As normas são úteis, e orientação baseada em evidências é muitas vezes ainda mais.
Âmbito de aplicação
Esta orientação fornece recomendações sobre instruções de reutilização na rotulagem de dispositivos médicos reutilizáveis e a validação do processo de reprocessamento recomendado nas instruções. As recomendações são aplicáveis às três situações dispositivo de reprocessamento abaixo.
- Reusable medical devices initially supplied as sterile to the end user and requiring the end user to process the device after initial use (ou seja, cleaning and disinfection or sterilization) prior to the subsequent patient use.
- Reusable medical devices initially supplied as non-sterile to the end user, and requiring the end user to disinfect or sterilize the initial packaged device and to subsequently reprocess the device after initial use (ou seja, cleaning and disinfection or sterilization).
- Single use medical devices initially supplied as non-sterile to the end user, and requiring the end user to sterilize the device prior to its use.
In particular of use to body artists and even more so to the providers of products to body artists are the seven criteria:
VI. FDA’s Seven Criteria for Reprocessing Instructions
Your labeling should address the seven criteria below for clear reprocessing instructions to help ensure users understand and correctly follow the instructions.
Criterion 1. Labeling should reflect the intended use of the device.
Your labeling should include instructions for a reprocessing method that reflects the physical design of the device, its intended use, and the soiling and contamination to which the device is subject during clinical use. Appropriate reprocessing instructions depend on whether the device will:
- contact only intact skin;
- contact intact mucosal surface;
- contact normally sterile tissues, sangue, or bodily fluids such as cerebrospinal fluid, peritoneal fluid, etc;
- be subject to splatter or splash of body fluids or blood because of proximity to the patient, although it is not in direct contact with the patient;
- be subject to microbial contamination during use from contact with soiled hands of patient caregivers or patients (both unwashed and gloved hands can carry both organic soil and microorganisms to the surfaces they touch);
- be subjected to contamination by unexpected or accidental events (por exemplo, patient bleeding, incontinence, vomiting, wounds leaking through dressings);
- be subject to reprocessing with disinfectants or other chemicals that might leave harmful residues, or adversely affect device materials or performance, if inadequately rinsed; e
- present specific or unique risks to the patient or user.
When likely contamination may include human blood or body fluids capable of transmitting bloodborne pathogens, the requirements of the OSHA Standard 29 CFR 1910.1030 Occupational Exposure to Bloodborne Pathogens must be included in labeling.6
—Read More at FDA’s Seven criteria
A clear reference to Spaulding’s system in the third criteria
- F2847-10 Standard Practice for Reporting and Assessment of Residues on Single Use Implants
- WK31799 New Guide for Designing Medical Devices for Cleanability
- WK32535 nova prática de estabelecimento de valores-limite para resíduos em implantes de uso único
- WK33439 Novo Guia para solos de teste padrão para a validação de métodos de limpeza para dispositivos médicos reutilizáveis
- WK33660 New Guide for Validating Cleaning Lines for Medical Devices
My hope is that our processing technologies can give validated results for questions raised about reuse of difficult to clean items.