Future of MedTech Patients

POOR QUALITY REPAIRS OF AND MODIFICATIONS TO MEDICAL EQUIPMENT PUTTING PATIENTS AT RISK

Would you allow this “repaired” endoscope to be used in your body?

Playing cards are fine for playing poker, not for gambling with a patient’s safety. The picture in Figure 1 shows a “repaired” endoscope by a hospital contractor hired to repair medical equipment. The playing card was used to separate the angulation wires from the image and light guide bundles to protect them from the open solder joints. No heat shrink was used to provide environment sealing protection. This is a serious material incompatibility issue. The paper of the playing card is flammable and its use on open solder joints can lead to fire and serious patient injury.

Although medical devices are regulated by the Therapeutic Goods Administration (TGA), the TGA does not have jurisdiction over hospitals. A lack of regulatory oversight has resulted in a proliferation of businesses selling repairs of medical equipment and maintenance-related services to hospitals. Most if not all of these businesses have no links to the original manufacturer. Therefore, it is anyone’s guess how hospitals ensure that medical equipment under their care remains safe and works as per the manufacturer’s original specifications, and who checks whether these contractors and consultants have the minimum level of competence and training to perform repairs and maintenance on medical equipment.

If a patient is injured by a poorly repaired medical equipment or by a medical device rendered unsafe by modifications, the hospital has no obligation to report the adverse event to the TGA. The poor level of incident reporting by hospitals is reflected in the TGA statistics (shown in Figure 2). According to the current law, only manufacturers and sponsors of medical devices have an obligation to report incidents and adverse events to the TGA. It is safe to assume then that, unless a hospital informs the manufacturer or sponsor, incidents involving medical equipment repaired and maintained by the hospital or on behalf of the hospital will go unreported.

Figure 2: Number of medical device incidents reported annually (Source: TGA, 2019)

Even if the original manufacturer is informed of adverse events involving repaired/ serviced medical equipment, the hospital has no obligation to provide TGA or anyone else with information and records related to repairs and modifications undertaken by the hospital or on behalf of the hospital.

Patient and consumer groups such as CHOICE or Consumer Health Forum (CHF) have a right and indeed an obligation to understand what is happening in relation to post-market repairs and modifications of medical devices. The Australian Commission for Safety and Quality in Health Care (ACSQHC) has issued a number of National Safety and Quality Health Service (NSQHS) standards. Unfortunately, none of the NSQHS standards cover repair and maintenance of medical equipment in hospitals. The only standardisation of repair and maintenance of medical equipment in healthcare facilities is left to Standards Australia HE-003 committee, however neither the ACQHC, nor the CHF are represented in HE-003.

Playing cards have no place in healthcare.

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