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Adverse Events - Are your products involved?
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A recent report by HHS’s inspector general revealed that adverse events are more prevalent and more costly than anticipated.  One in seven Medicare patients will suffer serious harm from medical care, which equals about 134,000 in a month 1.6 million over a year, and about 180,000 deaths.  Even greater numbers are related to harm that required medical intervention but was not as serious, and approximately 13.1% had an adverse event resulting in temporary harm.  Hospital care associated with adverse and temporary harm events cost Medicare paid approximately $324 million a month, and around $4.4 billion annually for that related treatment.  About 44% of these adverse events were preventable errors.  Two-thirds of the additional costs were associated with the additional hospital stays, but the calculations did not include the costs related to follow up care.

 The majority of preventable events were linked to medical errors, substandard care and lack of patient monitoring and assessment.  Common events included:

Types of Adverse Events

Number of Events and %s of Total Events

Events Related to Medication 

31% (40)

  Excessive bleeding 

12

  Delirium or change in mental status 

7

  Hypoglycemic event

6

  Acute renal insufficiency (kidney failure) 

4

  Severe hypotension 

4

  Respiratory complications 

4

  Severe allergic reactions 

3

Events Related to Patient Care

28% (36)

  Intravenous volume overload 

10

  Aspiration 

8

  Deep vein thrombosis or pulmonary embolism

5

  Exacerbation of preexisting medical condition 

5

  Stage III pressure ulcer 

3

  Breakdown of surgical wound

1

  Congestive heart failure 

1

  Hypoxia (oxygen deficiency) 

1

  Patient fall with injury 

1

  Prolonged weakness and dizziness 

1

Events Related to Surgery or Other Procedures 

25% (33)

  Excessive bleeding

5

  Severe hypotension 

4

  Respiratory complication 

4

  Iatrogenic pneumothorax 

3

  Postoperative ileus 

3

  Postoperative urinary retention 

3

  Acute coronary syndrome 

2

  Blood clot and other occlusion 

2

  Cardiac complication 

2

  Cardiac dysrhythmia  

1

  Delay in surgery because of equipment malfunction 

1

  Hemorrhage at surgical site 

1

  Seroma (fluid) following stomach resection 

1

  Urinary catheter-associated trauma 

1

Events Related to Infection

15% (10)

  Urinary tract infection 

5

  Vascular catheter-associated infection (central or peripheral line)  

4

  Other bloodstream infection  

4

  Respiratory infection 

4

  Surgical or procedural site infection

2

 There were similar findings for temporary harm issues:

Types of Temporary Harm Events

 

Events Related to Medication 

42% (73)

  Delirium or change in mental status 

22

  Hypoglycemic event 

11

  Thrush and other opportunistic infection  

7

  Allergic reaction or side effect related to skin 

6

  Gastrointestinal complication 

5

  Hypotension 

5

  Dysrhythmia 

3

  Excessive bleeding 

3

  Severe headache or dizziness

3

  Acute renal failure or insufficiency 

2

  Allergic reaction to blood or related products

2

  Respiratory complication 

2

  Other events related to medication 

2

Events Related to Patient Care

36% (63)

  Stage I, Stage II, or unstaged pressure ulcer 

20

  Intravenous volume overload 

15

  Skin tear, laceration, abrasion, or other breakdown 

9

  Intravenous infiltrate with symptoms 

6

  Patient fall with injury   

5

  Aspiration

3

  Failure to treat constipation or obstipation 

3

  Tachycardia or dysrhythmia 

2

Events Related to Surgery or Other Procedures 

18% (32)

  Urinary retention 

8

  Excessive bleeding 

6

  Cardiac complication 

4

  Surgical tear or laceration 

3

  Urinary catheter-related trauma 

3

  Prolonged nausea and vomiting 

2

  Postoperative or postprocedural hypotension 

2

  Respiratory complication 

2

  Other events related to surgery or other procedures 

2

Events Related to Infection

4% (6)

  Surgical site infection   

2

  Bacterial infection

1

  Respiratory infection 

1

  Urinary tract infection 

1

  Vascular catheter-associated infection 

1

Source: OIG analysis of hospital stays for 780 Medicare beneficiaries in October 2008

Nearly all the events listed in the NQF adverse events and the HACs were considered preventable.  As a result of these findings. CMS is further dedicated to broadening patient safety efforts and to expand them beyond the CMS HACs.  The study looked at preventable adverse events and only .6% of the adverse events would have been on the NQF list and1% would qualify as a HAC, and CMS responded that it would “aggressively pursue” efforts to expand adverse event reporting to include more types of events.  Therefore, the OIG tasked CMS with expanding its list of HACs and to hold hospitals accountable for the adoption of evidence-based guidelines. 

 Product lines that could reduce these adverse or preventable events should partner with their customers to address these issues before financial penalties or disincentives become attached to their occurrence.  SMT can help you understand the opportunities and help you develop the message to promote patient safety in light of these forthcoming anticipated reforms.

 

Office of Inspector General Adverse Events in Hospitals: National Incidence Among Medicare Beneficiaries http://oig.hhs.gov/oei/reports/oei-06-09-00090.pdf

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