Future of MedTech Health Reform

Poorly written standards perpetuate questionable medical equipment repair practices in health facilities

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

The picture in Figure 1 shows a “repaired” endoscope by a hospital contractor hired to repair medical equipment. In order to repair the tip of this endoscope the repairer used an adhesive with a softer consistency than that specified by the original manufacturer. Instead of achieving a smooth surface, the poor quality of the adhesive and workmanship resulted in cracks and pin holes left at the bonding site. Cracks and pin holes are notoriously difficult to clean and sterilise. The tip of this “repaired” endoscope becomes a cross-contamination hazard.

Representatives of businesses selling repairs of medical equipment and maintenance-related services to hospitals are quick to point to standards such as AS/NZS 3551 and AS/NZS 2500 as the “bible” of clinical engineering. Both standards were written by these vested interests with little or no input from other stakeholders such as MedTech industry or consumer groups.

For example, AS/NZS 3551 Management program for medical equipment contains aspirational, conveniently vague statements such as: “modification shall not reduce the safety of medical equipment or accessories for patients, operators or the environment”, but fails to provide specifics on requirements for repairs and modifications performed by or on behalf of health facilities, i.e.:

  • repaired medical equipment must continue to meet the safety and performance specifications as defined by the original manufacturer;
  • modified medical equipment must comply with all applicable Essential Principles of safety and performance defined in the Australian Therapeutic Goods Act 1989.

AS/NZS 3551 and AS/NZS 2500 are long overdue for a substantial revision to align them with international standards and best practices, such as these IEC and ISO standards:

  • IEC 62353:2014 Medical electrical equipment – Recurrent test and test after repair of medical electrical equipment;
  • ISO 55001:2014 Asset management – Management systems;
  • IEC 60601-1:2012 Medical electrical equipment – Part 1: General requirements for basic safety and e performance. This international standard has already been adopted as an Australian & New Zealand standard: AS/NZS IEC 60601.1:2015.

The World Health Organisation has also published a series of guides for the management of resources in healthcare. In the WHO Guide 5 How to Organize the Maintenance of Your Healthcare Technology, the authors state:

The quality and effectiveness of a repair job is often jeopardized by the use of low quality parts and materials. Poor parts and materials may break if they are not strong enough, they may fail earlier than expected, or they may rub, corrode, or in some way damage other parts of the machine. Even if you do a first class repair job:

  • poor quality engine oil means the engine will not last as long as it should
  • poor quality batteries affect the performance of the equipment, have a short life, and leak
  • poor tyres compromise the safety of a vehicle
  • poor quality solder evaporates or cracks easily
  • poor gaskets and seals leak, or perish quickly.

Cost and quality often go together. Equipment manufacturers’ own brand of spare parts and maintenance materials often produce better results than ‘lookalikes’. Many companies are set up solely for the purpose of manufacturing lookalikes – these products are often (but not always) cheaper, but may be of inferior quality. We recommend that, as the items get more technically complex or critical, you should try and buy better quality spare parts and maintenance materials. A discussion on sourcing and obtaining good quality products can be found in Guide 3 on procurement and commissioning.

The TGA has no jurisdiction over repairs and modifications to medical equipment taking place in health facilities. Original manufacturers have no say on what happens to their equipment once it is purchased and put into service by health facilities. There is a need for appropriate regulatory oversight and better standards to address repairs and modifications of medical equipment performed by health facilities or on their behalf. Patient safety should always come first.

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