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Category Archives: General

Musculoskeletal Allograft Tissue Safety

The use of musculoskeletal allograft tissue in reconstructive orthopaedic procedures has markedly increased over the last decade. Surgeon knowledge of tissue bank practices in donor consent and screening, infectious disease testing and processing is important when making the decision to use these allograft tissues. The orthopaedic surgeon also has the responsibility to inform the patient about the risks, benefits and alternatives of using allograft tissue. Tissue recalls have occurred but hospitals were unable to identify all recipients or determine final disposition of the recalled tissue. This handout provides viewpoints that support a paradigm change. Imagine a national, real-time web-based system that contains a database for donor and allograft registries with systems built in that enhances widespread communication when an adverse event/reaction occurs. If participation by stakeholders is high, immediate identity of tissue that has been recalled could be realized at the hospital and an allograft not inadvertently used before official notification of recall is sent. Compliance by end users to such a web-based system would eliminate the need for completion and mailing of tissue usage cards (see The Joint Commission, Transplant Safety Chapter at Standard TS.03.02.01, EP 7.)

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The Evolving Role of Bone-Graft Substitutes

It is estimated that more than 500,000 bone-grafting procedures are performed annually in the United States, with approximately half of these procedures related to spine fusion. These numbers easily double on a global basis and indicate a shortage in the availability of musculoskeletal donor tissue traditionally used in these reconstructions. This reality has stimulated a proliferation of corporate interest in supplying what is seen as a growing market in bone replacement materials. These graft alternatives are subjected to varying degrees of regulatory scrutiny, and thus their true safety and effectiveness in patients may not be know prior to their use by orthopaedic surgeons. It is thus important to gain insight into this emerging class of bone-substitute alternatives.

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Adverse Event Reporting – An FDA Requirement: What, When, Who & How

Most orthopaedic surgeons in the course of their practice will encounter and explant medical devices which have failed. Such failures may simply result from long-term in-vivo device usage, component material breakdown, technique at the time of implantation or patient noncompliance. Changes in the Safe Medical Devices Act of 1990 (SMDA), a Law enacted by the Congress, requires that medical device user facilities inclusive of hospitals, ambulatory surgical facilities and nursing homes report such events to the Food and Drug Administration (FDA) and manufacturers. These events are inclusive of device problems which cause or contribute to the death, serious illness or serious injury of a patient. The orthopaedic surgeon is involved in the identification and interpretation of these problems. In June 1993, the FDA introduced MedWatch, a medical products reporting program, to facilitate the reporting of adverse events and product problems that arise from medical device usage.

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Orthopaedic Infection Prevention and Control: An Emerging New Paradigm

More than 65 million inpatient and outpatient surgeries are done each year at U.S. hospitals. The Centers for Disease Control and Prevention (CDC) estimate that the rates of surgical site infection (SSI) range from 2% – 3% of uninfected cases – actual rates, however, are probably higher. SSIs are associated with: 38% of all surgical-related nosocomial infections; other wound complications; 60% higher risk of an intensive care unit (ICU) stay; five times greater risk of readmission; a two- to three-fold higher risk of death; and Staphylococcus aureus most often.

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Bone Graft Substitutes: Facts, Fictions & Applications

It is estimated that more than 500,000 bone-grafting procedures are performed annually in the United States, with approximately half of these procedures related to spine fusion. These numbers easily double on a global basis and indicate a shortage in the availability of musculoskeletal donor tissue traditionally used in these reconstructions. This reality has stimulated a proliferation of corporate interest in supplying what is seen as a growing market in bone replacement materials. These graft alternatives are subjected to varying degrees of regulatory scrutiny, and thus their true safety and effectiveness in patients may not be know prior to their use by orthopaedic surgeons. It is thus important to gain insight into this emerging class of bone-substitute alternatives.

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Adverse Event Reporting – An FDA Requirement: What, When, Who & How

Most orthopaedic surgeons in the course of their practice will encounter and explant medical devices which have failed. Such failures may simply result from long-term in-vivo device usage, component material breakdown, technique at the time of implantation or patient noncompliance. Changes in the Safe Medical Devices Act of 1990 (SMDA), a Law enacted by the Congress, requires that medical device user facilities inclusive of hospitals, ambulatory surgical facilities and nursing homes report such events to the Food and Drug Administration (FDA) and manufacturers. These events are inclusive of device problems which cause or contribute to the death, serious illness or serious injury of a patient. The orthopaedic surgeon is involved in the identification and interpretation of these problems. In June 1993, the FDA introduced MedWatch, a medical products reporting program, to facilitate the reporting of adverse events and product problems that arise from medical device usage.

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Orthopaedic Infection: Community-Associated and Healthcare-Associated MRSA

Methicillin-resistant Staphylococcus aureus (MRSA) is a strain of the staph infection resistant to beta-lactam antibiotics (penicillin, oxacillin, amoxicillin, and methicillin). MRSA is a bacterium commonly carried on the skin or in the nose of healthy people who generally do not exhibit any symptoms. The CDC reports that an estimated 25 – 30% of the population is colonized with Staph and only 1% with MRSA; meaning, the bacteria is present, but not causing an infection. MRSA presents in two different environments: Community Associated MRSA (CA-MRSA) and Healthcare Associated MRSA (HA-MRSA).

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Musculoskeletal Allograft Tissue Safety

The use of musculoskeletal allograft tissue in reconstructive orthopaedic procedures has markedly increased over the last decade, Surgeon knowledge of tissue bank practices in donor consent and screening, infectious disease testing and processing is important when making the decision to use these allograft tissues. The orthopaedic surgeon also has the responsibility to inform the patient about the risks, benefits, and alternatives of using allograft tissue. This handout provides an overview of some of these issues.

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Bone Graft Substitutes: Facts, Fictions & Applications

It is estimated that more than 500,000 bone-grafting procedures are performed annually in the United States, with approximately half of these procedures related to spine fusion. These numbers easily double on a global basis and indicate a shortage in the availability of musculoskeletal donor tissue traditionally used in these reconstructions. This reality has stimulated a proliferation of corporate interest in supplying what is seen as a growing market in bone replacement materials. These graft alternatives are subjected to varying degrees of regulatory scrutiny, and thus their true safety and effectiveness in patients may not be know prior to their use by orthopaedic surgeons. It is thus important to gain insight into this emerging class of bone-substitute alternatives.

View PDF

Return to Library

Adverse Event Reporting – An FDA Requirement: What, When, Who & How

Most orthopaedic surgeons in the course of their practice will encounter and explant medical devices which have failed. Such failures may simply result from long-term in-vivo device usage, component material breakdown, technique at the time of implantation or patient noncompliance. Changes in the Safe Medical Devices Act of 1990 (SMDA), a Law enacted by the Congress, requires that medical device user facilities inclusive of hospitals, ambulatory surgical facilities and nursing homes report such events to the Food and Drug Administration (FDA) and manufacturers. These events are inclusive of device problems which cause or contribute to the death, serious illness or serious injury of a patient. The orthopaedic surgeon is involved in the identification and interpretation of these problems. In June 1993, the FDA introduced MedWatch, a medical products reporting program, to facilitate the reporting of adverse events and product problems that arise from medical device usage.

View PDF

Return to Library

Posted in General|