A Complete Guide about Biocompatibility for Medical Devices and Biocompatibility Testing

 

Biocompatibility ensures that a device is safe for any person who undergoes medical testing through that particular machine. Unintentional damages caused by a device can be life-threatening and may cause additional damages to the patient. Hence, every medical device needs to undergo a biocompatibility test to ensure it is safe.

The term biocompatibility is used to denote the interaction between a medical device and the physiological and tissue system of a patient that comes in contact with the machine for treatment or diagnosis. It is an essential part of the overall safety examination for any machine.

 Biocompatibility for medical devices depend on different factors like-

  • the chemical and physical nature of the machine and its parts
  • Patients and the type of patients that it will treat
  • The duration of the period used to use a particular machine on one patient

Manufacturers of medical machines use this biocompatibility test to ensure that their machines are safe and maintain the safety regulations before going on the market. ISO 10933-1 and FDA guidelines have laid the importance of a risk-based approach for biocompatibility testing. That means a manufacturer needs to get biocompatibility testing performed on the machine as a whole and on its different components to ensure an all-round safety.

 Steps for biocompatibility testing-

 Biomedical compatibility testing has become flexible in modern times. The biocompatibility testing for dental materials and other medical equipment was rigid in the past. That included an approach to free checkbox testing. The previous method was not full-proof and often was not feasible to address the risks faced by the patients. Hence, manufacturers, testing labs, and biomedical regulatory organizations came with this new procedure that emphasizes patient safety in a better way.

In modern times, the biomedical compatibility testing is done in three steps-

  • Biological Evaluation Plan (BEP)

It is the first step.  Initially, a Biological Evaluation Plan (BEP) is made to survey gadget materials, recognize expected dangers, and recommend potential assessments and testing to address the dangers distinguished depending on the idea of patient contact of the gadget. This fills in as an underlying danger appraisal laid out in ISO 10993-1 and gives great inward documentation of the methodology used to address biocompatibility. This arrangement can be imparted to the FDA during a free pre-accommodation conversation.

  • Testing for risks identified in BEP

In the second step, the gadget is assessed and tried utilizing an assortment of techniques to address the potential dangers recognized in the BEP. These dangers (and related tests) incorporate those recorded in Annex A of ISO 10993-1. Regularly, this is cultivated utilizing a mix of the accompanying:

  • Customary in vivo or in vitro organic tests.
  • Science tests are followed by the toxicological danger evaluation.
  • Composed evaluation is dependent on logical writing data and clinical utilization of the materials.
  • Biological Evaluation Report or BER

At the third and last step, the consequences of all things considered and composed assessments ought to be summed up in a capstone Biological Evaluation Report (BER) that is submitted alongside test results to the FDA.

Hence, if you are trying to buy any medical equipment, make sure to buy something that has passed the biocompatibility test and is safe for your patients.

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