class=\"column-1\"><\/td><td class=\"column-2\">Catastrophic<\/td><td class=\"column-3\">Critical<\/td><td class=\"column-4\">Serious<\/td><td class=\"column-5\">Minor<\/td><td class=\"column-6\">Negligible<\/td>\n<\/tr>\n<tr class=\"row-3\">\n\t<td class=\"column-1\">Infection<\/td><td class=\"column-2\">0.000010<\/td><td class=\"column-3\">0.00004<\/td><td class=\"column-4\">0.00005<\/td><td class=\"column-5\">0.40000<\/td><td class=\"column-6\">0.59990<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-4 from cache -->\n<p>The\u00a0harm severity distribution should be developed based upon historical clinical data and a detailed analysis of the therapy or procedure.<\/p>\n<p>After the identification of clinical hazards and the characterization of harms, harms are mapped to the hazards. \u00a0The mapping must consider that a single hazard may result multiple harms.\u00a0 \u00a0\u00a0As an example, over delivery may result in several harms, with each harm will having an associated distribution of severity.\u00a0 The following table shows the linking of harms severity distributions to a specific hazard.<\/p>\n\n<table id=\"tablepress-5\" class=\"tablepress tablepress-id-5\">\n<thead>\n<tr class=\"row-1\">\n\t<td class=\"column-1\"><\/td><th class=\"column-2\">Harm Likelihood<\/th><th colspan=\"5\" class=\"column-3\">Severity of Harm Probability<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-striping row-hover\">\n<tr class=\"row-2\">\n\t<td class=\"column-1\">Hazard \u2013 Over Delivery<\/td><td class=\"column-2\"><\/td><td class=\"column-3\">Catastrophic<\/td><td class=\"column-4\">Critical<\/td><td class=\"column-5\">Serious<\/td><td class=\"column-6\">Minor<\/td><td class=\"column-7\">Negligible<\/td>\n<\/tr>\n<tr class=\"row-3\">\n\t<td class=\"column-1\">Associated Harm #1<\/td><td class=\"column-2\">0.5<\/td><td class=\"column-3\">0.000010<\/td><td class=\"column-4\">0.00004<\/td><td class=\"column-5\">0.00005<\/td><td class=\"column-6\">0.40000<\/td><td class=\"column-7\">0.59990<\/td>\n<\/tr>\n<tr class=\"row-4\">\n\t<td class=\"column-1\">Associated Harm #2<\/td><td class=\"column-2\">0.5<\/td><td class=\"column-3\">0.000010<\/td><td class=\"column-4\">0.00004<\/td><td class=\"column-5\">0.00005<\/td><td class=\"column-6\">0.30000<\/td><td class=\"column-7\">0.69990<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-5 from cache -->\n<p>The weight is the likelihood of the particular harm resulting from the specific hazard.\u00a0 This weight allows the development of an aggregated probability for each severity level.\u00a0 The aggregated probability of each severity can be characterized as shown below.<\/p>\n<h2 id=\"tablepress-6-name\" class=\"tablepress-table-name tablepress-table-name-id-6\">Hazard Severity Probability Distribution<\/h2>\n\n<table id=\"tablepress-6\" class=\"tablepress tablepress-id-6\" aria-labelledby=\"tablepress-6-name\">\n<thead>\n<tr class=\"row-1\">\n\t<td class=\"column-1\"><\/td><th colspan=\"5\" class=\"column-2\">Severity<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-striping row-hover\">\n<tr class=\"row-2\">\n\t<td class=\"column-1\">Hazard<\/td><td class=\"column-2\">Catastrophic<\/td><td class=\"column-3\">Critical<\/td><td class=\"column-4\">Serious<\/td><td class=\"column-5\">Minor<\/td><td class=\"column-6\">Negligilbe<\/td>\n<\/tr>\n<tr class=\"row-3\">\n\t<td class=\"column-1\">Over Delivery<\/td><td class=\"column-2\">0.000010<\/td><td class=\"column-3\">0.00004<\/td><td class=\"column-4\">0.00005<\/td><td class=\"column-5\">0.35<br \/>\n<\/td><td class=\"column-6\">0.6499<br \/>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-6 from cache -->\n<p>In this case the sum of probabilities across all of the severities is one, that is, the distribution of probability for a given hazard against the severities must sum to 1.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-full wp-image-154\" src=\"http:\/\/tgfrconsulting.com\/blog\/wp-content\/uploads\/2017\/01\/Hazard_Severity_Summation.png\" alt=\"\" width=\"352\" height=\"60\" srcset=\"https:\/\/www.tgfrconsulting.com\/blog\/wp-content\/uploads\/2017\/01\/Hazard_Severity_Summation.png 352w, https:\/\/www.tgfrconsulting.com\/blog\/wp-content\/uploads\/2017\/01\/Hazard_Severity_Summation-300x51.png 300w\" sizes=\"auto, (max-width: 352px) 100vw, 352px\" \/><\/p>\n<p>An alternative qualitative approach assigns a single, most likely severity to each hazard.\u00a0 With this qualitative approach, care must be taken assigning severity.\u00a0 The tendency during severity analysis is to assign a severity of \u201ccatastrophic\u201d because of some small but finite probability of death exists.\u00a0 This tendency for a qualitative approach to default to a \u201ccatastrophic\/improbable\u201d severity\/probability combination for a given hazard will distort subsequent hazard analysis. Even with a qualitative approach, awareness that each hazard results in a variety of harms and severities is needed to assign the \u201cmost likely\u201d severity<\/p>\n<p>The medical team most often performs this activity of identifying hazards and mapping harms, as the linkage and understanding of harms relates\u00a0to the therapy or procedure, that is, the medical uses.\u00a0 Probabilities of severity should be\u00a0established with extensive clinical research.<\/p>\n<p>At the completion of this step the Hazard Identification Table, as shown below, can be completed.<\/p>\n\n<table id=\"tablepress-7\" class=\"tablepress tablepress-id-7\">\n<thead>\n<tr class=\"row-1\">\n\t<th class=\"column-1\">Hazard Identification Element<\/th><th class=\"column-2\">Description<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-striping row-hover\">\n<tr class=\"row-2\">\n\t<td class=\"column-1\">Hazard<\/td><td class=\"column-2\">Short description of Hazard.<\/td>\n<\/tr>\n<tr class=\"row-3\">\n\t<td class=\"column-1\">Associated Harm(s)<\/td><td class=\"column-2\">Harm which may occur if Hazard is present.<\/td>\n<\/tr>\n<tr class=\"row-4\">\n\t<td class=\"column-1\">Probability of Harm (P2) <\/td><td class=\"column-2\">The probability of occurrence of harm given the hazardous situation is present.  This may either the most likely value or a distribution as shown in the Hazard Severity Probability Distribution<\/td>\n<\/tr>\n<tr class=\"row-5\">\n\t<td class=\"column-1\">Severity of Harm <\/td><td class=\"column-2\">Severity classification of the harm. This may either be a most likely value or a distribution as shown in Hazard Severity Probability Distribution<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-7 from cache -->\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>The therapy centric risk analysis begins with the identification of the hazards and the associated harms for the therapy or procedure.\u00a0 Hazards, a potential source of harm, should be specific to the therapy or procedure. Mapping to the therapy or procedure makes it easier to identify the possible harms associated with the hazard.\u00a0 For example, &#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[61,8],"tags":[],"class_list":{"0":"post-127","1":"post","2":"type-post","3":"status-publish","4":"format-standard","6":"category-archived","7":"category-risk-management","8":"anons"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Risk Analysis - Identification of Hazards and Harms - TGFR Consulting LLC<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.tgfrconsulting.com\/blog\/archived\/risk-management\/risk-analysis-identification-of-hazards-and-harms\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Risk Analysis - Identification of Hazards and Harms - TGFR Consulting LLC\" \/>\n<meta property=\"og:description\" content=\"The therapy centric risk analysis begins with the identification of the hazards and the associated harms for the therapy or procedure.\u00a0 Hazards, a potential source of harm, should be specific to the therapy or procedure. 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